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Bridging the Gap Between Inpatient and Outpatient Care

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The Olin E. Teague Veterans’ Center (OETVC) in Temple, Texas, is a teaching hospital with 189 beds that provides patients access to medical, surgical, and specialty care. In 2022, 116,359 veterans received care at OETVC and 5393 inpatient admissions were noted. The inpatient ward consists of 3 teaching teams staffed by an attending physician, a second-year internal medicine resident, and 2 to 3 interns while hospitalists staff the 3 nonteaching teams. OETVC residents receive training on both routine and complex medical problems.

Each day, teaching teams discharge patients. With the complexity of discharges, there is always a risk of patients not following up with their primary care physicians, potential issues with filling medications, confusion about new medication regiments, and even potential postdischarge questions. In 1990, Holloway and colleagues evaluated potential risk factors for readmission among veterans. This study found that discharge from a geriatrics or intermediate care bed, chronic disease diagnosis, ≥ 2 procedures performed, increasing age, and distance from a veterans affairs medical center were risk factors.1

Several community hospital studies have evaluated readmission risk factors. One from 2000 noted that patients with more hospitalizations, lower mental health function, a diagnosis of chronic obstructive pulmonary disorder, and increased satisfaction with access to emergency care were associated with increased readmission in 90 days.2 Due to the readmission risks, OETVC decided to construct a program that would help these patients successfully transition from inpatient to outpatient care while establishing means to discuss their care with a physician for reassurance and guidance.

 

TRANSITION OF CARE PROGRAM

Transition of care programs have been implemented and evaluated in many institutions. A 2017 systematic review of transition of care programs supported the use of tailored discharge planning and postdischarge phone calls to reduce hospital readmission, noting that 6 studies demonstrated a statistically significant reduction in 30-day readmission rate.3 Another study found that pharmacy involvement in the transition of care reduced medication-related problems following discharge.4

Program Goals

The foundational goal of our program was to bridge the gap between inpatient and outpatient medicine. We hoped to improve patient adherence with their discharge regimens, improve access to primary care physicians, and improve discharge follow-up. Since hospitalization can be overwhelming, we hoped to capture potential barriers to medical care postdischarge when patients return home while decreasing hospital readmissions. Our second- and third-year resident physicians spend as much time as needed going through the patient’s course of illness throughout their hospitalization and treatment plans to ensure their understanding and potential success.

This program benefits residents by providing medical education and patient communication opportunities. Residents must review the patient’s clinical trajectory before calling them. In this process, residents develop an understanding of routine and complex illness scripts, or pathways of common illnesses. They also prepare for potential questions about the hospitalization, new medications, and follow-up care. Lastly, residents can focus on communication skills. Without the time pressures of returning to a busy rotation, the residents spend as much time discussing the hospital course and ensuring patient understanding as needed.

 

 

Program Description

At the beginning of each week, second- and third-year residents review the list of discharges from the 3 teaching teams. The list is generated by a medical service management analyst. The residents review patient records for inpatient services, laboratory results, medication changes, and proposed follow-up plans designed by the admission team prior to their phone call. The resident is also responsible for reviewing and reconciling discharge instructions and orders. Then, the resident calls the patient and reviews their hospitalization. If a patient does not answer, the resident leaves a voicemail that complies with the Health Insurance Portability and Accountability Act.

swekotrucruphemakaperiwobufrahishosirivocruspuwitrumolacloprulicigukogamafruswujecrouevibrigodewavek

When patients answer the call, the resident follows a script (Appendix). Residents are encouraged to ask patients open-ended questions and address any new needs. They also discuss changes in symptoms, medications, functional status, and remind the patient about follow-up appointments. If imaging or specific orders were missed at discharge, the residents notify the chief resident, lead hospitalist, or deputy associate chief of staff for medical service. If additional laboratory tests need to be ordered, the resident devises a follow-up plan. If needed, specialty referrals can be placed. When residents feel there are multiple items that need to be addressed or if they notice any major concerns, they can recommend the patient present to the emergency department for evaluation. The chief resident, lead hospitalist, and deputy associate chair for medical service are available to assist with discussions about complex medical situations or new concerning symptoms. Residents document their encounters in the Computerized Patient Record System health record and any tests that need follow-up. This differs from the standard of care follow-up programs, which are conducted by primary care medicine nurses and do not fully discuss the hospitalization.

Implementation

This program was implemented as a 1-week elective for interested residents and part of the clinic rotation. The internal medicine medical service analyst pulls all discharges on Friday, which are then provided to the residents. The residents on rotation work through the discharges and find teaching team patients to follow up with and call.

 

Findings

Implementation of this program has yielded many benefits. The reminder of the importance of a primary care appointment has motivated patients to continue following up on an outpatient basis. Residents were also able to capture lapses in patient understanding. Residents could answer forgotten questions and help patients understand their admission pathology without time pressures. Residents have identified patients with hypoglycemia due to changed insulin regimens, set up specialist follow-up appointments, and provided additional education facilitating adherence. Additionally, several residents have expressed satisfaction with the ability to practice their communication skills. Others appreciated contributing to future patient successes.

While the focus on this article has been to share the program description, we have tabulated preliminary data. In January 2023, there were 239 internal medicine admissions; 158 admissions (66%) were teaching team patients, and 97 patients (61%) were called by a resident and spoken to regarding their care. There were 24 teaching team readmissions within 30 days, and 10 (42%) received a follow-up phone call. Eighty-one admitted patients were treated by nonteaching teams, 10 (12%) of whom were readmissions. Comparing 30-day readmission rates, 10 nonteaching team patients (12%), 10 teaching team patients (6.3%) who talk to a resident in the transition of care program were readmitted, and 24 teaching team patients who did not talk to a resident (10%) were readmitted.

 

 

DISCUSSION

The OETVC transition of care program was planned, formulated, and implemented without modeling after any other projects or institutions. This program aimed to utilize our residents as resources for patients.

Transition of care is defined as steps taken in a clinical encounter to assist with the coordination and continuity of patient care transferring between locations or levels of care.5 A 2018 study evaluating the utility of transition of care programs on adults aged ≥ 60 years found a reduction in rehospitalization rates, increased use of primary care services, and potential reduction in home health usage.6

In 2021, Johns Hopkins University School of Medicine implemented a program after polling residents and discovering their awareness of gaps in the transition of care.7 In 2002, pharmacists evaluated the impact of follow-up telephone calls to recently hospitalized patients. This group of pharmacists found that these calls were associated with increased patient satisfaction, resolution of medication-related problems and fewer emergency department returns.8

Our program differs from other transition of care programs in that resident physicians made the follow-up calls to patients. Residents could address all aspects of medical care, including new symptoms, new prescriptions, adverse events, and risk factors for readmission, or order new imaging and medications when appropriate. In the program, residents called all patients discharged after receiving care within their team. Calls were not based on risk assessments. The residents were able to speak with 61% of discharged patients. When readmission rates were compared between patients who received a resident follow-up phone call and those who did not, patients receiving the resident phone call were readmitted at a lower rate: 6.3% vs 10%, respectively.

While our data suggest a potential trend of decreased readmission, more follow-up over a longer period may be needed. We believe this program can benefit patients and our model can act as a template for other institutions interested in starting their own programs.

Challenges

Although our process is efficient, there have been some challenges. The discharge is created by the medical service management analyst and then sent to the chief resident, but there was concern that the list could be missed if either individual was unavailable. The chairperson for the department of medicine and their secretary are now involved in the process. To reduce unanswered telephone calls, residents use OETVC phones. Health Insurance Portability and Accountability Act-compliant voicemails providing a time for a follow-up call were implemented. As a result, veterans have answered their phones more regularly and are more aware of calls. Orders are generally placed by the chief resident, lead hospitalist, or chair of the medical service to ensure follow-up because residents are on rotation for 1 week at a time. Access to a physician also allows patients to discuss items unrelated to their hospitalization, introducing new symptoms, or situations requiring a resident to act with limited data.

 

CONCLUSIONS

The transition of care follow-up program described in this article may be beneficial for both internal medicine residents and patients. Second- and third-year residents are developing a better understanding of the trajectory of many illnesses and are given the opportunity to retrospectively analyze what they would do differently based on knowledge gained from their chart reviews. They are also given the opportunity to work on communication skills and explain courses of illnesses to patients in an easy-to-understand format without time constraints. Patients now have access to a physician following discharge to discuss any concerns with their hospitalization, condition, and follow-up. This program will continue to address barriers to care and adapt to improve the success of care transitions.

References

1. Holloway JJ, Medendorp SV, Bromberg J. Risk factors for early readmission among veterans. Health Serv Res. 1990;25(1 Pt 2):213-237.

2. Smith DM, Giobbie-Hurder A, Weinberger M, et al. Predicting non-elective hospital readmissions: a multi-site study. Department of Veterans Affairs Cooperative Study Group on Primary Care and Readmissions. J Clin Epidemiol. 2000;53(11):1113-1118. doi:10.1016/s0895-4356(00)00236-5

3. Kamermayer AK, Leasure AR, Anderson L. The Effectiveness of Transitions-of-Care Interventions in Reducing Hospital Readmissions and Mortality: A Systematic Review. Dimens Crit Care Nurs. 2017;36(6):311-316. doi:10.1097/DCC.0000000000000266

4. Daliri S, Hugtenburg JG, Ter Riet G, et al. The effect of a pharmacy-led transitional care program on medication-related problems post-discharge: A before-After prospective study. PLoS One. 2019;14(3):e0213593. Published 2019 Mar 12. doi:10.1371/journal.pone.0213593

5. Coleman EA. Falling through the cracks: challenges and opportunities for improving transitional care for persons with continuous complex care needs. J Am Geriatr Soc. 2003;51(4):549-555. doi:10.1046/j.1532-5415.2003.51185.x

6. Weeks LE, Macdonald M, Helwig M, Bishop A, Martin-Misener R, Iduye D. The impact of transitional care programs on health services utilization among community-dwelling older adults and their caregivers: a systematic review protocol of quantitative evidence. JBI Database System Rev Implement Rep. 2016;14(3):26-34. doi:10.11124/JBISRIR-2016-2568

7. Sheikh F, Gathecha E, Arbaje AI, Christmas C. Internal Medicine Residents’ Views About Care Transitions: Results of an Educational Intervention. J Med Educ Curric Dev. 2021;8:2382120520988590. Published 2021 Jan 20. doi:10.1177/2382120520988590

8. Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Dis Mon. 2002;48(4):239-248. doi:10.1016/s0011-5029(02)90031-3

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Nikhil Seth, MDa; George Martinez, MDa; Andrew Chapmanb; Nathan Childb; Anika Sikkac; Arshad Ghauri, MDa

Correspondence:  Nikhil Seth  (nseth2007@gmail.com)

aCentral Texas Veterans Affairs Hospital, Temple

bTexas A&M School of Medicine, Bryan

cTexas A&M University, College Station

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

Institutional review board approval was not needed for implementation of this program.

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Nikhil Seth, MDa; George Martinez, MDa; Andrew Chapmanb; Nathan Childb; Anika Sikkac; Arshad Ghauri, MDa

Correspondence:  Nikhil Seth  (nseth2007@gmail.com)

aCentral Texas Veterans Affairs Hospital, Temple

bTexas A&M School of Medicine, Bryan

cTexas A&M University, College Station

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

Institutional review board approval was not needed for implementation of this program.

Author and Disclosure Information

Nikhil Seth, MDa; George Martinez, MDa; Andrew Chapmanb; Nathan Childb; Anika Sikkac; Arshad Ghauri, MDa

Correspondence:  Nikhil Seth  (nseth2007@gmail.com)

aCentral Texas Veterans Affairs Hospital, Temple

bTexas A&M School of Medicine, Bryan

cTexas A&M University, College Station

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

Institutional review board approval was not needed for implementation of this program.

Article PDF
Article PDF

The Olin E. Teague Veterans’ Center (OETVC) in Temple, Texas, is a teaching hospital with 189 beds that provides patients access to medical, surgical, and specialty care. In 2022, 116,359 veterans received care at OETVC and 5393 inpatient admissions were noted. The inpatient ward consists of 3 teaching teams staffed by an attending physician, a second-year internal medicine resident, and 2 to 3 interns while hospitalists staff the 3 nonteaching teams. OETVC residents receive training on both routine and complex medical problems.

Each day, teaching teams discharge patients. With the complexity of discharges, there is always a risk of patients not following up with their primary care physicians, potential issues with filling medications, confusion about new medication regiments, and even potential postdischarge questions. In 1990, Holloway and colleagues evaluated potential risk factors for readmission among veterans. This study found that discharge from a geriatrics or intermediate care bed, chronic disease diagnosis, ≥ 2 procedures performed, increasing age, and distance from a veterans affairs medical center were risk factors.1

Several community hospital studies have evaluated readmission risk factors. One from 2000 noted that patients with more hospitalizations, lower mental health function, a diagnosis of chronic obstructive pulmonary disorder, and increased satisfaction with access to emergency care were associated with increased readmission in 90 days.2 Due to the readmission risks, OETVC decided to construct a program that would help these patients successfully transition from inpatient to outpatient care while establishing means to discuss their care with a physician for reassurance and guidance.

 

TRANSITION OF CARE PROGRAM

Transition of care programs have been implemented and evaluated in many institutions. A 2017 systematic review of transition of care programs supported the use of tailored discharge planning and postdischarge phone calls to reduce hospital readmission, noting that 6 studies demonstrated a statistically significant reduction in 30-day readmission rate.3 Another study found that pharmacy involvement in the transition of care reduced medication-related problems following discharge.4

Program Goals

The foundational goal of our program was to bridge the gap between inpatient and outpatient medicine. We hoped to improve patient adherence with their discharge regimens, improve access to primary care physicians, and improve discharge follow-up. Since hospitalization can be overwhelming, we hoped to capture potential barriers to medical care postdischarge when patients return home while decreasing hospital readmissions. Our second- and third-year resident physicians spend as much time as needed going through the patient’s course of illness throughout their hospitalization and treatment plans to ensure their understanding and potential success.

This program benefits residents by providing medical education and patient communication opportunities. Residents must review the patient’s clinical trajectory before calling them. In this process, residents develop an understanding of routine and complex illness scripts, or pathways of common illnesses. They also prepare for potential questions about the hospitalization, new medications, and follow-up care. Lastly, residents can focus on communication skills. Without the time pressures of returning to a busy rotation, the residents spend as much time discussing the hospital course and ensuring patient understanding as needed.

 

 

Program Description

At the beginning of each week, second- and third-year residents review the list of discharges from the 3 teaching teams. The list is generated by a medical service management analyst. The residents review patient records for inpatient services, laboratory results, medication changes, and proposed follow-up plans designed by the admission team prior to their phone call. The resident is also responsible for reviewing and reconciling discharge instructions and orders. Then, the resident calls the patient and reviews their hospitalization. If a patient does not answer, the resident leaves a voicemail that complies with the Health Insurance Portability and Accountability Act.

swekotrucruphemakaperiwobufrahishosirivocruspuwitrumolacloprulicigukogamafruswujecrouevibrigodewavek

When patients answer the call, the resident follows a script (Appendix). Residents are encouraged to ask patients open-ended questions and address any new needs. They also discuss changes in symptoms, medications, functional status, and remind the patient about follow-up appointments. If imaging or specific orders were missed at discharge, the residents notify the chief resident, lead hospitalist, or deputy associate chief of staff for medical service. If additional laboratory tests need to be ordered, the resident devises a follow-up plan. If needed, specialty referrals can be placed. When residents feel there are multiple items that need to be addressed or if they notice any major concerns, they can recommend the patient present to the emergency department for evaluation. The chief resident, lead hospitalist, and deputy associate chair for medical service are available to assist with discussions about complex medical situations or new concerning symptoms. Residents document their encounters in the Computerized Patient Record System health record and any tests that need follow-up. This differs from the standard of care follow-up programs, which are conducted by primary care medicine nurses and do not fully discuss the hospitalization.

Implementation

This program was implemented as a 1-week elective for interested residents and part of the clinic rotation. The internal medicine medical service analyst pulls all discharges on Friday, which are then provided to the residents. The residents on rotation work through the discharges and find teaching team patients to follow up with and call.

 

Findings

Implementation of this program has yielded many benefits. The reminder of the importance of a primary care appointment has motivated patients to continue following up on an outpatient basis. Residents were also able to capture lapses in patient understanding. Residents could answer forgotten questions and help patients understand their admission pathology without time pressures. Residents have identified patients with hypoglycemia due to changed insulin regimens, set up specialist follow-up appointments, and provided additional education facilitating adherence. Additionally, several residents have expressed satisfaction with the ability to practice their communication skills. Others appreciated contributing to future patient successes.

While the focus on this article has been to share the program description, we have tabulated preliminary data. In January 2023, there were 239 internal medicine admissions; 158 admissions (66%) were teaching team patients, and 97 patients (61%) were called by a resident and spoken to regarding their care. There were 24 teaching team readmissions within 30 days, and 10 (42%) received a follow-up phone call. Eighty-one admitted patients were treated by nonteaching teams, 10 (12%) of whom were readmissions. Comparing 30-day readmission rates, 10 nonteaching team patients (12%), 10 teaching team patients (6.3%) who talk to a resident in the transition of care program were readmitted, and 24 teaching team patients who did not talk to a resident (10%) were readmitted.

 

 

DISCUSSION

The OETVC transition of care program was planned, formulated, and implemented without modeling after any other projects or institutions. This program aimed to utilize our residents as resources for patients.

Transition of care is defined as steps taken in a clinical encounter to assist with the coordination and continuity of patient care transferring between locations or levels of care.5 A 2018 study evaluating the utility of transition of care programs on adults aged ≥ 60 years found a reduction in rehospitalization rates, increased use of primary care services, and potential reduction in home health usage.6

In 2021, Johns Hopkins University School of Medicine implemented a program after polling residents and discovering their awareness of gaps in the transition of care.7 In 2002, pharmacists evaluated the impact of follow-up telephone calls to recently hospitalized patients. This group of pharmacists found that these calls were associated with increased patient satisfaction, resolution of medication-related problems and fewer emergency department returns.8

Our program differs from other transition of care programs in that resident physicians made the follow-up calls to patients. Residents could address all aspects of medical care, including new symptoms, new prescriptions, adverse events, and risk factors for readmission, or order new imaging and medications when appropriate. In the program, residents called all patients discharged after receiving care within their team. Calls were not based on risk assessments. The residents were able to speak with 61% of discharged patients. When readmission rates were compared between patients who received a resident follow-up phone call and those who did not, patients receiving the resident phone call were readmitted at a lower rate: 6.3% vs 10%, respectively.

While our data suggest a potential trend of decreased readmission, more follow-up over a longer period may be needed. We believe this program can benefit patients and our model can act as a template for other institutions interested in starting their own programs.

Challenges

Although our process is efficient, there have been some challenges. The discharge is created by the medical service management analyst and then sent to the chief resident, but there was concern that the list could be missed if either individual was unavailable. The chairperson for the department of medicine and their secretary are now involved in the process. To reduce unanswered telephone calls, residents use OETVC phones. Health Insurance Portability and Accountability Act-compliant voicemails providing a time for a follow-up call were implemented. As a result, veterans have answered their phones more regularly and are more aware of calls. Orders are generally placed by the chief resident, lead hospitalist, or chair of the medical service to ensure follow-up because residents are on rotation for 1 week at a time. Access to a physician also allows patients to discuss items unrelated to their hospitalization, introducing new symptoms, or situations requiring a resident to act with limited data.

 

CONCLUSIONS

The transition of care follow-up program described in this article may be beneficial for both internal medicine residents and patients. Second- and third-year residents are developing a better understanding of the trajectory of many illnesses and are given the opportunity to retrospectively analyze what they would do differently based on knowledge gained from their chart reviews. They are also given the opportunity to work on communication skills and explain courses of illnesses to patients in an easy-to-understand format without time constraints. Patients now have access to a physician following discharge to discuss any concerns with their hospitalization, condition, and follow-up. This program will continue to address barriers to care and adapt to improve the success of care transitions.

The Olin E. Teague Veterans’ Center (OETVC) in Temple, Texas, is a teaching hospital with 189 beds that provides patients access to medical, surgical, and specialty care. In 2022, 116,359 veterans received care at OETVC and 5393 inpatient admissions were noted. The inpatient ward consists of 3 teaching teams staffed by an attending physician, a second-year internal medicine resident, and 2 to 3 interns while hospitalists staff the 3 nonteaching teams. OETVC residents receive training on both routine and complex medical problems.

Each day, teaching teams discharge patients. With the complexity of discharges, there is always a risk of patients not following up with their primary care physicians, potential issues with filling medications, confusion about new medication regiments, and even potential postdischarge questions. In 1990, Holloway and colleagues evaluated potential risk factors for readmission among veterans. This study found that discharge from a geriatrics or intermediate care bed, chronic disease diagnosis, ≥ 2 procedures performed, increasing age, and distance from a veterans affairs medical center were risk factors.1

Several community hospital studies have evaluated readmission risk factors. One from 2000 noted that patients with more hospitalizations, lower mental health function, a diagnosis of chronic obstructive pulmonary disorder, and increased satisfaction with access to emergency care were associated with increased readmission in 90 days.2 Due to the readmission risks, OETVC decided to construct a program that would help these patients successfully transition from inpatient to outpatient care while establishing means to discuss their care with a physician for reassurance and guidance.

 

TRANSITION OF CARE PROGRAM

Transition of care programs have been implemented and evaluated in many institutions. A 2017 systematic review of transition of care programs supported the use of tailored discharge planning and postdischarge phone calls to reduce hospital readmission, noting that 6 studies demonstrated a statistically significant reduction in 30-day readmission rate.3 Another study found that pharmacy involvement in the transition of care reduced medication-related problems following discharge.4

Program Goals

The foundational goal of our program was to bridge the gap between inpatient and outpatient medicine. We hoped to improve patient adherence with their discharge regimens, improve access to primary care physicians, and improve discharge follow-up. Since hospitalization can be overwhelming, we hoped to capture potential barriers to medical care postdischarge when patients return home while decreasing hospital readmissions. Our second- and third-year resident physicians spend as much time as needed going through the patient’s course of illness throughout their hospitalization and treatment plans to ensure their understanding and potential success.

This program benefits residents by providing medical education and patient communication opportunities. Residents must review the patient’s clinical trajectory before calling them. In this process, residents develop an understanding of routine and complex illness scripts, or pathways of common illnesses. They also prepare for potential questions about the hospitalization, new medications, and follow-up care. Lastly, residents can focus on communication skills. Without the time pressures of returning to a busy rotation, the residents spend as much time discussing the hospital course and ensuring patient understanding as needed.

 

 

Program Description

At the beginning of each week, second- and third-year residents review the list of discharges from the 3 teaching teams. The list is generated by a medical service management analyst. The residents review patient records for inpatient services, laboratory results, medication changes, and proposed follow-up plans designed by the admission team prior to their phone call. The resident is also responsible for reviewing and reconciling discharge instructions and orders. Then, the resident calls the patient and reviews their hospitalization. If a patient does not answer, the resident leaves a voicemail that complies with the Health Insurance Portability and Accountability Act.

swekotrucruphemakaperiwobufrahishosirivocruspuwitrumolacloprulicigukogamafruswujecrouevibrigodewavek

When patients answer the call, the resident follows a script (Appendix). Residents are encouraged to ask patients open-ended questions and address any new needs. They also discuss changes in symptoms, medications, functional status, and remind the patient about follow-up appointments. If imaging or specific orders were missed at discharge, the residents notify the chief resident, lead hospitalist, or deputy associate chief of staff for medical service. If additional laboratory tests need to be ordered, the resident devises a follow-up plan. If needed, specialty referrals can be placed. When residents feel there are multiple items that need to be addressed or if they notice any major concerns, they can recommend the patient present to the emergency department for evaluation. The chief resident, lead hospitalist, and deputy associate chair for medical service are available to assist with discussions about complex medical situations or new concerning symptoms. Residents document their encounters in the Computerized Patient Record System health record and any tests that need follow-up. This differs from the standard of care follow-up programs, which are conducted by primary care medicine nurses and do not fully discuss the hospitalization.

Implementation

This program was implemented as a 1-week elective for interested residents and part of the clinic rotation. The internal medicine medical service analyst pulls all discharges on Friday, which are then provided to the residents. The residents on rotation work through the discharges and find teaching team patients to follow up with and call.

 

Findings

Implementation of this program has yielded many benefits. The reminder of the importance of a primary care appointment has motivated patients to continue following up on an outpatient basis. Residents were also able to capture lapses in patient understanding. Residents could answer forgotten questions and help patients understand their admission pathology without time pressures. Residents have identified patients with hypoglycemia due to changed insulin regimens, set up specialist follow-up appointments, and provided additional education facilitating adherence. Additionally, several residents have expressed satisfaction with the ability to practice their communication skills. Others appreciated contributing to future patient successes.

While the focus on this article has been to share the program description, we have tabulated preliminary data. In January 2023, there were 239 internal medicine admissions; 158 admissions (66%) were teaching team patients, and 97 patients (61%) were called by a resident and spoken to regarding their care. There were 24 teaching team readmissions within 30 days, and 10 (42%) received a follow-up phone call. Eighty-one admitted patients were treated by nonteaching teams, 10 (12%) of whom were readmissions. Comparing 30-day readmission rates, 10 nonteaching team patients (12%), 10 teaching team patients (6.3%) who talk to a resident in the transition of care program were readmitted, and 24 teaching team patients who did not talk to a resident (10%) were readmitted.

 

 

DISCUSSION

The OETVC transition of care program was planned, formulated, and implemented without modeling after any other projects or institutions. This program aimed to utilize our residents as resources for patients.

Transition of care is defined as steps taken in a clinical encounter to assist with the coordination and continuity of patient care transferring between locations or levels of care.5 A 2018 study evaluating the utility of transition of care programs on adults aged ≥ 60 years found a reduction in rehospitalization rates, increased use of primary care services, and potential reduction in home health usage.6

In 2021, Johns Hopkins University School of Medicine implemented a program after polling residents and discovering their awareness of gaps in the transition of care.7 In 2002, pharmacists evaluated the impact of follow-up telephone calls to recently hospitalized patients. This group of pharmacists found that these calls were associated with increased patient satisfaction, resolution of medication-related problems and fewer emergency department returns.8

Our program differs from other transition of care programs in that resident physicians made the follow-up calls to patients. Residents could address all aspects of medical care, including new symptoms, new prescriptions, adverse events, and risk factors for readmission, or order new imaging and medications when appropriate. In the program, residents called all patients discharged after receiving care within their team. Calls were not based on risk assessments. The residents were able to speak with 61% of discharged patients. When readmission rates were compared between patients who received a resident follow-up phone call and those who did not, patients receiving the resident phone call were readmitted at a lower rate: 6.3% vs 10%, respectively.

While our data suggest a potential trend of decreased readmission, more follow-up over a longer period may be needed. We believe this program can benefit patients and our model can act as a template for other institutions interested in starting their own programs.

Challenges

Although our process is efficient, there have been some challenges. The discharge is created by the medical service management analyst and then sent to the chief resident, but there was concern that the list could be missed if either individual was unavailable. The chairperson for the department of medicine and their secretary are now involved in the process. To reduce unanswered telephone calls, residents use OETVC phones. Health Insurance Portability and Accountability Act-compliant voicemails providing a time for a follow-up call were implemented. As a result, veterans have answered their phones more regularly and are more aware of calls. Orders are generally placed by the chief resident, lead hospitalist, or chair of the medical service to ensure follow-up because residents are on rotation for 1 week at a time. Access to a physician also allows patients to discuss items unrelated to their hospitalization, introducing new symptoms, or situations requiring a resident to act with limited data.

 

CONCLUSIONS

The transition of care follow-up program described in this article may be beneficial for both internal medicine residents and patients. Second- and third-year residents are developing a better understanding of the trajectory of many illnesses and are given the opportunity to retrospectively analyze what they would do differently based on knowledge gained from their chart reviews. They are also given the opportunity to work on communication skills and explain courses of illnesses to patients in an easy-to-understand format without time constraints. Patients now have access to a physician following discharge to discuss any concerns with their hospitalization, condition, and follow-up. This program will continue to address barriers to care and adapt to improve the success of care transitions.

References

1. Holloway JJ, Medendorp SV, Bromberg J. Risk factors for early readmission among veterans. Health Serv Res. 1990;25(1 Pt 2):213-237.

2. Smith DM, Giobbie-Hurder A, Weinberger M, et al. Predicting non-elective hospital readmissions: a multi-site study. Department of Veterans Affairs Cooperative Study Group on Primary Care and Readmissions. J Clin Epidemiol. 2000;53(11):1113-1118. doi:10.1016/s0895-4356(00)00236-5

3. Kamermayer AK, Leasure AR, Anderson L. The Effectiveness of Transitions-of-Care Interventions in Reducing Hospital Readmissions and Mortality: A Systematic Review. Dimens Crit Care Nurs. 2017;36(6):311-316. doi:10.1097/DCC.0000000000000266

4. Daliri S, Hugtenburg JG, Ter Riet G, et al. The effect of a pharmacy-led transitional care program on medication-related problems post-discharge: A before-After prospective study. PLoS One. 2019;14(3):e0213593. Published 2019 Mar 12. doi:10.1371/journal.pone.0213593

5. Coleman EA. Falling through the cracks: challenges and opportunities for improving transitional care for persons with continuous complex care needs. J Am Geriatr Soc. 2003;51(4):549-555. doi:10.1046/j.1532-5415.2003.51185.x

6. Weeks LE, Macdonald M, Helwig M, Bishop A, Martin-Misener R, Iduye D. The impact of transitional care programs on health services utilization among community-dwelling older adults and their caregivers: a systematic review protocol of quantitative evidence. JBI Database System Rev Implement Rep. 2016;14(3):26-34. doi:10.11124/JBISRIR-2016-2568

7. Sheikh F, Gathecha E, Arbaje AI, Christmas C. Internal Medicine Residents’ Views About Care Transitions: Results of an Educational Intervention. J Med Educ Curric Dev. 2021;8:2382120520988590. Published 2021 Jan 20. doi:10.1177/2382120520988590

8. Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Dis Mon. 2002;48(4):239-248. doi:10.1016/s0011-5029(02)90031-3

References

1. Holloway JJ, Medendorp SV, Bromberg J. Risk factors for early readmission among veterans. Health Serv Res. 1990;25(1 Pt 2):213-237.

2. Smith DM, Giobbie-Hurder A, Weinberger M, et al. Predicting non-elective hospital readmissions: a multi-site study. Department of Veterans Affairs Cooperative Study Group on Primary Care and Readmissions. J Clin Epidemiol. 2000;53(11):1113-1118. doi:10.1016/s0895-4356(00)00236-5

3. Kamermayer AK, Leasure AR, Anderson L. The Effectiveness of Transitions-of-Care Interventions in Reducing Hospital Readmissions and Mortality: A Systematic Review. Dimens Crit Care Nurs. 2017;36(6):311-316. doi:10.1097/DCC.0000000000000266

4. Daliri S, Hugtenburg JG, Ter Riet G, et al. The effect of a pharmacy-led transitional care program on medication-related problems post-discharge: A before-After prospective study. PLoS One. 2019;14(3):e0213593. Published 2019 Mar 12. doi:10.1371/journal.pone.0213593

5. Coleman EA. Falling through the cracks: challenges and opportunities for improving transitional care for persons with continuous complex care needs. J Am Geriatr Soc. 2003;51(4):549-555. doi:10.1046/j.1532-5415.2003.51185.x

6. Weeks LE, Macdonald M, Helwig M, Bishop A, Martin-Misener R, Iduye D. The impact of transitional care programs on health services utilization among community-dwelling older adults and their caregivers: a systematic review protocol of quantitative evidence. JBI Database System Rev Implement Rep. 2016;14(3):26-34. doi:10.11124/JBISRIR-2016-2568

7. Sheikh F, Gathecha E, Arbaje AI, Christmas C. Internal Medicine Residents’ Views About Care Transitions: Results of an Educational Intervention. J Med Educ Curric Dev. 2021;8:2382120520988590. Published 2021 Jan 20. doi:10.1177/2382120520988590

8. Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Dis Mon. 2002;48(4):239-248. doi:10.1016/s0011-5029(02)90031-3

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0624 FED Transition</fileName> <TBEID>0C02F741.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F741</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20240603T111333</firstPublished> <LastPublished>20240603T111333</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240603T111333</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>Nikhil Seth, MDa; George Martinez, MDa; Andrew Chapmanb; Nathan Childb; Anika Sikkac; Arshad Ghauri, MDa</bylineText> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>The Olin E. Teague Veterans’ Center (OETVC) in Temple, Texas, is a teaching hospital with 189 beds that provides patients access to medical, surgical, and speci</metaDescription> <articlePDF/> <teaserImage/> <title>Bridging the Gap Between Inpatient and Outpatient Care</title> <deck/> <eyebrow>Program Profile</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>June</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>6</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>4473</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>June 2024</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Program Profile | 4473<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> </sections> <topics> <term canonical="true">27442</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Bridging the Gap Between Inpatient and Outpatient Care</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background: </b>The Olin E. Teague Veterans’ Center (OETVC) is a teaching hospital with a medical ward consisting of 189 beds, 3 teaching teams with 1 resident and 2 to 3 interns, and 3 nonteaching teams. Due to the complexity of hospitalization, there are concerns that patients may not follow up with primary care or fill their prescribed medication and may have postdischarge questions. <br/><br/><b>Observations: </b>A program was created at OETVC to bridge the gap between inpatient and outpatient care. Internal medicine residents call all teaching team patients a week following discharge. They discuss medications, changes in symptoms, follow-up plans, and address all questions. The residents also assist with missed orders and make treatment regimen changes if necessary. <br/><br/><b>Conclusions: </b>This new program has proven to be beneficial. Residents are developing a better understanding of illness scripts and are working on communication skills without time constraints. Patients now have access to a physician following discharge to discuss any concerns with their hospitalization, present condition, and follow-up. Data show a decreased 30-day readmission rate at 6% in the transition of care group compared to 10% in all patients who participated in the program. This program will continue to address barriers to care and adapt to improve the success of care transitions. </p> <p><span class="Drop">T</span>he Olin E. Teague Veterans’ Center (OETVC) in Temple, Texas, is a teaching hospital with 189 beds that provides patients access to medical, surgical, and specialty care. In 2022, 116,359 veterans received care at OETVC and 5393 inpatient admissions were noted. The inpatient ward consists of 3 teaching teams staffed by an attending physician, a second-year internal medicine resident, and 2 to 3 interns while hospitalists staff the 3 nonteaching teams. OETVC residents receive training on both routine and complex medical problems. </p> <p>Each day, teaching teams discharge patients. With the complexity of discharges, there is always a risk of patients not following up with their primary care physicians, potential issues with filling medications, confusion about new medication regiments, and even potential postdischarge questions. In 1990, Holloway and colleagues evaluated potential risk factors for readmission among veterans. This study found that discharge from a geriatrics or intermediate care bed, chronic disease diagnosis, ≥ 2 procedures performed, increasing age, and distance from a veterans affairs medical center were risk factors.<sup>1</sup> <br/><br/>Several community hospital studies have evaluated readmission risk factors. One from 2000 noted that patients with more hospitalizations, lower mental health function, a diagnosis of chronic obstructive pulmonary disorder, and increased satisfaction with access to emergency care were associated with increased readmission in 90 days.<sup>2</sup> Due to the readmission risks, OETVC decided to construct a program that would help these patients successfully transition from inpatient to outpatient care while establishing means to discuss their care with a physician for reassurance and guidance. </p> <h2>TRANSITION OF CARE PROGRAM</h2> <p>Transition of care programs have been implemented and evaluated in many institutions. A 2017 systematic review of transition of care programs supported the use of tailored discharge planning and postdischarge phone calls to reduce hospital readmission, noting that 6 studies demonstrated a statistically significant reduction in 30-day readmission rate.<sup>3</sup> Another study found that pharmacy involvement in the transition of care reduced medication-related problems following discharge.<sup>4</sup></p> <h3>Program Goals</h3> <p>The foundational goal of our program was to bridge the gap between inpatient and outpatient medicine. We hoped to improve patient adherence with their discharge regimens, improve access to primary care physicians, and improve discharge follow-up. Since hospitalization can be overwhelming, we hoped to capture potential barriers to medical care postdischarge when patients return home while decreasing hospital readmissions. Our second- and third-year resident physicians spend as much time as needed going through the patient’s course of illness throughout their hospitalization and treatment plans to ensure their understanding and potential success. </p> <p>This program benefits residents by providing medical education and patient communication opportunities. Residents must review the patient’s clinical trajectory before calling them. In this process, residents develop an understanding of routine and complex illness scripts, or<b> </b>pathways of common illnesses.<b> </b>They also prepare for potential questions about the hospitalization, new medications, and follow-up care. Lastly, residents can focus on communication skills. Without the time pressures of returning to a busy rotation, the residents spend as much time discussing the hospital course and ensuring patient understanding as needed. </p> <h3>Program Description</h3> <p>At the beginning of each week, second- and third-year residents review the list of discharges from the 3 teaching teams. The list is generated by a medical service management analyst. The residents review patient records for inpatient services, laboratory results, medication changes, and proposed follow-up plans designed by the admission team prior to their phone call. The resident is also responsible for reviewing and reconciling discharge instructions and orders. Then, the resident calls the patient and reviews their hospitalization. If a patient does not answer, the resident leaves a voicemail that complies with the Health Insurance Portability and Accountability Act. </p> <p>When patients answer the call, the resident follows a script (Appendix). Residents are encouraged to ask patients open-ended questions and address any new needs. They also discuss changes in symptoms, medications, functional status, and remind the patient about follow-up appointments. If imaging or specific orders were missed at discharge, the residents notify the chief resident, lead hospitalist, or deputy associate chief of staff for medical service. If additional laboratory tests need to be ordered, the resident devises a follow-up plan. If needed, specialty referrals can be placed. When residents feel there are multiple items that need to be addressed or if they notice any major concerns, they can recommend the patient present to the emergency department for evaluation. The chief resident, lead hospitalist, and deputy associate chair for medical service are available to assist with discussions about complex medical situations or new concerning symptoms. Residents document their encounters in the Computerized Patient Record System health record and any tests that need follow-up. This differs from the standard of care follow-up programs, which are conducted by primary care medicine nurses and do not fully discuss the hospitalization. </p> <h3>Implementation</h3> <p>This program was implemented as a 1-week elective for interested residents and part of the clinic rotation. The internal medicine medical service analyst pulls all discharges on Friday, which are then provided to the residents. The residents on rotation work through the discharges and find teaching team patients to follow up with and call. </p> <h3>Findings</h3> <p>Implementation of this program has yielded many benefits. The reminder of the importance of a primary care appointment has motivated patients to continue following up on an outpatient basis. Residents were also able to capture lapses in patient understanding. Residents could answer forgotten questions and help patients understand their admission pathology without time pressures. Residents have identified patients with hypoglycemia due to changed insulin regimens, set up specialist follow-up appointments, and provided additional education facilitating adherence. Additionally, several residents have expressed satisfaction with the ability to practice their communication skills. Others appreciated contributing to future patient successes. </p> <p>While the focus on this article has been to share the program description, we have tabulated preliminary data. In January 2023, there were 239 internal medicine admissions; 158 admissions (66%) were teaching team patients, and 97 patients (61%) were called by a resident and spoken to regarding their care. There were 24 teaching team readmissions within 30 days, and 10 (42%) received a follow-up phone call. Eighty-one admitted patients were treated by nonteaching teams, 10 (12%) of whom were readmissions. Comparing 30-day readmission rates, 10 nonteaching team patients (12%), 10<b> </b>teaching team patients (6.3%) who talk to a resident in the transition of care program were readmitted, and 24 teaching team patients who did not talk to a resident (10%) were readmitted. </p> <h2>DISCUSSION</h2> <p>The OETVC transition of care program was planned, formulated, and implemented without modeling after any other projects or institutions. This program aimed to utilize our residents as resources for patients. </p> <p>Transition of care is defined as steps taken in a clinical encounter to assist with the coordination and continuity of patient care transferring between locations or levels of care.<sup>5</sup> A 2018 study evaluating the utility of transition of care programs on adults aged ≥ 60 years found a reduction in rehospitalization rates, increased use of primary care services, and potential reduction in home health usage.<sup>6<br/><br/></sup>In 2021, Johns Hopkins University School of Medicine implemented a program after polling residents and discovering their awareness of gaps in the transition of care.<sup>7</sup> In 2002, pharmacists evaluated the impact of follow-up telephone calls to recently hospitalized patients. This group of pharmacists<b> </b>found that these calls were associated with increased patient satisfaction, resolution of medication-related problems and fewer emergency department returns.<sup>8<br/><br/></sup>Our program differs from other transition of care programs in that resident physicians made the follow-up calls to patients. Residents could address all aspects of medical care, including new symptoms, new prescriptions, adverse events, and risk factors for readmission, or order new imaging and medications when appropriate. In the program, residents called all patients discharged after receiving care within their team. Calls were not based on risk assessments. The residents were able to speak with 61% of discharged patients. When readmission rates were compared between patients who received a resident follow-up phone call and those who did not, patients receiving the resident phone call were readmitted at a lower rate: 6.3% vs 10%, respectively. <br/><br/>While our data suggest a potential trend of decreased readmission, more follow-up over a longer period may be needed. We believe this program can benefit patients and our model can act as a template for other institutions interested in starting their own programs. </p> <h3>Challenges</h3> <p>Although our process is efficient, there have been some challenges. The discharge is created by the medical service management analyst and then sent to the chief resident, but there was concern that the list could be missed if either individual was unavailable. The chairperson for the department of medicine and their secretary are now involved in the process. To reduce unanswered telephone calls, residents use OETVC phones. Health Insurance Portability and Accountability Act-compliant voicemails providing a time for a follow-up call were implemented. As a result, veterans have answered their phones more regularly and are more aware of calls. Orders are generally placed by the chief resident, lead hospitalist, or chair of the medical service to ensure follow-up because residents are on rotation for 1 week at a time. Access to a physician also allows patients to discuss items unrelated to their hospitalization, introducing new symptoms, or situations requiring a resident to act with limited data.</p> <h2>CONCLUSIONS</h2> <p>The transition of care follow-up program described in this article may be beneficial for both internal medicine residents and patients. Second- and third-year residents are developing a better understanding of the trajectory of many illnesses and are given the opportunity to retrospectively analyze what they would do differently based on knowledge gained from their chart reviews. They are also given the opportunity to work on communication skills and explain courses of illnesses to patients in an easy-to-understand format without time constraints. Patients now have access to a physician following discharge to discuss any concerns with their hospitalization, condition, and follow-up. This program will continue to address barriers to care and adapt to improve the success of care transitions. </p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>Central Texas Veterans Affairs Hospital, Temple<br/><br/><sup>b</sup>Texas A&amp;M School of Medicine, Bryan<br/><br/><sup>c</sup>Texas A&amp;M University, College Station</em> </p> <p class="isub">Author disclosures</p> <p> <em>The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <p class="isub">Disclaimer</p> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner</i>, Frontline Medical Communications Inc., the US Government, or any of its agencies.</em> </p> <p class="isub">Ethics and consent</p> <p> <em>Institutional review board approval was not needed for implementation of this program.</em> </p> <p class="isub">References</p> <p class="reference"> 1. Holloway JJ, Medendorp SV, Bromberg J. Risk factors for early readmission among veterans. <i>Health Serv Res</i>. 1990;25(1 Pt 2):213-237.<br/><br/> 2. Smith DM, Giobbie-Hurder A, Weinberger M, et al. Predicting non-elective hospital readmissions: a multi-site study. Department of Veterans Affairs Cooperative Study Group on Primary Care and Readmissions. <i>J Clin Epidemiol</i>. 2000;53(11):1113-1118. doi:10.1016/s0895-4356(00)00236-5 3. Kamermayer AK, Leasure AR, Anderson L. The Effectiveness of Transitions-of-Care Interventions in Reducing Hospital Readmissions and Mortality: A Systematic Review. <i>Dimens Crit Care Nurs</i>. 2017;36(6):311-316.doi:10.1097/DCC.0000000000000266 4. Daliri S, Hugtenburg JG, Ter Riet G, et al. The effect of a pharmacy-led transitional care program on medication-related problems post-discharge: A before-After prospective study. <i>PLoS One</i>. 2019;14(3):e0213593. Published 2019 Mar 12. doi:10.1371/journal.pone.0213593<br/><br/> 5. Coleman EA. Falling through the cracks: challenges and opportunities for improving transitional care for persons with continuous complex care needs. <i>J Am Geriatr Soc</i>. 2003;51(4):549-555. doi:10.1046/j.1532-5415.2003.51185.x <br/><br/> 6. Weeks LE, Macdonald M, Helwig M, Bishop A, Martin-Misener R, Iduye D. The impact of transitional care programs on health services utilization among community-dwelling older adults and their caregivers: a systematic review protocol of quantitative evidence. <i>JBI Database System Rev Implement Rep</i>. 2016;14(3):26-34. doi:10.11124/JBISRIR-2016-2568<br/><br/> 7. Sheikh F, Gathecha E, Arbaje AI, Christmas C. Internal Medicine Residents’ Views About Care Transitions: Results of an Educational Intervention. <i>J Med Educ Curric Dev</i>. 2021;8:2382120520988590. Published 2021 Jan 20. doi:10.1177/2382120520988590<br/><br/> 8. Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. <i>Dis Mon</i>. 2002;48(4):239-248. doi:10.1016/s0011-5029(02)90031-3</p> </itemContent> </newsItem> </itemSet></root>
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Evaluation of a Stress, Coping, and Resourcefulness Program for VA Nurses During the COVID-19 Pandemic

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Mon, 05/13/2024 - 10:58

Nurses are recognized among the most trusted professions in the United States.1 Since the time of Florence Nightingale, nurses have been challenged to provide care to patients and soldiers with complex needs, including acute and chronic physical illness, as well as mental health issues. Nurses have traditionally met those challenges with perseverance and creativity but have also experienced stress and burnout.

A shortage of nurses has been linked to many interrelated factors including the retirement of bedside caregivers and educators, diverse care settings, expanding roles for nurses, and nurse burnout.2-4 Therefore, there is a critical need to better understand of how nurses can be supported while they care for patients, cope with stress, and maintain positive personal and professional outcomes. The objective of this pilot project was to assess US Department of Veterans Affairs (VA) nurses’ levels of burnout and test an intervention to enhance resourcefulness skills during the COVID-19 pandemic.

Background

Stress has many definitions. Hans Selye described it as a biological response of the body to any demand.5,6 Occupational stress is a process that occurs in which work environment stressors result in the development of psychological, behavioral, or physiological effects that can contribute to health.6 Occupational stress has been observed as prevalent among nurses.6 In 1960, Menzies identified sources of stress among nurses that include complex decision-making within a dynamic environment.7 Since the mid-1980s, nurses’ stress at work has increased because of legal, accreditation, ethical issues, fiscal pressures, staffing shortages, and the increasing integration of technology associated with clinical care.8

Sustained stress can lead to emotional exhaustion or burnout, which has been associated with nursing turnover, lower patient satisfaction, and patient safety risk.2,9 An American Nurses Foundation survey reported that 51% of US nurses feel exhausted, 43% overwhelmed, and 36% anxious; 28% express willingness to leave the profession.2 Burnout has been described as a response to physical or emotional stress leading to exhaustion, self-doubt, cynicism, and ineffectiveness.10 Employees with burnout are more likely to leave their jobs, take sick leave, and suffer from depression and relationship problems,and it affects nearly half of all US nurses, especially among critical care, pediatric, and oncology specialities.10,11 It has been well documented that unmitigated stress can lead to burnout and contribute to nurses leaving bedside care and the health care profession.2,3 Several studies on nursing stress and burnout have focused on its prevalence and negative outcomes.4,7,9 However, few studies have addressed building resiliency and resourcefulness for nurses.10,12,13

A 2021 National Academy of Medicine report advocated a multilevel approach to managing burnout and building resiliency among nurses.14 Taylor further identified specific interventions, ranging from primary prevention to treatment.15 Primary prevention could include educating nurses on self-awareness, coping strategies, and communication skills. Screening for burnout and providing resources for support would be a secondary level of intervention. For nurses who experienced severe burnout symptoms and left the workplace, strategies are sorely needed to provide healing and a return-to-work plan.15 This may include adjusting nurse schedules and nursing roles (such as admitting/discharge nurse or resource nurse).

 

 

RESILIENCY AND RESOURCEFULNESS

Rushton and colleagues describe resiliency as the “ability to face adverse situations, remain focused, and continue to be optimistic for the future.”4 For nurses in complex health care systems, resiliency is associated with reduced turnover and symptoms of burnout and improved mental health. Humans are thought to have an innate resiliency potential that evolves over time and fluctuates depending on the context (eg, societal conditions, moral/ethical values, commitments).4 It is believed that resiliency can contribute to the development of new neuropathways that can be used to manage and cope with stress, prevent burnout, and improve quality of life. However, it appears these adaptations are individualized and contingent on situations, available resources, and changing priorities.16 Consequently, resiliency may be an essential tool for nurses to combat burnout in today’s complex health care systems.17

Although resilience and resourcefulness are conceptually related, each has distinctive features.18 Celinski frames resilience as transcendence and resourcefulness as transformation.19 Thus, while resilience suggests transcendence in terms of rising above, going beyond, exceeding, or excelling; resourcefulness reflects transformation, such as making changes in thoughts, feelings, behaviors, actions, or reactions. Resourcefulness has been conceptualized as an indicator of resilience.18

Resourcefulness comprises 2 dimensions, including the use of self-help strategies (personal resourcefulness) and seeking help from others (social resourcefulness), to self-regulate one’s thoughts, feelings, and behaviors to cope with high levels of stress, anxiety, or depression.18,20,21 Personal resourcefulness skills include the use of cognitive reframing, positive thinking, problem-solving, priority-setting, and planning ahead. Social resourcefulness involves actively seeking help from others. Formal sources of help include, but are not limited to, nursing and medical care practitioners and community organizations such as hospitals and clinics. Informal sources of help include family members, friends, peers, and coworkers.

During the COVID-19 pandemic, nurses were especially challenged to provide support for each other because of limited nursing staff and treatment options, increased complex patient assignments, shortages of supplies, and reduced support services. Many nurses, however, were able to find innovative, peer-supported strategies for coping.13 Nurses’ use of resourcefulness skills is believed to be indicative of their resilience. This pilot project aimed to identify and evaluate some of these strategies and resourcefulness skills.

INTERVENTION

This pilot study among VA Northeast Ohio Health Care System (VANEOHS) nurses was designed to assess nursing burnout and resourcefulness during the pandemic. Those who agreed to participate completed a baseline survey on burnout and resourcefulness. Participants agreed to review a training video on resourcefulness skills (eg, relying on and exchanging ideas with others, and reframing and using ‘positive self-talk’). They were encouraged to document their experience with familiar and new resourcefulness skills. Weekly reminders (eg, emails and phone messages) reminded and coached participants in their journey.

The study identified and implemented an existing Resourcefulness Training (RT) intervention, which was developed for informal family caregivers and found to be effective.22 We measured burnout and resourcefulness preintervention and postintervention.23 This survey and educational intervention were reviewed by the VANEOHS institutional review board and ruled exempt. The survey also gathered information on nurses' contact with individuals infected with COVID-19.

Despite the many staffing and resource challenges during the COVID-19 pandemic, a convenience sample of 12 nurses was recruited from nursing committees that continued to have scheduled meetings. These meetings allowed time to answer questions and provide information about the study. The majority of nurses queried declined to participate, citing no time, interest, or burnout. Participants completed a baseline survey, reviewed a 30-minute RT video, and tracked their experience for 28 days. Participants completed postintervention surveys 6 weeks after the video. Details of the survey and measures can be found in previous studies.20,21

 

 

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RT is an online cognitive-behavioral intervention that teaches and reinforces personal (self-help) and social (help-seeking) resourcefulness skills that have not yet been tested in nurses or other health care professionals.22,24 The training included social resourcefulness (eg, from family, friends, others, and professionals) and personal resourcefulness (eg, problem-solving, positive thinking, self-control, organization skills). Participants were encouraged to review the videos as often as they preferred during these 4 weeks.

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All 12 survey respondents were female and had received COVID-19 vaccinations according to the federal policy at the time of data collection. The number of patients cared for with COVID-19 infections varied widely (range, 1-1000). The baseline burnout score ranged from 1 (no burnout) to 3 (1 symptom of burnout, such as physical and emotional exhaustion), with a mean score of 2.2. In the follow-up survey, the mean score was 2.0. At baseline, participants reported a variety of activities to manage stress and burnout, including times with friends and family, engaging in hobbies, and prayer. Postintervention, some participants mentioned using skills learned from RT, including reframing the situation positively by refocusing and putting stressors in perspective (Table 1).

DISCUSSION

Recent American Nurses Association efforts to develop organizational and professional goals include the importance of nurses to recognize and manage stress to prevent burnout.25 The American Nurses Association Code of Ethics notes that nurses have the same duties to care for themselves as they do for others.25 Nurses have demonstrated the ability to adapt and remain resilient during stressful times. VA nurses are a resourceful group. Many used resourcefulness skills to manage stress and burnout even before the pandemic. For example, nurses identified using family/friends for support and validation, as well as prayer and meditation. Some of the new activities may have been influenced/inspired by RT, such as organizing schedules for problem-solving and distraction.

Relying on family and peers emerged as an essential resourcefulness skill. Support from peers—battle buddies—has been recognized as a key strategy among combat soldiers. A battle buddy is paired with a fellow soldier for support to keep each other informed about key instructions and information. This promotes cooperative problem-solving. Outcomes associated with battle buddies include increased morale and confidence, and decreased stress.25 Over time, it is hoped that these coaching/mentoring relationships will result in enhanced leadership skills. Battle buddy strategies are currently being adapted into health care environments.12,26 Such programs need to be further evaluated and information disseminated.

Findings from this pilot program support the use of interventions such as RT to decrease burnout among nurses. This study suggests that RT should be tested in a larger more representative sample to determine efficacy.

Limitations

This pilot study was limited by its small sample size, single facility, and female-only participants; the findings are not generalizable. Nurses were recruited from VA nursing committees and may not be representative of nurses in the general population. In addition, the RT intervention may require a longer time commitment to adequately determine efficacy. Another limitation was that personal or family exposure to COVID-19 was not measured, but may be a confounding variable. An additional limitation may have been the time interval. A baseline survey was completed prior to watching the teaching video. Daily logs were to be completed for 28 days. A post survey followed at 6 weeks. It is possible that there was insufficient time for the nurses to have the opportunity to use their resourcefulness skills within the short time frame of the study. While it supports the need for further studies, findings should be interpreted cautiously and not generalized. It may be premature based on these findings to conclude that the intervention will be effective for other populations. Further studies are needed to assess nurses’ preferences for healthy coping mechanisms, including RT.

Conclusions

As the nursing shortage continues, efforts to support diverse, innovative coping strategies remain a priority postpandemic. Nurses must be vigilant in appraising and managing their ability to cope and adapt to individual stress, while also being aware of the stress their colleagues are experiencing. Educational institutions, professional organizations, and health care facilities must strive to educate and support nurses to identify not only stress, but healthy coping mechanisms.

Acknowledgments

This work was supported by the US Department of Veterans Affairs Central Office rapid response COVID-19 funding initiative, the Veteran Affairs Northeast Ohio Health Care System, and Geriatric Research, Education, and Clinical Center (GRECC). The Resourcefulness Scale, Resourcefulness Skills Scale, and the Resourcefulness Training intervention are copyrighted and were used with permission of the copyright holder, Jaclene A. Zauszniewski, MD.

References

1. Walker A. Nursing ranked as the most trusted profession for 22nd year in a row. January 23, 2024. Accessed January 31, 2024. https://nurse.org/articles/nursing-ranked-most-honest-profession

2. Mental health and wellness survey 1. American Nurses Foundation. August 2020. Accessed January 31, 2024. https://www.nursingworld.org/practice-policy/work-environment/health-safety/disaster-preparedness/coronavirus/what-you-need-to-know/mental-health-and-wellbeing-survey/

3. Healthy nurse, healthy nation. American Nurses Association. May 1, 2017. Accessed January 31, 2024. https://www.healthynursehealthynation.org/

4. Rushton CH, Batcheller J, Schroeder K, Donohue P. Burnout and resilience among nurses practicing in high-intensity settings. Am J Crit Care. 2015;24(5):412-420. doi:10.4037/ajcc2015291

5. Selye HA. History and general outline of the stress concept. Stress in Health and Disease. Butterworths; 1976:3-34.

6. Levy BS, Wegman DH, Baron SL, Sokas RK. Recognizing and preventing occupational and environmental disease and injury. Occupational and Environmental Health: Recognizing and Preventing Disease and Injury. 6th ed. Oxford University Press; 2011:59-77.

7. Menzies IEP. Nurses under stress. Int Nurs Rev. 1960;7:9-16.

8. Jennings BM. Turbulence. In: Hughes RG, ed. Advances in Patient Safety and Quality: An Evidence-Based Handbook for Nurses. 3rd ed. AHRQ Publication; 2007;2;193-202.

9. Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA. 2002;288(16):1987-1993. doi:10.1001/jama.288.16.1987

10. Magtibay DL, Chesak SS, Coughlin K, Sood A. Decreasing stress and burnout in nurses: efficacy of blended learning with stress management and resilience training program. J Nurs Adm. 2017;47(7-8):391-395. doi:10.1097/NNA.0000000000000501

11. Halbesleben JR, Wakefield BJ, Wakefield DS, Cooper LB. Nurse burnout and patient safety outcomes: nurse safety perception versus reporting behavior. West J Nurs Res. 2008;30(5):560-577. doi:10.1177/0193945907311322

12. Sherman RO. Creating a Battle Buddy program. September 2, 2021. Accessed September 27, 2022. https://www.emergingrnleader.com/creating-a-battle-buddy-program

13. Godfrey KM, Scott SD. At the heart of the pandemic: nursing peer support. Nurse Leader. 2021:19(2),188-193. doi:10.1016/j.mnl.2020.09.006

14. Wakefield M, Williams DR, Le Menestrel S, and Flaubert JL, Editors; Committee on the future of nursing 2020 2030; National Academy of Medicine; National Academies of Sciences, Engineering, and Medicine Institute of Medicine 2008. Retooling for an Aging America: Building the Health Care Workforce. Washington, DC: The National Academies Press. doi:10.17226/12089

15. Taylor RA. Contemporary issues: resilience training alone is an incomplete intervention. Nurs Educ Today. 2019;78:10-13. doi:10.1016/j.nedt.2019.03.014

16. Hofmann SG, Gómez AF. Mindfulness-based interventions for anxiety and depression. Psychiatr Clin North Am. 2017;40(4):739-749. doi:10.1016/j.psc.2017.08.008

17. Rutter M. Resilience in the face of adversity. Protective factors and resistance to psychiatric disorder. Br J Psychiatry. 1985;147:598-611. doi:10.1192/bjp.147.6.598

18. Zauszniewski JA, Bekhet AK, Suresky MJ. Indicators of resilience in family members of persons with serious mental Illness. Psychiatr Clin North Am. 2015;38(1):131-146. doi:10.1016/j.psc.2014.11.009

19. Celinski MJ. Framing resilience as transcendence and resourcefulness as transformation. In: Celinski MJ, Gow KM, eds. Continuity Versus Creative Response to Challenge: The Primacy of Resilience and Resourcefulness in Life and Therapy. Nova Science Pub Inc; 2011:11-30.

20. Zauszniewski JA, Lai CY, Tithiphontumrong S. Development and testing of the Resourcefulness Scale for Older Adults. J Nurs Meas. 2006:14(1):57-68. doi:10.1891.jnum.14.1.57

21. Zauszniewski JA, Bekhet AK. Measuring use of resourcefulness skills: psychometric testing of a new scale. ISRN Nurs. 2011;2011:787363. doi:10.5402/2011/787363

22. Zauszniewski JA, Lekhak N, Burant CJ, Variath M, Morris DL. preliminary evidence for effectiveness of resourcefulness training for women dementia caregivers. J Fam Med. 2016:3(5):1069.

23. Dolan ED, Mohr D, Lempa M, et al. Using a single item to measure burnout in primary care staff: a psychometric evaluation. J Gen Intern Med. 2015;30(5):582-587. doi:10.1007/s11606-014-3112-6

24. Zauszniewski JA Resourcefulness. In: Fitzpatrick JJ, ed. Encyclopedia of Nursing Research. 4th ed. 2018:632-634.

25. Combating Stress. American Nurses Association. Accessed November 28, 2022. https://www.nursingworld.org/practice-policy/work-environment/health-safety/combating-stress/

26. Albott CS, Wozniak JR, McGlinch BP, Wall MH, Gold BS, Vinogradov S. Battle Buddies: Rapid deployment of a psychological resilience intervention for health care workers during the COVID-19 pandemic. Anesth Analg. 2020;131(1):43-54. doi:10.1213/ANE.0000000000004912

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Denise M. Kresevic, RN, PhD, APN-BCa,b; Christopher J. Burant, PhD, MACTMa,c; Marilyn J. Swanson, DNP, FNP-Ca;  Jaclene A. Zauszniewski, PhD, RN-BCc

Correspondence:  Denise Kresevic  (denise.kresevic@va.gov)

aVA Northeast Ohio Healthcare System, Geriatric Research, Education, and Clinical Center, Cleveland

bUniversity Hospitals of Cleveland, Ohio

cFrances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio

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The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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The Veterans Affairs Northeast Ohio Healthcare System Institutional Review Board considered this project and determined that it was exempt from review.

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Correspondence:  Denise Kresevic  (denise.kresevic@va.gov)

aVA Northeast Ohio Healthcare System, Geriatric Research, Education, and Clinical Center, Cleveland

bUniversity Hospitals of Cleveland, Ohio

cFrances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The Veterans Affairs Northeast Ohio Healthcare System Institutional Review Board considered this project and determined that it was exempt from review.

Author and Disclosure Information

Denise M. Kresevic, RN, PhD, APN-BCa,b; Christopher J. Burant, PhD, MACTMa,c; Marilyn J. Swanson, DNP, FNP-Ca;  Jaclene A. Zauszniewski, PhD, RN-BCc

Correspondence:  Denise Kresevic  (denise.kresevic@va.gov)

aVA Northeast Ohio Healthcare System, Geriatric Research, Education, and Clinical Center, Cleveland

bUniversity Hospitals of Cleveland, Ohio

cFrances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The Veterans Affairs Northeast Ohio Healthcare System Institutional Review Board considered this project and determined that it was exempt from review.

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Related Articles

Nurses are recognized among the most trusted professions in the United States.1 Since the time of Florence Nightingale, nurses have been challenged to provide care to patients and soldiers with complex needs, including acute and chronic physical illness, as well as mental health issues. Nurses have traditionally met those challenges with perseverance and creativity but have also experienced stress and burnout.

A shortage of nurses has been linked to many interrelated factors including the retirement of bedside caregivers and educators, diverse care settings, expanding roles for nurses, and nurse burnout.2-4 Therefore, there is a critical need to better understand of how nurses can be supported while they care for patients, cope with stress, and maintain positive personal and professional outcomes. The objective of this pilot project was to assess US Department of Veterans Affairs (VA) nurses’ levels of burnout and test an intervention to enhance resourcefulness skills during the COVID-19 pandemic.

Background

Stress has many definitions. Hans Selye described it as a biological response of the body to any demand.5,6 Occupational stress is a process that occurs in which work environment stressors result in the development of psychological, behavioral, or physiological effects that can contribute to health.6 Occupational stress has been observed as prevalent among nurses.6 In 1960, Menzies identified sources of stress among nurses that include complex decision-making within a dynamic environment.7 Since the mid-1980s, nurses’ stress at work has increased because of legal, accreditation, ethical issues, fiscal pressures, staffing shortages, and the increasing integration of technology associated with clinical care.8

Sustained stress can lead to emotional exhaustion or burnout, which has been associated with nursing turnover, lower patient satisfaction, and patient safety risk.2,9 An American Nurses Foundation survey reported that 51% of US nurses feel exhausted, 43% overwhelmed, and 36% anxious; 28% express willingness to leave the profession.2 Burnout has been described as a response to physical or emotional stress leading to exhaustion, self-doubt, cynicism, and ineffectiveness.10 Employees with burnout are more likely to leave their jobs, take sick leave, and suffer from depression and relationship problems,and it affects nearly half of all US nurses, especially among critical care, pediatric, and oncology specialities.10,11 It has been well documented that unmitigated stress can lead to burnout and contribute to nurses leaving bedside care and the health care profession.2,3 Several studies on nursing stress and burnout have focused on its prevalence and negative outcomes.4,7,9 However, few studies have addressed building resiliency and resourcefulness for nurses.10,12,13

A 2021 National Academy of Medicine report advocated a multilevel approach to managing burnout and building resiliency among nurses.14 Taylor further identified specific interventions, ranging from primary prevention to treatment.15 Primary prevention could include educating nurses on self-awareness, coping strategies, and communication skills. Screening for burnout and providing resources for support would be a secondary level of intervention. For nurses who experienced severe burnout symptoms and left the workplace, strategies are sorely needed to provide healing and a return-to-work plan.15 This may include adjusting nurse schedules and nursing roles (such as admitting/discharge nurse or resource nurse).

 

 

RESILIENCY AND RESOURCEFULNESS

Rushton and colleagues describe resiliency as the “ability to face adverse situations, remain focused, and continue to be optimistic for the future.”4 For nurses in complex health care systems, resiliency is associated with reduced turnover and symptoms of burnout and improved mental health. Humans are thought to have an innate resiliency potential that evolves over time and fluctuates depending on the context (eg, societal conditions, moral/ethical values, commitments).4 It is believed that resiliency can contribute to the development of new neuropathways that can be used to manage and cope with stress, prevent burnout, and improve quality of life. However, it appears these adaptations are individualized and contingent on situations, available resources, and changing priorities.16 Consequently, resiliency may be an essential tool for nurses to combat burnout in today’s complex health care systems.17

Although resilience and resourcefulness are conceptually related, each has distinctive features.18 Celinski frames resilience as transcendence and resourcefulness as transformation.19 Thus, while resilience suggests transcendence in terms of rising above, going beyond, exceeding, or excelling; resourcefulness reflects transformation, such as making changes in thoughts, feelings, behaviors, actions, or reactions. Resourcefulness has been conceptualized as an indicator of resilience.18

Resourcefulness comprises 2 dimensions, including the use of self-help strategies (personal resourcefulness) and seeking help from others (social resourcefulness), to self-regulate one’s thoughts, feelings, and behaviors to cope with high levels of stress, anxiety, or depression.18,20,21 Personal resourcefulness skills include the use of cognitive reframing, positive thinking, problem-solving, priority-setting, and planning ahead. Social resourcefulness involves actively seeking help from others. Formal sources of help include, but are not limited to, nursing and medical care practitioners and community organizations such as hospitals and clinics. Informal sources of help include family members, friends, peers, and coworkers.

During the COVID-19 pandemic, nurses were especially challenged to provide support for each other because of limited nursing staff and treatment options, increased complex patient assignments, shortages of supplies, and reduced support services. Many nurses, however, were able to find innovative, peer-supported strategies for coping.13 Nurses’ use of resourcefulness skills is believed to be indicative of their resilience. This pilot project aimed to identify and evaluate some of these strategies and resourcefulness skills.

INTERVENTION

This pilot study among VA Northeast Ohio Health Care System (VANEOHS) nurses was designed to assess nursing burnout and resourcefulness during the pandemic. Those who agreed to participate completed a baseline survey on burnout and resourcefulness. Participants agreed to review a training video on resourcefulness skills (eg, relying on and exchanging ideas with others, and reframing and using ‘positive self-talk’). They were encouraged to document their experience with familiar and new resourcefulness skills. Weekly reminders (eg, emails and phone messages) reminded and coached participants in their journey.

The study identified and implemented an existing Resourcefulness Training (RT) intervention, which was developed for informal family caregivers and found to be effective.22 We measured burnout and resourcefulness preintervention and postintervention.23 This survey and educational intervention were reviewed by the VANEOHS institutional review board and ruled exempt. The survey also gathered information on nurses' contact with individuals infected with COVID-19.

Despite the many staffing and resource challenges during the COVID-19 pandemic, a convenience sample of 12 nurses was recruited from nursing committees that continued to have scheduled meetings. These meetings allowed time to answer questions and provide information about the study. The majority of nurses queried declined to participate, citing no time, interest, or burnout. Participants completed a baseline survey, reviewed a 30-minute RT video, and tracked their experience for 28 days. Participants completed postintervention surveys 6 weeks after the video. Details of the survey and measures can be found in previous studies.20,21

 

 

curuchupacralokislufrusuticraspejispipraredrubradriuifrushofraslechitocarahasishanacrelastutrihobruwifrucoshacrostoslosobipru

RT is an online cognitive-behavioral intervention that teaches and reinforces personal (self-help) and social (help-seeking) resourcefulness skills that have not yet been tested in nurses or other health care professionals.22,24 The training included social resourcefulness (eg, from family, friends, others, and professionals) and personal resourcefulness (eg, problem-solving, positive thinking, self-control, organization skills). Participants were encouraged to review the videos as often as they preferred during these 4 weeks.

caditrobifrebrostoswejuriswewaclashastuprudropacaciwrobecokacrobucrihostifruphedoshepreswesaduhifrowrudricreproshuvehaphucicloslithovubritobochifrechacrimewrochetikawruspotricadrupopruwagagurap

All 12 survey respondents were female and had received COVID-19 vaccinations according to the federal policy at the time of data collection. The number of patients cared for with COVID-19 infections varied widely (range, 1-1000). The baseline burnout score ranged from 1 (no burnout) to 3 (1 symptom of burnout, such as physical and emotional exhaustion), with a mean score of 2.2. In the follow-up survey, the mean score was 2.0. At baseline, participants reported a variety of activities to manage stress and burnout, including times with friends and family, engaging in hobbies, and prayer. Postintervention, some participants mentioned using skills learned from RT, including reframing the situation positively by refocusing and putting stressors in perspective (Table 1).

DISCUSSION

Recent American Nurses Association efforts to develop organizational and professional goals include the importance of nurses to recognize and manage stress to prevent burnout.25 The American Nurses Association Code of Ethics notes that nurses have the same duties to care for themselves as they do for others.25 Nurses have demonstrated the ability to adapt and remain resilient during stressful times. VA nurses are a resourceful group. Many used resourcefulness skills to manage stress and burnout even before the pandemic. For example, nurses identified using family/friends for support and validation, as well as prayer and meditation. Some of the new activities may have been influenced/inspired by RT, such as organizing schedules for problem-solving and distraction.

Relying on family and peers emerged as an essential resourcefulness skill. Support from peers—battle buddies—has been recognized as a key strategy among combat soldiers. A battle buddy is paired with a fellow soldier for support to keep each other informed about key instructions and information. This promotes cooperative problem-solving. Outcomes associated with battle buddies include increased morale and confidence, and decreased stress.25 Over time, it is hoped that these coaching/mentoring relationships will result in enhanced leadership skills. Battle buddy strategies are currently being adapted into health care environments.12,26 Such programs need to be further evaluated and information disseminated.

Findings from this pilot program support the use of interventions such as RT to decrease burnout among nurses. This study suggests that RT should be tested in a larger more representative sample to determine efficacy.

Limitations

This pilot study was limited by its small sample size, single facility, and female-only participants; the findings are not generalizable. Nurses were recruited from VA nursing committees and may not be representative of nurses in the general population. In addition, the RT intervention may require a longer time commitment to adequately determine efficacy. Another limitation was that personal or family exposure to COVID-19 was not measured, but may be a confounding variable. An additional limitation may have been the time interval. A baseline survey was completed prior to watching the teaching video. Daily logs were to be completed for 28 days. A post survey followed at 6 weeks. It is possible that there was insufficient time for the nurses to have the opportunity to use their resourcefulness skills within the short time frame of the study. While it supports the need for further studies, findings should be interpreted cautiously and not generalized. It may be premature based on these findings to conclude that the intervention will be effective for other populations. Further studies are needed to assess nurses’ preferences for healthy coping mechanisms, including RT.

Conclusions

As the nursing shortage continues, efforts to support diverse, innovative coping strategies remain a priority postpandemic. Nurses must be vigilant in appraising and managing their ability to cope and adapt to individual stress, while also being aware of the stress their colleagues are experiencing. Educational institutions, professional organizations, and health care facilities must strive to educate and support nurses to identify not only stress, but healthy coping mechanisms.

Acknowledgments

This work was supported by the US Department of Veterans Affairs Central Office rapid response COVID-19 funding initiative, the Veteran Affairs Northeast Ohio Health Care System, and Geriatric Research, Education, and Clinical Center (GRECC). The Resourcefulness Scale, Resourcefulness Skills Scale, and the Resourcefulness Training intervention are copyrighted and were used with permission of the copyright holder, Jaclene A. Zauszniewski, MD.

Nurses are recognized among the most trusted professions in the United States.1 Since the time of Florence Nightingale, nurses have been challenged to provide care to patients and soldiers with complex needs, including acute and chronic physical illness, as well as mental health issues. Nurses have traditionally met those challenges with perseverance and creativity but have also experienced stress and burnout.

A shortage of nurses has been linked to many interrelated factors including the retirement of bedside caregivers and educators, diverse care settings, expanding roles for nurses, and nurse burnout.2-4 Therefore, there is a critical need to better understand of how nurses can be supported while they care for patients, cope with stress, and maintain positive personal and professional outcomes. The objective of this pilot project was to assess US Department of Veterans Affairs (VA) nurses’ levels of burnout and test an intervention to enhance resourcefulness skills during the COVID-19 pandemic.

Background

Stress has many definitions. Hans Selye described it as a biological response of the body to any demand.5,6 Occupational stress is a process that occurs in which work environment stressors result in the development of psychological, behavioral, or physiological effects that can contribute to health.6 Occupational stress has been observed as prevalent among nurses.6 In 1960, Menzies identified sources of stress among nurses that include complex decision-making within a dynamic environment.7 Since the mid-1980s, nurses’ stress at work has increased because of legal, accreditation, ethical issues, fiscal pressures, staffing shortages, and the increasing integration of technology associated with clinical care.8

Sustained stress can lead to emotional exhaustion or burnout, which has been associated with nursing turnover, lower patient satisfaction, and patient safety risk.2,9 An American Nurses Foundation survey reported that 51% of US nurses feel exhausted, 43% overwhelmed, and 36% anxious; 28% express willingness to leave the profession.2 Burnout has been described as a response to physical or emotional stress leading to exhaustion, self-doubt, cynicism, and ineffectiveness.10 Employees with burnout are more likely to leave their jobs, take sick leave, and suffer from depression and relationship problems,and it affects nearly half of all US nurses, especially among critical care, pediatric, and oncology specialities.10,11 It has been well documented that unmitigated stress can lead to burnout and contribute to nurses leaving bedside care and the health care profession.2,3 Several studies on nursing stress and burnout have focused on its prevalence and negative outcomes.4,7,9 However, few studies have addressed building resiliency and resourcefulness for nurses.10,12,13

A 2021 National Academy of Medicine report advocated a multilevel approach to managing burnout and building resiliency among nurses.14 Taylor further identified specific interventions, ranging from primary prevention to treatment.15 Primary prevention could include educating nurses on self-awareness, coping strategies, and communication skills. Screening for burnout and providing resources for support would be a secondary level of intervention. For nurses who experienced severe burnout symptoms and left the workplace, strategies are sorely needed to provide healing and a return-to-work plan.15 This may include adjusting nurse schedules and nursing roles (such as admitting/discharge nurse or resource nurse).

 

 

RESILIENCY AND RESOURCEFULNESS

Rushton and colleagues describe resiliency as the “ability to face adverse situations, remain focused, and continue to be optimistic for the future.”4 For nurses in complex health care systems, resiliency is associated with reduced turnover and symptoms of burnout and improved mental health. Humans are thought to have an innate resiliency potential that evolves over time and fluctuates depending on the context (eg, societal conditions, moral/ethical values, commitments).4 It is believed that resiliency can contribute to the development of new neuropathways that can be used to manage and cope with stress, prevent burnout, and improve quality of life. However, it appears these adaptations are individualized and contingent on situations, available resources, and changing priorities.16 Consequently, resiliency may be an essential tool for nurses to combat burnout in today’s complex health care systems.17

Although resilience and resourcefulness are conceptually related, each has distinctive features.18 Celinski frames resilience as transcendence and resourcefulness as transformation.19 Thus, while resilience suggests transcendence in terms of rising above, going beyond, exceeding, or excelling; resourcefulness reflects transformation, such as making changes in thoughts, feelings, behaviors, actions, or reactions. Resourcefulness has been conceptualized as an indicator of resilience.18

Resourcefulness comprises 2 dimensions, including the use of self-help strategies (personal resourcefulness) and seeking help from others (social resourcefulness), to self-regulate one’s thoughts, feelings, and behaviors to cope with high levels of stress, anxiety, or depression.18,20,21 Personal resourcefulness skills include the use of cognitive reframing, positive thinking, problem-solving, priority-setting, and planning ahead. Social resourcefulness involves actively seeking help from others. Formal sources of help include, but are not limited to, nursing and medical care practitioners and community organizations such as hospitals and clinics. Informal sources of help include family members, friends, peers, and coworkers.

During the COVID-19 pandemic, nurses were especially challenged to provide support for each other because of limited nursing staff and treatment options, increased complex patient assignments, shortages of supplies, and reduced support services. Many nurses, however, were able to find innovative, peer-supported strategies for coping.13 Nurses’ use of resourcefulness skills is believed to be indicative of their resilience. This pilot project aimed to identify and evaluate some of these strategies and resourcefulness skills.

INTERVENTION

This pilot study among VA Northeast Ohio Health Care System (VANEOHS) nurses was designed to assess nursing burnout and resourcefulness during the pandemic. Those who agreed to participate completed a baseline survey on burnout and resourcefulness. Participants agreed to review a training video on resourcefulness skills (eg, relying on and exchanging ideas with others, and reframing and using ‘positive self-talk’). They were encouraged to document their experience with familiar and new resourcefulness skills. Weekly reminders (eg, emails and phone messages) reminded and coached participants in their journey.

The study identified and implemented an existing Resourcefulness Training (RT) intervention, which was developed for informal family caregivers and found to be effective.22 We measured burnout and resourcefulness preintervention and postintervention.23 This survey and educational intervention were reviewed by the VANEOHS institutional review board and ruled exempt. The survey also gathered information on nurses' contact with individuals infected with COVID-19.

Despite the many staffing and resource challenges during the COVID-19 pandemic, a convenience sample of 12 nurses was recruited from nursing committees that continued to have scheduled meetings. These meetings allowed time to answer questions and provide information about the study. The majority of nurses queried declined to participate, citing no time, interest, or burnout. Participants completed a baseline survey, reviewed a 30-minute RT video, and tracked their experience for 28 days. Participants completed postintervention surveys 6 weeks after the video. Details of the survey and measures can be found in previous studies.20,21

 

 

curuchupacralokislufrusuticraspejispipraredrubradriuifrushofraslechitocarahasishanacrelastutrihobruwifrucoshacrostoslosobipru

RT is an online cognitive-behavioral intervention that teaches and reinforces personal (self-help) and social (help-seeking) resourcefulness skills that have not yet been tested in nurses or other health care professionals.22,24 The training included social resourcefulness (eg, from family, friends, others, and professionals) and personal resourcefulness (eg, problem-solving, positive thinking, self-control, organization skills). Participants were encouraged to review the videos as often as they preferred during these 4 weeks.

caditrobifrebrostoswejuriswewaclashastuprudropacaciwrobecokacrobucrihostifruphedoshepreswesaduhifrowrudricreproshuvehaphucicloslithovubritobochifrechacrimewrochetikawruspotricadrupopruwagagurap

All 12 survey respondents were female and had received COVID-19 vaccinations according to the federal policy at the time of data collection. The number of patients cared for with COVID-19 infections varied widely (range, 1-1000). The baseline burnout score ranged from 1 (no burnout) to 3 (1 symptom of burnout, such as physical and emotional exhaustion), with a mean score of 2.2. In the follow-up survey, the mean score was 2.0. At baseline, participants reported a variety of activities to manage stress and burnout, including times with friends and family, engaging in hobbies, and prayer. Postintervention, some participants mentioned using skills learned from RT, including reframing the situation positively by refocusing and putting stressors in perspective (Table 1).

DISCUSSION

Recent American Nurses Association efforts to develop organizational and professional goals include the importance of nurses to recognize and manage stress to prevent burnout.25 The American Nurses Association Code of Ethics notes that nurses have the same duties to care for themselves as they do for others.25 Nurses have demonstrated the ability to adapt and remain resilient during stressful times. VA nurses are a resourceful group. Many used resourcefulness skills to manage stress and burnout even before the pandemic. For example, nurses identified using family/friends for support and validation, as well as prayer and meditation. Some of the new activities may have been influenced/inspired by RT, such as organizing schedules for problem-solving and distraction.

Relying on family and peers emerged as an essential resourcefulness skill. Support from peers—battle buddies—has been recognized as a key strategy among combat soldiers. A battle buddy is paired with a fellow soldier for support to keep each other informed about key instructions and information. This promotes cooperative problem-solving. Outcomes associated with battle buddies include increased morale and confidence, and decreased stress.25 Over time, it is hoped that these coaching/mentoring relationships will result in enhanced leadership skills. Battle buddy strategies are currently being adapted into health care environments.12,26 Such programs need to be further evaluated and information disseminated.

Findings from this pilot program support the use of interventions such as RT to decrease burnout among nurses. This study suggests that RT should be tested in a larger more representative sample to determine efficacy.

Limitations

This pilot study was limited by its small sample size, single facility, and female-only participants; the findings are not generalizable. Nurses were recruited from VA nursing committees and may not be representative of nurses in the general population. In addition, the RT intervention may require a longer time commitment to adequately determine efficacy. Another limitation was that personal or family exposure to COVID-19 was not measured, but may be a confounding variable. An additional limitation may have been the time interval. A baseline survey was completed prior to watching the teaching video. Daily logs were to be completed for 28 days. A post survey followed at 6 weeks. It is possible that there was insufficient time for the nurses to have the opportunity to use their resourcefulness skills within the short time frame of the study. While it supports the need for further studies, findings should be interpreted cautiously and not generalized. It may be premature based on these findings to conclude that the intervention will be effective for other populations. Further studies are needed to assess nurses’ preferences for healthy coping mechanisms, including RT.

Conclusions

As the nursing shortage continues, efforts to support diverse, innovative coping strategies remain a priority postpandemic. Nurses must be vigilant in appraising and managing their ability to cope and adapt to individual stress, while also being aware of the stress their colleagues are experiencing. Educational institutions, professional organizations, and health care facilities must strive to educate and support nurses to identify not only stress, but healthy coping mechanisms.

Acknowledgments

This work was supported by the US Department of Veterans Affairs Central Office rapid response COVID-19 funding initiative, the Veteran Affairs Northeast Ohio Health Care System, and Geriatric Research, Education, and Clinical Center (GRECC). The Resourcefulness Scale, Resourcefulness Skills Scale, and the Resourcefulness Training intervention are copyrighted and were used with permission of the copyright holder, Jaclene A. Zauszniewski, MD.

References

1. Walker A. Nursing ranked as the most trusted profession for 22nd year in a row. January 23, 2024. Accessed January 31, 2024. https://nurse.org/articles/nursing-ranked-most-honest-profession

2. Mental health and wellness survey 1. American Nurses Foundation. August 2020. Accessed January 31, 2024. https://www.nursingworld.org/practice-policy/work-environment/health-safety/disaster-preparedness/coronavirus/what-you-need-to-know/mental-health-and-wellbeing-survey/

3. Healthy nurse, healthy nation. American Nurses Association. May 1, 2017. Accessed January 31, 2024. https://www.healthynursehealthynation.org/

4. Rushton CH, Batcheller J, Schroeder K, Donohue P. Burnout and resilience among nurses practicing in high-intensity settings. Am J Crit Care. 2015;24(5):412-420. doi:10.4037/ajcc2015291

5. Selye HA. History and general outline of the stress concept. Stress in Health and Disease. Butterworths; 1976:3-34.

6. Levy BS, Wegman DH, Baron SL, Sokas RK. Recognizing and preventing occupational and environmental disease and injury. Occupational and Environmental Health: Recognizing and Preventing Disease and Injury. 6th ed. Oxford University Press; 2011:59-77.

7. Menzies IEP. Nurses under stress. Int Nurs Rev. 1960;7:9-16.

8. Jennings BM. Turbulence. In: Hughes RG, ed. Advances in Patient Safety and Quality: An Evidence-Based Handbook for Nurses. 3rd ed. AHRQ Publication; 2007;2;193-202.

9. Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA. 2002;288(16):1987-1993. doi:10.1001/jama.288.16.1987

10. Magtibay DL, Chesak SS, Coughlin K, Sood A. Decreasing stress and burnout in nurses: efficacy of blended learning with stress management and resilience training program. J Nurs Adm. 2017;47(7-8):391-395. doi:10.1097/NNA.0000000000000501

11. Halbesleben JR, Wakefield BJ, Wakefield DS, Cooper LB. Nurse burnout and patient safety outcomes: nurse safety perception versus reporting behavior. West J Nurs Res. 2008;30(5):560-577. doi:10.1177/0193945907311322

12. Sherman RO. Creating a Battle Buddy program. September 2, 2021. Accessed September 27, 2022. https://www.emergingrnleader.com/creating-a-battle-buddy-program

13. Godfrey KM, Scott SD. At the heart of the pandemic: nursing peer support. Nurse Leader. 2021:19(2),188-193. doi:10.1016/j.mnl.2020.09.006

14. Wakefield M, Williams DR, Le Menestrel S, and Flaubert JL, Editors; Committee on the future of nursing 2020 2030; National Academy of Medicine; National Academies of Sciences, Engineering, and Medicine Institute of Medicine 2008. Retooling for an Aging America: Building the Health Care Workforce. Washington, DC: The National Academies Press. doi:10.17226/12089

15. Taylor RA. Contemporary issues: resilience training alone is an incomplete intervention. Nurs Educ Today. 2019;78:10-13. doi:10.1016/j.nedt.2019.03.014

16. Hofmann SG, Gómez AF. Mindfulness-based interventions for anxiety and depression. Psychiatr Clin North Am. 2017;40(4):739-749. doi:10.1016/j.psc.2017.08.008

17. Rutter M. Resilience in the face of adversity. Protective factors and resistance to psychiatric disorder. Br J Psychiatry. 1985;147:598-611. doi:10.1192/bjp.147.6.598

18. Zauszniewski JA, Bekhet AK, Suresky MJ. Indicators of resilience in family members of persons with serious mental Illness. Psychiatr Clin North Am. 2015;38(1):131-146. doi:10.1016/j.psc.2014.11.009

19. Celinski MJ. Framing resilience as transcendence and resourcefulness as transformation. In: Celinski MJ, Gow KM, eds. Continuity Versus Creative Response to Challenge: The Primacy of Resilience and Resourcefulness in Life and Therapy. Nova Science Pub Inc; 2011:11-30.

20. Zauszniewski JA, Lai CY, Tithiphontumrong S. Development and testing of the Resourcefulness Scale for Older Adults. J Nurs Meas. 2006:14(1):57-68. doi:10.1891.jnum.14.1.57

21. Zauszniewski JA, Bekhet AK. Measuring use of resourcefulness skills: psychometric testing of a new scale. ISRN Nurs. 2011;2011:787363. doi:10.5402/2011/787363

22. Zauszniewski JA, Lekhak N, Burant CJ, Variath M, Morris DL. preliminary evidence for effectiveness of resourcefulness training for women dementia caregivers. J Fam Med. 2016:3(5):1069.

23. Dolan ED, Mohr D, Lempa M, et al. Using a single item to measure burnout in primary care staff: a psychometric evaluation. J Gen Intern Med. 2015;30(5):582-587. doi:10.1007/s11606-014-3112-6

24. Zauszniewski JA Resourcefulness. In: Fitzpatrick JJ, ed. Encyclopedia of Nursing Research. 4th ed. 2018:632-634.

25. Combating Stress. American Nurses Association. Accessed November 28, 2022. https://www.nursingworld.org/practice-policy/work-environment/health-safety/combating-stress/

26. Albott CS, Wozniak JR, McGlinch BP, Wall MH, Gold BS, Vinogradov S. Battle Buddies: Rapid deployment of a psychological resilience intervention for health care workers during the COVID-19 pandemic. Anesth Analg. 2020;131(1):43-54. doi:10.1213/ANE.0000000000004912

References

1. Walker A. Nursing ranked as the most trusted profession for 22nd year in a row. January 23, 2024. Accessed January 31, 2024. https://nurse.org/articles/nursing-ranked-most-honest-profession

2. Mental health and wellness survey 1. American Nurses Foundation. August 2020. Accessed January 31, 2024. https://www.nursingworld.org/practice-policy/work-environment/health-safety/disaster-preparedness/coronavirus/what-you-need-to-know/mental-health-and-wellbeing-survey/

3. Healthy nurse, healthy nation. American Nurses Association. May 1, 2017. Accessed January 31, 2024. https://www.healthynursehealthynation.org/

4. Rushton CH, Batcheller J, Schroeder K, Donohue P. Burnout and resilience among nurses practicing in high-intensity settings. Am J Crit Care. 2015;24(5):412-420. doi:10.4037/ajcc2015291

5. Selye HA. History and general outline of the stress concept. Stress in Health and Disease. Butterworths; 1976:3-34.

6. Levy BS, Wegman DH, Baron SL, Sokas RK. Recognizing and preventing occupational and environmental disease and injury. Occupational and Environmental Health: Recognizing and Preventing Disease and Injury. 6th ed. Oxford University Press; 2011:59-77.

7. Menzies IEP. Nurses under stress. Int Nurs Rev. 1960;7:9-16.

8. Jennings BM. Turbulence. In: Hughes RG, ed. Advances in Patient Safety and Quality: An Evidence-Based Handbook for Nurses. 3rd ed. AHRQ Publication; 2007;2;193-202.

9. Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA. 2002;288(16):1987-1993. doi:10.1001/jama.288.16.1987

10. Magtibay DL, Chesak SS, Coughlin K, Sood A. Decreasing stress and burnout in nurses: efficacy of blended learning with stress management and resilience training program. J Nurs Adm. 2017;47(7-8):391-395. doi:10.1097/NNA.0000000000000501

11. Halbesleben JR, Wakefield BJ, Wakefield DS, Cooper LB. Nurse burnout and patient safety outcomes: nurse safety perception versus reporting behavior. West J Nurs Res. 2008;30(5):560-577. doi:10.1177/0193945907311322

12. Sherman RO. Creating a Battle Buddy program. September 2, 2021. Accessed September 27, 2022. https://www.emergingrnleader.com/creating-a-battle-buddy-program

13. Godfrey KM, Scott SD. At the heart of the pandemic: nursing peer support. Nurse Leader. 2021:19(2),188-193. doi:10.1016/j.mnl.2020.09.006

14. Wakefield M, Williams DR, Le Menestrel S, and Flaubert JL, Editors; Committee on the future of nursing 2020 2030; National Academy of Medicine; National Academies of Sciences, Engineering, and Medicine Institute of Medicine 2008. Retooling for an Aging America: Building the Health Care Workforce. Washington, DC: The National Academies Press. doi:10.17226/12089

15. Taylor RA. Contemporary issues: resilience training alone is an incomplete intervention. Nurs Educ Today. 2019;78:10-13. doi:10.1016/j.nedt.2019.03.014

16. Hofmann SG, Gómez AF. Mindfulness-based interventions for anxiety and depression. Psychiatr Clin North Am. 2017;40(4):739-749. doi:10.1016/j.psc.2017.08.008

17. Rutter M. Resilience in the face of adversity. Protective factors and resistance to psychiatric disorder. Br J Psychiatry. 1985;147:598-611. doi:10.1192/bjp.147.6.598

18. Zauszniewski JA, Bekhet AK, Suresky MJ. Indicators of resilience in family members of persons with serious mental Illness. Psychiatr Clin North Am. 2015;38(1):131-146. doi:10.1016/j.psc.2014.11.009

19. Celinski MJ. Framing resilience as transcendence and resourcefulness as transformation. In: Celinski MJ, Gow KM, eds. Continuity Versus Creative Response to Challenge: The Primacy of Resilience and Resourcefulness in Life and Therapy. Nova Science Pub Inc; 2011:11-30.

20. Zauszniewski JA, Lai CY, Tithiphontumrong S. Development and testing of the Resourcefulness Scale for Older Adults. J Nurs Meas. 2006:14(1):57-68. doi:10.1891.jnum.14.1.57

21. Zauszniewski JA, Bekhet AK. Measuring use of resourcefulness skills: psychometric testing of a new scale. ISRN Nurs. 2011;2011:787363. doi:10.5402/2011/787363

22. Zauszniewski JA, Lekhak N, Burant CJ, Variath M, Morris DL. preliminary evidence for effectiveness of resourcefulness training for women dementia caregivers. J Fam Med. 2016:3(5):1069.

23. Dolan ED, Mohr D, Lempa M, et al. Using a single item to measure burnout in primary care staff: a psychometric evaluation. J Gen Intern Med. 2015;30(5):582-587. doi:10.1007/s11606-014-3112-6

24. Zauszniewski JA Resourcefulness. In: Fitzpatrick JJ, ed. Encyclopedia of Nursing Research. 4th ed. 2018:632-634.

25. Combating Stress. American Nurses Association. Accessed November 28, 2022. https://www.nursingworld.org/practice-policy/work-environment/health-safety/combating-stress/

26. Albott CS, Wozniak JR, McGlinch BP, Wall MH, Gold BS, Vinogradov S. Battle Buddies: Rapid deployment of a psychological resilience intervention for health care workers during the COVID-19 pandemic. Anesth Analg. 2020;131(1):43-54. doi:10.1213/ANE.0000000000004912

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Zauszniewski, PhD, RN-BCc</bylineText> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>Nurses are recognized among the most trusted professions in the United States.1 Since the time of Florence Nightingale, nurses have been challenged to provide c</metaDescription> <articlePDF/> <teaserImage/> <title>Evaluation of a Stress, Coping, and Resourcefulness Program for VA Nurses During the COVID-19 Pandemic</title> <deck/> <eyebrow>Program Profile</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>May</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>5</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>4473</CMSID> <CMSID>3729</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>May 2024</pubIssueName> <pubArticleType>Columns | 3729</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Program Profile | 4473<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> </sections> <topics> <term canonical="true">248</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Evaluation of a Stress, Coping, and Resourcefulness Program for VA Nurses During the COVID-19 Pandemic</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>B</b><b>ackground:</b> The COVID-19 pandemic, combined with the shortage of nursing staff, contributed to higher levels of stress. Sustained stress has been associated with burnout. However, nurses have traditionally demonstrated resourcefulness skills that resulted in building resilience. <br/><br/><b>Observations:</b> This pilot project recruited US Department of Veterans (VA) registered and advanced practice nurses to participate in a resourcefulness skills training initiative. VA nurses were found to have a moderate level of burnout at baseline. Nurses participated in Resourcefulness Training to handle stress and possible burnout. Resourcefulness Training themes included accessing family and peer support, developing organizational and problem-solving skills, and using distraction.<br/><br/><b>Conclusions:</b> Nurses must be vigilant in appraising and managing their ability to cope and adapt to individual stress, while also being aware of their colleagues' stress levels. Educational institutions, professional organizations, and health care facilities must strive to educate and support nurses in identifying stress and healthy coping mechanisms. In this project, relying on family and peers emerged as an important resourcefulness skill. </p> <p><span class="Drop">N</span>urses are recognized among the most trusted professions in the United States.<sup>1</sup> Since the time of Florence Nightingale, nurses have been challenged to provide care to patients and soldiers with complex needs, including acute and chronic physical illness, as well as mental health issues. Nurses have traditionally met those challenges with perseverance and creativity but have also experienced stress and burnout. </p> <p>A shortage of nurses has been linked to many interrelated factors including the retirement of bedside caregivers and educators, diverse care settings, expanding roles for nurses, and nurse burnout.<sup>2-4</sup> Therefore, there is a critical need to better understand of how nurses can be supported while they care for patients, cope with stress, and maintain positive personal and professional outcomes. The objective of this pilot project was to assess US Department of Veterans Affairs (VA) nurses’ levels of burnout and test an intervention to enhance resourcefulness skills during the COVID-19 pandemic. </p> <h2>Background</h2> <p>Stress has many definitions. Hans Selye described it as a biological response of the body to any demand.<sup>5,6</sup> Occupational stress is a process that occurs in which work environment stressors result in the development of psychological, behavioral, or physiological effects that can contribute to health.<sup>6</sup> Occupational stress has been observed as prevalent among nurses.<sup>6</sup> In 1960, Menzies identified sources of stress among nurses that include complex decision-making within a dynamic environment.<sup>7</sup> Since the mid-1980s, nurses’ stress at work has increased because of legal, accreditation, ethical issues, fiscal pressures, staffing shortages, and the increasing integration of technology associated with clinical care.<sup>8</sup></p> <p>Sustained stress can lead to emotional exhaustion or burnout, which has been associated with nursing turnover, lower patient satisfaction, and patient safety risk.<sup>2,9</sup> An American Nurses Foundation survey reported that 51% of US nurses feel exhausted, 43% overwhelmed, and 36% anxious; 28% express willingness to leave the profession.<sup>2</sup> Burnout has been described as a response to physical or emotional stress leading to exhaustion, self-doubt, cynicism, and ineffectiveness.<sup>10</sup> Employees with burnout are more likely to leave their jobs, take sick leave, and suffer from depression and relationship problems,<sup> </sup>and it affects nearly half of all US nurses, especially among critical care, pediatric, and oncology specialities.<sup>10,11</sup> It has been well documented that unmitigated stress can lead to burnout and contribute to nurses leaving bedside care and the health care profession.<sup>2,3</sup> Several studies on nursing stress and burnout have focused on its prevalence and negative outcomes.<sup>4,7,9</sup> However, few studies have addressed building resiliency and resourcefulness for nurses.<sup>10,12,13<br/><br/></sup>A 2021 National Academy of Medicine report advocated a multilevel approach to managing burnout and building resiliency among nurses.<sup>14</sup> Taylor further identified specific interventions, ranging from primary prevention to treatment.<sup>15</sup> Primary prevention could include educating nurses on self-awareness, coping strategies, and communication skills. Screening for burnout and providing resources for support would be a secondary level of intervention. For nurses who experienced severe burnout symptoms and left the workplace, strategies are sorely needed to provide healing and a return-to-work plan.<sup>15</sup> This may include adjusting nurse schedules and nursing roles (such as admitting/discharge nurse or resource nurse).</p> <h2>RESILIENCY AND RESOURCEFULNESS</h2> <p>Rushton and colleagues describe resiliency as the “ability to face adverse situations, remain focused, and continue to be optimistic for the future.”<sup>4</sup> For nurses in complex health care systems, resiliency is associated with reduced turnover and symptoms of burnout and improved mental health. Humans are thought to have an innate resiliency potential that evolves over time and fluctuates depending on the context (eg, societal conditions, moral/ethical values, commitments).<sup>4</sup> It is believed that resiliency can contribute to the development of new neuropathways that can be used to manage and cope with stress, prevent burnout, and improve quality of life. However, it appears these adaptations are individualized and contingent on situations, available resources, and changing priorities.<sup>16</sup> Consequently, resiliency may be an essential tool for nurses to combat burnout in today’s complex health care systems.<sup>17</sup></p> <p>Although resilience and resourcefulness are conceptually related, each has distinctive features.<sup>18</sup> Celinski frames resilience as transcendence and resourcefulness as transformation.<sup>19</sup> Thus, while resilience suggests transcendence in terms of rising above, going beyond, exceeding, or excelling; resourcefulness reflects transformation, such as making changes in thoughts, feelings, behaviors, actions, or reactions. Resourcefulness has been conceptualized as an indicator of resilience.<sup>18<br/><br/></sup>Resourcefulness comprises 2 dimensions, including the use of self-help strategies (personal resourcefulness) and seeking help from others (social resourcefulness), to self-regulate one’s thoughts, feelings, and behaviors to cope with high levels of stress, anxiety, or depression.<sup>18,20,21</sup> Personal resourcefulness skills include the use of cognitive reframing, positive thinking, problem-solving, priority-setting, and planning ahead. Social resourcefulness involves actively seeking help from others. Formal sources of help include, but are not limited to, nursing and medical care practitioners and community organizations such as hospitals and clinics. Informal sources of help include family members, friends, peers, and coworkers.<br/><br/>During the COVID-19 pandemic, nurses were especially challenged to provide support for each other because of limited nursing staff and treatment options, increased complex patient assignments, shortages of supplies, and reduced support services. Many nurses, however, were able to find innovative, peer-supported strategies for coping.<sup>13</sup> Nurses’ use of resourcefulness skills is believed to be indicative of their resilience. This pilot project aimed to identify and evaluate some of these strategies and resourcefulness skills.</p> <h2>INTERVENTION</h2> <p>This pilot study among VA Northeast Ohio Health Care System<b> </b>(VANEOHS) nurses was designed to assess nursing burnout and resourcefulness during the pandemic. Those who agreed to participate completed a baseline survey on burnout and resourcefulness. Participants agreed to review a training video on resourcefulness skills (eg, relying on and exchanging ideas with others, and reframing and using ‘positive self-talk’). They were encouraged to document their experience with familiar and new resourcefulness skills. Weekly reminders (eg, emails and phone messages) reminded and coached participants in their journey.</p> <p>The study identified and implemented an existing Resourcefulness Training (RT) intervention, which was developed for informal family caregivers and found to be effective.<sup>22</sup> We measured burnout and resourcefulness preintervention and postintervention.<sup>23</sup> This survey and educational intervention were reviewed by the VANEOHS institutional review board and ruled exempt. The survey also gathered information on nurses' contact with individuals infected with COVID-19.<br/><br/>Despite the many staffing and resource challenges during the COVID-19 pandemic, a convenience sample of 12 nurses was recruited from nursing committees that continued to have scheduled meetings. These meetings allowed time to answer questions and provide information about the study. The majority of nurses queried declined to participate, citing no time, interest, or burnout. Participants completed a baseline survey, reviewed a 30-minute RT video, and tracked their experience for 28 days. Participants completed postintervention surveys 6 weeks after the video. Details of the survey and measures can be found in previous studies.<sup>20,21</sup> <br/><br/>RT is an online cognitive-behavioral intervention that teaches and reinforces personal (self-help) and social (help-seeking) resourcefulness skills that have not yet been tested in nurses or other health care professionals.<sup>22,24</sup> The training included social resourcefulness (eg, from family, friends, others, and professionals) and personal resourcefulness (eg, problem-solving, positive thinking, self-control, organization skills). Participants were encouraged to review the videos as often as they preferred during these 4 weeks.<br/><br/>All 12 survey respondents were female and had received COVID-19 vaccinations according to the federal policy at the time of data collection (Table 1). The number of patients cared for with COVID-19 infections varied widely (range, 1-1000). The baseline burnout score ranged from 1 (no burnout) to 3 (1 symptom of burnout, such as physical and emotional exhaustion), with a mean score of 2.2. In the follow-up survey, the mean score was 2.0. At baseline, participants reported a variety of activities to manage stress and burnout, including times with friends and family, engaging in hobbies, and prayer. Postintervention, some participants mentioned using skills learned from RT, including reframing the situation positively by refocusing and putting stressors in perspective (Table 2). </p> <h2>DISCUSSION </h2> <p>Recent American Nurses Association efforts to develop organizational and professional goals include the importance of nurses to recognize and manage stress to prevent burnout.<sup>25</sup> The American Nurses Association Code of Ethics notes that nurses have the same duties to care for themselves as they do for others.<sup>25</sup> Nurses have demonstrated the ability to adapt and remain resilient during stressful times. VA nurses are a resourceful group. Many used resourcefulness skills to manage stress and burnout even before the pandemic. For example, nurses identified using family/friends for support and validation, as well as prayer and meditation. Some of the new activities may have been influenced/inspired by RT, such as organizing schedules for problem-solving and distraction.</p> <p>Relying on family and peers emerged as an essential resourcefulness skill. Support from peers—battle buddies—has been recognized as a key strategy among combat soldiers. A battle buddy is paired with a fellow soldier for support to keep each other informed about key instructions and information. This promotes cooperative problem-solving. Outcomes associated with battle buddies include increased morale and confidence, and decreased stress.<sup>25</sup> Over time, it is hoped that these coaching/mentoring relationships will result in enhanced leadership skills. Battle buddy strategies are currently being adapted into health care environments.<sup>12,26</sup> Such programs need to be further evaluated and information disseminated.<br/><br/>Findings from this pilot program support the use of interventions such as RT to decrease burnout among nurses. This study suggests that RT should be tested in a larger more representative sample to determine efficacy. </p> <h3>Limitations</h3> <p>This pilot study was limited by its small sample size, single facility, and female-only participants; the findings are not generalizable. Nurses were recruited from VA nursing committees and may not be representative of nurses in the general population. In addition, the RT intervention may require a longer time commitment to adequately determine efficacy. Another limitation was that personal or family exposure to COVID-19 was not measured, but may be a confounding variable. An additional limitation may have been the time interval. A baseline survey was completed prior to watching the teaching video. Daily logs were to be completed for 28 days. A post survey followed at 6 weeks. It is possible that there was insufficient time for the nurses to have the opportunity to use their resourcefulness skills within the short time frame of the study. While it supports the need for further studies, findings should be interpreted cautiously and not generalized. It may be premature based on these findings to conclude that the intervention will be effective for other populations. Further studies are needed to assess nurses’ preferences for healthy coping mechanisms, including RT.</p> <h2>Conclusions</h2> <p>As the nursing shortage continues, efforts to support diverse, innovative coping strategies remain a priority postpandemic. Nurses must be vigilant in appraising and managing their ability to cope and adapt to individual stress, while also being aware of the stress their colleagues are experiencing. Educational institutions, professional organizations, and health care facilities must strive to educate and support nurses to identify not only stress, but healthy coping mechanisms. </p> <p class="isub">Acknowledgments</p> <p> <em>This work was supported by the US Department of Veterans Affairs Central Office rapid response COVID-19 funding initiative, the Veteran Affairs Northeast Ohio Health Care System, and Geriatric Research, Education, and Clinical Center (GRECC). The Resourcefulness Scale, Resourcefulness Skills Scale, and the Resourcefulness Training intervention are copyrighted and were used with permission of the copyright holder, Jaclene A. Zauszniewski, MD.</em> </p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>VA Northeast Ohio Healthcare System, Geriatric Research, Education, and Clinical Center, Cleveland<br/><br/><sup>b</sup>University Hospitals of Cleveland, Ohio<br/><br/><sup>c</sup>Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio </em> </p> <p class="isub">Author disclosures</p> <p> <em>The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <p class="isub">Disclaimer</p> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner,</i> Frontline Medical Communications Inc., the US Government, or any of its agencies.</em> </p> <p class="isub">Ethics and consent</p> <p> <em>The Veterans Affairs Northeast Ohio Healthcare System Institutional Review Board considered this project and determined that it was exempt from review.</em> </p> <p class="isub">References</p> <p class="reference"> 1. Walker A. Nursing ranked as the most trusted profession for 22nd year in a row. January 23, 2024. Accessed January 31, 2024. https://nurse.org/articles/nursing-ranked-most-honest-profession <br/><br/> 2. Mental health and wellness survey 1. American Nurses Foundation. August 2020. Accessed January 31, 2024. https://www.nursingworld.org/practice-policy/work-environment/health-safety/disaster-preparedness/coronavirus/what-you-need-to-know/mental-health-and-wellbeing-survey/<br/><br/> 3. Healthy nurse, healthy nation. American Nurses Association. May 1, 2017. Accessed January 31, 2024. https://www.healthynursehealthynation.org/ <br/><br/> 4. Rushton CH, Batcheller J, Schroeder K, Donohue P. Burnout and resilience among nurses practicing in high-intensity settings.<i> Am J Crit Care</i>. 2015;24(5):412-420. doi:10.4037/ajcc2015291<br/><br/> 5. Selye HA. History and general outline of the stress concept. <i>Stress in Health and Disease</i>. Butterworths; 1976:3-34.<br/><br/> 6. Levy BS, Wegman DH, Baron SL, Sokas RK. Recognizing and preventing occupational and environmental disease and injury<i>. Occupational and Environmental Health: Recognizing and Preventing Disease and Injury</i>. 6th ed. Oxford University Press; 2011:59-77.<br/><br/> 7. Menzies IEP. Nurses under stress. <i>Int Nurs Rev</i>. 1960;7:9-16.<br/><br/> 8. Jennings BM. Turbulence. In: Hughes RG, ed. <i>Advances in Patient Safety and Quality: An Evidence-Based Handbook for Nurses.</i> 3rd ed. AHRQ Publication; 2007;2;193-202.<br/><br/> 9. Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. <i>JAMA</i>. 2002;288(16):1987-1993. doi:10.1001/jama.288.16.1987<br/><br/>10. Magtibay DL, Chesak SS, Coughlin K, Sood A. Decreasing stress and burnout in nurses: efficacy of blended learning with stress management and resilience training program. <i>J Nurs Adm</i>. 2017;47(7-8):391-395. doi:10.1097/NNA.0000000000000501<br/><br/>11. Halbesleben JR, Wakefield BJ, Wakefield DS, Cooper LB. Nurse burnout and patient safety outcomes: nurse safety perception versus reporting behavior. <i>West J Nurs Res</i>. 2008;30(5):560-577. doi:10.1177/0193945907311322<br/><br/>12. Sherman RO. Creating a Battle Buddy program. September 2, 2021. Accessed September 27, 2022. https://www.emergingrnleader.com/creating-a-battle-buddy-program<br/><br/>13. Godfrey KM, Scott SD. At the heart of the pandemic: nursing peer support. <i>Nurse Leader</i>. 2021:19(2),188-193. doi:10.1016/j.mnl.2020.09.006<br/><br/>14. Wakefield M, Williams DR, Le Menestrel S, and Flaubert JL, Editors; Committee on the future of nursing 2020 2030; National Academy of Medicine; National Academies of Sciences, Engineering, and Medicine Institute of Medicine 2008. <i>Retooling for an Aging America: Building the Health Care Workforce</i>. Washington, DC: The National Academies Press. doi:10.17226/12089<br/><br/>15. Taylor RA. Contemporary issues: resilience training alone is an incomplete intervention. <i>Nurs Educ Today</i>. 2019;78:10-13. doi:10.1016/j.nedt.2019.03.014<br/><br/>16. Hofmann SG, Gómez AF. Mindfulness-based interventions for anxiety and depression. <i>Psychiatr Clin North Am</i>. 2017;40(4):739-749. doi:10.1016/j.psc.2017.08.008<br/><br/>17. Rutter M. Resilience in the face of adversity. Protective factors and resistance to psychiatric disorder. <i>Br J Psychiatry</i>. 1985;147:598-611. doi:10.1192/bjp.147.6.598<br/><br/>18. Zauszniewski JA, Bekhet AK, Suresky MJ. Indicators of resilience in family members of persons with serious mental Illness. <i>Psychiatr Clin North Am</i>. 2015;38(1):131-146. doi:10.1016/j.psc.2014.11.009<br/><br/>19. Celinski MJ. Framing resilience as transcendence and resourcefulness as transformation. In: Celinski MJ, Gow KM, eds. <i>Continuity Versus Creative Response to Challenge: The Primacy of Resilience and Resourcefulness in Life and Therapy</i>. Nova Science Pub Inc; 2011:11-30.<br/><br/>20. Zauszniewski JA, Lai CY, Tithiphontumrong S. Development and testing of the Resourcefulness Scale for Older Adults. <i>J Nurs Meas</i>. 2006:14(1):57-68. doi:10.1891.jnum.14.1.57<br/><br/>21. Zauszniewski JA, Bekhet AK. Measuring use of resourcefulness skills: psychometric testing of a new scale. <i>ISRN Nurs</i>. 2011;2011:787363. doi:10.5402/2011/787363<br/><br/>22. Zauszniewski JA, Lekhak N, Burant CJ, Variath M, Morris DL. preliminary evidence for effectiveness of resourcefulness training for women dementia caregivers. <i>J Fam Med</i>. 2016:3(5):1069.23. Dolan ED, Mohr D, Lempa M, et al. Using a single item to measure burnout in primary care staff: a psychometric evaluation<i>. J Gen Intern Med</i>. 2015;30(5):582-587. doi:10.1007/s11606-014-3112-6<br/><br/>24. Zauszniewski JA Resourcefulness. In: Fitzpatrick JJ, ed. <i>Encyclopedia of Nursing Research</i>. 4th ed. 2018:632-634. <br/><br/>25. Combating Stress. American Nurses Association. Accessed November 28, 2022. https://www.nursingworld.org/practice-policy/work-environment/health-safety/combating-stress/<br/><br/>26. Albott CS, Wozniak JR, McGlinch BP, Wall MH, Gold BS, Vinogradov S. Battle Buddies: Rapid deployment of a psychological resilience intervention for health care workers during the COVID-19 pandemic. <i>Anesth Analg</i>. 2020;131(1):43-54. doi:10.1213/ANE.0000000000004912</p> </itemContent> </newsItem> </itemSet></root>
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Robotic Pet Therapy in the Intensive Care Unit

Article Type
Changed
Mon, 05/13/2024 - 14:38

Critical illness is commonly associated with interrelated conditions including pain, agitation, delirium, immobility, and sleep disruption (PADIS). Managing PADIS is often complex and includes pharmacologic and nonpharmacologic interventions.1 Incorporating multifaceted practices to enhance PADIS management has been shown to improve several intensive care unit (ICU)-related outcomes.2

Many pharmacologic PADIS treatments are ineffective or associated with adverse effects. For example, antipsychotics used for treating ICU-related delirium have not shown improved outcomes.3,4 Commonly used medications for agitation, such as benzodiazepines, increase delirium risk.5,6 Because of these limitations, several nonpharmacologic interventions for PADIS have been evaluated.

Pet therapy has been implemented in some ICU settings, but is not widely adopted.7 Also referred to as animal-assisted activities, animal-assisted therapy, or animal-assisted interventions, pet therapy typically involves interaction between a patient and a live animal (most commonly a dog) under the direction of an animal handler, with the intention of providing therapeutic benefit. Interactions frequently include meet and greet activities such as petting, but also could include walking or other activities. Pet therapy has been reported to reduce pain, agitation, and stress among ICU patients.8 Introducing a pet therapy program with live animals in the ICU could be challenging because of factors such as identifying trained, accredited animals and handlers, and managing infection control and other risks.9 As an alternative to live pets, robotic pet therapy has been shown to be beneficial—mostly outside the ICU—in settings such as long-term care.10,11 Although uncommon, robotic pets have been used in the ICU and hospital settings for therapeutic purposes.12 Robotic pets reduce many concerns associated with live animals while mimicking the behaviors of live animals and potentially offering many of the same benefits.

 

OBSERVATIONS

chuspeprethedatrachuslodraswiuejiwethuthepovoroswapebruvudophefrokeswogeriuadonikucoslafropekeroueticutathigatracrahubradahuprab

The North Florida/South Georgia Veterans Health System (NF/SGVHS) implemented a novel robotic pet therapy program for patients requiring ICU care to improve the treatment of PADIS. Funding was provided through a Veterans Health Administration Innovation Grant procured by a clinical pharmacy specialist as the program’s champion. Goals of the robotic pet therapy program include reductions in: distressing symptoms associated with PADIS, use of psychoactive drugs and physical restraints, and ICU length of stay. The ICU team developed standard operating procedures and an order menu, which were integrated into the ICU prescriber ordering menu. Patients were selected for pet therapy based on PADIS scores and potential for positive response to pet therapy as assessed by the ICU team.Patients in medical and surgical ICU settings were eligible for the program. The robotic pets used in the program were Joy for AllCompanion Pets (Ageless Innovation LLC). Robotic cats and dogs were available and pets were “adopted’ by each patient (Figure). As an infection control measure, pets were not reissued or shared amongpatients and pets could be cleaned with a disinfectant solution. Nurses were primarily responsible for monitoring and documenting responses to robotic pet therapy.

dredrishipruchefrojestetustuprichochevupipivelobrachephulaswudrocrawriswophedrudohopristomusluvuhuclaspetrifrutrimiludrucrapraswigicucrajajodephospitrijaclorichatrichejuwufrethostuwrifrocouaswashebruhaduswerispunadututheti

It was necessary to secure buy-in from several services to successfully implement the program. The critical care clinical pharmacy specialists were responsible for ordering, storing, and dispensing the robotic pets. The NF/SGVHS innovation specialist helped secure funding, procure the robotic pet, and promote the program. The standard operating procedures for the program were developed by a multidisciplinary team with input from critical care nurses, intensivists, pharmacists, patient safety, and infection control (Table 1). Success of the program also required buy-in from ICU team members.

 

 

Program Impact

A retrospective cohort study was conducted to assess for improvements in PADIS symptoms and medication use post-intervention. Patients were included if they received robotic pet therapy in the ICU from July 10, 2019, to February 1, 2021. Individuals aged < 18 years or > 89 years, were pregnant, or were not receiving ICU-level care were excluded. Outcomes assessed included improvement in pain scores, agitation scores, sleep quality, resolution of delirium, and use of pain or psychoactive medications during patients’ ICU stay.

voclataswaleswebrespespuwuwrabrostutrucliswicogalacacrethecalucevitobithunihulehospacruwefrafracufrepribrothacrapriwatrilegunoshugasauehedesuhatajoloclawraprejukachucrogidrawribrobeuuspiuilunaclurispuphijudraswuthavojicravutoswostacusepilasijos

Thirty patients were included in the study (Table 2). After receiving a robotic pet, 9 (30%) patients recorded decreased pain scores, 15 (50%) recorded decreased agitation scores, 8 (27%) had resolution of delirium, and 2 (7%) described improvement in sleep. Pain medication use decreased in 12 (40%) patients and psychoactive medication use was reduced in 7 (23%) patients.

Limitations

The robotic pet therapy program has shown promising results; however, some aspects merit discussion. Evaluation of this program is limited by factors such as the observational study design, single-center patient sample, and lack of comparator group. Although no known adverse effects of robotic pet therapy were seen, it is possible that some patients may not have a favorable response. Challenges of implementing a robotic pet therapy program include cost and additional operational activities (storage, ordering, dispensing) necessary to maintain the program. Additional research is needed to evaluate the impact of robotic pet therapy on other outcomes including cost, ICU length of stay, and patient satisfaction.

 

CONCLUSIONS

Robotic pet therapy can be successfully implemented in the ICU and appears to provide a simple, safe, beneficial, nonpharmacologic intervention for PADIS. This study showed that many patients had favorable response to robotic pet therapy, indicating that it may be a viable alternative to traditional pet therapy. Other health systems could benefit from implementing programs similar to the robotic pet therapy program at NF/SGVHS.

Acknowledgments

The author would like to acknowledge Simran Panesar, PharmD, and Theresa Faison, PharmD, for their contributions to this project.

References

1. Devlin JW, Skrobik Y, Gélinas C, et al. Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med. 2018;46:e825-e873. doi:10.1097/CCM.0000000000003299

2. Pun BT, Balas MC, Barnes-Daly MA, et al. Caring for critically ill patients with the ABCDEF bundle: results of the ICU Liberation Collaborative in over 15,000 adults. Crit Care Med. 2019;47:3-14. doi:10.1097/CCM.0000000000003482

3. Andersen-Ranberg NC, Poulsen LM, Perner A, et al; AID-ICU Trial Group. Haloperidol for the treatment of delirium in ICU patients. N Engl J Med. 2022;387:2425-2435. doi:10.1056/NEJMoa2211868

4. Girard TD, Exline MC, Carson SS, et al; MIND-USA Investigators. Haloperidol and ziprasidone for treatment of delirium in critical illness. N Engl J Med. 2018;379:2506-2516. doi:10.1056/NEJMoa1808217

5. Riker RR, Shehabi Y, Bokesch PM, et al; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009;301:489-499. doi:10.1001/jama.2009.56

6. Pandharipande P, Shintani A, Peterson J, et al. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006;104:21-26. doi:10.1097/00000542-200601000-00005

7. Society of Critical Care Medicine. ICU liberation bundle. Accessed February 27, 2024. https://www.sccm.org/ICULiberation/Home/ABCDEF-Bundles

8. Lovell T, Ranse K. Animal-assisted activities in the intensive care unit: a scoping review. Intensive Crit Care Nurs. 2022;73:103304. doi:10.1016/j.iccn.2022.103304

9. Hosey MM, Jaskulski J, Wegener ST, Chlan LL, Needham DM. Animal-assisted intervention in the ICU: a tool for humanization. Crit Care. 2018;22:22. doi:10.1186/s13054-018-1946-8

10. Jøranson N, Pedersen I, Rokstad AM, Ihlebæk C. Effects on symptoms of agitation and depression in persons with dementia participating in robot-assisted activity: a cluster-randomized controlled trial. J Am Med Dir Assoc. 2015;16:867-873. doi:10.1016/j.jamda.2015.05.002

11. Robinson H, Macdonald B, Kerse N, Broadbent E. The psychosocial effects of a companion robot: a randomized controlled trial. J Am Med Dir Assoc. 2013;14:661-667. doi:10.1016/j.jamda.2013.02.007

12. Schulman-Marcus J, Mookherjee S, Rice L, Lyubarova R. New approaches for the treatment of delirium: a case for robotic pets. Am J Med. 2019;132:781-782. doi:10.1016/j.amjmed.2018.12.039

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Andrew J. Franck, PharmDa

Correspondence:  Andrew Franck  (andrew.franck@va.gov)

aNorth Florida/South Georgia Veterans Health System, Gainesville

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Correspondence:  Andrew Franck  (andrew.franck@va.gov)

aNorth Florida/South Georgia Veterans Health System, Gainesville

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The author reports no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Author and Disclosure Information

Andrew J. Franck, PharmDa

Correspondence:  Andrew Franck  (andrew.franck@va.gov)

aNorth Florida/South Georgia Veterans Health System, Gainesville

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The author reports no actual or potential conflicts of interest or outside sources of funding with regard to this article.

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The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Related Articles

Critical illness is commonly associated with interrelated conditions including pain, agitation, delirium, immobility, and sleep disruption (PADIS). Managing PADIS is often complex and includes pharmacologic and nonpharmacologic interventions.1 Incorporating multifaceted practices to enhance PADIS management has been shown to improve several intensive care unit (ICU)-related outcomes.2

Many pharmacologic PADIS treatments are ineffective or associated with adverse effects. For example, antipsychotics used for treating ICU-related delirium have not shown improved outcomes.3,4 Commonly used medications for agitation, such as benzodiazepines, increase delirium risk.5,6 Because of these limitations, several nonpharmacologic interventions for PADIS have been evaluated.

Pet therapy has been implemented in some ICU settings, but is not widely adopted.7 Also referred to as animal-assisted activities, animal-assisted therapy, or animal-assisted interventions, pet therapy typically involves interaction between a patient and a live animal (most commonly a dog) under the direction of an animal handler, with the intention of providing therapeutic benefit. Interactions frequently include meet and greet activities such as petting, but also could include walking or other activities. Pet therapy has been reported to reduce pain, agitation, and stress among ICU patients.8 Introducing a pet therapy program with live animals in the ICU could be challenging because of factors such as identifying trained, accredited animals and handlers, and managing infection control and other risks.9 As an alternative to live pets, robotic pet therapy has been shown to be beneficial—mostly outside the ICU—in settings such as long-term care.10,11 Although uncommon, robotic pets have been used in the ICU and hospital settings for therapeutic purposes.12 Robotic pets reduce many concerns associated with live animals while mimicking the behaviors of live animals and potentially offering many of the same benefits.

 

OBSERVATIONS

chuspeprethedatrachuslodraswiuejiwethuthepovoroswapebruvudophefrokeswogeriuadonikucoslafropekeroueticutathigatracrahubradahuprab

The North Florida/South Georgia Veterans Health System (NF/SGVHS) implemented a novel robotic pet therapy program for patients requiring ICU care to improve the treatment of PADIS. Funding was provided through a Veterans Health Administration Innovation Grant procured by a clinical pharmacy specialist as the program’s champion. Goals of the robotic pet therapy program include reductions in: distressing symptoms associated with PADIS, use of psychoactive drugs and physical restraints, and ICU length of stay. The ICU team developed standard operating procedures and an order menu, which were integrated into the ICU prescriber ordering menu. Patients were selected for pet therapy based on PADIS scores and potential for positive response to pet therapy as assessed by the ICU team.Patients in medical and surgical ICU settings were eligible for the program. The robotic pets used in the program were Joy for AllCompanion Pets (Ageless Innovation LLC). Robotic cats and dogs were available and pets were “adopted’ by each patient (Figure). As an infection control measure, pets were not reissued or shared amongpatients and pets could be cleaned with a disinfectant solution. Nurses were primarily responsible for monitoring and documenting responses to robotic pet therapy.

dredrishipruchefrojestetustuprichochevupipivelobrachephulaswudrocrawriswophedrudohopristomusluvuhuclaspetrifrutrimiludrucrapraswigicucrajajodephospitrijaclorichatrichejuwufrethostuwrifrocouaswashebruhaduswerispunadututheti

It was necessary to secure buy-in from several services to successfully implement the program. The critical care clinical pharmacy specialists were responsible for ordering, storing, and dispensing the robotic pets. The NF/SGVHS innovation specialist helped secure funding, procure the robotic pet, and promote the program. The standard operating procedures for the program were developed by a multidisciplinary team with input from critical care nurses, intensivists, pharmacists, patient safety, and infection control (Table 1). Success of the program also required buy-in from ICU team members.

 

 

Program Impact

A retrospective cohort study was conducted to assess for improvements in PADIS symptoms and medication use post-intervention. Patients were included if they received robotic pet therapy in the ICU from July 10, 2019, to February 1, 2021. Individuals aged < 18 years or > 89 years, were pregnant, or were not receiving ICU-level care were excluded. Outcomes assessed included improvement in pain scores, agitation scores, sleep quality, resolution of delirium, and use of pain or psychoactive medications during patients’ ICU stay.

voclataswaleswebrespespuwuwrabrostutrucliswicogalacacrethecalucevitobithunihulehospacruwefrafracufrepribrothacrapriwatrilegunoshugasauehedesuhatajoloclawraprejukachucrogidrawribrobeuuspiuilunaclurispuphijudraswuthavojicravutoswostacusepilasijos

Thirty patients were included in the study (Table 2). After receiving a robotic pet, 9 (30%) patients recorded decreased pain scores, 15 (50%) recorded decreased agitation scores, 8 (27%) had resolution of delirium, and 2 (7%) described improvement in sleep. Pain medication use decreased in 12 (40%) patients and psychoactive medication use was reduced in 7 (23%) patients.

Limitations

The robotic pet therapy program has shown promising results; however, some aspects merit discussion. Evaluation of this program is limited by factors such as the observational study design, single-center patient sample, and lack of comparator group. Although no known adverse effects of robotic pet therapy were seen, it is possible that some patients may not have a favorable response. Challenges of implementing a robotic pet therapy program include cost and additional operational activities (storage, ordering, dispensing) necessary to maintain the program. Additional research is needed to evaluate the impact of robotic pet therapy on other outcomes including cost, ICU length of stay, and patient satisfaction.

 

CONCLUSIONS

Robotic pet therapy can be successfully implemented in the ICU and appears to provide a simple, safe, beneficial, nonpharmacologic intervention for PADIS. This study showed that many patients had favorable response to robotic pet therapy, indicating that it may be a viable alternative to traditional pet therapy. Other health systems could benefit from implementing programs similar to the robotic pet therapy program at NF/SGVHS.

Acknowledgments

The author would like to acknowledge Simran Panesar, PharmD, and Theresa Faison, PharmD, for their contributions to this project.

Critical illness is commonly associated with interrelated conditions including pain, agitation, delirium, immobility, and sleep disruption (PADIS). Managing PADIS is often complex and includes pharmacologic and nonpharmacologic interventions.1 Incorporating multifaceted practices to enhance PADIS management has been shown to improve several intensive care unit (ICU)-related outcomes.2

Many pharmacologic PADIS treatments are ineffective or associated with adverse effects. For example, antipsychotics used for treating ICU-related delirium have not shown improved outcomes.3,4 Commonly used medications for agitation, such as benzodiazepines, increase delirium risk.5,6 Because of these limitations, several nonpharmacologic interventions for PADIS have been evaluated.

Pet therapy has been implemented in some ICU settings, but is not widely adopted.7 Also referred to as animal-assisted activities, animal-assisted therapy, or animal-assisted interventions, pet therapy typically involves interaction between a patient and a live animal (most commonly a dog) under the direction of an animal handler, with the intention of providing therapeutic benefit. Interactions frequently include meet and greet activities such as petting, but also could include walking or other activities. Pet therapy has been reported to reduce pain, agitation, and stress among ICU patients.8 Introducing a pet therapy program with live animals in the ICU could be challenging because of factors such as identifying trained, accredited animals and handlers, and managing infection control and other risks.9 As an alternative to live pets, robotic pet therapy has been shown to be beneficial—mostly outside the ICU—in settings such as long-term care.10,11 Although uncommon, robotic pets have been used in the ICU and hospital settings for therapeutic purposes.12 Robotic pets reduce many concerns associated with live animals while mimicking the behaviors of live animals and potentially offering many of the same benefits.

 

OBSERVATIONS

chuspeprethedatrachuslodraswiuejiwethuthepovoroswapebruvudophefrokeswogeriuadonikucoslafropekeroueticutathigatracrahubradahuprab

The North Florida/South Georgia Veterans Health System (NF/SGVHS) implemented a novel robotic pet therapy program for patients requiring ICU care to improve the treatment of PADIS. Funding was provided through a Veterans Health Administration Innovation Grant procured by a clinical pharmacy specialist as the program’s champion. Goals of the robotic pet therapy program include reductions in: distressing symptoms associated with PADIS, use of psychoactive drugs and physical restraints, and ICU length of stay. The ICU team developed standard operating procedures and an order menu, which were integrated into the ICU prescriber ordering menu. Patients were selected for pet therapy based on PADIS scores and potential for positive response to pet therapy as assessed by the ICU team.Patients in medical and surgical ICU settings were eligible for the program. The robotic pets used in the program were Joy for AllCompanion Pets (Ageless Innovation LLC). Robotic cats and dogs were available and pets were “adopted’ by each patient (Figure). As an infection control measure, pets were not reissued or shared amongpatients and pets could be cleaned with a disinfectant solution. Nurses were primarily responsible for monitoring and documenting responses to robotic pet therapy.

dredrishipruchefrojestetustuprichochevupipivelobrachephulaswudrocrawriswophedrudohopristomusluvuhuclaspetrifrutrimiludrucrapraswigicucrajajodephospitrijaclorichatrichejuwufrethostuwrifrocouaswashebruhaduswerispunadututheti

It was necessary to secure buy-in from several services to successfully implement the program. The critical care clinical pharmacy specialists were responsible for ordering, storing, and dispensing the robotic pets. The NF/SGVHS innovation specialist helped secure funding, procure the robotic pet, and promote the program. The standard operating procedures for the program were developed by a multidisciplinary team with input from critical care nurses, intensivists, pharmacists, patient safety, and infection control (Table 1). Success of the program also required buy-in from ICU team members.

 

 

Program Impact

A retrospective cohort study was conducted to assess for improvements in PADIS symptoms and medication use post-intervention. Patients were included if they received robotic pet therapy in the ICU from July 10, 2019, to February 1, 2021. Individuals aged < 18 years or > 89 years, were pregnant, or were not receiving ICU-level care were excluded. Outcomes assessed included improvement in pain scores, agitation scores, sleep quality, resolution of delirium, and use of pain or psychoactive medications during patients’ ICU stay.

voclataswaleswebrespespuwuwrabrostutrucliswicogalacacrethecalucevitobithunihulehospacruwefrafracufrepribrothacrapriwatrilegunoshugasauehedesuhatajoloclawraprejukachucrogidrawribrobeuuspiuilunaclurispuphijudraswuthavojicravutoswostacusepilasijos

Thirty patients were included in the study (Table 2). After receiving a robotic pet, 9 (30%) patients recorded decreased pain scores, 15 (50%) recorded decreased agitation scores, 8 (27%) had resolution of delirium, and 2 (7%) described improvement in sleep. Pain medication use decreased in 12 (40%) patients and psychoactive medication use was reduced in 7 (23%) patients.

Limitations

The robotic pet therapy program has shown promising results; however, some aspects merit discussion. Evaluation of this program is limited by factors such as the observational study design, single-center patient sample, and lack of comparator group. Although no known adverse effects of robotic pet therapy were seen, it is possible that some patients may not have a favorable response. Challenges of implementing a robotic pet therapy program include cost and additional operational activities (storage, ordering, dispensing) necessary to maintain the program. Additional research is needed to evaluate the impact of robotic pet therapy on other outcomes including cost, ICU length of stay, and patient satisfaction.

 

CONCLUSIONS

Robotic pet therapy can be successfully implemented in the ICU and appears to provide a simple, safe, beneficial, nonpharmacologic intervention for PADIS. This study showed that many patients had favorable response to robotic pet therapy, indicating that it may be a viable alternative to traditional pet therapy. Other health systems could benefit from implementing programs similar to the robotic pet therapy program at NF/SGVHS.

Acknowledgments

The author would like to acknowledge Simran Panesar, PharmD, and Theresa Faison, PharmD, for their contributions to this project.

References

1. Devlin JW, Skrobik Y, Gélinas C, et al. Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med. 2018;46:e825-e873. doi:10.1097/CCM.0000000000003299

2. Pun BT, Balas MC, Barnes-Daly MA, et al. Caring for critically ill patients with the ABCDEF bundle: results of the ICU Liberation Collaborative in over 15,000 adults. Crit Care Med. 2019;47:3-14. doi:10.1097/CCM.0000000000003482

3. Andersen-Ranberg NC, Poulsen LM, Perner A, et al; AID-ICU Trial Group. Haloperidol for the treatment of delirium in ICU patients. N Engl J Med. 2022;387:2425-2435. doi:10.1056/NEJMoa2211868

4. Girard TD, Exline MC, Carson SS, et al; MIND-USA Investigators. Haloperidol and ziprasidone for treatment of delirium in critical illness. N Engl J Med. 2018;379:2506-2516. doi:10.1056/NEJMoa1808217

5. Riker RR, Shehabi Y, Bokesch PM, et al; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009;301:489-499. doi:10.1001/jama.2009.56

6. Pandharipande P, Shintani A, Peterson J, et al. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006;104:21-26. doi:10.1097/00000542-200601000-00005

7. Society of Critical Care Medicine. ICU liberation bundle. Accessed February 27, 2024. https://www.sccm.org/ICULiberation/Home/ABCDEF-Bundles

8. Lovell T, Ranse K. Animal-assisted activities in the intensive care unit: a scoping review. Intensive Crit Care Nurs. 2022;73:103304. doi:10.1016/j.iccn.2022.103304

9. Hosey MM, Jaskulski J, Wegener ST, Chlan LL, Needham DM. Animal-assisted intervention in the ICU: a tool for humanization. Crit Care. 2018;22:22. doi:10.1186/s13054-018-1946-8

10. Jøranson N, Pedersen I, Rokstad AM, Ihlebæk C. Effects on symptoms of agitation and depression in persons with dementia participating in robot-assisted activity: a cluster-randomized controlled trial. J Am Med Dir Assoc. 2015;16:867-873. doi:10.1016/j.jamda.2015.05.002

11. Robinson H, Macdonald B, Kerse N, Broadbent E. The psychosocial effects of a companion robot: a randomized controlled trial. J Am Med Dir Assoc. 2013;14:661-667. doi:10.1016/j.jamda.2013.02.007

12. Schulman-Marcus J, Mookherjee S, Rice L, Lyubarova R. New approaches for the treatment of delirium: a case for robotic pets. Am J Med. 2019;132:781-782. doi:10.1016/j.amjmed.2018.12.039

References

1. Devlin JW, Skrobik Y, Gélinas C, et al. Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med. 2018;46:e825-e873. doi:10.1097/CCM.0000000000003299

2. Pun BT, Balas MC, Barnes-Daly MA, et al. Caring for critically ill patients with the ABCDEF bundle: results of the ICU Liberation Collaborative in over 15,000 adults. Crit Care Med. 2019;47:3-14. doi:10.1097/CCM.0000000000003482

3. Andersen-Ranberg NC, Poulsen LM, Perner A, et al; AID-ICU Trial Group. Haloperidol for the treatment of delirium in ICU patients. N Engl J Med. 2022;387:2425-2435. doi:10.1056/NEJMoa2211868

4. Girard TD, Exline MC, Carson SS, et al; MIND-USA Investigators. Haloperidol and ziprasidone for treatment of delirium in critical illness. N Engl J Med. 2018;379:2506-2516. doi:10.1056/NEJMoa1808217

5. Riker RR, Shehabi Y, Bokesch PM, et al; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009;301:489-499. doi:10.1001/jama.2009.56

6. Pandharipande P, Shintani A, Peterson J, et al. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006;104:21-26. doi:10.1097/00000542-200601000-00005

7. Society of Critical Care Medicine. ICU liberation bundle. Accessed February 27, 2024. https://www.sccm.org/ICULiberation/Home/ABCDEF-Bundles

8. Lovell T, Ranse K. Animal-assisted activities in the intensive care unit: a scoping review. Intensive Crit Care Nurs. 2022;73:103304. doi:10.1016/j.iccn.2022.103304

9. Hosey MM, Jaskulski J, Wegener ST, Chlan LL, Needham DM. Animal-assisted intervention in the ICU: a tool for humanization. Crit Care. 2018;22:22. doi:10.1186/s13054-018-1946-8

10. Jøranson N, Pedersen I, Rokstad AM, Ihlebæk C. Effects on symptoms of agitation and depression in persons with dementia participating in robot-assisted activity: a cluster-randomized controlled trial. J Am Med Dir Assoc. 2015;16:867-873. doi:10.1016/j.jamda.2015.05.002

11. Robinson H, Macdonald B, Kerse N, Broadbent E. The psychosocial effects of a companion robot: a randomized controlled trial. J Am Med Dir Assoc. 2013;14:661-667. doi:10.1016/j.jamda.2013.02.007

12. Schulman-Marcus J, Mookherjee S, Rice L, Lyubarova R. New approaches for the treatment of delirium: a case for robotic pets. Am J Med. 2019;132:781-782. doi:10.1016/j.amjmed.2018.12.039

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Franck, PharmD a </bylineTitleText> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>Critical illness is commonly associated with interrelated conditions including pain, agitation, delirium, immobility, and sleep disruption (PADIS). Managing PAD</metaDescription> <articlePDF/> <teaserImage/> <title>Robotic Pet Therapy in the Intensive Care Unit</title> <deck/> <eyebrow>Program Profile</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>May</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>5</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>4473</CMSID> <CMSID>3729</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>May 2024</pubIssueName> <pubArticleType>Columns | 3729</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Program Profile | 4473<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> </sections> <topics> <term>27442</term> <term>248</term> <term canonical="true">258</term> <term>268</term> <term>296</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Robotic Pet Therapy in the Intensive Care Unit</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background:</b> Robotic pet therapy could aid in the nonpharmacologic treatment of pain, agitation, delirium, immobility, and sleep disruption (PADIS) in the intensive care unit (ICU), similar to traditional pet therapy.<br/><br/><b>Observations:</b> The North Florida/South Georgia Veterans Health System implemented a robotic pet therapy program for patients requiring ICU care. Details of this program are described in this article, including evaluating its impact on PADIS management.<br/><br/><b>Conclusions:</b> Robotic pet therapy can be successfully implemented in the ICU and could be a simple, safe, and beneficial nonpharmacologic intervention for PADIS.</p> <p><span class="Drop">C</span>ritical illness is commonly associated with interrelated conditions including pain, agitation, delirium, immobility, and sleep disruption (PADIS). Managing PADIS is often complex and includes pharmacologic and nonpharmacologic interventions.<sup>1</sup> Incorporating multifaceted practices to enhance PADIS management has been shown to improve several intensive care unit (ICU)-related outcomes.<sup>2</sup> </p> <p>Many pharmacologic PADIS treatments are ineffective or associated with adverse effects. For example, antipsychotics used for treating ICU-related delirium have not shown improved outcomes.<sup>3,4 </sup>Commonly used medications for agitation, such as benzodiazepines, increase delirium risk.<sup>5,6</sup> Because of these limitations, several nonpharmacologic interventions for PADIS have been evaluated. <br/><br/>Pet therapy has been implemented in some ICU settings, but is not widely adopted.<sup>7</sup> Also referred to as animal-assisted activities, animal-assisted therapy, or animal-assisted interventions, pet therapy typically involves interaction between a patient and a live animal (most commonly a dog) under the direction of an animal handler, with the intention of providing therapeutic benefit. Interactions frequently include meet and greet activities such as petting, but also could include walking or other activities. Pet therapy has been reported to reduce pain, agitation, and stress among ICU patients.<sup>8</sup> Introducing a pet therapy program with live animals in the ICU could be challenging because of factors such as identifying trained, accredited animals and handlers, and managing infection control and other risks.<sup>9</sup> As an alternative to live pets, robotic pet therapy has been shown to be beneficial—mostly outside the ICU—in settings such as long-term care.<sup>10,11</sup> Although uncommon, robotic pets have been used in the ICU and hospital settings for therapeutic purposes.<sup>12</sup> Robotic pets reduce many concerns associated with live animals while mimicking the behaviors of live animals and potentially offering many of the same benefits. </p> <h2>OBSERVATIONS</h2> <p>The North Florida/South Georgia Veterans Health System (NF/SGVHS) implemented a novel robotic pet therapy program for patients requiring ICU care to improve the treatment of PADIS. Funding was provided through a Veterans Health Administration Innovation Grant procured by a clinical pharmacy specialist as the program’s champion. Goals of the robotic pet therapy program include reductions in: distressing symptoms associated with PADIS, use of psychoactive drugs and physical restraints, and ICU length of stay. The ICU team developed standard operating procedures and an order menu, which were integrated into the ICU prescriber ordering menu. Patients were selected for pet therapy based on PADIS scores and potential for positive response to pet therapy as assessed by the ICU team.Patients in medical and surgical ICU settings were eligible for the program. The robotic pets used in the program were Joy for All<sup> </sup>Companion Pets (Ageless Innovation LLC). Robotic cats and dogs were available and pets were “adopted’ by each patient (Figure). As an infection control measure, pets were not reissued or shared amongpatients and pets could be cleaned with a disinfectant solution. Nurses were primarily responsible for monitoring and documenting responses to robotic pet therapy.</p> <p>It was necessary to secure buy-in from several services to successfully implement the program. The critical care clinical pharmacy specialists were responsible for ordering, storing, and dispensing the robotic pets. The NF/SGVHS innovation specialist helped secure funding, procure the robotic pet, and promote the program. The standard operating procedures for the program were developed by a multidisciplinary team with input from critical care nurses, intensivists, pharmacists, patient safety, and infection control (Table 1). Success of the program also required buy-in from ICU team members. </p> <h2>program Impact</h2> <p>A retrospective cohort study was conducted to assess for improvements in PADIS symptoms and medication use post-intervention. Patients were included if they received robotic pet therapy in the ICU from July 10, 2019, to February 1, 2021. Individuals aged &lt; 18 years or &gt; 89 years, were pregnant, or were not receiving ICU-level care were excluded. Outcomes assessed included improvement in pain scores, agitation scores, sleep quality, resolution of delirium, and use of pain or psychoactive medications during patients’ ICU stay. </p> <p>Thirty patients were included in the study (Table 2). After receiving a robotic pet, 9 (30%) patients recorded decreased pain scores, 15 (50%) recorded decreased agitation scores, 8 (27%) had resolution of delirium, and 2 (7%) described improvement in sleep. Pain medication use decreased in 12 (40%) patients and psychoactive medication use was reduced in 7 (23%) patients. </p> <h3>Limitations</h3> <p>The robotic pet therapy program has shown promising results; however, some aspects merit discussion. Evaluation of this program is limited by factors such as the observational study design, single-center patient sample, and lack of comparator group. Although no known adverse effects of robotic pet therapy were seen, it is possible that some patients may not have a favorable response. Challenges of implementing a robotic pet therapy program include cost and additional operational activities (storage, ordering, dispensing) necessary to maintain the program. Additional research is needed to evaluate the impact of robotic pet therapy on other outcomes including cost, ICU length of stay, and patient satisfaction. </p> <h2>CONCLUSIONS</h2> <p>Robotic pet therapy can be successfully implemented in the ICU and appears to provide a simple, safe, beneficial, nonpharmacologic intervention for PADIS. This study showed that many patients had favorable response to robotic pet therapy, indicating that it may be a viable alternative to traditional pet therapy. Other health systems could benefit from implementing programs similar to the robotic pet therapy program at NF/SGVHS. </p> <h3> Acknowledgments </h3> <p> <em>The author would like to acknowledge Simran Panesar, PharmD, and Theresa Faison, PharmD, for their contributions to this project.</em> </p> <h3> Author affiliation </h3> <p> <em><sup>a</sup>North Florida/South Georgia Veterans Health System, Gainesville</em> </p> <h3> Author disclosures </h3> <p> <em>The author reports no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <h3> Disclaimer </h3> <p> <em>The opinions expressed herein are those of the author and do not necessarily reflect those of <i>Federal Practitioner,</i> Frontline Medical Communications Inc., the US Government, or any of its agencies. </em> </p> <h3> References </h3> <p class="reference"> 1. Devlin JW, Skrobik Y, Gélinas C, et al. Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. <i>Crit Care Med</i>. 2018;46:e825-e873. doi:10.1097/CCM.0000000000003299 <br/><br/> 2. Pun BT, Balas MC, Barnes-Daly MA, et al. Caring for critically ill patients with the ABCDEF bundle: results of the ICU Liberation Collaborative in over 15,000 adults. <i>Crit Care Med</i>. 2019;47:3-14. doi:10.1097/CCM.0000000000003482 <br/><br/> 3. Andersen-Ranberg NC, Poulsen LM, Perner A, et al; AID-ICU Trial Group. Haloperidol for the treatment of delirium in ICU patients. <i>N Engl J Med</i>. 2022;387:2425-2435. doi:10.1056/NEJMoa2211868<br/><br/> 4. Girard TD, Exline MC, Carson SS, et al; MIND-USA Investigators. Haloperidol and ziprasidone for treatment of delirium in critical illness. <i>N Engl J Med</i>. 2018;379:2506-2516. doi:10.1056/NEJMoa1808217<br/><br/> 5. Riker RR, Shehabi Y, Bokesch PM, et al; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. <i>JAMA</i>. 2009;301:489-499. doi:10.1001/jama.2009.56<br/><br/> 6. Pandharipande P, Shintani A, Peterson J, et al. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. <i>Anesthesiology</i>. 2006;104:21-26. doi:10.1097/00000542-200601000-00005<br/><br/> 7. Society of Critical Care Medicine. ICU liberation bundle. Accessed February 27, 2024. https://www.sccm.org/ICULiberation/Home/ABCDEF-Bundles<br/><br/> 8. Lovell T, Ranse K. Animal-assisted activities in the intensive care unit: a scoping review. <i>Intensive Crit Care Nurs</i>. 2022;73:103304. doi:10.1016/j.iccn.2022.103304<br/><br/> 9. Hosey MM, Jaskulski J, Wegener ST, Chlan LL, Needham DM. Animal-assisted intervention in the ICU: a tool for humanization. <i>Crit Care</i>. 2018;22:22. doi:10.1186/s13054-018-1946-8<br/><br/>10. Jøranson N, Pedersen I, Rokstad AM, Ihlebæk C. Effects on symptoms of agitation and depression in persons with dementia participating in robot-assisted activity: a cluster-randomized controlled trial. <i>J Am Med Dir Assoc</i>. 2015;16:867-873. doi:10.1016/j.jamda.2015.05.002<br/><br/>11. Robinson H, Macdonald B, Kerse N, Broadbent E. The psychosocial effects of a companion robot: a randomized controlled trial. <i>J Am Med Dir Assoc</i>. 2013;14:661-667. doi:10.1016/j.jamda.2013.02.007 <br/><br/>12. Schulman-Marcus J, Mookherjee S, Rice L, Lyubarova R. New approaches for the treatment of delirium: a case for robotic pets. <i>Am J Med</i>. 2019;132:781-782. doi:10.1016/j.amjmed.2018.12.039.</p> </itemContent> </newsItem> </itemSet></root>
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3D Printing for the Development of Palatal Defect Prosthetics

Article Type
Changed
Mon, 04/29/2024 - 19:26

Three-dimensional (3D) printing has become a promising area of innovation in biomedical research.1,2 Previous research in orthopedic surgery has found that customized 3D printed implants, casts, orthoses, and prosthetics (eg, prosthetic hands) matched to an individual’s unique anatomy can result in more precise placement and better surgical outcomes.3-5 Customized prosthetics have also been found to lead to fewer complications.3,6

Recent advances in 3D printing technology has prompted investigation from surgeons to identify how this new tool may be incorporated into patient care.1,7 One of the most common applications of 3D printing is during preoperative planning in which surgeons gain better insight into patient-specific anatomy by using patient-specific printed models.8 Another promising application is the production of customized prosthetics suited to each patient’s unique anatomy.9 As a result, 3D printing has significantly impacted bone and cartilage restoration procedures and has the potential to completely transform the treatment of patients with debilitating musculoskeletal injuries.3,10

The potential surrounding 3D printed prosthetics has led to their adoption by several other specialties, including otolaryngology.11 The most widely used application of 3D printing among otolaryngologists is preoperative planning, and the incorporation of printed prosthetics intoreconstruction of the orbit, nasal septum, auricle, and palate has also been reported.2,12,13 Patient-specific implants might allow otolaryngologists to better rehabilitate, reconstruct, and/or regenerate craniofacial defects using more humane procedures.14

Patients with palatomaxillary cancers are treated by prosthodontists or otolaryngologists. An impression is made with a resin–which can be painful for postoperative patients–and a prosthetic is manufactured and implanted.15-17 Patients with cancer often see many specialists, though reconstructive care is a low priority. Many of these individuals also experience dynamic anatomic functional changes over time, leading to the need for multiple prothesis.

palatomaxillary prosthetics

This program aims to use patients’ previous computed tomography (CT) to tailor customized 3D printed palatomaxillary prosthetics to specifically fit their anatomy. Palatomaxillary defects are a source of profound disability for patients with head and neck cancers who are left with large anatomic defects as a direct result of treatment. Reconstruction of palatal defects poses unique challenges due to the complexity of patient anatomy.18,19

3D printed prosthetics for palatomaxillary defects have not been incorporated into patient care. We reviewed previous imaging research to determine if it could be used to assist patients who struggle with their function and appearance following treatment for head and neck cancers. The primary aim was to investigate whether 3D printing was a feasible strategy for creating patient-specific palatomaxillary prosthetics. The secondary aim is to determine whether these prosthetics should be tested in the future for use in reconstruction of maxillary defects.

 

 

Data Acquisition

This study was conducted at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) and was approved by the Stanford University Institutional Review Board (approval #28958, informed consent and patient contact excluded). A retrospective chart review was conducted on all patients with head and neck cancers who were treated at VAPAHCS from 2010 to 2022. Patients aged ≥ 18 years who had a palatomaxillary defect due to cancer treatment, had undergone a palatal resection, and who received treatment at any point from 2010 to 2022 were included in the review. CTs were not a specific inclusion criterion, though the quality of the scans was analyzed for eligible patients. Younger patients and those treated at VAPAHCS prior to 2010 were excluded.

There was no control group; all data was sourced from the US Department of Veterans Affairs (VA) imaging system database. Among the 3595 patients reviewed, 5 met inclusion criteria and the quality of their craniofacial anatomy CTs were analyzed. To maintain accurate craniofacial 3D modeling, CTs require a maximum of 1 mm slice thickness. Of the 5 patients who met the inclusion criteria, 4 were found to have variability in the quality of their CTs and severe defects not suitable for prosthetic reconstruction, which led to their exclusion from the study. One patient was investigated to demonstrate if making these prostheses was feasible. This patient was diagnosed with a malignant neoplasm of the hard palate, underwent a partial maxillectomy, and a palatal obturator was placed to cover the defect.

The primary data collected was patient identifiers as well as the gross anatomy and dimensions of the patients’ craniofacial anatomy, as seen in previous imaging research.20 Before the imaging analysis, all personal health information was removed and the dataset was deidentified to ensure patient anonymity and noninvolvement.

CT Segmentation and 3D Printing

Using CTs of the patient’s craniofacial anatomy, we developed a model of the defects. This was achieved with deidentified CTs imported into the Food and Drug Administration (FDA)-approved computerized aid design (CAD) software, Materialise Mimics. The hard palate was segmented and isolated based off the presented scan and any holes in the image were filled using the CAD software. The model was subsequently mirrored in Materialise 3-matic to replicate an original anatomical hard palate prosthesis. The final product was converted into a 3D model and imported into Formlabs preform software to generate 3D printing supports and orient it for printing. The prosthetic was printed using FDA-approved Biocompatible Denture Base Resin by a Formlabs 3B+ printer at the Palo Alto VA Simulation Center. The 3D printed prosthesis was washed using Formlabs Form Wash 80% ethyl alcohol to remove excess resin and subsequently cured to harden the malleable resin. Supports were later removed, and the prosthesis was sanded.

figure.png

The primary aim of this study was to investigate whether using CTs to create patient-specific prosthetic renderings for patients with head and neck cancer could be a feasible strategy. The CTs from the patient were successfully used to generate a 3D printed prosthesis, and the prosthesis matched the original craniofacial anatomy seen in the patient's imaging (Figure). These results demonstrate that high quality CTs can be used as a template for 3D printed prostheses for mild to moderate palatomaxillary defects.

3D Printing Costs

One liter of Denture Base Resin costs $299; prostheses use about 5 mL of resin. The average annual salary of a 3D printing technician in the United States is $42,717, or $20.54 per hour.21 For an experienced 3D printing technician, the time required to segment the hard palate and prepare it for 3D printing is 1 to 2 hours. The process may exceed 2 hours if the technician is presented with a lower quality CT or if the patient has a complex craniofacial anatomy.

The average time it takes to print a palatal prosthetic is 5 hours. An additional hour is needed for postprocessing, which includes washing and sanding. Therefore, the cost of the materials and labor for an average 3D printed prosthetic is about $150. A Formlabs 3B+ printer is competitively priced around $10,000. The cost for Materialise Mimics software varies, but is estimated at $16,000 at VAPAHCS. The prices for these 2 items are not included in our price estimation but should be taken into consideration.

Prosthodontist Process and Cost

The typical process of creating a palatal prosthesis by a prosthodontist begins by examining the patient, creating a stone model, then creating a wax model. Biocompatible materials are selected and processed into a mold that is trimmed and polished to the desired shape. This is followed by another patient visit to ensure the prosthesis fits properly. Follow-up care is also necessary for maintenance and comfort.

The average cost of a palatal prosthesis varies depending on the type needed (ie, metal implant, teeth replacement), the materials used, the region in which the patient is receiving care, and the complexity of the case. For complex and customizable options like those required for patients with cancer, the prostheses typically cost several thousands of dollars. The Healthcare Common Procedure Coding System code for a palatal lift prosthesis (D5955) lists prices ranging from $4000 to $8000 per prosthetic, not including the cost of the prosthodontist visits.22,23

 

 

Discussion

This program sought to determine whether imaging studies of maxillary defects are effective templates for developing 3D printed prosthetics and whether these prosthetics should be tested for future use in reconstruction of palatomaxillary defects. Our program illustrated that CTs served as feasible templates for developing hard palate prostheses for patients with palatomaxillary defects. It is important to note the CTs used were from a newer and more modern scanner and therefore yielded detailed palatal structures with higher accuracy more suitable for 3D modeling. Lower-quality CTs from the 4 patients excluded from the program were not suitable for 3D modeling. This suggests that with high-quality imaging, 3D printed prosthesis may be a viable strategy to help patients who struggle with their function following treatment for head and neck cancers.

3D printed prosthesis may also be a more patient centered and convenient option. In the traditional prosthesis creation workflow, the patient must physically bite down onto a resin (alginate or silicone) to make an impression, a very painful postoperative process that is irritating to the raw edges of the surgical bed.15,16 Prosthodontists then create a prosthetic minus the tumor and typically secure it with clips or glue.17 Many patients also experience changes in their anatomy over time requiring them to have a new protheses created. This is particularly important in veterans with palatomaxillary defects since many VA medical centers do not have a prosthodontist on staff, making accessibility to these specialists difficult. 3D printing provides a contactless prosthetic creation process. This convenience may reduce a patient’s pain and the number of visits for which they need a specialist.

Future Directions

Additional research is needed to determine the full potential of 3D printed prosthetics. 3D printed prostheses have been effectively used for patient education in areas of presurgical planning, prosthesis creation, and trainee education.24 This research represents an early step in the development of a new technology for use in otolaryngology. Specifically, many veterans with a history of head and neck cancers have sustained changes to their craniofacial anatomy following treatment. Using imaging to create 3D printed prosthetics could be very effective for these patients. Prosthetics could improve a patient’s quality of life by restoring/approximating their anatomy after cancer treatment.

Significant time and care must be taken by cancer and reconstructive surgeons to properly fit a prosthesis. Improperly fitting prosthetics leads to mucosal ulceration that then may lead to a need for fitting a new prosthetic. The advantage of 3D printed prosthetics is that they may more precisely fit the anatomy of each patient using CT results, thus potentially reducing the time needed to fit the prosthetic as well as the risk associated with an improperly fit prosthetic. 3D printed prosthesis could be used directly in the future, however, clinical trials are needed to verify its efficacy vs prosthodontic options.

Another consideration for potential future use of 3D printed prosthetics is cost. We estimated that the cost of the materials and labor of our 3D printed prosthetic to be about $150. Pricing of current molded prosthetics varies, but is often listed at several thousand dollars. Another consideration is the durability of 3D printed prosthetics vs standard prosthetics. Since we were unable to use the prosthetic in the patient, it was difficult to determine its durability. The significant cost of the 3D printer and software necessary for 3D printed prosthetics must also be considered and may be prohibitive. While many academic hospitals are considering the purchase of 3D printers and licenses, this may be challenging for resource-constrained institutions. 3D printing may also be difficult for groups without any prior experience in the field. Outsourcing to a third party is possible, though doing so adds more cost to the project. While we recognize there is a learning curve associated with adopting any new technology, it’s equally important to note that 3D printing is being rapidly integrated and has already made significant advancements in personalized medicine.8,25,26

Limitations

This program had several limitations. First, we only obtained CTs of sufficient quality from 1 patient to generate a 3D printed prosthesis. Further research with additional patients is necessary to validate this process. Second, we were unable to trial the prosthesis in the patient because we did not have FDA approval. Additionally, it is difficult to calculate a true cost estimate for this process as materials and software costs vary dramatically across institutions as well as over time.

Conclusions

The purpose of this study was to demonstrate the possibility to develop prosthetics for the hard palate for patients suffering from palatomaxillary defects. A 3D printed prosthetic was generated that matched the patient’s craniofacial anatomy. Future research should test the feasibility of these prosthetics in patient care against a traditional prosthodontic impression. Though this is a proof-of-concept study and no prosthetics were implanted as part of this investigation, we showcase the feasibility of printing prosthetics for palatomaxillary defects. The use of 3D printed prosthetics may be a more humane process, potentially lower cost, and be more accessible to veterans.

References

1. Crafts TD, Ellsperman SE, Wannemuehler TJ, Bellicchi TD, Shipchandler TZ, Mantravadi AV. Three-dimensional printing and its applications in otorhinolaryngology-head and neck surgery. Otolaryngol Head Neck Surg. 2017;156(6):999-1010. doi:10.1177/0194599816678372

2. Virani FR, Chua EC, Timbang MR, Hsieh TY, Senders CW. Three-dimensional printing in cleft care: a systematic review. Cleft Palate Craniofac J. 2022;59(4):484-496. doi:10.1177/10556656211013175

3. Lal H, Patralekh MK. 3D printing and its applications in orthopaedic trauma: A technological marvel. J Clin Orthop Trauma. 2018;9(3):260-268. doi:10.1016/j.jcot.2018.07.022

4. Vujaklija I, Farina D. 3D printed upper limb prosthetics. Expert Rev Med Devices. 2018;15(7):505-512. doi:10.1080/17434440.2018.1494568

5. Ten Kate J, Smit G, Breedveld P. 3D-printed upper limb prostheses: a review. Disabil Rehabil Assist Technol. 2017;12(3):300-314. doi:10.1080/17483107.2016.1253117

6. Thomas CN, Mavrommatis S, Schroder LK, Cole PA. An overview of 3D printing and the orthopaedic application of patient-specific models in malunion surgery. Injury. 2022;53(3):977-983. doi:10.1016/j.injury.2021.11.019

7. Colaco M, Igel DA, Atala A. The potential of 3D printing in urological research and patient care. Nat Rev Urol. 2018;15(4):213-221. doi:10.1038/nrurol.2018.6

8. Meyer-Szary J, Luis MS, Mikulski S, et al. The role of 3D printing in planning complex medical procedures and training of medical professionals-cross-sectional multispecialty review. Int J Environ Res Public Health. 2022;19(6):3331. Published 2022 Mar 11. doi:10.3390/ijerph19063331

9. Moya D, Gobbato B, Valente S, Roca R. Use of preoperative planning and 3D printing in orthopedics and traumatology: entering a new era. Acta Ortop Mex. 2022;36(1):39-47.

10. Wixted CM, Peterson JR, Kadakia RJ, Adams SB. Three-dimensional printing in orthopaedic surgery: current applications and future developments. J Am Acad Orthop Surg Glob Res Rev. 2021;5(4):e20.00230-11. Published 2021 Apr 20. doi:10.5435/JAAOSGlobal-D-20-00230

11. Hong CJ, Giannopoulos AA, Hong BY, et al. Clinical applications of three-dimensional printing in otolaryngology-head and neck surgery: a systematic review. Laryngoscope. 2019;129(9):2045-2052. doi:10.1002/lary.2783112. Sigron GR, Barba M, Chammartin F, Msallem B, Berg BI, Thieringer FM. Functional and cosmetic outcome after reconstruction of isolated, unilateral orbital floor fractures (blow-out fractures) with and without the support of 3D-printed orbital anatomical models. J Clin Med. 2021;10(16):3509. Published 2021 Aug 9. doi:10.3390/jcm10163509

13. Kimura K, Davis S, Thomas E, et al. 3D Customization for microtia repair in hemifacial microsomia. Laryngoscope. 2022;132(3):545-549. doi:10.1002/lary.29823

14. Nyberg EL, Farris AL, Hung BP, et al. 3D-printing technologies for craniofacial rehabilitation, reconstruction, and regeneration. Ann Biomed Eng. 2017;45(1):45-57. doi:10.1007/s10439-016-1668-5

15. Flores-Ruiz R, Castellanos-Cosano L, Serrera-Figallo MA, et al. Evolution of oral cancer treatment in an andalusian population sample: rehabilitation with prosthetic obturation and removable partial prosthesis. J Clin Exp Dent. 2017;9(8):e1008-e1014. doi:10.4317/jced.54023

16. Rogers SN, Lowe D, McNally D, Brown JS, Vaughan ED. Health-related quality of life after maxillectomy: a comparison between prosthetic obturation and free flap. J Oral Maxillofac Surg. 2003;61(2):174-181. doi:10.1053/joms.2003.50044

17. Pool C, Shokri T, Vincent A, Wang W, Kadakia S, Ducic Y. Prosthetic reconstruction of the maxilla and palate. Semin Plast Surg. 2020;34(2):114-119. doi:10.1055/s-0040-1709143

18. Badhey AK, Khan MN. Palatomaxillary reconstruction: fibula or scapula. Semin Plast Surg. 2020;34(2):86-91. doi:10.1055/s-0040-1709431

19. Jategaonkar AA, Kaul VF, Lee E, Genden EM. Surgery of the palatomaxillary structure. Semin Plast Surg. 2020;34(2):71-76. doi:10.1055/s-0040-1709430

20. Lobb DC, Cottler P, Dart D, Black JS. The use of patient-specific three-dimensional printed surgical models enhances plastic surgery resident education in craniofacial surgery. J Craniofac Surg. 2019;30(2):339-341. doi:10.1097/SCS.0000000000005322

21. 3D printing technician salary in the United States. Accessed February 27, 2024. https://www.salary.com/research/salary/posting/3d-printing-technician-salary22. US Dept of Veterans Affairs. Healthcare Common Procedure Coding System. Outpatient dental professional nationwide charges by HCPCS code. January-December 2020. Accessed February 27, 2024. https://www.va.gov/COMMUNITYCARE/docs/RO/Outpatient-DataTables/v3-27_Table-I.pdf23. Washington State Department of Labor and Industries. Professional services fee schedule HCPCS level II fees. October 1, 2020. Accessed February 27, 2024. https://lni.wa.gov/patient-care/billing-payments/marfsdocs/2020/2020FSHCPCS.pdf24. Low CM, Morris JM, Price DL, et al. Three-dimensional printing: current use in rhinology and endoscopic skull base surgery. Am J Rhinol Allergy. 2019;33(6):770-781. doi:10.1177/1945892419866319

25. Aimar A, Palermo A, Innocenti B. The role of 3D printing in medical applications: a state of the art. J Healthc Eng. 2019;2019:5340616. Published 2019 Mar 21. doi:10.1155/2019/5340616

26. Garcia J, Yang Z, Mongrain R, Leask RL, Lachapelle K. 3D printing materials and their use in medical education: a review of current technology and trends for the future. BMJ Simul Technol Enhanc Learn. 2018;4(1):27-40. doi:10.1136/bmjstel-2017-000234

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Christian Calderona,b; Autreen Golzara,b; Stephen Marcott, MDa,b; Kyle Giffordc; Sandy Napel, PhDc; Dominik Fleischmann, MDc; Fred M. Baik, MDa,b; Thomas F. Osborne, MDa,b; Andrey Finegersh, MD, PhDa,b; Davud Sirjani, MDa,b

Correspondence:  Davud Sirjani  (dsirjani@stanford.edu)

aStanford University School of Medicine, California

bVeterans Affairs Palo Alto Health Care System, California

c3D and Quantitative Imaging Laboratory, Stanford, California

Author disclosures

Sandy Napel receives honoraria from Fovia, Inc. The other authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of the Federal Practitioner, Frontline Medical Communications, Inc., the US Government, or any of its agencies.

Ethics and consent

This study was reviewed and approved by the Stanford University Institutional Review Board (approval No. 28958).

Funding/Support

This study was funded by the Stanford University School of Medicine Department of Otolaryngology-Head and Neck Surgery. Collection, management, analysis, and interpretation of data was completed at the Veterans Affairs Palo Alto Health Care System, using innovation funds to purchase a 3D printer for the division of otolaryngology.

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Christian Calderona,b; Autreen Golzara,b; Stephen Marcott, MDa,b; Kyle Giffordc; Sandy Napel, PhDc; Dominik Fleischmann, MDc; Fred M. Baik, MDa,b; Thomas F. Osborne, MDa,b; Andrey Finegersh, MD, PhDa,b; Davud Sirjani, MDa,b

Correspondence:  Davud Sirjani  (dsirjani@stanford.edu)

aStanford University School of Medicine, California

bVeterans Affairs Palo Alto Health Care System, California

c3D and Quantitative Imaging Laboratory, Stanford, California

Author disclosures

Sandy Napel receives honoraria from Fovia, Inc. The other authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of the Federal Practitioner, Frontline Medical Communications, Inc., the US Government, or any of its agencies.

Ethics and consent

This study was reviewed and approved by the Stanford University Institutional Review Board (approval No. 28958).

Funding/Support

This study was funded by the Stanford University School of Medicine Department of Otolaryngology-Head and Neck Surgery. Collection, management, analysis, and interpretation of data was completed at the Veterans Affairs Palo Alto Health Care System, using innovation funds to purchase a 3D printer for the division of otolaryngology.

Author and Disclosure Information

Christian Calderona,b; Autreen Golzara,b; Stephen Marcott, MDa,b; Kyle Giffordc; Sandy Napel, PhDc; Dominik Fleischmann, MDc; Fred M. Baik, MDa,b; Thomas F. Osborne, MDa,b; Andrey Finegersh, MD, PhDa,b; Davud Sirjani, MDa,b

Correspondence:  Davud Sirjani  (dsirjani@stanford.edu)

aStanford University School of Medicine, California

bVeterans Affairs Palo Alto Health Care System, California

c3D and Quantitative Imaging Laboratory, Stanford, California

Author disclosures

Sandy Napel receives honoraria from Fovia, Inc. The other authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of the Federal Practitioner, Frontline Medical Communications, Inc., the US Government, or any of its agencies.

Ethics and consent

This study was reviewed and approved by the Stanford University Institutional Review Board (approval No. 28958).

Funding/Support

This study was funded by the Stanford University School of Medicine Department of Otolaryngology-Head and Neck Surgery. Collection, management, analysis, and interpretation of data was completed at the Veterans Affairs Palo Alto Health Care System, using innovation funds to purchase a 3D printer for the division of otolaryngology.

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Article PDF

Three-dimensional (3D) printing has become a promising area of innovation in biomedical research.1,2 Previous research in orthopedic surgery has found that customized 3D printed implants, casts, orthoses, and prosthetics (eg, prosthetic hands) matched to an individual’s unique anatomy can result in more precise placement and better surgical outcomes.3-5 Customized prosthetics have also been found to lead to fewer complications.3,6

Recent advances in 3D printing technology has prompted investigation from surgeons to identify how this new tool may be incorporated into patient care.1,7 One of the most common applications of 3D printing is during preoperative planning in which surgeons gain better insight into patient-specific anatomy by using patient-specific printed models.8 Another promising application is the production of customized prosthetics suited to each patient’s unique anatomy.9 As a result, 3D printing has significantly impacted bone and cartilage restoration procedures and has the potential to completely transform the treatment of patients with debilitating musculoskeletal injuries.3,10

The potential surrounding 3D printed prosthetics has led to their adoption by several other specialties, including otolaryngology.11 The most widely used application of 3D printing among otolaryngologists is preoperative planning, and the incorporation of printed prosthetics intoreconstruction of the orbit, nasal septum, auricle, and palate has also been reported.2,12,13 Patient-specific implants might allow otolaryngologists to better rehabilitate, reconstruct, and/or regenerate craniofacial defects using more humane procedures.14

Patients with palatomaxillary cancers are treated by prosthodontists or otolaryngologists. An impression is made with a resin–which can be painful for postoperative patients–and a prosthetic is manufactured and implanted.15-17 Patients with cancer often see many specialists, though reconstructive care is a low priority. Many of these individuals also experience dynamic anatomic functional changes over time, leading to the need for multiple prothesis.

palatomaxillary prosthetics

This program aims to use patients’ previous computed tomography (CT) to tailor customized 3D printed palatomaxillary prosthetics to specifically fit their anatomy. Palatomaxillary defects are a source of profound disability for patients with head and neck cancers who are left with large anatomic defects as a direct result of treatment. Reconstruction of palatal defects poses unique challenges due to the complexity of patient anatomy.18,19

3D printed prosthetics for palatomaxillary defects have not been incorporated into patient care. We reviewed previous imaging research to determine if it could be used to assist patients who struggle with their function and appearance following treatment for head and neck cancers. The primary aim was to investigate whether 3D printing was a feasible strategy for creating patient-specific palatomaxillary prosthetics. The secondary aim is to determine whether these prosthetics should be tested in the future for use in reconstruction of maxillary defects.

 

 

Data Acquisition

This study was conducted at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) and was approved by the Stanford University Institutional Review Board (approval #28958, informed consent and patient contact excluded). A retrospective chart review was conducted on all patients with head and neck cancers who were treated at VAPAHCS from 2010 to 2022. Patients aged ≥ 18 years who had a palatomaxillary defect due to cancer treatment, had undergone a palatal resection, and who received treatment at any point from 2010 to 2022 were included in the review. CTs were not a specific inclusion criterion, though the quality of the scans was analyzed for eligible patients. Younger patients and those treated at VAPAHCS prior to 2010 were excluded.

There was no control group; all data was sourced from the US Department of Veterans Affairs (VA) imaging system database. Among the 3595 patients reviewed, 5 met inclusion criteria and the quality of their craniofacial anatomy CTs were analyzed. To maintain accurate craniofacial 3D modeling, CTs require a maximum of 1 mm slice thickness. Of the 5 patients who met the inclusion criteria, 4 were found to have variability in the quality of their CTs and severe defects not suitable for prosthetic reconstruction, which led to their exclusion from the study. One patient was investigated to demonstrate if making these prostheses was feasible. This patient was diagnosed with a malignant neoplasm of the hard palate, underwent a partial maxillectomy, and a palatal obturator was placed to cover the defect.

The primary data collected was patient identifiers as well as the gross anatomy and dimensions of the patients’ craniofacial anatomy, as seen in previous imaging research.20 Before the imaging analysis, all personal health information was removed and the dataset was deidentified to ensure patient anonymity and noninvolvement.

CT Segmentation and 3D Printing

Using CTs of the patient’s craniofacial anatomy, we developed a model of the defects. This was achieved with deidentified CTs imported into the Food and Drug Administration (FDA)-approved computerized aid design (CAD) software, Materialise Mimics. The hard palate was segmented and isolated based off the presented scan and any holes in the image were filled using the CAD software. The model was subsequently mirrored in Materialise 3-matic to replicate an original anatomical hard palate prosthesis. The final product was converted into a 3D model and imported into Formlabs preform software to generate 3D printing supports and orient it for printing. The prosthetic was printed using FDA-approved Biocompatible Denture Base Resin by a Formlabs 3B+ printer at the Palo Alto VA Simulation Center. The 3D printed prosthesis was washed using Formlabs Form Wash 80% ethyl alcohol to remove excess resin and subsequently cured to harden the malleable resin. Supports were later removed, and the prosthesis was sanded.

figure.png

The primary aim of this study was to investigate whether using CTs to create patient-specific prosthetic renderings for patients with head and neck cancer could be a feasible strategy. The CTs from the patient were successfully used to generate a 3D printed prosthesis, and the prosthesis matched the original craniofacial anatomy seen in the patient's imaging (Figure). These results demonstrate that high quality CTs can be used as a template for 3D printed prostheses for mild to moderate palatomaxillary defects.

3D Printing Costs

One liter of Denture Base Resin costs $299; prostheses use about 5 mL of resin. The average annual salary of a 3D printing technician in the United States is $42,717, or $20.54 per hour.21 For an experienced 3D printing technician, the time required to segment the hard palate and prepare it for 3D printing is 1 to 2 hours. The process may exceed 2 hours if the technician is presented with a lower quality CT or if the patient has a complex craniofacial anatomy.

The average time it takes to print a palatal prosthetic is 5 hours. An additional hour is needed for postprocessing, which includes washing and sanding. Therefore, the cost of the materials and labor for an average 3D printed prosthetic is about $150. A Formlabs 3B+ printer is competitively priced around $10,000. The cost for Materialise Mimics software varies, but is estimated at $16,000 at VAPAHCS. The prices for these 2 items are not included in our price estimation but should be taken into consideration.

Prosthodontist Process and Cost

The typical process of creating a palatal prosthesis by a prosthodontist begins by examining the patient, creating a stone model, then creating a wax model. Biocompatible materials are selected and processed into a mold that is trimmed and polished to the desired shape. This is followed by another patient visit to ensure the prosthesis fits properly. Follow-up care is also necessary for maintenance and comfort.

The average cost of a palatal prosthesis varies depending on the type needed (ie, metal implant, teeth replacement), the materials used, the region in which the patient is receiving care, and the complexity of the case. For complex and customizable options like those required for patients with cancer, the prostheses typically cost several thousands of dollars. The Healthcare Common Procedure Coding System code for a palatal lift prosthesis (D5955) lists prices ranging from $4000 to $8000 per prosthetic, not including the cost of the prosthodontist visits.22,23

 

 

Discussion

This program sought to determine whether imaging studies of maxillary defects are effective templates for developing 3D printed prosthetics and whether these prosthetics should be tested for future use in reconstruction of palatomaxillary defects. Our program illustrated that CTs served as feasible templates for developing hard palate prostheses for patients with palatomaxillary defects. It is important to note the CTs used were from a newer and more modern scanner and therefore yielded detailed palatal structures with higher accuracy more suitable for 3D modeling. Lower-quality CTs from the 4 patients excluded from the program were not suitable for 3D modeling. This suggests that with high-quality imaging, 3D printed prosthesis may be a viable strategy to help patients who struggle with their function following treatment for head and neck cancers.

3D printed prosthesis may also be a more patient centered and convenient option. In the traditional prosthesis creation workflow, the patient must physically bite down onto a resin (alginate or silicone) to make an impression, a very painful postoperative process that is irritating to the raw edges of the surgical bed.15,16 Prosthodontists then create a prosthetic minus the tumor and typically secure it with clips or glue.17 Many patients also experience changes in their anatomy over time requiring them to have a new protheses created. This is particularly important in veterans with palatomaxillary defects since many VA medical centers do not have a prosthodontist on staff, making accessibility to these specialists difficult. 3D printing provides a contactless prosthetic creation process. This convenience may reduce a patient’s pain and the number of visits for which they need a specialist.

Future Directions

Additional research is needed to determine the full potential of 3D printed prosthetics. 3D printed prostheses have been effectively used for patient education in areas of presurgical planning, prosthesis creation, and trainee education.24 This research represents an early step in the development of a new technology for use in otolaryngology. Specifically, many veterans with a history of head and neck cancers have sustained changes to their craniofacial anatomy following treatment. Using imaging to create 3D printed prosthetics could be very effective for these patients. Prosthetics could improve a patient’s quality of life by restoring/approximating their anatomy after cancer treatment.

Significant time and care must be taken by cancer and reconstructive surgeons to properly fit a prosthesis. Improperly fitting prosthetics leads to mucosal ulceration that then may lead to a need for fitting a new prosthetic. The advantage of 3D printed prosthetics is that they may more precisely fit the anatomy of each patient using CT results, thus potentially reducing the time needed to fit the prosthetic as well as the risk associated with an improperly fit prosthetic. 3D printed prosthesis could be used directly in the future, however, clinical trials are needed to verify its efficacy vs prosthodontic options.

Another consideration for potential future use of 3D printed prosthetics is cost. We estimated that the cost of the materials and labor of our 3D printed prosthetic to be about $150. Pricing of current molded prosthetics varies, but is often listed at several thousand dollars. Another consideration is the durability of 3D printed prosthetics vs standard prosthetics. Since we were unable to use the prosthetic in the patient, it was difficult to determine its durability. The significant cost of the 3D printer and software necessary for 3D printed prosthetics must also be considered and may be prohibitive. While many academic hospitals are considering the purchase of 3D printers and licenses, this may be challenging for resource-constrained institutions. 3D printing may also be difficult for groups without any prior experience in the field. Outsourcing to a third party is possible, though doing so adds more cost to the project. While we recognize there is a learning curve associated with adopting any new technology, it’s equally important to note that 3D printing is being rapidly integrated and has already made significant advancements in personalized medicine.8,25,26

Limitations

This program had several limitations. First, we only obtained CTs of sufficient quality from 1 patient to generate a 3D printed prosthesis. Further research with additional patients is necessary to validate this process. Second, we were unable to trial the prosthesis in the patient because we did not have FDA approval. Additionally, it is difficult to calculate a true cost estimate for this process as materials and software costs vary dramatically across institutions as well as over time.

Conclusions

The purpose of this study was to demonstrate the possibility to develop prosthetics for the hard palate for patients suffering from palatomaxillary defects. A 3D printed prosthetic was generated that matched the patient’s craniofacial anatomy. Future research should test the feasibility of these prosthetics in patient care against a traditional prosthodontic impression. Though this is a proof-of-concept study and no prosthetics were implanted as part of this investigation, we showcase the feasibility of printing prosthetics for palatomaxillary defects. The use of 3D printed prosthetics may be a more humane process, potentially lower cost, and be more accessible to veterans.

Three-dimensional (3D) printing has become a promising area of innovation in biomedical research.1,2 Previous research in orthopedic surgery has found that customized 3D printed implants, casts, orthoses, and prosthetics (eg, prosthetic hands) matched to an individual’s unique anatomy can result in more precise placement and better surgical outcomes.3-5 Customized prosthetics have also been found to lead to fewer complications.3,6

Recent advances in 3D printing technology has prompted investigation from surgeons to identify how this new tool may be incorporated into patient care.1,7 One of the most common applications of 3D printing is during preoperative planning in which surgeons gain better insight into patient-specific anatomy by using patient-specific printed models.8 Another promising application is the production of customized prosthetics suited to each patient’s unique anatomy.9 As a result, 3D printing has significantly impacted bone and cartilage restoration procedures and has the potential to completely transform the treatment of patients with debilitating musculoskeletal injuries.3,10

The potential surrounding 3D printed prosthetics has led to their adoption by several other specialties, including otolaryngology.11 The most widely used application of 3D printing among otolaryngologists is preoperative planning, and the incorporation of printed prosthetics intoreconstruction of the orbit, nasal septum, auricle, and palate has also been reported.2,12,13 Patient-specific implants might allow otolaryngologists to better rehabilitate, reconstruct, and/or regenerate craniofacial defects using more humane procedures.14

Patients with palatomaxillary cancers are treated by prosthodontists or otolaryngologists. An impression is made with a resin–which can be painful for postoperative patients–and a prosthetic is manufactured and implanted.15-17 Patients with cancer often see many specialists, though reconstructive care is a low priority. Many of these individuals also experience dynamic anatomic functional changes over time, leading to the need for multiple prothesis.

palatomaxillary prosthetics

This program aims to use patients’ previous computed tomography (CT) to tailor customized 3D printed palatomaxillary prosthetics to specifically fit their anatomy. Palatomaxillary defects are a source of profound disability for patients with head and neck cancers who are left with large anatomic defects as a direct result of treatment. Reconstruction of palatal defects poses unique challenges due to the complexity of patient anatomy.18,19

3D printed prosthetics for palatomaxillary defects have not been incorporated into patient care. We reviewed previous imaging research to determine if it could be used to assist patients who struggle with their function and appearance following treatment for head and neck cancers. The primary aim was to investigate whether 3D printing was a feasible strategy for creating patient-specific palatomaxillary prosthetics. The secondary aim is to determine whether these prosthetics should be tested in the future for use in reconstruction of maxillary defects.

 

 

Data Acquisition

This study was conducted at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) and was approved by the Stanford University Institutional Review Board (approval #28958, informed consent and patient contact excluded). A retrospective chart review was conducted on all patients with head and neck cancers who were treated at VAPAHCS from 2010 to 2022. Patients aged ≥ 18 years who had a palatomaxillary defect due to cancer treatment, had undergone a palatal resection, and who received treatment at any point from 2010 to 2022 were included in the review. CTs were not a specific inclusion criterion, though the quality of the scans was analyzed for eligible patients. Younger patients and those treated at VAPAHCS prior to 2010 were excluded.

There was no control group; all data was sourced from the US Department of Veterans Affairs (VA) imaging system database. Among the 3595 patients reviewed, 5 met inclusion criteria and the quality of their craniofacial anatomy CTs were analyzed. To maintain accurate craniofacial 3D modeling, CTs require a maximum of 1 mm slice thickness. Of the 5 patients who met the inclusion criteria, 4 were found to have variability in the quality of their CTs and severe defects not suitable for prosthetic reconstruction, which led to their exclusion from the study. One patient was investigated to demonstrate if making these prostheses was feasible. This patient was diagnosed with a malignant neoplasm of the hard palate, underwent a partial maxillectomy, and a palatal obturator was placed to cover the defect.

The primary data collected was patient identifiers as well as the gross anatomy and dimensions of the patients’ craniofacial anatomy, as seen in previous imaging research.20 Before the imaging analysis, all personal health information was removed and the dataset was deidentified to ensure patient anonymity and noninvolvement.

CT Segmentation and 3D Printing

Using CTs of the patient’s craniofacial anatomy, we developed a model of the defects. This was achieved with deidentified CTs imported into the Food and Drug Administration (FDA)-approved computerized aid design (CAD) software, Materialise Mimics. The hard palate was segmented and isolated based off the presented scan and any holes in the image were filled using the CAD software. The model was subsequently mirrored in Materialise 3-matic to replicate an original anatomical hard palate prosthesis. The final product was converted into a 3D model and imported into Formlabs preform software to generate 3D printing supports and orient it for printing. The prosthetic was printed using FDA-approved Biocompatible Denture Base Resin by a Formlabs 3B+ printer at the Palo Alto VA Simulation Center. The 3D printed prosthesis was washed using Formlabs Form Wash 80% ethyl alcohol to remove excess resin and subsequently cured to harden the malleable resin. Supports were later removed, and the prosthesis was sanded.

figure.png

The primary aim of this study was to investigate whether using CTs to create patient-specific prosthetic renderings for patients with head and neck cancer could be a feasible strategy. The CTs from the patient were successfully used to generate a 3D printed prosthesis, and the prosthesis matched the original craniofacial anatomy seen in the patient's imaging (Figure). These results demonstrate that high quality CTs can be used as a template for 3D printed prostheses for mild to moderate palatomaxillary defects.

3D Printing Costs

One liter of Denture Base Resin costs $299; prostheses use about 5 mL of resin. The average annual salary of a 3D printing technician in the United States is $42,717, or $20.54 per hour.21 For an experienced 3D printing technician, the time required to segment the hard palate and prepare it for 3D printing is 1 to 2 hours. The process may exceed 2 hours if the technician is presented with a lower quality CT or if the patient has a complex craniofacial anatomy.

The average time it takes to print a palatal prosthetic is 5 hours. An additional hour is needed for postprocessing, which includes washing and sanding. Therefore, the cost of the materials and labor for an average 3D printed prosthetic is about $150. A Formlabs 3B+ printer is competitively priced around $10,000. The cost for Materialise Mimics software varies, but is estimated at $16,000 at VAPAHCS. The prices for these 2 items are not included in our price estimation but should be taken into consideration.

Prosthodontist Process and Cost

The typical process of creating a palatal prosthesis by a prosthodontist begins by examining the patient, creating a stone model, then creating a wax model. Biocompatible materials are selected and processed into a mold that is trimmed and polished to the desired shape. This is followed by another patient visit to ensure the prosthesis fits properly. Follow-up care is also necessary for maintenance and comfort.

The average cost of a palatal prosthesis varies depending on the type needed (ie, metal implant, teeth replacement), the materials used, the region in which the patient is receiving care, and the complexity of the case. For complex and customizable options like those required for patients with cancer, the prostheses typically cost several thousands of dollars. The Healthcare Common Procedure Coding System code for a palatal lift prosthesis (D5955) lists prices ranging from $4000 to $8000 per prosthetic, not including the cost of the prosthodontist visits.22,23

 

 

Discussion

This program sought to determine whether imaging studies of maxillary defects are effective templates for developing 3D printed prosthetics and whether these prosthetics should be tested for future use in reconstruction of palatomaxillary defects. Our program illustrated that CTs served as feasible templates for developing hard palate prostheses for patients with palatomaxillary defects. It is important to note the CTs used were from a newer and more modern scanner and therefore yielded detailed palatal structures with higher accuracy more suitable for 3D modeling. Lower-quality CTs from the 4 patients excluded from the program were not suitable for 3D modeling. This suggests that with high-quality imaging, 3D printed prosthesis may be a viable strategy to help patients who struggle with their function following treatment for head and neck cancers.

3D printed prosthesis may also be a more patient centered and convenient option. In the traditional prosthesis creation workflow, the patient must physically bite down onto a resin (alginate or silicone) to make an impression, a very painful postoperative process that is irritating to the raw edges of the surgical bed.15,16 Prosthodontists then create a prosthetic minus the tumor and typically secure it with clips or glue.17 Many patients also experience changes in their anatomy over time requiring them to have a new protheses created. This is particularly important in veterans with palatomaxillary defects since many VA medical centers do not have a prosthodontist on staff, making accessibility to these specialists difficult. 3D printing provides a contactless prosthetic creation process. This convenience may reduce a patient’s pain and the number of visits for which they need a specialist.

Future Directions

Additional research is needed to determine the full potential of 3D printed prosthetics. 3D printed prostheses have been effectively used for patient education in areas of presurgical planning, prosthesis creation, and trainee education.24 This research represents an early step in the development of a new technology for use in otolaryngology. Specifically, many veterans with a history of head and neck cancers have sustained changes to their craniofacial anatomy following treatment. Using imaging to create 3D printed prosthetics could be very effective for these patients. Prosthetics could improve a patient’s quality of life by restoring/approximating their anatomy after cancer treatment.

Significant time and care must be taken by cancer and reconstructive surgeons to properly fit a prosthesis. Improperly fitting prosthetics leads to mucosal ulceration that then may lead to a need for fitting a new prosthetic. The advantage of 3D printed prosthetics is that they may more precisely fit the anatomy of each patient using CT results, thus potentially reducing the time needed to fit the prosthetic as well as the risk associated with an improperly fit prosthetic. 3D printed prosthesis could be used directly in the future, however, clinical trials are needed to verify its efficacy vs prosthodontic options.

Another consideration for potential future use of 3D printed prosthetics is cost. We estimated that the cost of the materials and labor of our 3D printed prosthetic to be about $150. Pricing of current molded prosthetics varies, but is often listed at several thousand dollars. Another consideration is the durability of 3D printed prosthetics vs standard prosthetics. Since we were unable to use the prosthetic in the patient, it was difficult to determine its durability. The significant cost of the 3D printer and software necessary for 3D printed prosthetics must also be considered and may be prohibitive. While many academic hospitals are considering the purchase of 3D printers and licenses, this may be challenging for resource-constrained institutions. 3D printing may also be difficult for groups without any prior experience in the field. Outsourcing to a third party is possible, though doing so adds more cost to the project. While we recognize there is a learning curve associated with adopting any new technology, it’s equally important to note that 3D printing is being rapidly integrated and has already made significant advancements in personalized medicine.8,25,26

Limitations

This program had several limitations. First, we only obtained CTs of sufficient quality from 1 patient to generate a 3D printed prosthesis. Further research with additional patients is necessary to validate this process. Second, we were unable to trial the prosthesis in the patient because we did not have FDA approval. Additionally, it is difficult to calculate a true cost estimate for this process as materials and software costs vary dramatically across institutions as well as over time.

Conclusions

The purpose of this study was to demonstrate the possibility to develop prosthetics for the hard palate for patients suffering from palatomaxillary defects. A 3D printed prosthetic was generated that matched the patient’s craniofacial anatomy. Future research should test the feasibility of these prosthetics in patient care against a traditional prosthodontic impression. Though this is a proof-of-concept study and no prosthetics were implanted as part of this investigation, we showcase the feasibility of printing prosthetics for palatomaxillary defects. The use of 3D printed prosthetics may be a more humane process, potentially lower cost, and be more accessible to veterans.

References

1. Crafts TD, Ellsperman SE, Wannemuehler TJ, Bellicchi TD, Shipchandler TZ, Mantravadi AV. Three-dimensional printing and its applications in otorhinolaryngology-head and neck surgery. Otolaryngol Head Neck Surg. 2017;156(6):999-1010. doi:10.1177/0194599816678372

2. Virani FR, Chua EC, Timbang MR, Hsieh TY, Senders CW. Three-dimensional printing in cleft care: a systematic review. Cleft Palate Craniofac J. 2022;59(4):484-496. doi:10.1177/10556656211013175

3. Lal H, Patralekh MK. 3D printing and its applications in orthopaedic trauma: A technological marvel. J Clin Orthop Trauma. 2018;9(3):260-268. doi:10.1016/j.jcot.2018.07.022

4. Vujaklija I, Farina D. 3D printed upper limb prosthetics. Expert Rev Med Devices. 2018;15(7):505-512. doi:10.1080/17434440.2018.1494568

5. Ten Kate J, Smit G, Breedveld P. 3D-printed upper limb prostheses: a review. Disabil Rehabil Assist Technol. 2017;12(3):300-314. doi:10.1080/17483107.2016.1253117

6. Thomas CN, Mavrommatis S, Schroder LK, Cole PA. An overview of 3D printing and the orthopaedic application of patient-specific models in malunion surgery. Injury. 2022;53(3):977-983. doi:10.1016/j.injury.2021.11.019

7. Colaco M, Igel DA, Atala A. The potential of 3D printing in urological research and patient care. Nat Rev Urol. 2018;15(4):213-221. doi:10.1038/nrurol.2018.6

8. Meyer-Szary J, Luis MS, Mikulski S, et al. The role of 3D printing in planning complex medical procedures and training of medical professionals-cross-sectional multispecialty review. Int J Environ Res Public Health. 2022;19(6):3331. Published 2022 Mar 11. doi:10.3390/ijerph19063331

9. Moya D, Gobbato B, Valente S, Roca R. Use of preoperative planning and 3D printing in orthopedics and traumatology: entering a new era. Acta Ortop Mex. 2022;36(1):39-47.

10. Wixted CM, Peterson JR, Kadakia RJ, Adams SB. Three-dimensional printing in orthopaedic surgery: current applications and future developments. J Am Acad Orthop Surg Glob Res Rev. 2021;5(4):e20.00230-11. Published 2021 Apr 20. doi:10.5435/JAAOSGlobal-D-20-00230

11. Hong CJ, Giannopoulos AA, Hong BY, et al. Clinical applications of three-dimensional printing in otolaryngology-head and neck surgery: a systematic review. Laryngoscope. 2019;129(9):2045-2052. doi:10.1002/lary.2783112. Sigron GR, Barba M, Chammartin F, Msallem B, Berg BI, Thieringer FM. Functional and cosmetic outcome after reconstruction of isolated, unilateral orbital floor fractures (blow-out fractures) with and without the support of 3D-printed orbital anatomical models. J Clin Med. 2021;10(16):3509. Published 2021 Aug 9. doi:10.3390/jcm10163509

13. Kimura K, Davis S, Thomas E, et al. 3D Customization for microtia repair in hemifacial microsomia. Laryngoscope. 2022;132(3):545-549. doi:10.1002/lary.29823

14. Nyberg EL, Farris AL, Hung BP, et al. 3D-printing technologies for craniofacial rehabilitation, reconstruction, and regeneration. Ann Biomed Eng. 2017;45(1):45-57. doi:10.1007/s10439-016-1668-5

15. Flores-Ruiz R, Castellanos-Cosano L, Serrera-Figallo MA, et al. Evolution of oral cancer treatment in an andalusian population sample: rehabilitation with prosthetic obturation and removable partial prosthesis. J Clin Exp Dent. 2017;9(8):e1008-e1014. doi:10.4317/jced.54023

16. Rogers SN, Lowe D, McNally D, Brown JS, Vaughan ED. Health-related quality of life after maxillectomy: a comparison between prosthetic obturation and free flap. J Oral Maxillofac Surg. 2003;61(2):174-181. doi:10.1053/joms.2003.50044

17. Pool C, Shokri T, Vincent A, Wang W, Kadakia S, Ducic Y. Prosthetic reconstruction of the maxilla and palate. Semin Plast Surg. 2020;34(2):114-119. doi:10.1055/s-0040-1709143

18. Badhey AK, Khan MN. Palatomaxillary reconstruction: fibula or scapula. Semin Plast Surg. 2020;34(2):86-91. doi:10.1055/s-0040-1709431

19. Jategaonkar AA, Kaul VF, Lee E, Genden EM. Surgery of the palatomaxillary structure. Semin Plast Surg. 2020;34(2):71-76. doi:10.1055/s-0040-1709430

20. Lobb DC, Cottler P, Dart D, Black JS. The use of patient-specific three-dimensional printed surgical models enhances plastic surgery resident education in craniofacial surgery. J Craniofac Surg. 2019;30(2):339-341. doi:10.1097/SCS.0000000000005322

21. 3D printing technician salary in the United States. Accessed February 27, 2024. https://www.salary.com/research/salary/posting/3d-printing-technician-salary22. US Dept of Veterans Affairs. Healthcare Common Procedure Coding System. Outpatient dental professional nationwide charges by HCPCS code. January-December 2020. Accessed February 27, 2024. https://www.va.gov/COMMUNITYCARE/docs/RO/Outpatient-DataTables/v3-27_Table-I.pdf23. Washington State Department of Labor and Industries. Professional services fee schedule HCPCS level II fees. October 1, 2020. Accessed February 27, 2024. https://lni.wa.gov/patient-care/billing-payments/marfsdocs/2020/2020FSHCPCS.pdf24. Low CM, Morris JM, Price DL, et al. Three-dimensional printing: current use in rhinology and endoscopic skull base surgery. Am J Rhinol Allergy. 2019;33(6):770-781. doi:10.1177/1945892419866319

25. Aimar A, Palermo A, Innocenti B. The role of 3D printing in medical applications: a state of the art. J Healthc Eng. 2019;2019:5340616. Published 2019 Mar 21. doi:10.1155/2019/5340616

26. Garcia J, Yang Z, Mongrain R, Leask RL, Lachapelle K. 3D printing materials and their use in medical education: a review of current technology and trends for the future. BMJ Simul Technol Enhanc Learn. 2018;4(1):27-40. doi:10.1136/bmjstel-2017-000234

References

1. Crafts TD, Ellsperman SE, Wannemuehler TJ, Bellicchi TD, Shipchandler TZ, Mantravadi AV. Three-dimensional printing and its applications in otorhinolaryngology-head and neck surgery. Otolaryngol Head Neck Surg. 2017;156(6):999-1010. doi:10.1177/0194599816678372

2. Virani FR, Chua EC, Timbang MR, Hsieh TY, Senders CW. Three-dimensional printing in cleft care: a systematic review. Cleft Palate Craniofac J. 2022;59(4):484-496. doi:10.1177/10556656211013175

3. Lal H, Patralekh MK. 3D printing and its applications in orthopaedic trauma: A technological marvel. J Clin Orthop Trauma. 2018;9(3):260-268. doi:10.1016/j.jcot.2018.07.022

4. Vujaklija I, Farina D. 3D printed upper limb prosthetics. Expert Rev Med Devices. 2018;15(7):505-512. doi:10.1080/17434440.2018.1494568

5. Ten Kate J, Smit G, Breedveld P. 3D-printed upper limb prostheses: a review. Disabil Rehabil Assist Technol. 2017;12(3):300-314. doi:10.1080/17483107.2016.1253117

6. Thomas CN, Mavrommatis S, Schroder LK, Cole PA. An overview of 3D printing and the orthopaedic application of patient-specific models in malunion surgery. Injury. 2022;53(3):977-983. doi:10.1016/j.injury.2021.11.019

7. Colaco M, Igel DA, Atala A. The potential of 3D printing in urological research and patient care. Nat Rev Urol. 2018;15(4):213-221. doi:10.1038/nrurol.2018.6

8. Meyer-Szary J, Luis MS, Mikulski S, et al. The role of 3D printing in planning complex medical procedures and training of medical professionals-cross-sectional multispecialty review. Int J Environ Res Public Health. 2022;19(6):3331. Published 2022 Mar 11. doi:10.3390/ijerph19063331

9. Moya D, Gobbato B, Valente S, Roca R. Use of preoperative planning and 3D printing in orthopedics and traumatology: entering a new era. Acta Ortop Mex. 2022;36(1):39-47.

10. Wixted CM, Peterson JR, Kadakia RJ, Adams SB. Three-dimensional printing in orthopaedic surgery: current applications and future developments. J Am Acad Orthop Surg Glob Res Rev. 2021;5(4):e20.00230-11. Published 2021 Apr 20. doi:10.5435/JAAOSGlobal-D-20-00230

11. Hong CJ, Giannopoulos AA, Hong BY, et al. Clinical applications of three-dimensional printing in otolaryngology-head and neck surgery: a systematic review. Laryngoscope. 2019;129(9):2045-2052. doi:10.1002/lary.2783112. Sigron GR, Barba M, Chammartin F, Msallem B, Berg BI, Thieringer FM. Functional and cosmetic outcome after reconstruction of isolated, unilateral orbital floor fractures (blow-out fractures) with and without the support of 3D-printed orbital anatomical models. J Clin Med. 2021;10(16):3509. Published 2021 Aug 9. doi:10.3390/jcm10163509

13. Kimura K, Davis S, Thomas E, et al. 3D Customization for microtia repair in hemifacial microsomia. Laryngoscope. 2022;132(3):545-549. doi:10.1002/lary.29823

14. Nyberg EL, Farris AL, Hung BP, et al. 3D-printing technologies for craniofacial rehabilitation, reconstruction, and regeneration. Ann Biomed Eng. 2017;45(1):45-57. doi:10.1007/s10439-016-1668-5

15. Flores-Ruiz R, Castellanos-Cosano L, Serrera-Figallo MA, et al. Evolution of oral cancer treatment in an andalusian population sample: rehabilitation with prosthetic obturation and removable partial prosthesis. J Clin Exp Dent. 2017;9(8):e1008-e1014. doi:10.4317/jced.54023

16. Rogers SN, Lowe D, McNally D, Brown JS, Vaughan ED. Health-related quality of life after maxillectomy: a comparison between prosthetic obturation and free flap. J Oral Maxillofac Surg. 2003;61(2):174-181. doi:10.1053/joms.2003.50044

17. Pool C, Shokri T, Vincent A, Wang W, Kadakia S, Ducic Y. Prosthetic reconstruction of the maxilla and palate. Semin Plast Surg. 2020;34(2):114-119. doi:10.1055/s-0040-1709143

18. Badhey AK, Khan MN. Palatomaxillary reconstruction: fibula or scapula. Semin Plast Surg. 2020;34(2):86-91. doi:10.1055/s-0040-1709431

19. Jategaonkar AA, Kaul VF, Lee E, Genden EM. Surgery of the palatomaxillary structure. Semin Plast Surg. 2020;34(2):71-76. doi:10.1055/s-0040-1709430

20. Lobb DC, Cottler P, Dart D, Black JS. The use of patient-specific three-dimensional printed surgical models enhances plastic surgery resident education in craniofacial surgery. J Craniofac Surg. 2019;30(2):339-341. doi:10.1097/SCS.0000000000005322

21. 3D printing technician salary in the United States. Accessed February 27, 2024. https://www.salary.com/research/salary/posting/3d-printing-technician-salary22. US Dept of Veterans Affairs. Healthcare Common Procedure Coding System. Outpatient dental professional nationwide charges by HCPCS code. January-December 2020. Accessed February 27, 2024. https://www.va.gov/COMMUNITYCARE/docs/RO/Outpatient-DataTables/v3-27_Table-I.pdf23. Washington State Department of Labor and Industries. Professional services fee schedule HCPCS level II fees. October 1, 2020. Accessed February 27, 2024. https://lni.wa.gov/patient-care/billing-payments/marfsdocs/2020/2020FSHCPCS.pdf24. Low CM, Morris JM, Price DL, et al. Three-dimensional printing: current use in rhinology and endoscopic skull base surgery. Am J Rhinol Allergy. 2019;33(6):770-781. doi:10.1177/1945892419866319

25. Aimar A, Palermo A, Innocenti B. The role of 3D printing in medical applications: a state of the art. J Healthc Eng. 2019;2019:5340616. Published 2019 Mar 21. doi:10.1155/2019/5340616

26. Garcia J, Yang Z, Mongrain R, Leask RL, Lachapelle K. 3D printing materials and their use in medical education: a review of current technology and trends for the future. BMJ Simul Technol Enhanc Learn. 2018;4(1):27-40. doi:10.1136/bmjstel-2017-000234

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0524 FED AVAHO 3D</fileName> <TBEID>0C02F59E.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F59E</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20240428T215428</firstPublished> <LastPublished>20240428T215428</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240428T215428</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>Christian Calderona,b; Autreen Golzara,b; Stephen Marcott, MDa,b; Kyle Giffordc; Sandy Napel, PhDc; Dominik Fleischmann, MDc; Fred M. Baik, MDa,b; Thomas F. Osborne, MDa,b; Andrey Finegersh, MD, PhDa,b; Davud Sirjani, MDa,b</bylineText> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>Three-dimensional (3D) printing has become a promising area of innovation in biomedical research.1,2 Previous research in orthopedic surgery has found that cust</metaDescription> <articlePDF/> <teaserImage/> <title>3D Printing for the Development of Palatal Defect Prosthetics</title> <deck/> <eyebrow>Program Profile</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>May</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>5</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>4473</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>May 2024</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Program Profile | 4473<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> </sections> <topics> <term>27442</term> <term canonical="true">263</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>3D Printing for the Development of Palatal Defect Prosthetics</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background:</b> Three-dimensional (3D) printing has emerged as a promising new technology for the development of surgical prosthetics. Research in orthopedic surgery has demonstrated that using 3D printed customized prosthetics results in more precise implant placements and better patient outcomes. However, there has been little research on implementing customized 3D printed prosthetics in otolaryngology. The program sought to determine whether computed tomography (CT) serves as feasible templates to construct 3D printed palatal obturator prosthetics for defects in patients who have been treated for head and neck cancers. <br/><br/><b>Observations:</b> A retrospective review of patients with palatal defects was conducted and identified 1 patient with high quality CTs compatible with 3D modeling. CTs of the patient’s craniofacial anatomy were used to develop a 3D model and a Formlabs 3B+ printer printed the palatal prosthetic.<b> </b>We successfully developed and produced an individualized prosthetic using CTs from a veteran with head and neck deformities caused by cancer treatment who was previously treated at the Veterans Affairs Palo Alto Health Care System. This project was successful in printing patient-specific implants using CT reproductions of the patient’s craniofacial anatomy, particularly of the palate. The program was a proof of concept and the implant we created was not used on the patient. <br/><br/><b>Conclusions:</b> Customized 3D printed implants may allow otolaryngologists to enhance the performance and efficiency of surgeries and better rehabilitate and reconstruct craniofacial deformities to restore appearance and function to patients. Additional research will strive to enhance the therapeutic potential of these prosthetics to serve as low-cost, patient-specific implants.</p> <p>Three-dimensional (3D) printing has become a promising area of innovation in biomedical research.<sup>1,2</sup> Previous research in orthopedic surgery has found that customized 3D printed implants, casts, orthoses, and prosthetics (eg, prosthetic hands) matched to an individual’s unique anatomy can result in more precise placement and better surgical outcomes.<sup>3-5</sup> Customized prosthetics have also been found to lead to fewer complications.<sup>3,6</sup></p> <p>Recent advances in 3D printing technology has prompted investigation from surgeons to identify how this new tool may be incorporated into patient care.<sup>1,7</sup> One of the most common applications of 3D printing is during preoperative planning in which surgeons gain better insight into patient-specific anatomy by using patient-specific printed models.<sup>8</sup> Another promising application is the production of customized prosthetics suited to each patient’s unique anatomy.<sup>9</sup> As a result, 3D printing has significantly impacted bone and cartilage restoration procedures and has the potential to completely transform the treatment of patients with debilitating musculoskeletal injuries.<sup>3,10<br/><br/></sup>The potential surrounding 3D printed prosthetics has led to their adoption by several other specialties, including otolaryngology.<sup>11</sup> The most widely used application of 3D printing among otolaryngologists is preoperative planning, and the incorporation of printed prosthetics intoreconstruction of the orbit, nasal septum, auricle, and palate has also been reported.<sup>2,12,13</sup> Patient-specific implants might allow otolaryngologists to better rehabilitate, reconstruct, and/or regenerate craniofacial defects using more humane procedures.<sup>14</sup><br/><br/>Patients with palatomaxillary cancers are treated by prosthodontists or otolaryngologists. An impression is made with a resin–which can be painful for postoperative patients–and a prosthetic is manufactured and implanted.<sup>15-17</sup> Patients with cancer often see many specialists, though reconstructive care is a low priority. Many of these individuals also experience dynamic anatomic functional changes over time, leading to the need for multiple prothesis.</p> <h2>palatomaxillary prosthetics</h2> <p>This program aims to use patients’ previous computed tomography (CT) to tailor customized 3D printed palatomaxillary prosthetics to specifically fit their anatomy. Palatomaxillary defects are a source of profound disability for patients with head and neck cancers who are left with large anatomic defects as a direct result of treatment. Reconstruction of palatal defects poses unique challenges due to the complexity of patient anatomy.<sup>18,19</sup></p> <p>3D printed prosthetics for palatomaxillary defects have not been incorporated into patient care. We reviewed previous imaging research to determine if it could be used to assist patients who struggle with their function and appearance following treatment for head and neck cancers. The primary aim was to investigate whether 3D printing was a feasible strategy for creating patient-specific palatomaxillary prosthetics. The secondary aim is to determine whether these prosthetics should be tested in the future for use in reconstruction of maxillary defects.</p> <h3>Data Acquisition</h3> <p>This study was conducted at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) and was approved by the Stanford University Institutional Review Board (approval #28958, informed consent and patient contact excluded). A retrospective chart review was conducted on all patients with head and neck cancers who were treated at VAPAHCS from 2010 to 2022. Patients aged ≥ 18 years who had a palatomaxillary defect due to cancer treatment, had undergone a palatal resection, and who received treatment at any point from 2010 to 2022 were included in the review. CTs were not a specific inclusion criterion, though the quality of the scans was analyzed for eligible patients. Younger patients and those treated at VAPAHCS prior to 2010 were excluded.</p> <p>There was no control group; all data was sourced from the US Department of Veterans Affairs (VA) imaging system database. Among the 3595 patients reviewed, 5 met inclusion criteria and the quality of their craniofacial anatomy CTs were analyzed. To maintain accurate craniofacial 3D modeling, CTs require a maximum of 1 mm slice thickness. Of the 5 patients who met the inclusion criteria, 4 were found to have variability in the quality of their CTs and severe defects not suitable for prosthetic reconstruction, which led to their exclusion from the study. One patient was investigated to demonstrate if making these prostheses was feasible. This patient was diagnosed with a malignant neoplasm of the hard palate, underwent a partial maxillectomy, and a palatal obturator was placed to cover the defect.<br/><br/>The primary data collected was patient identifiers as well as the gross anatomy and dimensions of the patients’ craniofacial anatomy, as seen in previous imaging research.<sup>20</sup> Before the imaging analysis, all personal health information was removed and the dataset was deidentified to ensure patient anonymity and noninvolvement.</p> <h3>CT Segmentation and 3D Printing</h3> <p>Using CTs of the patient’s craniofacial anatomy, we developed a model of the defects. This was achieved with deidentified CTs imported into the Food and Drug Administration (FDA)-approved computerized aid design (CAD) software, Materialise Mimics. The hard palate was segmented and isolated based off the presented scan and any holes in the image were filled using the CAD software. The model was subsequently mirrored in Materialise 3-matic to replicate an original anatomical hard palate prosthesis. The final product was converted into a 3D model and imported into Formlabs preform software to generate 3D printing supports and orient it for printing. The prosthetic was printed using FDA-approved Biocompatible Denture Base Resin by a Formlabs 3B+ printer at the Palo Alto VA Simulation Center. The 3D printed prosthesis was washed using Formlabs Form Wash 80% ethyl alcohol to remove excess resin and subsequently cured to harden the malleable resin. Supports were later removed, and the prosthesis was sanded.</p> <p>The primary aim of this study was to investigate whether using CTs to create patient-specific prosthetic renderings for patients with head and neck cancer could be a feasible strategy. The CTs from the patient were successfully used to generate a 3D printed prosthesis, and the prosthesis matched the original craniofacial anatomy seen in the patient's imaging (Figure). These results demonstrate that high quality CTs can be used as a template for 3D printed prostheses for mild to moderate palatomaxillary defects.</p> <h3>3D Printing Costs</h3> <p>One liter of Denture Base Resin costs $299; prostheses use about 5 mL of resin. The average annual salary of a 3D printing technician in the United States is $42,717, or $20.54 per hour.<sup>21</sup> For an experienced 3D printing technician, the time required to segment the hard palate and prepare it for 3D printing is 1 to 2 hours. The process may exceed 2 hours if the technician is presented with a lower quality CT or if the patient has a complex craniofacial anatomy.</p> <p>The average time it takes to print a palatal prosthetic is 5 hours. An additional hour is needed for postprocessing, which includes washing and sanding. Therefore, the cost of the materials and labor for an average 3D printed prosthetic is about $150. A Formlabs 3B+ printer is competitively priced around $10,000. The cost for Materialise Mimics software varies, but is estimated at $16,000 at VAPAHCS. The prices for these 2 items are not included in our price estimation but should be taken into consideration.</p> <h3>Prosthodontist Process and Cost </h3> <p>The typical process of creating a palatal prosthesis by a prosthodontist begins by examining the patient, creating a stone model, then creating a wax model. Biocompatible materials are selected and processed into a mold that is trimmed and polished to the desired shape. This is followed by another patient visit to ensure the prosthesis fits properly. Follow-up care is also necessary for maintenance and comfort. </p> <p>The average cost of a palatal prosthesis varies depending on the type needed (ie, metal implant, teeth replacement), the materials used, the region in which the patient is receiving care, and the complexity of the case. For complex and customizable options like those required for patients with cancer, the prostheses typically cost several thousands of dollars. The Healthcare Common Procedure Coding System code for a palatal lift prosthesis (D5955) lists prices ranging from $4000 to $8000 per prosthetic, not including the cost of the prosthodontist visits.<sup>22,23</sup></p> <h2>Discussion</h2> <p>This program sought to determine whether imaging studies of maxillary defects are effective templates for developing 3D printed prosthetics and whether these prosthetics should be tested for future use in reconstruction of palatomaxillary defects. Our program illustrated that CTs served as feasible templates for developing hard palate prostheses for patients with palatomaxillary defects. It is important to note the CTs used were from a newer and more modern scanner and therefore yielded detailed palatal structures with higher accuracy more suitable for 3D modeling. Lower-quality CTs from the 4 patients excluded from the program were not suitable for 3D modeling. This suggests that with high-quality imaging, 3D printed prosthesis may be a viable strategy to help patients who struggle with their function following treatment for head and neck cancers.</p> <p>3D printed prosthesis may also be a more patient centered and convenient option. In the traditional prosthesis creation workflow, the patient must physically bite down onto a resin (alginate or silicone) to make an impression, a very painful postoperative process that is irritating to the raw edges of the surgical bed.<sup>15,16</sup> Prosthodontists then create a prosthetic minus the tumor and typically secure it with clips or glue.<sup>17</sup> Many patients also experience changes in their anatomy over time requiring them to have a new protheses created. This is particularly important in veterans with palatomaxillary defects since many VA medical centers do not have a prosthodontist on staff, making accessibility to these specialists difficult. 3D printing provides a contactless prosthetic creation process. This convenience may reduce a patient’s pain and the number of visits for which they need a specialist.</p> <h3>Future Directions</h3> <p>Additional research is needed to determine the full potential of 3D printed prosthetics. 3D printed prostheses have been effectively used for patient education in areas of presurgical planning, prosthesis creation, and trainee education.<sup>24</sup> This research represents an early step in the development of a new technology for use in otolaryngology. Specifically, many veterans with a history of head and neck cancers have sustained changes to their craniofacial anatomy following treatment. Using imaging to create 3D printed prosthetics could be very effective for these patients. Prosthetics could improve a patient’s quality of life by restoring/approximating their anatomy after cancer treatment.</p> <p>Significant time and care must be taken by cancer and reconstructive surgeons to properly fit a prosthesis. Improperly fitting prosthetics leads to mucosal ulceration that then may lead to a need for fitting a new prosthetic. The advantage of 3D printed prosthetics is that they may more precisely fit the anatomy of each patient using CT results, thus potentially reducing the time needed to fit the prosthetic as well as the risk associated with an improperly fit prosthetic. 3D printed prosthesis could be used directly in the future, however, clinical trials are needed to verify its efficacy vs prosthodontic options.<br/><br/>Another consideration for potential future use of 3D printed prosthetics is cost. We estimated that the cost of the materials and labor of our 3D printed prosthetic to be about $150. Pricing of current molded prosthetics varies, but is often listed at several thousand dollars. Another consideration is the durability of 3D printed prosthetics vs standard prosthetics. Since we were unable to use the prosthetic in the patient, it was difficult to determine its durability. The significant cost of the 3D printer and software necessary for 3D printed prosthetics must also be considered and may be prohibitive. While many academic hospitals are considering the purchase of 3D printers and licenses, this may be challenging for resource-constrained institutions. 3D printing may also be difficult for groups without any prior experience in the field. Outsourcing to a third party is possible, though doing so adds more cost to the project. While we recognize there is a learning curve associated with adopting any new technology, it’s equally important to note that 3D printing is being rapidly integrated and has already made significant advancements in personalized medicine.<sup>8,25,26</sup></p> <h3>Limitations</h3> <p>This program had several limitations. First, we only obtained CTs of sufficient quality from 1 patient to generate a 3D printed prosthesis. Further research with additional patients is necessary to validate this process. Second, we were unable to trial the prosthesis in the patient because we did not have FDA approval. Additionally, it is difficult to calculate a true cost estimate for this process as materials and software costs vary dramatically across institutions as well as over time. </p> <h2>Conclusions</h2> <p>The purpose of this study was to demonstrate the possibility to develop prosthetics for the hard palate for patients suffering from palatomaxillary defects. A 3D printed prosthetic was generated that matched the patient’s craniofacial anatomy. Future research should test the feasibility of these prosthetics in patient care against a traditional prosthodontic impression. Though this is a proof-of-concept study and no prosthetics were implanted as part of this investigation, we showcase the feasibility of printing prosthetics for palatomaxillary defects. The use of 3D printed prosthetics may be a more humane process, potentially lower cost, and be more accessible to veterans. </p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>Stanford University School of Medicine, California<br/><br/><sup>b</sup>Veterans Affairs Palo Alto Health Care System, California<br/><br/><sup>c</sup>3D and Quantitative Imaging Laboratory, Stanford, California</em> </p> <p class="isub">Author disclosures</p> <p> <em>Sandy Napel receives honoraria from Fovia, Inc. The other authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <p class="isub">Disclaimer</p> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of the <i>Federal Practitioner</i>, Frontline Medical Communications, Inc., the US Government, or any of its agencies. </em> </p> <p class="isub">Ethics and consent</p> <p> <em>This study was reviewed and approved by the Stanford University Institutional Review Board (approval No. 28958).</em> </p> <p class="isub">Funding/Support</p> <p> <em>This study was funded by the Stanford University School of Medicine Department of Otolaryngology-Head and Neck Surgery. Collection, management, analysis, and interpretation of data was completed at the Veterans Affairs Palo Alto Health Care System, using innovation funds to purchase a 3D printer for the division of otolaryngology.</em> </p> <h2>References</h2> <p class="reference"> 1. Crafts TD, Ellsperman SE, Wannemuehler TJ, Bellicchi TD, Shipchandler TZ, Mantravadi AV. Three-dimensional printing and its applications in otorhinolaryngology-head and neck surgery. <i>Otolaryngol Head Neck Surg</i>. 2017;156(6):999-1010. doi:10.1177/0194599816678372<br/><br/> 2. Virani FR, Chua EC, Timbang MR, Hsieh TY, Senders CW. Three-dimensional printing in cleft care: a systematic review. <i>Cleft Palate Craniofac J</i>. 2022;59(4):484-496. doi:10.1177/10556656211013175<br/><br/> 3. Lal H, Patralekh MK. 3D printing and its applications in orthopaedic trauma: A technological marvel. <i>J Clin Orthop Trauma</i>. 2018;9(3):260-268. doi:10.1016/j.jcot.2018.07.022<br/><br/> 4. Vujaklija I, Farina D. 3D printed upper limb prosthetics. <i>Expert Rev Med Devices</i>. 2018;15(7):505-512. doi:10.1080/17434440.2018.1494568<br/><br/> 5. Ten Kate J, Smit G, Breedveld P. 3D-printed upper limb prostheses: a review. <i>Disabil Rehabil Assist Technol</i>. 2017;12(3):300-314. doi:10.1080/17483107.2016.1253117<br/><br/> 6. Thomas CN, Mavrommatis S, Schroder LK, Cole PA. An overview of 3D printing and the orthopaedic application of patient-specific models in malunion surgery. <i>Injury</i>. 2022;53(3):977-983. doi:10.1016/j.injury.2021.11.019<br/><br/> 7. Colaco M, Igel DA, Atala A. The potential of 3D printing in urological research and patient care. <i>Nat Rev Urol</i>. 2018;15(4):213-221. doi:10.1038/nrurol.2018.6<br/><br/> 8. Meyer-Szary J, Luis MS, Mikulski S, et al. The role of 3D printing in planning complex medical procedures and training of medical professionals-cross-sectional multispecialty review. <i>Int J Environ Res Public Health</i>. 2022;19(6):3331. Published 2022 Mar 11. doi:10.3390/ijerph19063331<br/><br/> 9. Moya D, Gobbato B, Valente S, Roca R. Use of preoperative planning and 3D printing in orthopedics and traumatology: entering a new era. <i>Acta Ortop Mex</i>. 2022;36(1):39-47.<br/><br/>10. Wixted CM, Peterson JR, Kadakia RJ, Adams SB. Three-dimensional printing in orthopaedic surgery: current applications and future developments. <i>J Am Acad Orthop Surg Glob Res Rev</i>. 2021;5(4):e20.00230-11. Published 2021 Apr 20. doi:10.5435/JAAOSGlobal-D-20-00230<br/><br/>11. Hong CJ, Giannopoulos AA, Hong BY, et al. Clinical applications of three-dimensional printing in otolaryngology-head and neck surgery: a systematic review. <i>Laryngoscope</i>. 2019;129(9):2045-2052. doi:10.1002/lary.2783112. Sigron GR, Barba M, Chammartin F, Msallem B, Berg BI, Thieringer FM. Functional and cosmetic outcome after reconstruction of isolated, unilateral orbital floor fractures (blow-out fractures) with and without the support of 3D-printed orbital anatomical models. <i>J Clin Med</i>. 2021;10(16):3509. Published 2021 Aug 9. doi:10.3390/jcm10163509<br/><br/>13. Kimura K, Davis S, Thomas E, et al. 3D Customization for microtia repair in hemifacial microsomia. <i>Laryngoscope</i>. 2022;132(3):545-549. doi:10.1002/lary.29823<br/><br/>14. Nyberg EL, Farris AL, Hung BP, et al. 3D-printing technologies for craniofacial rehabilitation, reconstruction, and regeneration. <i>Ann Biomed Eng</i>. 2017;45(1):45-57. doi:10.1007/s10439-016-1668-5<br/><br/>15. Flores-Ruiz R, Castellanos-Cosano L, Serrera-Figallo MA, et al. Evolution of oral cancer treatment in an andalusian population sample: rehabilitation with prosthetic obturation and removable partial prosthesis. <i>J Clin Exp Dent</i>. 2017;9(8):e1008-e1014. doi:10.4317/jced.54023<br/><br/>16. Rogers SN, Lowe D, McNally D, Brown JS, Vaughan ED. Health-related quality of life after maxillectomy: a comparison between prosthetic obturation and free flap. <i>J Oral Maxillofac Surg</i>. 2003;61(2):174-181. doi:10.1053/joms.2003.50044<br/><br/>17. Pool C, Shokri T, Vincent A, Wang W, Kadakia S, Ducic Y. Prosthetic reconstruction of the maxilla and palate. <i>Semin Plast Surg</i>. 2020;34(2):114-119. doi:10.1055/s-0040-1709143<br/><br/>18. Badhey AK, Khan MN. Palatomaxillary reconstruction: fibula or scapula. <i>Semin Plast Surg</i>. 2020;34(2):86-91. doi:10.1055/s-0040-1709431<br/><br/>19. Jategaonkar AA, Kaul VF, Lee E, Genden EM. Surgery of the palatomaxillary structure. <i>Semin Plast Surg</i>. 2020;34(2):71-76. doi:10.1055/s-0040-1709430<br/><br/>20. Lobb DC, Cottler P, Dart D, Black JS. The use of patient-specific three-dimensional printed surgical models enhances plastic surgery resident education in craniofacial surgery. <i>J Craniofac Surg</i>. 2019;30(2):339-341. doi:10.1097/SCS.0000000000005322<br/><br/>21. 3D printing technician salary in the United States. Accessed February 27, 2024. https://www.salary.com/research/salary/posting/3d-printing-technician-salary22. US Dept of Veterans Affairs. Healthcare Common Procedure Coding System. Outpatient dental professional nationwide charges by HCPCS code. January-December 2020. Accessed February 27, 2024. https://www.va.gov/COMMUNITYCARE/docs/RO/Outpatient-DataTables/v3-27_Table-I.pdf23. Washington State Department of Labor and Industries. Professional services fee schedule HCPCS level II fees. October 1, 2020. Accessed February 27, 2024. https://lni.wa.gov/patient-care/billing-payments/marfsdocs/2020/2020FSHCPCS.pdf24. Low CM, Morris JM, Price DL, et al. Three-dimensional printing: current use in rhinology and endoscopic skull base surgery. <i>Am J Rhinol Allergy</i>. 2019;33(6):770-781. doi:10.1177/1945892419866319<br/><br/>25. Aimar A, Palermo A, Innocenti B. The role of 3D printing in medical applications: a state of the art. <i>J Healthc Eng</i>. 2019;2019:5340616. Published 2019 Mar 21. doi:10.1155/2019/5340616<br/><br/>26. Garcia J, Yang Z, Mongrain R, Leask RL, Lachapelle K. 3D printing materials and their use in medical education: a review of current technology and trends for the future. <i>BMJ Simul Technol Enhanc Learn</i>. 2018;4(1):27-40. doi:10.1136/bmjstel-2017-000234</p> </itemContent> </newsItem> </itemSet></root>
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Improving Fecal Immunochemical Test Collection for Colorectal Cancer Screening During the COVID-19 Pandemic

Article Type
Changed
Mon, 04/29/2024 - 19:29

Colorectal cancer (CRC) is the third-most common cancer worldwide and accounts for almost 11% of all cancer diagnoses, with > 1.9 million cases reported globally.1,2 CRC is the second-most deadly cancer, responsible for about 935,000 deaths.1 Over the past several decades, a steady decline in CRC incidence and mortality has been reported in developed countries, including the US.3,4 From 2008 through 2017, an annual reduction of 3% in CRC death rates was reported in individuals aged ≥ 65 years.5 This decline can mainly be attributed to improvements made in health systems and advancements in CRC screening programs.3,5

US Preventive Services Task Force (USPSTF) recommends CRC screening in individuals aged 45 to 75 years. USPSTF recommends direct visualization tests, such as colonoscopy and flexible sigmoidoscopy for CRC screening.6 Although colonoscopy is commonly used for CRC screening, it is an invasive procedure that requires bowel preparation and sedation, and has the potential risk of colonic perforation, bleeding, and infection. Additionally, social determinants—such as health care costs, missed work, and geographic location (eg, rural communities)—may limit colonoscopy utilization.7 As a result, other cost-effective, noninvasive tests such as high-sensitivity guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT) are also used for CRC screening. These tests detect occult blood in the stool of individuals who may be at risk for CRC, helping direct them to colonoscopy if they screen positive.8

The gFOBT relies on simple oxidation and requires a stool sample to detect the presence of the heme component of blood.9 If heme is present in the stool sample, it will enable the oxidation of guaiac to form a blue-colored dye when added to hydrogen peroxide. It is important to note that the oxidation component of this test may lead to false-positive results, as it may detect dietary hemoglobin present in red meat. Medications or foods that have peroxidase properties may also result in a false-positive gFOBT result. Additionally, false-negative results may be caused by antioxidants, which may interfere with the oxidation of guaiac.

FIT uses antibodies, which bind to the intact globin component of human hemoglobin.9 The quantity of bound antibody-hemoglobin complex is detected and measured by a variety of automated quantitative techniques. This testing strategy eliminates the need for food or medication restrictions and the subjective visual assessment of change in color, as required for the gFOBT.9 A 2016 meta-analysis found that FIT performed better compared with gFOBT in terms of specificity, positivity rate, number needed to scope, and number needed to screen.8 The FIT screening method has also been found to have greater adherence rates, which is likely due to fewer stool sampling requirements and the lack of medication or dietary restrictions, compared with gFOBT.7,8

The COVID-19 pandemic had a drastic impact on CRC preventive care services. In March 2020, elective colonoscopies were temporarily ceased across the country and the US Department of Veterans Affairs (VA) deferred all elective surgeries and medical procedures, including screening and surveillance colonoscopies. In line with these recommendations, elective colonoscopies were temporarily ceased across the country.10 The National Cancer Institute’s Population-Based Research to Optimize the Screening Process consortium reported that CRC screening rates decreased by 82% across the US in 2020.11 Public health measures are likely the main reason for this decline, but other factors may include a lack of resource availability in outpatient settings and public fear of the pandemic.10

figure_1.png

The James A. Haley Veterans Affairs Hospital (JAHVAH) in Tampa, Florida, encouraged the use of FIT in place of colonoscopies to avoid delaying preventive services. The initiative to continue CRC screening methods via FIT was scrutinized when laboratory personnel reported that in fiscal year (FY) 2020, 62% of the FIT kits that patients returned to the laboratory were missing information or had other errors (Figure 1). These improperly returned FIT kits led to delayed processing, canceled orders, increased staff workload, and more costs for FIT repetition.

Research shows many patients often fail to adhere to the instructions for proper FIT sample collection and return. Wang and colleagues reported that of 4916 FIT samples returned to the laboratory, 971 (20%) had collection errors, and 910 (94%) of those samples were missing a sample collection date.12 The sample collection date is important because hemoglobin degradation occurs over time, which may create false-negative FIT results. Although studies have found that sample return times of ≤ 10 days are not associated with a decrease in FIT positive rates, it is recommended to mail completed FITs within 24 hours of sample collection.13

Because remote screening methods like FIT were preferred during the COVID-19 pandemic, we conducted a quality improvement (QI) project to address FIT inefficiency. The aim of this initiative was to determine the root cause behind incorrectly returned FIT kits and to increase correctly collected and testable FIT kits upon initial laboratory arrival by at least 20% by the second quarter of FY 2021.

 

 

Quality Improvement Project

This QI project was conducted from July 2020 to June 2021 at the JAHVAH, which provides primary care and specialty health services to veterans in central and south Florida. The QI was designed based on the Plan-Do-Study-Act (PDSA) model of health care improvement. The QI team consisted of physicians, nurses, administrative staff, and laboratory personnel. A SIPOC (Suppliers, Input, Process, Output, Customers) map was initially designed to help clarify the different groups involved in the process of FIT kit distribution and return. This map helped the team decide who should be involved in the solution process.

The QI team performed a root cause analysis using a fishbone diagram and identified the reasons FIT kits were returned to the laboratory with errors that prevented processing. The team brainstormed potential change ideas and created an impact vs effort chart to increase the number of correctly returned and testable FIT kits upon initial arrival at the laboratory by at least 20% by the second quarter of FY 2021. We identified strengths and prioritized change ideas to improve the number of testable and correctly returned FIT kits to the hospital laboratory. These ideas included centralizing FIT kit dispersal to a new administrative group, building redundant patient reminders on kit completion and giving patients more accessible places for kit return.

Patients included in the study were adults aged 50 to 75 years seen at the JAHVAH outpatient clinic who were asked to undergo FIT CRC screening. FIT orders for other facilities were excluded. The primary endpoint of this project was to improve the number of correctly returned FITs. The number of correct and incorrect returned FITs were measured from July 2020 to June 2021. FITs returned with errors were categorized by the type of error, including: no order on file in the electronic health record (EHR), canceled test, expired test, unable to identify test, missing information, and missing collection date.

We attempted to calculate costs of FITs that were returned to the laboratory but could not be analyzed and were discarded. In FY 2020, 1568 FITs were discarded. Each FIT cost about $7.80 to process for an annualized expense of $12,230 for discarded FITs.

Root Cause Analysis

Root causes were obtained by making a fishbone diagram. From this diagram, an impact vs effort chart was created to form and prioritize ideas for our PDSA cycles. Data about correctly and incorrectly returned kits were collected monthly from laboratory personnel, then analyzed by the QI team using run charts to look for change in frequency and patterns.

To improve this process, a swim lane chart for FIT processing was assembled and later used to make a comprehensive fishbone diagram to establish the 6 main root cause errors: missing FIT EHR order, cancelled FIT EHR order, expired stool specimen, partial patient identifiers, no patient identifiers, and no stool collection date. Pareto and run charts were superimposed with the laboratory data. The most common cause of incorrectly returned FITs was no collection date.

PDSA Cycles

figure_2.png

Beginning in January 2021, PDSA cycles from the ideas in the impact vs effort chart were used. Organization and implementation of the project occurred from July 2020 to April 2021. The team reassessed the data in April 2021 to evaluate progress after PDSA initiation. The mean rate of missing collection date dropped from 24% in FY 2020 prior to PDSA cycles to 14% in April 2021; however, the number of incorrectly returned kits was similar to the baseline level. When reviewing this discrepancy, the QI team found that although the missing collection date rate had improved, the rate of FITs with not enough information had increased from 5% in FY 2020 to 67% in April 2021 (Figure 2). After discussing with laboratory personnel, it was determined that the EHR order was missing when the process pathway changed. Our PDSA initiative changed the process pathway and different individuals were responsible for FIT dispersal. The error was quickly addressed with the help of clinical and administrative staff; a 30-day follow-up on June 21, 2021, revealed that only 9% of the patients had sent back kits with not enough information.

After troubleshooting, the team achieved a sustainable increase in the number of correctly returned FIT kits from an average of 38% before the project to 72% after 30-day follow-up.

 

 

Discussion

Proper collection and return of FIT samples are vital for process efficiency for both physicians and patients. This initiative aimed to improve the rate of correctly returned FIT kits by 20%, but its final numbers showed an improvement of 33.6%. Operational benefits from this project included early detection of CRC, improved laboratory workflow, decreased FIT kit waste, and increased patient satisfaction.

The multipronged PDSA cycle attempted to increase the rate of correctly returned FIT kits. We improved kit comprehension and laboratory accessibility, and instituted redundant return reminders for patients. We also centralized a new process pathway for FIT distribution and educated physicians and support staff. Sampling and FIT return may seem like a simple procedure, but the FIT can be cumbersome for patients and directions can be confusing. Therefore, to maximize screening participation, it is essential to minimize confusion in the collection and return of a FIT sample.14,15

This QI initiative was presented at Grand Rounds at the University of South Florida in June 2021 and has since been shared with other VA hospitals. It was also presented at the American College of Gastroenterology Conference in 2021.

 

Limitations

This study was a single-center QI project and focused mostly on FIT kit return rates. To fully address CRC screening, it is important to ensure that individuals with a positive screen are appropriately followed up with a colonoscopy. Although follow-up was not in the scope of this project, it is key to CRC screening in general and should be the subject of future research.

Conclusions

FIT is a useful method for CRC screening that can be particularly helpful when in-person visits are limited, as seen during the COVID-19 pandemic. This increase in demand for FITs during the pandemic revealed process deficiencies and gave JAHVAH an opportunity to improve workflow. Through the aid of a multidisciplinary team, the process to complete and return FITs improved and surpassed the goal of 20% improvement. Our goal is to continue to fine-tune the workflow and troubleshoot the system as needed.

References

1. Sawicki T, Ruszkowska M, Danielewicz A, Niedz′wiedzka E, Arłukowicz T, Przybyłowicz KE. A review of colorectal cancer in terms of epidemiology, risk factors, development, symptoms and diagnosis. Cancers (Basel). 2021;13(9):2025. Published 2021 Apr 22. doi:10.3390/cancers13092025

2. Rawla P, Sunkara T, Barsouk A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. Prz Gastroenterol. 2019;14(2):89-103. doi:10.5114/pg.2018.81072

3. Yang DX, Gross CP, Soulos PR, Yu JB. Estimating the magnitude of colorectal cancers prevented during the era of screening: 1976 to 2009. Cancer. 2014;120(18):2893-2901. doi:10.1002/cncr.28794

4. Naishadham D, Lansdorp-Vogelaar I, Siegel R, Cokkinides V, Jemal A. State disparities in colorectal cancer mortality patterns in the United States. Cancer Epidemiol Biomarkers Prev. 2011;20(7):1296-1302. doi:10.1158/1055-9965.EPI-11-0250

5. Siegel RL, Miller KD, Goding Sauer A, et al. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020;70(3):145-164. doi:10.3322/caac.21601

6. US Preventive Services Task Force, Davidson KW, Barry MJ, et al. Screening for colorectal cancer: US Preventive

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Shruthi Narasimha, MDa; Sukhjinder Chauhan, MDb; Roger Nehaul, MDa; Jeffrey Cummings, MDa; Susan Wrighta; Alexis Pattersona; Raymond Mullinsa; William Messina, DNPa; Brian Zilka, MDa; Ana Kraus, MDa

Correspondence: Sukhjinder Chauhan (sukhjindermd@gmail.com)

aJames A. Haley Veterans Affairs Medical Center, Tampa, Florida

bHCA Sunrise Health Graduate Medical EducationConsortium, Las Vegas, Nevada

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This project did not require institutional review board approval.

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Shruthi Narasimha, MDa; Sukhjinder Chauhan, MDb; Roger Nehaul, MDa; Jeffrey Cummings, MDa; Susan Wrighta; Alexis Pattersona; Raymond Mullinsa; William Messina, DNPa; Brian Zilka, MDa; Ana Kraus, MDa

Correspondence: Sukhjinder Chauhan (sukhjindermd@gmail.com)

aJames A. Haley Veterans Affairs Medical Center, Tampa, Florida

bHCA Sunrise Health Graduate Medical EducationConsortium, Las Vegas, Nevada

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This project did not require institutional review board approval.

Author and Disclosure Information

Shruthi Narasimha, MDa; Sukhjinder Chauhan, MDb; Roger Nehaul, MDa; Jeffrey Cummings, MDa; Susan Wrighta; Alexis Pattersona; Raymond Mullinsa; William Messina, DNPa; Brian Zilka, MDa; Ana Kraus, MDa

Correspondence: Sukhjinder Chauhan (sukhjindermd@gmail.com)

aJames A. Haley Veterans Affairs Medical Center, Tampa, Florida

bHCA Sunrise Health Graduate Medical EducationConsortium, Las Vegas, Nevada

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This project did not require institutional review board approval.

Article PDF
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Colorectal cancer (CRC) is the third-most common cancer worldwide and accounts for almost 11% of all cancer diagnoses, with > 1.9 million cases reported globally.1,2 CRC is the second-most deadly cancer, responsible for about 935,000 deaths.1 Over the past several decades, a steady decline in CRC incidence and mortality has been reported in developed countries, including the US.3,4 From 2008 through 2017, an annual reduction of 3% in CRC death rates was reported in individuals aged ≥ 65 years.5 This decline can mainly be attributed to improvements made in health systems and advancements in CRC screening programs.3,5

US Preventive Services Task Force (USPSTF) recommends CRC screening in individuals aged 45 to 75 years. USPSTF recommends direct visualization tests, such as colonoscopy and flexible sigmoidoscopy for CRC screening.6 Although colonoscopy is commonly used for CRC screening, it is an invasive procedure that requires bowel preparation and sedation, and has the potential risk of colonic perforation, bleeding, and infection. Additionally, social determinants—such as health care costs, missed work, and geographic location (eg, rural communities)—may limit colonoscopy utilization.7 As a result, other cost-effective, noninvasive tests such as high-sensitivity guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT) are also used for CRC screening. These tests detect occult blood in the stool of individuals who may be at risk for CRC, helping direct them to colonoscopy if they screen positive.8

The gFOBT relies on simple oxidation and requires a stool sample to detect the presence of the heme component of blood.9 If heme is present in the stool sample, it will enable the oxidation of guaiac to form a blue-colored dye when added to hydrogen peroxide. It is important to note that the oxidation component of this test may lead to false-positive results, as it may detect dietary hemoglobin present in red meat. Medications or foods that have peroxidase properties may also result in a false-positive gFOBT result. Additionally, false-negative results may be caused by antioxidants, which may interfere with the oxidation of guaiac.

FIT uses antibodies, which bind to the intact globin component of human hemoglobin.9 The quantity of bound antibody-hemoglobin complex is detected and measured by a variety of automated quantitative techniques. This testing strategy eliminates the need for food or medication restrictions and the subjective visual assessment of change in color, as required for the gFOBT.9 A 2016 meta-analysis found that FIT performed better compared with gFOBT in terms of specificity, positivity rate, number needed to scope, and number needed to screen.8 The FIT screening method has also been found to have greater adherence rates, which is likely due to fewer stool sampling requirements and the lack of medication or dietary restrictions, compared with gFOBT.7,8

The COVID-19 pandemic had a drastic impact on CRC preventive care services. In March 2020, elective colonoscopies were temporarily ceased across the country and the US Department of Veterans Affairs (VA) deferred all elective surgeries and medical procedures, including screening and surveillance colonoscopies. In line with these recommendations, elective colonoscopies were temporarily ceased across the country.10 The National Cancer Institute’s Population-Based Research to Optimize the Screening Process consortium reported that CRC screening rates decreased by 82% across the US in 2020.11 Public health measures are likely the main reason for this decline, but other factors may include a lack of resource availability in outpatient settings and public fear of the pandemic.10

figure_1.png

The James A. Haley Veterans Affairs Hospital (JAHVAH) in Tampa, Florida, encouraged the use of FIT in place of colonoscopies to avoid delaying preventive services. The initiative to continue CRC screening methods via FIT was scrutinized when laboratory personnel reported that in fiscal year (FY) 2020, 62% of the FIT kits that patients returned to the laboratory were missing information or had other errors (Figure 1). These improperly returned FIT kits led to delayed processing, canceled orders, increased staff workload, and more costs for FIT repetition.

Research shows many patients often fail to adhere to the instructions for proper FIT sample collection and return. Wang and colleagues reported that of 4916 FIT samples returned to the laboratory, 971 (20%) had collection errors, and 910 (94%) of those samples were missing a sample collection date.12 The sample collection date is important because hemoglobin degradation occurs over time, which may create false-negative FIT results. Although studies have found that sample return times of ≤ 10 days are not associated with a decrease in FIT positive rates, it is recommended to mail completed FITs within 24 hours of sample collection.13

Because remote screening methods like FIT were preferred during the COVID-19 pandemic, we conducted a quality improvement (QI) project to address FIT inefficiency. The aim of this initiative was to determine the root cause behind incorrectly returned FIT kits and to increase correctly collected and testable FIT kits upon initial laboratory arrival by at least 20% by the second quarter of FY 2021.

 

 

Quality Improvement Project

This QI project was conducted from July 2020 to June 2021 at the JAHVAH, which provides primary care and specialty health services to veterans in central and south Florida. The QI was designed based on the Plan-Do-Study-Act (PDSA) model of health care improvement. The QI team consisted of physicians, nurses, administrative staff, and laboratory personnel. A SIPOC (Suppliers, Input, Process, Output, Customers) map was initially designed to help clarify the different groups involved in the process of FIT kit distribution and return. This map helped the team decide who should be involved in the solution process.

The QI team performed a root cause analysis using a fishbone diagram and identified the reasons FIT kits were returned to the laboratory with errors that prevented processing. The team brainstormed potential change ideas and created an impact vs effort chart to increase the number of correctly returned and testable FIT kits upon initial arrival at the laboratory by at least 20% by the second quarter of FY 2021. We identified strengths and prioritized change ideas to improve the number of testable and correctly returned FIT kits to the hospital laboratory. These ideas included centralizing FIT kit dispersal to a new administrative group, building redundant patient reminders on kit completion and giving patients more accessible places for kit return.

Patients included in the study were adults aged 50 to 75 years seen at the JAHVAH outpatient clinic who were asked to undergo FIT CRC screening. FIT orders for other facilities were excluded. The primary endpoint of this project was to improve the number of correctly returned FITs. The number of correct and incorrect returned FITs were measured from July 2020 to June 2021. FITs returned with errors were categorized by the type of error, including: no order on file in the electronic health record (EHR), canceled test, expired test, unable to identify test, missing information, and missing collection date.

We attempted to calculate costs of FITs that were returned to the laboratory but could not be analyzed and were discarded. In FY 2020, 1568 FITs were discarded. Each FIT cost about $7.80 to process for an annualized expense of $12,230 for discarded FITs.

Root Cause Analysis

Root causes were obtained by making a fishbone diagram. From this diagram, an impact vs effort chart was created to form and prioritize ideas for our PDSA cycles. Data about correctly and incorrectly returned kits were collected monthly from laboratory personnel, then analyzed by the QI team using run charts to look for change in frequency and patterns.

To improve this process, a swim lane chart for FIT processing was assembled and later used to make a comprehensive fishbone diagram to establish the 6 main root cause errors: missing FIT EHR order, cancelled FIT EHR order, expired stool specimen, partial patient identifiers, no patient identifiers, and no stool collection date. Pareto and run charts were superimposed with the laboratory data. The most common cause of incorrectly returned FITs was no collection date.

PDSA Cycles

figure_2.png

Beginning in January 2021, PDSA cycles from the ideas in the impact vs effort chart were used. Organization and implementation of the project occurred from July 2020 to April 2021. The team reassessed the data in April 2021 to evaluate progress after PDSA initiation. The mean rate of missing collection date dropped from 24% in FY 2020 prior to PDSA cycles to 14% in April 2021; however, the number of incorrectly returned kits was similar to the baseline level. When reviewing this discrepancy, the QI team found that although the missing collection date rate had improved, the rate of FITs with not enough information had increased from 5% in FY 2020 to 67% in April 2021 (Figure 2). After discussing with laboratory personnel, it was determined that the EHR order was missing when the process pathway changed. Our PDSA initiative changed the process pathway and different individuals were responsible for FIT dispersal. The error was quickly addressed with the help of clinical and administrative staff; a 30-day follow-up on June 21, 2021, revealed that only 9% of the patients had sent back kits with not enough information.

After troubleshooting, the team achieved a sustainable increase in the number of correctly returned FIT kits from an average of 38% before the project to 72% after 30-day follow-up.

 

 

Discussion

Proper collection and return of FIT samples are vital for process efficiency for both physicians and patients. This initiative aimed to improve the rate of correctly returned FIT kits by 20%, but its final numbers showed an improvement of 33.6%. Operational benefits from this project included early detection of CRC, improved laboratory workflow, decreased FIT kit waste, and increased patient satisfaction.

The multipronged PDSA cycle attempted to increase the rate of correctly returned FIT kits. We improved kit comprehension and laboratory accessibility, and instituted redundant return reminders for patients. We also centralized a new process pathway for FIT distribution and educated physicians and support staff. Sampling and FIT return may seem like a simple procedure, but the FIT can be cumbersome for patients and directions can be confusing. Therefore, to maximize screening participation, it is essential to minimize confusion in the collection and return of a FIT sample.14,15

This QI initiative was presented at Grand Rounds at the University of South Florida in June 2021 and has since been shared with other VA hospitals. It was also presented at the American College of Gastroenterology Conference in 2021.

 

Limitations

This study was a single-center QI project and focused mostly on FIT kit return rates. To fully address CRC screening, it is important to ensure that individuals with a positive screen are appropriately followed up with a colonoscopy. Although follow-up was not in the scope of this project, it is key to CRC screening in general and should be the subject of future research.

Conclusions

FIT is a useful method for CRC screening that can be particularly helpful when in-person visits are limited, as seen during the COVID-19 pandemic. This increase in demand for FITs during the pandemic revealed process deficiencies and gave JAHVAH an opportunity to improve workflow. Through the aid of a multidisciplinary team, the process to complete and return FITs improved and surpassed the goal of 20% improvement. Our goal is to continue to fine-tune the workflow and troubleshoot the system as needed.

Colorectal cancer (CRC) is the third-most common cancer worldwide and accounts for almost 11% of all cancer diagnoses, with > 1.9 million cases reported globally.1,2 CRC is the second-most deadly cancer, responsible for about 935,000 deaths.1 Over the past several decades, a steady decline in CRC incidence and mortality has been reported in developed countries, including the US.3,4 From 2008 through 2017, an annual reduction of 3% in CRC death rates was reported in individuals aged ≥ 65 years.5 This decline can mainly be attributed to improvements made in health systems and advancements in CRC screening programs.3,5

US Preventive Services Task Force (USPSTF) recommends CRC screening in individuals aged 45 to 75 years. USPSTF recommends direct visualization tests, such as colonoscopy and flexible sigmoidoscopy for CRC screening.6 Although colonoscopy is commonly used for CRC screening, it is an invasive procedure that requires bowel preparation and sedation, and has the potential risk of colonic perforation, bleeding, and infection. Additionally, social determinants—such as health care costs, missed work, and geographic location (eg, rural communities)—may limit colonoscopy utilization.7 As a result, other cost-effective, noninvasive tests such as high-sensitivity guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT) are also used for CRC screening. These tests detect occult blood in the stool of individuals who may be at risk for CRC, helping direct them to colonoscopy if they screen positive.8

The gFOBT relies on simple oxidation and requires a stool sample to detect the presence of the heme component of blood.9 If heme is present in the stool sample, it will enable the oxidation of guaiac to form a blue-colored dye when added to hydrogen peroxide. It is important to note that the oxidation component of this test may lead to false-positive results, as it may detect dietary hemoglobin present in red meat. Medications or foods that have peroxidase properties may also result in a false-positive gFOBT result. Additionally, false-negative results may be caused by antioxidants, which may interfere with the oxidation of guaiac.

FIT uses antibodies, which bind to the intact globin component of human hemoglobin.9 The quantity of bound antibody-hemoglobin complex is detected and measured by a variety of automated quantitative techniques. This testing strategy eliminates the need for food or medication restrictions and the subjective visual assessment of change in color, as required for the gFOBT.9 A 2016 meta-analysis found that FIT performed better compared with gFOBT in terms of specificity, positivity rate, number needed to scope, and number needed to screen.8 The FIT screening method has also been found to have greater adherence rates, which is likely due to fewer stool sampling requirements and the lack of medication or dietary restrictions, compared with gFOBT.7,8

The COVID-19 pandemic had a drastic impact on CRC preventive care services. In March 2020, elective colonoscopies were temporarily ceased across the country and the US Department of Veterans Affairs (VA) deferred all elective surgeries and medical procedures, including screening and surveillance colonoscopies. In line with these recommendations, elective colonoscopies were temporarily ceased across the country.10 The National Cancer Institute’s Population-Based Research to Optimize the Screening Process consortium reported that CRC screening rates decreased by 82% across the US in 2020.11 Public health measures are likely the main reason for this decline, but other factors may include a lack of resource availability in outpatient settings and public fear of the pandemic.10

figure_1.png

The James A. Haley Veterans Affairs Hospital (JAHVAH) in Tampa, Florida, encouraged the use of FIT in place of colonoscopies to avoid delaying preventive services. The initiative to continue CRC screening methods via FIT was scrutinized when laboratory personnel reported that in fiscal year (FY) 2020, 62% of the FIT kits that patients returned to the laboratory were missing information or had other errors (Figure 1). These improperly returned FIT kits led to delayed processing, canceled orders, increased staff workload, and more costs for FIT repetition.

Research shows many patients often fail to adhere to the instructions for proper FIT sample collection and return. Wang and colleagues reported that of 4916 FIT samples returned to the laboratory, 971 (20%) had collection errors, and 910 (94%) of those samples were missing a sample collection date.12 The sample collection date is important because hemoglobin degradation occurs over time, which may create false-negative FIT results. Although studies have found that sample return times of ≤ 10 days are not associated with a decrease in FIT positive rates, it is recommended to mail completed FITs within 24 hours of sample collection.13

Because remote screening methods like FIT were preferred during the COVID-19 pandemic, we conducted a quality improvement (QI) project to address FIT inefficiency. The aim of this initiative was to determine the root cause behind incorrectly returned FIT kits and to increase correctly collected and testable FIT kits upon initial laboratory arrival by at least 20% by the second quarter of FY 2021.

 

 

Quality Improvement Project

This QI project was conducted from July 2020 to June 2021 at the JAHVAH, which provides primary care and specialty health services to veterans in central and south Florida. The QI was designed based on the Plan-Do-Study-Act (PDSA) model of health care improvement. The QI team consisted of physicians, nurses, administrative staff, and laboratory personnel. A SIPOC (Suppliers, Input, Process, Output, Customers) map was initially designed to help clarify the different groups involved in the process of FIT kit distribution and return. This map helped the team decide who should be involved in the solution process.

The QI team performed a root cause analysis using a fishbone diagram and identified the reasons FIT kits were returned to the laboratory with errors that prevented processing. The team brainstormed potential change ideas and created an impact vs effort chart to increase the number of correctly returned and testable FIT kits upon initial arrival at the laboratory by at least 20% by the second quarter of FY 2021. We identified strengths and prioritized change ideas to improve the number of testable and correctly returned FIT kits to the hospital laboratory. These ideas included centralizing FIT kit dispersal to a new administrative group, building redundant patient reminders on kit completion and giving patients more accessible places for kit return.

Patients included in the study were adults aged 50 to 75 years seen at the JAHVAH outpatient clinic who were asked to undergo FIT CRC screening. FIT orders for other facilities were excluded. The primary endpoint of this project was to improve the number of correctly returned FITs. The number of correct and incorrect returned FITs were measured from July 2020 to June 2021. FITs returned with errors were categorized by the type of error, including: no order on file in the electronic health record (EHR), canceled test, expired test, unable to identify test, missing information, and missing collection date.

We attempted to calculate costs of FITs that were returned to the laboratory but could not be analyzed and were discarded. In FY 2020, 1568 FITs were discarded. Each FIT cost about $7.80 to process for an annualized expense of $12,230 for discarded FITs.

Root Cause Analysis

Root causes were obtained by making a fishbone diagram. From this diagram, an impact vs effort chart was created to form and prioritize ideas for our PDSA cycles. Data about correctly and incorrectly returned kits were collected monthly from laboratory personnel, then analyzed by the QI team using run charts to look for change in frequency and patterns.

To improve this process, a swim lane chart for FIT processing was assembled and later used to make a comprehensive fishbone diagram to establish the 6 main root cause errors: missing FIT EHR order, cancelled FIT EHR order, expired stool specimen, partial patient identifiers, no patient identifiers, and no stool collection date. Pareto and run charts were superimposed with the laboratory data. The most common cause of incorrectly returned FITs was no collection date.

PDSA Cycles

figure_2.png

Beginning in January 2021, PDSA cycles from the ideas in the impact vs effort chart were used. Organization and implementation of the project occurred from July 2020 to April 2021. The team reassessed the data in April 2021 to evaluate progress after PDSA initiation. The mean rate of missing collection date dropped from 24% in FY 2020 prior to PDSA cycles to 14% in April 2021; however, the number of incorrectly returned kits was similar to the baseline level. When reviewing this discrepancy, the QI team found that although the missing collection date rate had improved, the rate of FITs with not enough information had increased from 5% in FY 2020 to 67% in April 2021 (Figure 2). After discussing with laboratory personnel, it was determined that the EHR order was missing when the process pathway changed. Our PDSA initiative changed the process pathway and different individuals were responsible for FIT dispersal. The error was quickly addressed with the help of clinical and administrative staff; a 30-day follow-up on June 21, 2021, revealed that only 9% of the patients had sent back kits with not enough information.

After troubleshooting, the team achieved a sustainable increase in the number of correctly returned FIT kits from an average of 38% before the project to 72% after 30-day follow-up.

 

 

Discussion

Proper collection and return of FIT samples are vital for process efficiency for both physicians and patients. This initiative aimed to improve the rate of correctly returned FIT kits by 20%, but its final numbers showed an improvement of 33.6%. Operational benefits from this project included early detection of CRC, improved laboratory workflow, decreased FIT kit waste, and increased patient satisfaction.

The multipronged PDSA cycle attempted to increase the rate of correctly returned FIT kits. We improved kit comprehension and laboratory accessibility, and instituted redundant return reminders for patients. We also centralized a new process pathway for FIT distribution and educated physicians and support staff. Sampling and FIT return may seem like a simple procedure, but the FIT can be cumbersome for patients and directions can be confusing. Therefore, to maximize screening participation, it is essential to minimize confusion in the collection and return of a FIT sample.14,15

This QI initiative was presented at Grand Rounds at the University of South Florida in June 2021 and has since been shared with other VA hospitals. It was also presented at the American College of Gastroenterology Conference in 2021.

 

Limitations

This study was a single-center QI project and focused mostly on FIT kit return rates. To fully address CRC screening, it is important to ensure that individuals with a positive screen are appropriately followed up with a colonoscopy. Although follow-up was not in the scope of this project, it is key to CRC screening in general and should be the subject of future research.

Conclusions

FIT is a useful method for CRC screening that can be particularly helpful when in-person visits are limited, as seen during the COVID-19 pandemic. This increase in demand for FITs during the pandemic revealed process deficiencies and gave JAHVAH an opportunity to improve workflow. Through the aid of a multidisciplinary team, the process to complete and return FITs improved and surpassed the goal of 20% improvement. Our goal is to continue to fine-tune the workflow and troubleshoot the system as needed.

References

1. Sawicki T, Ruszkowska M, Danielewicz A, Niedz′wiedzka E, Arłukowicz T, Przybyłowicz KE. A review of colorectal cancer in terms of epidemiology, risk factors, development, symptoms and diagnosis. Cancers (Basel). 2021;13(9):2025. Published 2021 Apr 22. doi:10.3390/cancers13092025

2. Rawla P, Sunkara T, Barsouk A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. Prz Gastroenterol. 2019;14(2):89-103. doi:10.5114/pg.2018.81072

3. Yang DX, Gross CP, Soulos PR, Yu JB. Estimating the magnitude of colorectal cancers prevented during the era of screening: 1976 to 2009. Cancer. 2014;120(18):2893-2901. doi:10.1002/cncr.28794

4. Naishadham D, Lansdorp-Vogelaar I, Siegel R, Cokkinides V, Jemal A. State disparities in colorectal cancer mortality patterns in the United States. Cancer Epidemiol Biomarkers Prev. 2011;20(7):1296-1302. doi:10.1158/1055-9965.EPI-11-0250

5. Siegel RL, Miller KD, Goding Sauer A, et al. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020;70(3):145-164. doi:10.3322/caac.21601

6. US Preventive Services Task Force, Davidson KW, Barry MJ, et al. Screening for colorectal cancer: US Preventive

References

1. Sawicki T, Ruszkowska M, Danielewicz A, Niedz′wiedzka E, Arłukowicz T, Przybyłowicz KE. A review of colorectal cancer in terms of epidemiology, risk factors, development, symptoms and diagnosis. Cancers (Basel). 2021;13(9):2025. Published 2021 Apr 22. doi:10.3390/cancers13092025

2. Rawla P, Sunkara T, Barsouk A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. Prz Gastroenterol. 2019;14(2):89-103. doi:10.5114/pg.2018.81072

3. Yang DX, Gross CP, Soulos PR, Yu JB. Estimating the magnitude of colorectal cancers prevented during the era of screening: 1976 to 2009. Cancer. 2014;120(18):2893-2901. doi:10.1002/cncr.28794

4. Naishadham D, Lansdorp-Vogelaar I, Siegel R, Cokkinides V, Jemal A. State disparities in colorectal cancer mortality patterns in the United States. Cancer Epidemiol Biomarkers Prev. 2011;20(7):1296-1302. doi:10.1158/1055-9965.EPI-11-0250

5. Siegel RL, Miller KD, Goding Sauer A, et al. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020;70(3):145-164. doi:10.3322/caac.21601

6. US Preventive Services Task Force, Davidson KW, Barry MJ, et al. Screening for colorectal cancer: US Preventive

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0524 FED AVAHO FIT</fileName> <TBEID>0C02F569.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F569</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20240428T215119</firstPublished> <LastPublished>20240428T215119</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240428T215118</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>Shruthi Narasimha, MDa; Sukhjinder Chauhan, MDb; Roger Nehaul, MDa; Jeffrey Cummings, MDa; Susan Wrighta;Alexis Pattersona; Raymond Mullinsa; William Messina, DNPa; Brian Zilka, MDa; Ana Kraus, MDa</bylineText> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>Colorectal cancer (CRC) is the third-most common cancer worldwide and accounts for almost 11% of all cancer diagnoses, with &gt; 1.9 million cases reported globall</metaDescription> <articlePDF/> <teaserImage/> <title>Improving Fecal Immunochemical Test Collection for Colorectal Cancer Screening During the COVID-19 Pandemic</title> <deck/> <eyebrow>program profile</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>May</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>5</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>4473</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>May 2024</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Program Profile | 4473<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> </sections> <topics> <term canonical="true">337</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Improving Fecal Immunochemical Test Collection for Colorectal Cancer Screening During the COVID-19 Pandemic</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b/><b>Background:</b> Colonoscopy is a first-line method for colorectal cancer (CRC) screening. However, cost-effective noninvasive tests, such as high-sensitivity guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT), are also used. The COVID-19 pandemic had a substantial negative impact on CRC screening rates. The James A. Haley Veterans Affairs Hospital (JAHVAH) continued socially distant CRC screening using FITs, but encountered inefficiencies due to high rates of incorrectly collected FIT samples. A quality improvement (QI) project was conducted to increase correctly collected and testable FIT kits upon initial laboratory submission.<br/><br/><b>Observations</b>: The ambulatory QI project sought out root causes for incorrectly returned FITs and proposed Plan-Do-Study-Act (PDSA) cycles based on a series of approved action plans. A multidisciplinary team of laboratory, nursing, administrative, and primary care staff worked together to discover 6 major root causes. Our multipronged PDSA cycle attempted to set up redundant patient reminders, centralize the FIT dispersal process, and make the patient-FIT interface more user-friendly. All PDSA solutions were implemented over 4 months. Lack of collection date was the most common reason for incorrectly returned FIT kits and the focus of PDSA improvements. The rate of FITs with missing collection dates dropped from 24% prior to PDSA to 14% in April 2021. The rate of correctly returned FIT kits rose from 38% before the project to 72% afterwards, surpassing the 20% improvement goal.<b>Conclusions</b>: FIT is a useful method for CRC screening that can be particularly helpful when in-person visits are limited, as seen during the COVID-19 pandemic. The increase in demand for FITs during the pandemic revealed process deficiencies and gave JAHVAH an opportunity to improve workflow.</p> <p>Colorectal cancer (CRC) is the third-most common cancer worldwide and accounts for almost 11% of all cancer diagnoses, with &gt; 1.9 million cases reported globally.<sup>1,2</sup> CRC is the second-most deadly cancer, responsible for about 935,000 deaths.<sup>1</sup> Over the past several decades, a steady decline in CRC incidence and mortality has been reported in developed countries, including the US.<sup>3,4</sup> From 2008 through 2017, an annual reduction of 3% in CRC death rates was reported in individuals aged ≥ 65 years.<sup>5</sup> This decline can mainly be attributed to improvements made in health systems and advancements in CRC screening programs.<sup>3,5</sup></p> <p>US Preventive Services Task Force (USPSTF) recommends CRC screening in individuals aged 45 to 75 years. USPSTF recommends direct visualization tests, such as colonoscopy and flexible sigmoidoscopy for CRC screening.<sup>6</sup> Although colonoscopy is commonly used for CRC screening, it is an invasive procedure that requires bowel preparation and sedation, and has the potential risk of colonic perforation, bleeding, and infection. Additionally, social determinants—such as health care costs, missed work, and geographic location (eg, rural communities)—may limit colonoscopy utilization.<sup>7</sup> As a result, other cost-effective, noninvasive tests such as high-sensitivity guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT) are also used for CRC screening. These tests detect occult blood in the stool of individuals who may be at risk for CRC, helping direct them to colonoscopy if they screen positive.<sup>8<br/><br/></sup>The gFOBT relies on simple oxidation and requires a stool sample to detect the presence of the heme component of blood.<sup>9</sup> If heme is present in the stool sample, it will enable the oxidation of guaiac to form a blue-colored dye when added to hydrogen peroxide. It is important to note that the oxidation component of this test may lead to false-positive results, as it may detect dietary hemoglobin present in red meat. Medications or foods that have peroxidase properties may also result in a false-positive gFOBT result. Additionally, false-negative results may be caused by antioxidants, which may interfere with the oxidation of guaiac. <br/><br/>FIT uses antibodies, which bind to the intact globin component of human hemoglobin.<sup>9</sup> The quantity of bound antibody-hemoglobin complex is detected and measured by a variety of automated quantitative techniques. This testing strategy eliminates the need for food or medication restrictions and the subjective visual assessment of change in color, as required for the gFOBT.<sup>9</sup> A 2016 meta-analysis found that FIT performed better compared with gFOBT in terms of specificity, positivity rate, number needed to scope, and number needed to screen.<sup>8</sup> The FIT screening method has also been found to have greater adherence rates, which is likely due to fewer stool sampling requirements and the lack of medication or dietary restrictions, compared with gFOBT.<sup>7,8<br/><br/></sup>The COVID-19 pandemic had a drastic impact on CRC preventive care services. In March 2020, elective colonoscopies were temporarily ceased across the country and the US Department of Veterans Affairs (VA) deferred all elective surgeries and medical procedures, including screening and surveillance colonoscopies. In line with these recommendations, elective colonoscopies were temporarily ceased across the country.<sup>10</sup> The National Cancer Institute’s Population-Based Research to Optimize the Screening Process consortium reported that CRC screening rates decreased by 82% across the US in 2020.<sup>11</sup> Public health measures are likely the main reason for this decline, but other factors may include a lack of resource availability in outpatient settings and public fear of the pandemic.<sup>10<br/><br/></sup>The James A. Haley Veterans Affairs Hospital (JAHVAH) in Tampa, Florida, encouraged the use of FIT in place of colonoscopies to avoid delaying preventive services. The initiative to continue CRC screening methods via FIT was scrutinized when laboratory personnel reported that in fiscal year (FY) 2020, 62% of the FIT kits that patients returned to the laboratory were missing information or had other errors (Figure 1). These improperly returned FIT kits led to delayed processing, canceled orders, increased staff workload, and more costs for FIT repetition.Research shows many patients often fail to adhere to the instructions for proper FIT sample collection and return. Wang and colleagues reported that of 4916 FIT samples returned to the laboratory, 971 (20%) had collection errors, and 910 (94%) of those samples were missing a sample collection date.<sup>12</sup> The sample collection date is important because hemoglobin degradation occurs over time, which may create false-negative FIT results. Although studies have found that sample return times of ≤ 10 days are not associated with a decrease in FIT positive rates, it is recommended to mail completed FITs within 24 hours of sample collection.<sup>13<br/><br/></sup>Because remote screening methods like FIT were preferred during the COVID-19 pandemic, we conducted a quality improvement (QI) project to address FIT inefficiency. The aim of this initiative was to determine the root cause behind incorrectly returned FIT kits and to increase correctly collected and testable FIT kits upon initial laboratory arrival by at least 20% by the second quarter of FY 2021.</p> <h2>Quality Improvement Project</h2> <p>This QI project was conducted from July 2020 to June 2021 at the JAHVAH, which provides primary care and specialty health services to veterans in central and south Florida. The QI was designed based on the Plan-Do-Study-Act (PDSA) model of health care improvement. The QI team consisted of physicians, nurses, administrative staff, and laboratory personnel. A SIPOC (Suppliers, Input, Process, Output, Customers) map was initially designed to help clarify the different groups involved in the process of FIT kit distribution and return. This map helped the team decide who should be involved in the solution process.</p> <p>The QI team performed a root cause analysis using a fishbone diagram and identified the reasons FIT kits were returned to the laboratory with errors that prevented processing. The team brainstormed potential change ideas and created an impact vs effort chart to increase the number of correctly returned and testable FIT kits upon initial arrival at the laboratory by at least 20% by the second quarter of FY 2021. We identified strengths and prioritized change ideas to improve the number of testable and correctly returned FIT kits to the hospital laboratory. These ideas included centralizing FIT kit dispersal to a new administrative group, building redundant patient reminders on kit completion and giving patients more accessible places for kit return. <br/><br/>Patients included in the study were adults aged 50 to 75 years seen at the JAHVAH outpatient clinic who were asked to undergo FIT CRC screening. FIT orders for other facilities were excluded. The primary endpoint of this project was to improve the number of correctly returned FITs. The number of correct and incorrect returned FITs were measured from July 2020 to June 2021. FITs returned with errors were categorized by the type of error, including: no order on file in the electronic health record (EHR), canceled test, expired test, unable to identify test, missing information, and missing collection date.<br/><br/>We attempted to calculate costs of FITs that were returned to the laboratory but could not be analyzed and were discarded. In FY 2020, 1568 FITs were discarded. Each FIT cost about $7.80 to process for an annualized expense of $12,230 for discarded FITs.</p> <h3>Root Cause Analysis</h3> <p>Root causes were obtained by making a fishbone diagram. From this diagram, an impact vs effort chart was created to form and prioritize ideas for our PDSA cycles. Data about correctly and incorrectly returned kits were collected monthly from laboratory personnel, then analyzed by the QI team using run charts to look for change in frequency and patterns.</p> <p>To improve this process, a swim lane chart for FIT processing was assembled and later used to make a comprehensive fishbone diagram to establish the 6 main root cause errors: missing FIT EHR order, cancelled FIT EHR order, expired stool specimen, partial patient identifiers, no patient identifiers, and no stool collection date. Pareto and run charts were superimposed with the laboratory data. The most common cause of incorrectly returned FITs was no collection date.</p> <h3>PDSA Cycles</h3> <p>Beginning in January 2021, PDSA cycles from the ideas in the impact vs effort chart were used. Organization and implementation of the project occurred from July 2020 to April 2021. The team reassessed the data in April 2021 to evaluate progress after PDSA initiation. The mean rate of missing collection date dropped from 24% in FY 2020 prior to PDSA cycles to 14% in April 2021; however, the number of incorrectly returned kits was similar to the baseline level. When reviewing this discrepancy, the QI team found that although the missing collection date rate had improved, the rate of FITs with not enough information had increased from 5% in FY 2020<b> </b>to 67% in April 2021 (Figure 2). After discussing with laboratory personnel, it was determined that the EHR order was missing when the process pathway changed. Our PDSA initiative changed the process pathway and different individuals were responsible for FIT dispersal. The error was quickly addressed with the help of clinical and administrative staff; a 30-day follow-up on June 21, 2021, revealed that only 9% of the patients had sent back kits with not enough information.</p> <p>After troubleshooting, the team achieved a sustainable increase in the number of correctly returned FIT kits from an average of 38% before the project to 72% after 30-day follow-up.</p> <h2>Discussion</h2> <p>Proper collection and return of FIT samples are vital for process efficiency for both physicians and patients. This initiative aimed to improve the rate of correctly returned FIT kits by 20%, but its final numbers showed an improvement of 33.6%. Operational benefits from this project included early detection of CRC, improved laboratory workflow, decreased FIT kit waste, and increased patient satisfaction.</p> <p>The multipronged PDSA cycle attempted to increase the rate of correctly returned FIT kits. We improved kit comprehension and laboratory accessibility, and instituted redundant return reminders for patients. We also centralized a new process pathway for FIT distribution and educated physicians and support staff. Sampling and FIT return may seem like a simple procedure, but the FIT can be cumbersome for patients and directions can be confusing. Therefore, to maximize screening participation, it is essential to minimize confusion in the collection and return of a FIT sample.<sup>14,15<br/><br/></sup>This QI initiative was presented at Grand Rounds at the University of South Florida in June 2021 and has since been shared with other VA hospitals. It was also presented at the American College of Gastroenterology Conference in 2021.</p> <h3>Limitations</h3> <p>This study was a single-center QI project and focused mostly on FIT kit return rates. To fully address CRC screening, it is important to ensure that individuals with a positive screen are appropriately followed up with a colonoscopy. Although follow-up was not in the scope of this project, it is key to CRC screening in general and should be the subject of future research.</p> <h2>Conclusions</h2> <p>FIT is a useful method for CRC screening that can be particularly helpful when in-person visits are limited, as seen during the COVID-19 pandemic. This increase in demand for FITs during the pandemic revealed process deficiencies and gave JAHVAH an opportunity to improve workflow. Through the aid of a multidisciplinary team, the process to complete and return FITs improved and surpassed the goal of 20% improvement. Our goal is to continue to fine-tune the workflow and troubleshoot the system as needed.</p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>James A. Haley Veterans Affairs Medical Center, Tampa, Florida<br/><br/><sup>b</sup>HCA Sunrise Health Graduate Medical EducationConsortium, Las Vegas, Nevada</em> </p> <p class="isub">Author disclosures</p> <p> <em>The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <p class="isub">Disclaimer</p> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner</i>, Frontline Medical Communications Inc., the US Government, or any of its agencies.</em> </p> <p class="isub">Ethics and consent</p> <p> <em>This project did not require institutional review board approval.</em> </p> <h2>References</h2> <p class="reference"> 1. Sawicki T, Ruszkowska M, Danielewicz A, Niedz′wiedzka E, Arłukowicz T, Przybyłowicz KE. A review of colorectal cancer in terms of epidemiology, risk factors, development, symptoms and diagnosis. <i>Cancers (Basel)</i>. 2021;13(9):2025. Published 2021 Apr 22. doi:10.3390/cancers13092025<br/><br/> 2. Rawla P, Sunkara T, Barsouk A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. <i>Prz Gastroenterol</i>. 2019;14(2):89-103. doi:10.5114/pg.2018.81072<br/><br/> 3. Yang DX, Gross CP, Soulos PR, Yu JB. Estimating the magnitude of colorectal cancers prevented during the era of screening: 1976 to 2009. <i>Cancer</i>. 2014;120(18):2893-2901. doi:10.1002/cncr.28794<br/><br/> 4. Naishadham D, Lansdorp-Vogelaar I, Siegel R, Cokkinides V, Jemal A. State disparities in colorectal cancer mortality patterns in the United States. <i>Cancer Epidemiol Biomarkers Prev</i>. 2011;20(7):1296-1302. doi:10.1158/1055-9965.EPI-11-0250<br/><br/> 5. Siegel RL, Miller KD, Goding Sauer A, et al. Colorectal cancer statistics, 2020. <i>CA Cancer J Clin</i>. 2020;70(3):145-164. doi:10.3322/caac.21601</p> <p class="reference"> 6. US Preventive Services Task Force, Davidson KW, Barry MJ, et al. Screening for colorectal cancer: US Preventive</p> </itemContent> </newsItem> </itemSet></root>
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Graduate Medical Education Financing in the US Department of Veterans Affairs

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The US Department of Veterans Affairs (VA) has partnered with academic medical centers and programs since 1946 to provide clinical training for physician residents. Ranking second in federal graduate medical education (GME) funding to the Centers for Medicare and Medicaid Services (CMS), the $850 million VA GME budget annually reimburses > 250 GME-sponsoring institutions (affiliates) of 8000 GME programs for the clinical training of 49,000 individual residents rotating through > 11,000 full-time equivalent (FTE) positions.1 The VA also distributes $1.6 billion to VA facilities to offset the costs of conducting health professions education (HPE) (eg, facility infrastructure, salary support for VA instructors and preceptors, education office administration, and instructional equipment).2 The VA financial and educational contributions account for payment of 11% of resident positions nationally and allow academic medical centers to be less reliant on CMS GME funding.3,4 The VA contributions also provide opportunities for GME expansion,1,5,6 educational innovations,5,7 interprofessional and team-based care,8,9 and quality and safety training.10,11 The Table provides a comparison of CMS and VA GME reimbursability based on activity.

GME financing is complex, particularly the formulaic approach used by CMS, the details of which are often obscured in federal regulations. Due to this complexity and the $16 billion CMS GME budget, academic publications have focused on CMS GME financing while not fully explaining the VA GME policies and processes.4,12-14 By comparison, the VA GME financing model is relatively straightforward and governed by different statues and VA regulations, yet sharing some of the same principles as CMS regulations. Given the challenges in CMS reimbursement to fully support the cost of resident education, as well as the educational opportunities at the VA, the VA designs its reimbursement model to assure that affiliates receive appropriate payments.4,12,15 To ensure the continued success of VA GME partnerships, knowledge of VA GME financing has become increasingly important for designated institutional officers (DIOs) and residency program directors, particularly in light of recent investigations into oversight of the VA’s reimbursement to academic affiliates.16-18 This report describes VA GME reimbursement and, where applicable, VA and CMS reimbursement policies are compared to highlight similarities, differences, and common principles.

VA AUTHORITY

While the VA’s primary mission is “to provide a complete hospital medical service for the medical care and treatment of veterans,”early VA leaders recognized the importance of affiliating with the nation’s academic institutions.19 In 1946, the VA Policy Memorandum Number 2 established a partnership between the VA and the academic medical community.20 Additional legislation authorized specific agreements with academic affiliates for the central administration of salary and benefits for residents rotating at VA facilities. This process, known as disbursement, is an alternative payroll mechanism whereby the VA reimburses the academic affiliate for resident salary and benefits and the affiliate acts as the disbursing agent, issuing paychecks to residents.21,22

Resident FUNDING

By policy, with rare exceptions, the VA does not sponsor residency programs due to the challenges of providing an appropriate patient mix of age, sex, and medical conditions to meet accreditation standards.4 Nearly all VA reimbursements are for residents in affiliate-sponsored programs, while just 1% pays for residents in legacy, VA-sponsored residency programs at 2 VA facilities. The VA budget for resident (including fellows) salary and benefits is managed by the VA Office of Academic Affiliations (OAA), the national VA office responsible for oversight, policy, and funding of VA HPE programs.

Resident Salaries and Benefits

VA funding of resident salary and benefits are analogous with CMS direct GME (DGME), which is designed to cover resident salary and benefits costs.4,14,23 CMS DGME payments depend on a hospital’s volume of CMS inpatients and are based on a statutory formula, which uses the hospital’s resident FTE positions, the per-resident amount, and Medicare’s share of inpatient beds (Medicare patient load) to determine payments.12 The per-resident amount is set by statute, varies geographically, and is calculated by dividing the hospital’s allowable costs of GME (percentage of CMS inpatient days) divided by the number of residents.12,24

By comparison, the VA GME payment reimburses for each FTE based on the salary and benefits rate set by the academic affiliate. Reimbursement is calculated based on resident time spent at the VA multiplied by a daily salary rate. The daily salary rate is determined by dividing the resident’s total compensation (salary and benefits) by the number of calendar days in an academic year. Resident time spent at the VA facility is determined by obtaining rotation schedules provided by the academic affiliate and verifying resident clinical and educational activity during scheduled rotations.

Indirect Medical Education Funding

In addition to resident salary and benefits, funds to offset the cost of conducting HPE are provided to VA facilities. These funds are intended to improve and maintain necessary infrastructure for all HPE programs not just GME, including education office administration needs, teaching costs (ie, a portion of VA preceptors salary), and instructional equipment.

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The Veterans Equitable Resource Allocation (VERA) is a national budgeting process for VA medical facilities that funds facility operational needs such as staff salary and benefits, infrastructure, and equipment.2 The education portion of the VERA, the VERA Education Support Component (VESC), is not managed by the OAA, but rather is distributed through the VERA model to the general budget of VA facilities hosting HPE (Figure). VESC funding in the VA budget is based on labor mapping of physician time spent in education; other labor mapping categories include clinical care, research, and administration. VA facility VESC funding is calculated based on the number of paid health profession trainees (HPTs) from all professions, apportioned according to the number of FTEs for physician residents and VA-paid HPTs in other disciplines. In fiscal year 2024, VA facilities received $115,812 for each physician resident FTE position and $84,906 for each VA-paid, non-GME FTE position.

The VESC is like CMS's indirect GME funding, termed Indirect Medical Education (IME), an additional payment for each Medicare patient discharged reflecting teaching hospitals’ higher patient care costs relative to nonteaching hospitals. Described elsewhere, IME is calculated using a resident-to-bed ratio and a multiplier, which is set by statute.4,25 While IME can be used for reimbursement for some resident clinical and educational activities(eg, research), VA VESC funds cannot be used for such activities and are part of the general facility budget and appropriated per the discretion of the medical facility director.

 

 

ESTABLISHING GME PARTNERSHIPS

An affiliation agreement establishes the administrative and legal requirements for educational relationships with academic affiliates and includes standards for conducting HPE, responsibilities for accreditation standards, program leadership, faculty, resources, supervision, academic policies, and procedures. The VA uses standardized affiliation agreement templates that have been vetted with accrediting bodies and the VA Office of General Counsel.

A disbursement agreement authorizes the VA to reimburse affiliates for resident salary and benefits for VA clinical and educational activities. The disbursement agreement details the fiscal arrangements (eg, payment in advance vs arrears, salary, and benefit rates, leave) for the reimbursement payments. Veterans Health Administration (VHA) Directive 1400.05 provides the policy and procedures for calculating reimbursement for HPT educational activities.26

The VA facility designated education officer (DEO) oversees all HPE programs and coordinates the affiliation and disbursement agreement processes.27 The DEO, affiliate DIO, residency program director, and VA residency site director determine the physician resident FTE positions assigned to a VA facility based on educational objectives and availability of educational resources at the VA facility, such as patient care opportunities, faculty supervisors, space, and equipment. The VA facility requests for resident FTE positions are submitted to the OAA by the facility DEO.

Once GME FTE positions are approved by the OAA, VA facilities work with their academic affiliate to submit the physician resident salary and benefit rate. Affiliate DIOs attest to the accuracy of the salary rate schedule and the local DEO submits the budget request to the OAA. Upon approval, the funds are transferred to the VA facility each fiscal year, which begins October 1. DEOs report quarterly to the OAA both budget needs and excesses based on variations in the approved FTEs due to additional VA rotations, physician resident attrition, or reassignment.

Resident Position Allocation

VA GME financing provides flexibility through periodic needs assessments and expansion initiatives. In August and December, DEOs collaborate with an academic affiliate to submit reports to the OAA confirming their projected GME needs for the next academic year. Additional positions requests are reviewed by the OAA; funding depends on budget and the educational justification. The OAA periodically issues GME expansion requests for proposal, which typically arise from legislation to address specific VA workforce needs. The VA facility DEO and affiliate GME leaders collaborate to apply for additional positions. For example, a VA GME expansion under the Veterans Access, Choice, and Accountability Act of 2014 added 1500 GME positions in 8 years for critically needed specialties and in rural and underserved areas.5 The Maintaining Internal Systems and Strengthening Outside Networks (MISSION) Act of 2018 authorized a pilot program for VA to fund residents at non-VA facilities with priority for Indian Health Services, Tribes and Tribal Organizations, Federally Qualified Health Centers, and US Department of Defense facilities to provide access to veterans in underserved areas.6

The VA GME financing system has flexibility to meet local needs for additional resident positions and to address broader VA workforce gaps through targeted expansion. Generally, CMS does not fund positions to address workforce needs, place residents in specific geographic areas, or require the training of certain types of residents.4 However, the Consolidated Appropriations Act of 2021 has provided the opportunity to address rural workforce needs.28

 

 

Reimbursement

The VA provides reimbursement for clinical and educational activities performed in VA facilities for the benefit of veterans as well as research, didactics, meetings and conferences, annual and sick leave, and orientation. The VA also may provide reimbursement for educational activities that occur off VA grounds (eg, the VA proportional share of a residency program’s didactic sessions). The VA does not reimburse for affiliate clinical duties or administrative costs, although a national policy allows VA facilities to reimburse affiliates for some GME overhead costs.29

CMS similarly reimburses for residency training time spent in patient care activities as well as orientation activities, didactics, leave, and, in some cases, research.4,30,31 CMS makes payments to hospitals, which may include sponsoring institutions and Medicare-eligible participating training sites.4,30,31 For both the VA and CMS, residents may not be counted twice for reimbursement by 2 federal agencies; in other words, a resident may not count for > 1 FTE.4,30-32

GME Oversight

VA GME funding came under significant scrutiny. At a 2016 House Veterans Affairs Committee hearing, Representative Phil Roe, MD (R-Tennessee), noted that no process existed at many VA facilities for “determining trainee presence” and that many VA medical centers had “difficulty tracking resident rotations”16 A VA Office of the Inspector General investigation recommended that the VA implement policies and procedures to improve oversight to “ensure residents are fully participating in educational activities” and that the VA is “paying the correct amount” to the affiliate.17 A 2020 General Accountability Office report outlined unclear policy guidance, incomplete tracking of resident activities, and improper fiscal processes for reimbursement and reconciliation of affiliate invoices.18

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In response, the OAA created an oversight and compliance unit, revised VHA Directive 1400.05 (the policy for disbursement), and improved resident tracking procedures.26 The standard operating procedure that accompanied VHA Directive 1400.05 provides detailed information for the DEO and VA facility staff for tracking resident clinical and educational activities. FTE counts are essential to both VA and CMS for accurate reimbursement. The eAppendix and the Table provide a guide to reimbursable activities in the VA for the calculation of reimbursement, with a comparison to CMS.33,34 The OAA in cooperation with other VA staff and officers periodically conducts audits to assess compliance with disbursement policy and affiliate reimbursement accuracy.

In the VA, resident activities are captured on the VA Educational Activity Record, a standardized spreadsheet to track activities and calculate reimbursement. Each VA facility hosting resident physicians manually records resident activity by the half-day. This process is labor intensive, involving both VA and affiliate staff to accurately reconcile payments. To address the workload demands, the OAA is developing an online tool that will automate aspects of the tracking process. Also, to ensure adequate staffing, the OAA is in the process of implementing an office optimization project, providing standardized position descriptions, an organizational chart, and staffing levels for DEO offices in VA facilities.

 

 

Conclusions

This report describes the key policies and principles of VA GME financing, highlighting the essential similarities and differences between VA and CMS. Neither the VA nor CMS regulations allow for reimbursement for > 1 FTE position per resident, a principle that underpins the assignment of resident rotations and federal funding for GME and are similar with respect to reimbursement for patient care activities, didactics, research, orientation, and scholarly activity. While reimbursable activities in the VA require physical presence and care of veteran patients, CMS also limits reimbursement to resident activities in the hospital and approved other settings if the hospital is paying for resident salary and benefits in these settings. The VA provides some flexibility for offsite activities including didactics and, in specific circumstances, remote care of veteran patients (eg, teleradiology).

The VA and CMS use different GME financing models. For example, the CMS calculations for resident FTEs are complex, whereas VA calculations reimburse the salary and benefits as set by the academic affiliate. The VA process accounts for local variation in salary rates, whereas the per-resident amount set by CMS varies regionally and does not fully account for differences in the cost of living.24 Because all patients in VA facilities are veterans, VA calculations for reimbursement do not involve ratios of beds like the CMS calculations to determine a proportional share of reimbursement. The VA GME expansion tends to be more directed to VA health workforce needs than CMS, specifying the types of programs and geographic locations to address these needs.

The VA regularly reevaluates how affiliates are reimbursed for VA resident activity, balancing compliance with VA policies and the workload for VA and its affiliates. The VA obtains input from key stakeholders including DEOs, DIOs, and professional organizations such as the Association of American Medical Colleges and the Accreditation Council for Graduate Medical Education.35,36

Looking ahead, the VA is developing an online tool to improve the accuracy of affiliate reimbursement. The VA will also implement a standardized staffing model, organizational structure, and position descriptions for DEO offices. These initiatives will help reduce the burden of tracking and verifying resident activity and continue to support the 77-year partnership between VA and its affiliated institutions.

References

1. Klink KA, Albanese AP, Bope ET, Sanders KM. Veterans Affairs graduate medical education expansion addresses US physician workforce needs. Acad Med. 2022;97(8):1144-1150. doi:10.1097/ACM.0000000000004545

2. Andrus CH, Johnson K, Pierce E, Romito PJ, Hartel P, Berrios‐Guccione S, Best W. Finance modeling in the delivery of medical care in tertiary‐care hospitals in the Department of Veterans Affairs. J Surg Res. 2001;96(2):152-157. doi:10.1006/jsre.1999.5728

3. Petrakis IL, Kozal M. Academic medical centers and the U.S. Department of Veterans Affairs: a 75-year partnership influences medical education, scientific discovery, and clinical care. Acad Med. 2022;97(8):1110-1113. doi:10.1097/ACM.0000000000004734

4. Heisler EJ, Mendez BH, Mitchell A, Panangala SV, Villagrana MA. Federal support for graduate medical education: an overview (R44376). Congressional Research Service report R44376; version 11. Updated December 27, 2018. Accessed March 2, 2024. https://crsreports.congress.gov/product/pdf/R/R44376/11

5. Chang BK, Brannen JL. The Veterans Access, Choice, and Accountability Act of 2014: examining graduate medical education enhancement in the Department of Veterans Affairs. Acad Med. 2015;90(9):1196-1198. doi:10.1097/ACM.0000000000000795

6. Albanese AP, Bope ET, Sanders KM, Bowman M. The VA MISSION Act of 2018: a potential game changer for rural GME expansion and veteran health care. J Rural Health. 2020;36(1):133-136. doi:10.1111/jrh.12360

7. Lypson ML, Roberts LW. Valuing the partnership between the Veterans Health Administration and academic medicine. Acad Med. 2022;97(8):1091-1093. doi:10.1097/ACM.0000000000004748

8. Harada ND, Traylor L, Rugen KW, et al. Interprofessional transformation of clinical education: the first six years of the Veterans Affairs Centers of Excellence in Primary Care Education. J Interprof Care. 2023;37(suppl 1):S86-S94. doi:10.1080/13561820.2018.1433642

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9. Harada ND, Rajashekara S, Sansgiry S, et al. Developing interprofessional primary care teams: alumni evaluation of the Department of Veterans Affairs Centers of Excellence in Primary Care Education Program. J Med Educ Curric Dev. 2019;6:2382120519875455. doi:10.1177/2382120519875455

10. Splaine ME, Ogrinc G, Gilman SC, et al. The Department of Veterans Affairs National Quality Scholars Fellowship Program: experience from 10 years of training quality scholars. Acad Med. 2009;84(12):1741-1748. doi:10.1097/ACM.0b013e3181bfdcef

11. Watts BV, Paull DE, Williams LC, Neily J, Hemphill RR, Brannen JL. Department of Veterans Affairs chief resident in quality and patient safety program: a model to spread change. Am J Med Qual. 2016;31(6):598-600. doi:10.1177/1062860616643403

12. He K, Whang E, Kristo G. Graduate medical education funding mechanisms, challenges, and solutions: a narrative review. Am J Surg. 2021;221(1):65-71. doi:10.1016/j.amjsurg.2020.06.007

13. Villagrana M. Medicare graduate medical education payments: an overview. Congressional Research Service report IF10960. Updated September 29, 2022. Accessed March 2, 2024. https://crsreports.congress.gov/product/pdf/IF/IF10960

14. Committee on the Governance and Financing of Graduate Medical Education; Board on Health Care Services; Institute of Medicine. Graduate Medical Education That Meets the Nation’s Health Needs. Eden J, Berwick DM, Wilensky GR, eds. Washington, DC: National Academies Press; 2014. doi:10.17226/18754

15. Physician workforce: caps on Medicare-funded graduate medical education at teaching hospitals. Report to congressional requesters. GAO-21-391. May 21, 2021. Accessed March 1, 2024. https://www.gao.gov/assets/gao-21-391.pdf

16. VA and Academic Affiliates: Who Benefits? Hearing Before the Subcommittee on Oversight and Investigations of the Committee on Veterans’ Affairs, 114th Cong, 2nd Sess (2016). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CHRG-115hhrg29685/html/CHRG-115hhrg29685.htm

17. US Department of Veterans Affairs, Office of Inspector General (OIG). Veterans Health Administration. Review of resident and part-time physician time and attendance at the Oklahoma City VA Health Care System. OIG report 17-00253-93. March 28, 2018. Accessed March 1, 2024. https://www.oversight.gov/sites/default/files/oig-reports/VAOIG-17-00253-93.pdf

18. VA health care: actions needed to improve oversight of graduate medical education reimbursement. Report to the ranking member, Committee on Veterans’ Affairs, House of Representatives. GAO-20-553. July 2020. Accessed March 1, 2024. https://www.gao.gov/assets/710/708275.pdf

19. Functions of Veterans Health Administration: in general, 38 USC §7301 (2022). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/USCODE-2022-title38/pdf/USCODE-2022-title38-partV-chap73-subchapI-sec7301.pdf

20. US Department of Veterans Affairs. Policy memorandum no. 2, policy in association of veterans’ hospitals with medical schools. January 30, 1946.

21. Veterans Health Care Expansion Act of 1973, Public Law 93-82. August 2, 1973. Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/STATUTE-87/pdf/STATUTE-87-Pg179.pdf

22. Residencies and internships, 38 USC § 7406 (2022). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/USCODE-2022-title38/pdf/USCODE-2022-title38-partV-chap74-subchapI-sec7406.pdf

23. Direct graduate medical education (DGME). Centers for Medicaid and Medicare Services. Updated December 5, 2023. Accessed March 1, 2024. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/DGME

24. Drezdzon MK, Cowley NJ, Sweeney DP, et al. Going for broke: the impact of cost of living on surgery resident stipend value. Ann Surg. 2023;278(6):1053-1059. doi:10.1097/SLA.0000000000005923

25. Special treatment: hospitals that incur indirect costs for graduate medical education programs, 42 CFR § 412.105 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec412-105.pdf

26. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1400.05, Disbursement agreements for health professions trainees appointed under 38 U.S.C. § 7406. June 2, 2021. Accessed March 1, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9293

27. Harada ND, Sanders KM, Bowman MA. Health systems education leadership: learning from the VA designated education officer role. Fed Pract. 2022;39(6):266-273. doi:10.12788/fp.0278

28. Schleiter Hitchell K, Johnson L. CMS finalizes rules for distribution of 1000 new Medicare-funded residency positions and changes to rural training track programs. J Grad Med Educ. 2022;14(2):245-249. doi:10.4300/JGME-D-22-00193.1

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29. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1400.10, Educational cost contracts for health professions education. September 25, 2023. Accessed March 1, 2024. https://www.va.gov/VHAPUBLICATIONS/ViewPublication.asp?pub_ID=11480

30. Direct GME payments: general requirements, 42 CFR § 413.75 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec413-75.pdf

31. Direct GME payments: determination of the total number of FTE residents, 42 CFR § 413.78 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec413-78.pdf

32. US Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare financial management manual, chapter 8. Contractor procedures for provider audits. Accessed March 1, 2024. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/fin106c08.pdf

33. US Department of Health and Human Services, Office of Inspector General. CMS did not always ensure hospitals complied with Medicare reimbursement requirements for graduate medical education. OIG report A-02-17-01017. November 2018. Accessed March 1, 2024. https://oig.hhs.gov/oas/reports/region2/21701017.pdf

34. US Department of Health and Human Services, Centers for Medicare and Medicaid Services. Interns and Residents Information System (IRIS) XML format. Publication 100-20. Transmittal 11418. Change request 12724. May 19, 2022. Accessed March 1, 2024. https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/R11418OTN.pdf

35. Birnbaum AD, Byrne J, on behalf of the VA Office of Academic Affiliations. VHA Updates: Disbursement Policy and Education Cost Contracts. Presented at: American Association of Medical Colleges Webinar; June 2021. Accessed March 1, 2024. https://vimeo.com/644415670

36. Byrne JM, on behalf of the VA Office of Academic Affiliations. Disbursement procedures update for AY 23-24. Accessed March 1, 2024. https://www.va.gov/oaa/Videos/AffiliatePresentationDisbursementandEARsAY23-24.pptx

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John M. Byrne, DOa; Paul B. Greenberg, MDb,c; Karen M. Sanders, MDa,d; Andrea D. Birnbaum, MD, PhDa,e;  Erin L. Patel, PsyD, ABPPa; and Ryan M. Scilla, MDa,f

Correspondence:  John M. Byrne  (john.byrne3@va.gov)

aOffice of Academic Affiliations, Veterans Health Administration, Department of Veterans Affairs, Washington, DC

bVA Providence Health Care System, Rhode Island

cThe Warren Alpert Medical School of Brown University, Providence, Rhode Island

dVirginia Commonwealth University, Richmond

eNorthwestern University Feinberg School of Medicine, Chicago, Illinois

fUniversity of Maryland School of Medicine, Baltimore

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John M. Byrne, DOa; Paul B. Greenberg, MDb,c; Karen M. Sanders, MDa,d; Andrea D. Birnbaum, MD, PhDa,e;  Erin L. Patel, PsyD, ABPPa; and Ryan M. Scilla, MDa,f

Correspondence:  John M. Byrne  (john.byrne3@va.gov)

aOffice of Academic Affiliations, Veterans Health Administration, Department of Veterans Affairs, Washington, DC

bVA Providence Health Care System, Rhode Island

cThe Warren Alpert Medical School of Brown University, Providence, Rhode Island

dVirginia Commonwealth University, Richmond

eNorthwestern University Feinberg School of Medicine, Chicago, Illinois

fUniversity of Maryland School of Medicine, Baltimore

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This report is a program description and did not involve collection of data from human or animal subjects.

Author and Disclosure Information

John M. Byrne, DOa; Paul B. Greenberg, MDb,c; Karen M. Sanders, MDa,d; Andrea D. Birnbaum, MD, PhDa,e;  Erin L. Patel, PsyD, ABPPa; and Ryan M. Scilla, MDa,f

Correspondence:  John M. Byrne  (john.byrne3@va.gov)

aOffice of Academic Affiliations, Veterans Health Administration, Department of Veterans Affairs, Washington, DC

bVA Providence Health Care System, Rhode Island

cThe Warren Alpert Medical School of Brown University, Providence, Rhode Island

dVirginia Commonwealth University, Richmond

eNorthwestern University Feinberg School of Medicine, Chicago, Illinois

fUniversity of Maryland School of Medicine, Baltimore

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This report is a program description and did not involve collection of data from human or animal subjects.

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Article PDF

table.png

The US Department of Veterans Affairs (VA) has partnered with academic medical centers and programs since 1946 to provide clinical training for physician residents. Ranking second in federal graduate medical education (GME) funding to the Centers for Medicare and Medicaid Services (CMS), the $850 million VA GME budget annually reimburses > 250 GME-sponsoring institutions (affiliates) of 8000 GME programs for the clinical training of 49,000 individual residents rotating through > 11,000 full-time equivalent (FTE) positions.1 The VA also distributes $1.6 billion to VA facilities to offset the costs of conducting health professions education (HPE) (eg, facility infrastructure, salary support for VA instructors and preceptors, education office administration, and instructional equipment).2 The VA financial and educational contributions account for payment of 11% of resident positions nationally and allow academic medical centers to be less reliant on CMS GME funding.3,4 The VA contributions also provide opportunities for GME expansion,1,5,6 educational innovations,5,7 interprofessional and team-based care,8,9 and quality and safety training.10,11 The Table provides a comparison of CMS and VA GME reimbursability based on activity.

GME financing is complex, particularly the formulaic approach used by CMS, the details of which are often obscured in federal regulations. Due to this complexity and the $16 billion CMS GME budget, academic publications have focused on CMS GME financing while not fully explaining the VA GME policies and processes.4,12-14 By comparison, the VA GME financing model is relatively straightforward and governed by different statues and VA regulations, yet sharing some of the same principles as CMS regulations. Given the challenges in CMS reimbursement to fully support the cost of resident education, as well as the educational opportunities at the VA, the VA designs its reimbursement model to assure that affiliates receive appropriate payments.4,12,15 To ensure the continued success of VA GME partnerships, knowledge of VA GME financing has become increasingly important for designated institutional officers (DIOs) and residency program directors, particularly in light of recent investigations into oversight of the VA’s reimbursement to academic affiliates.16-18 This report describes VA GME reimbursement and, where applicable, VA and CMS reimbursement policies are compared to highlight similarities, differences, and common principles.

VA AUTHORITY

While the VA’s primary mission is “to provide a complete hospital medical service for the medical care and treatment of veterans,”early VA leaders recognized the importance of affiliating with the nation’s academic institutions.19 In 1946, the VA Policy Memorandum Number 2 established a partnership between the VA and the academic medical community.20 Additional legislation authorized specific agreements with academic affiliates for the central administration of salary and benefits for residents rotating at VA facilities. This process, known as disbursement, is an alternative payroll mechanism whereby the VA reimburses the academic affiliate for resident salary and benefits and the affiliate acts as the disbursing agent, issuing paychecks to residents.21,22

Resident FUNDING

By policy, with rare exceptions, the VA does not sponsor residency programs due to the challenges of providing an appropriate patient mix of age, sex, and medical conditions to meet accreditation standards.4 Nearly all VA reimbursements are for residents in affiliate-sponsored programs, while just 1% pays for residents in legacy, VA-sponsored residency programs at 2 VA facilities. The VA budget for resident (including fellows) salary and benefits is managed by the VA Office of Academic Affiliations (OAA), the national VA office responsible for oversight, policy, and funding of VA HPE programs.

Resident Salaries and Benefits

VA funding of resident salary and benefits are analogous with CMS direct GME (DGME), which is designed to cover resident salary and benefits costs.4,14,23 CMS DGME payments depend on a hospital’s volume of CMS inpatients and are based on a statutory formula, which uses the hospital’s resident FTE positions, the per-resident amount, and Medicare’s share of inpatient beds (Medicare patient load) to determine payments.12 The per-resident amount is set by statute, varies geographically, and is calculated by dividing the hospital’s allowable costs of GME (percentage of CMS inpatient days) divided by the number of residents.12,24

By comparison, the VA GME payment reimburses for each FTE based on the salary and benefits rate set by the academic affiliate. Reimbursement is calculated based on resident time spent at the VA multiplied by a daily salary rate. The daily salary rate is determined by dividing the resident’s total compensation (salary and benefits) by the number of calendar days in an academic year. Resident time spent at the VA facility is determined by obtaining rotation schedules provided by the academic affiliate and verifying resident clinical and educational activity during scheduled rotations.

Indirect Medical Education Funding

In addition to resident salary and benefits, funds to offset the cost of conducting HPE are provided to VA facilities. These funds are intended to improve and maintain necessary infrastructure for all HPE programs not just GME, including education office administration needs, teaching costs (ie, a portion of VA preceptors salary), and instructional equipment.

figure.png

The Veterans Equitable Resource Allocation (VERA) is a national budgeting process for VA medical facilities that funds facility operational needs such as staff salary and benefits, infrastructure, and equipment.2 The education portion of the VERA, the VERA Education Support Component (VESC), is not managed by the OAA, but rather is distributed through the VERA model to the general budget of VA facilities hosting HPE (Figure). VESC funding in the VA budget is based on labor mapping of physician time spent in education; other labor mapping categories include clinical care, research, and administration. VA facility VESC funding is calculated based on the number of paid health profession trainees (HPTs) from all professions, apportioned according to the number of FTEs for physician residents and VA-paid HPTs in other disciplines. In fiscal year 2024, VA facilities received $115,812 for each physician resident FTE position and $84,906 for each VA-paid, non-GME FTE position.

The VESC is like CMS's indirect GME funding, termed Indirect Medical Education (IME), an additional payment for each Medicare patient discharged reflecting teaching hospitals’ higher patient care costs relative to nonteaching hospitals. Described elsewhere, IME is calculated using a resident-to-bed ratio and a multiplier, which is set by statute.4,25 While IME can be used for reimbursement for some resident clinical and educational activities(eg, research), VA VESC funds cannot be used for such activities and are part of the general facility budget and appropriated per the discretion of the medical facility director.

 

 

ESTABLISHING GME PARTNERSHIPS

An affiliation agreement establishes the administrative and legal requirements for educational relationships with academic affiliates and includes standards for conducting HPE, responsibilities for accreditation standards, program leadership, faculty, resources, supervision, academic policies, and procedures. The VA uses standardized affiliation agreement templates that have been vetted with accrediting bodies and the VA Office of General Counsel.

A disbursement agreement authorizes the VA to reimburse affiliates for resident salary and benefits for VA clinical and educational activities. The disbursement agreement details the fiscal arrangements (eg, payment in advance vs arrears, salary, and benefit rates, leave) for the reimbursement payments. Veterans Health Administration (VHA) Directive 1400.05 provides the policy and procedures for calculating reimbursement for HPT educational activities.26

The VA facility designated education officer (DEO) oversees all HPE programs and coordinates the affiliation and disbursement agreement processes.27 The DEO, affiliate DIO, residency program director, and VA residency site director determine the physician resident FTE positions assigned to a VA facility based on educational objectives and availability of educational resources at the VA facility, such as patient care opportunities, faculty supervisors, space, and equipment. The VA facility requests for resident FTE positions are submitted to the OAA by the facility DEO.

Once GME FTE positions are approved by the OAA, VA facilities work with their academic affiliate to submit the physician resident salary and benefit rate. Affiliate DIOs attest to the accuracy of the salary rate schedule and the local DEO submits the budget request to the OAA. Upon approval, the funds are transferred to the VA facility each fiscal year, which begins October 1. DEOs report quarterly to the OAA both budget needs and excesses based on variations in the approved FTEs due to additional VA rotations, physician resident attrition, or reassignment.

Resident Position Allocation

VA GME financing provides flexibility through periodic needs assessments and expansion initiatives. In August and December, DEOs collaborate with an academic affiliate to submit reports to the OAA confirming their projected GME needs for the next academic year. Additional positions requests are reviewed by the OAA; funding depends on budget and the educational justification. The OAA periodically issues GME expansion requests for proposal, which typically arise from legislation to address specific VA workforce needs. The VA facility DEO and affiliate GME leaders collaborate to apply for additional positions. For example, a VA GME expansion under the Veterans Access, Choice, and Accountability Act of 2014 added 1500 GME positions in 8 years for critically needed specialties and in rural and underserved areas.5 The Maintaining Internal Systems and Strengthening Outside Networks (MISSION) Act of 2018 authorized a pilot program for VA to fund residents at non-VA facilities with priority for Indian Health Services, Tribes and Tribal Organizations, Federally Qualified Health Centers, and US Department of Defense facilities to provide access to veterans in underserved areas.6

The VA GME financing system has flexibility to meet local needs for additional resident positions and to address broader VA workforce gaps through targeted expansion. Generally, CMS does not fund positions to address workforce needs, place residents in specific geographic areas, or require the training of certain types of residents.4 However, the Consolidated Appropriations Act of 2021 has provided the opportunity to address rural workforce needs.28

 

 

Reimbursement

The VA provides reimbursement for clinical and educational activities performed in VA facilities for the benefit of veterans as well as research, didactics, meetings and conferences, annual and sick leave, and orientation. The VA also may provide reimbursement for educational activities that occur off VA grounds (eg, the VA proportional share of a residency program’s didactic sessions). The VA does not reimburse for affiliate clinical duties or administrative costs, although a national policy allows VA facilities to reimburse affiliates for some GME overhead costs.29

CMS similarly reimburses for residency training time spent in patient care activities as well as orientation activities, didactics, leave, and, in some cases, research.4,30,31 CMS makes payments to hospitals, which may include sponsoring institutions and Medicare-eligible participating training sites.4,30,31 For both the VA and CMS, residents may not be counted twice for reimbursement by 2 federal agencies; in other words, a resident may not count for > 1 FTE.4,30-32

GME Oversight

VA GME funding came under significant scrutiny. At a 2016 House Veterans Affairs Committee hearing, Representative Phil Roe, MD (R-Tennessee), noted that no process existed at many VA facilities for “determining trainee presence” and that many VA medical centers had “difficulty tracking resident rotations”16 A VA Office of the Inspector General investigation recommended that the VA implement policies and procedures to improve oversight to “ensure residents are fully participating in educational activities” and that the VA is “paying the correct amount” to the affiliate.17 A 2020 General Accountability Office report outlined unclear policy guidance, incomplete tracking of resident activities, and improper fiscal processes for reimbursement and reconciliation of affiliate invoices.18

eappendix.png

In response, the OAA created an oversight and compliance unit, revised VHA Directive 1400.05 (the policy for disbursement), and improved resident tracking procedures.26 The standard operating procedure that accompanied VHA Directive 1400.05 provides detailed information for the DEO and VA facility staff for tracking resident clinical and educational activities. FTE counts are essential to both VA and CMS for accurate reimbursement. The eAppendix and the Table provide a guide to reimbursable activities in the VA for the calculation of reimbursement, with a comparison to CMS.33,34 The OAA in cooperation with other VA staff and officers periodically conducts audits to assess compliance with disbursement policy and affiliate reimbursement accuracy.

In the VA, resident activities are captured on the VA Educational Activity Record, a standardized spreadsheet to track activities and calculate reimbursement. Each VA facility hosting resident physicians manually records resident activity by the half-day. This process is labor intensive, involving both VA and affiliate staff to accurately reconcile payments. To address the workload demands, the OAA is developing an online tool that will automate aspects of the tracking process. Also, to ensure adequate staffing, the OAA is in the process of implementing an office optimization project, providing standardized position descriptions, an organizational chart, and staffing levels for DEO offices in VA facilities.

 

 

Conclusions

This report describes the key policies and principles of VA GME financing, highlighting the essential similarities and differences between VA and CMS. Neither the VA nor CMS regulations allow for reimbursement for > 1 FTE position per resident, a principle that underpins the assignment of resident rotations and federal funding for GME and are similar with respect to reimbursement for patient care activities, didactics, research, orientation, and scholarly activity. While reimbursable activities in the VA require physical presence and care of veteran patients, CMS also limits reimbursement to resident activities in the hospital and approved other settings if the hospital is paying for resident salary and benefits in these settings. The VA provides some flexibility for offsite activities including didactics and, in specific circumstances, remote care of veteran patients (eg, teleradiology).

The VA and CMS use different GME financing models. For example, the CMS calculations for resident FTEs are complex, whereas VA calculations reimburse the salary and benefits as set by the academic affiliate. The VA process accounts for local variation in salary rates, whereas the per-resident amount set by CMS varies regionally and does not fully account for differences in the cost of living.24 Because all patients in VA facilities are veterans, VA calculations for reimbursement do not involve ratios of beds like the CMS calculations to determine a proportional share of reimbursement. The VA GME expansion tends to be more directed to VA health workforce needs than CMS, specifying the types of programs and geographic locations to address these needs.

The VA regularly reevaluates how affiliates are reimbursed for VA resident activity, balancing compliance with VA policies and the workload for VA and its affiliates. The VA obtains input from key stakeholders including DEOs, DIOs, and professional organizations such as the Association of American Medical Colleges and the Accreditation Council for Graduate Medical Education.35,36

Looking ahead, the VA is developing an online tool to improve the accuracy of affiliate reimbursement. The VA will also implement a standardized staffing model, organizational structure, and position descriptions for DEO offices. These initiatives will help reduce the burden of tracking and verifying resident activity and continue to support the 77-year partnership between VA and its affiliated institutions.

table.png

The US Department of Veterans Affairs (VA) has partnered with academic medical centers and programs since 1946 to provide clinical training for physician residents. Ranking second in federal graduate medical education (GME) funding to the Centers for Medicare and Medicaid Services (CMS), the $850 million VA GME budget annually reimburses > 250 GME-sponsoring institutions (affiliates) of 8000 GME programs for the clinical training of 49,000 individual residents rotating through > 11,000 full-time equivalent (FTE) positions.1 The VA also distributes $1.6 billion to VA facilities to offset the costs of conducting health professions education (HPE) (eg, facility infrastructure, salary support for VA instructors and preceptors, education office administration, and instructional equipment).2 The VA financial and educational contributions account for payment of 11% of resident positions nationally and allow academic medical centers to be less reliant on CMS GME funding.3,4 The VA contributions also provide opportunities for GME expansion,1,5,6 educational innovations,5,7 interprofessional and team-based care,8,9 and quality and safety training.10,11 The Table provides a comparison of CMS and VA GME reimbursability based on activity.

GME financing is complex, particularly the formulaic approach used by CMS, the details of which are often obscured in federal regulations. Due to this complexity and the $16 billion CMS GME budget, academic publications have focused on CMS GME financing while not fully explaining the VA GME policies and processes.4,12-14 By comparison, the VA GME financing model is relatively straightforward and governed by different statues and VA regulations, yet sharing some of the same principles as CMS regulations. Given the challenges in CMS reimbursement to fully support the cost of resident education, as well as the educational opportunities at the VA, the VA designs its reimbursement model to assure that affiliates receive appropriate payments.4,12,15 To ensure the continued success of VA GME partnerships, knowledge of VA GME financing has become increasingly important for designated institutional officers (DIOs) and residency program directors, particularly in light of recent investigations into oversight of the VA’s reimbursement to academic affiliates.16-18 This report describes VA GME reimbursement and, where applicable, VA and CMS reimbursement policies are compared to highlight similarities, differences, and common principles.

VA AUTHORITY

While the VA’s primary mission is “to provide a complete hospital medical service for the medical care and treatment of veterans,”early VA leaders recognized the importance of affiliating with the nation’s academic institutions.19 In 1946, the VA Policy Memorandum Number 2 established a partnership between the VA and the academic medical community.20 Additional legislation authorized specific agreements with academic affiliates for the central administration of salary and benefits for residents rotating at VA facilities. This process, known as disbursement, is an alternative payroll mechanism whereby the VA reimburses the academic affiliate for resident salary and benefits and the affiliate acts as the disbursing agent, issuing paychecks to residents.21,22

Resident FUNDING

By policy, with rare exceptions, the VA does not sponsor residency programs due to the challenges of providing an appropriate patient mix of age, sex, and medical conditions to meet accreditation standards.4 Nearly all VA reimbursements are for residents in affiliate-sponsored programs, while just 1% pays for residents in legacy, VA-sponsored residency programs at 2 VA facilities. The VA budget for resident (including fellows) salary and benefits is managed by the VA Office of Academic Affiliations (OAA), the national VA office responsible for oversight, policy, and funding of VA HPE programs.

Resident Salaries and Benefits

VA funding of resident salary and benefits are analogous with CMS direct GME (DGME), which is designed to cover resident salary and benefits costs.4,14,23 CMS DGME payments depend on a hospital’s volume of CMS inpatients and are based on a statutory formula, which uses the hospital’s resident FTE positions, the per-resident amount, and Medicare’s share of inpatient beds (Medicare patient load) to determine payments.12 The per-resident amount is set by statute, varies geographically, and is calculated by dividing the hospital’s allowable costs of GME (percentage of CMS inpatient days) divided by the number of residents.12,24

By comparison, the VA GME payment reimburses for each FTE based on the salary and benefits rate set by the academic affiliate. Reimbursement is calculated based on resident time spent at the VA multiplied by a daily salary rate. The daily salary rate is determined by dividing the resident’s total compensation (salary and benefits) by the number of calendar days in an academic year. Resident time spent at the VA facility is determined by obtaining rotation schedules provided by the academic affiliate and verifying resident clinical and educational activity during scheduled rotations.

Indirect Medical Education Funding

In addition to resident salary and benefits, funds to offset the cost of conducting HPE are provided to VA facilities. These funds are intended to improve and maintain necessary infrastructure for all HPE programs not just GME, including education office administration needs, teaching costs (ie, a portion of VA preceptors salary), and instructional equipment.

figure.png

The Veterans Equitable Resource Allocation (VERA) is a national budgeting process for VA medical facilities that funds facility operational needs such as staff salary and benefits, infrastructure, and equipment.2 The education portion of the VERA, the VERA Education Support Component (VESC), is not managed by the OAA, but rather is distributed through the VERA model to the general budget of VA facilities hosting HPE (Figure). VESC funding in the VA budget is based on labor mapping of physician time spent in education; other labor mapping categories include clinical care, research, and administration. VA facility VESC funding is calculated based on the number of paid health profession trainees (HPTs) from all professions, apportioned according to the number of FTEs for physician residents and VA-paid HPTs in other disciplines. In fiscal year 2024, VA facilities received $115,812 for each physician resident FTE position and $84,906 for each VA-paid, non-GME FTE position.

The VESC is like CMS's indirect GME funding, termed Indirect Medical Education (IME), an additional payment for each Medicare patient discharged reflecting teaching hospitals’ higher patient care costs relative to nonteaching hospitals. Described elsewhere, IME is calculated using a resident-to-bed ratio and a multiplier, which is set by statute.4,25 While IME can be used for reimbursement for some resident clinical and educational activities(eg, research), VA VESC funds cannot be used for such activities and are part of the general facility budget and appropriated per the discretion of the medical facility director.

 

 

ESTABLISHING GME PARTNERSHIPS

An affiliation agreement establishes the administrative and legal requirements for educational relationships with academic affiliates and includes standards for conducting HPE, responsibilities for accreditation standards, program leadership, faculty, resources, supervision, academic policies, and procedures. The VA uses standardized affiliation agreement templates that have been vetted with accrediting bodies and the VA Office of General Counsel.

A disbursement agreement authorizes the VA to reimburse affiliates for resident salary and benefits for VA clinical and educational activities. The disbursement agreement details the fiscal arrangements (eg, payment in advance vs arrears, salary, and benefit rates, leave) for the reimbursement payments. Veterans Health Administration (VHA) Directive 1400.05 provides the policy and procedures for calculating reimbursement for HPT educational activities.26

The VA facility designated education officer (DEO) oversees all HPE programs and coordinates the affiliation and disbursement agreement processes.27 The DEO, affiliate DIO, residency program director, and VA residency site director determine the physician resident FTE positions assigned to a VA facility based on educational objectives and availability of educational resources at the VA facility, such as patient care opportunities, faculty supervisors, space, and equipment. The VA facility requests for resident FTE positions are submitted to the OAA by the facility DEO.

Once GME FTE positions are approved by the OAA, VA facilities work with their academic affiliate to submit the physician resident salary and benefit rate. Affiliate DIOs attest to the accuracy of the salary rate schedule and the local DEO submits the budget request to the OAA. Upon approval, the funds are transferred to the VA facility each fiscal year, which begins October 1. DEOs report quarterly to the OAA both budget needs and excesses based on variations in the approved FTEs due to additional VA rotations, physician resident attrition, or reassignment.

Resident Position Allocation

VA GME financing provides flexibility through periodic needs assessments and expansion initiatives. In August and December, DEOs collaborate with an academic affiliate to submit reports to the OAA confirming their projected GME needs for the next academic year. Additional positions requests are reviewed by the OAA; funding depends on budget and the educational justification. The OAA periodically issues GME expansion requests for proposal, which typically arise from legislation to address specific VA workforce needs. The VA facility DEO and affiliate GME leaders collaborate to apply for additional positions. For example, a VA GME expansion under the Veterans Access, Choice, and Accountability Act of 2014 added 1500 GME positions in 8 years for critically needed specialties and in rural and underserved areas.5 The Maintaining Internal Systems and Strengthening Outside Networks (MISSION) Act of 2018 authorized a pilot program for VA to fund residents at non-VA facilities with priority for Indian Health Services, Tribes and Tribal Organizations, Federally Qualified Health Centers, and US Department of Defense facilities to provide access to veterans in underserved areas.6

The VA GME financing system has flexibility to meet local needs for additional resident positions and to address broader VA workforce gaps through targeted expansion. Generally, CMS does not fund positions to address workforce needs, place residents in specific geographic areas, or require the training of certain types of residents.4 However, the Consolidated Appropriations Act of 2021 has provided the opportunity to address rural workforce needs.28

 

 

Reimbursement

The VA provides reimbursement for clinical and educational activities performed in VA facilities for the benefit of veterans as well as research, didactics, meetings and conferences, annual and sick leave, and orientation. The VA also may provide reimbursement for educational activities that occur off VA grounds (eg, the VA proportional share of a residency program’s didactic sessions). The VA does not reimburse for affiliate clinical duties or administrative costs, although a national policy allows VA facilities to reimburse affiliates for some GME overhead costs.29

CMS similarly reimburses for residency training time spent in patient care activities as well as orientation activities, didactics, leave, and, in some cases, research.4,30,31 CMS makes payments to hospitals, which may include sponsoring institutions and Medicare-eligible participating training sites.4,30,31 For both the VA and CMS, residents may not be counted twice for reimbursement by 2 federal agencies; in other words, a resident may not count for > 1 FTE.4,30-32

GME Oversight

VA GME funding came under significant scrutiny. At a 2016 House Veterans Affairs Committee hearing, Representative Phil Roe, MD (R-Tennessee), noted that no process existed at many VA facilities for “determining trainee presence” and that many VA medical centers had “difficulty tracking resident rotations”16 A VA Office of the Inspector General investigation recommended that the VA implement policies and procedures to improve oversight to “ensure residents are fully participating in educational activities” and that the VA is “paying the correct amount” to the affiliate.17 A 2020 General Accountability Office report outlined unclear policy guidance, incomplete tracking of resident activities, and improper fiscal processes for reimbursement and reconciliation of affiliate invoices.18

eappendix.png

In response, the OAA created an oversight and compliance unit, revised VHA Directive 1400.05 (the policy for disbursement), and improved resident tracking procedures.26 The standard operating procedure that accompanied VHA Directive 1400.05 provides detailed information for the DEO and VA facility staff for tracking resident clinical and educational activities. FTE counts are essential to both VA and CMS for accurate reimbursement. The eAppendix and the Table provide a guide to reimbursable activities in the VA for the calculation of reimbursement, with a comparison to CMS.33,34 The OAA in cooperation with other VA staff and officers periodically conducts audits to assess compliance with disbursement policy and affiliate reimbursement accuracy.

In the VA, resident activities are captured on the VA Educational Activity Record, a standardized spreadsheet to track activities and calculate reimbursement. Each VA facility hosting resident physicians manually records resident activity by the half-day. This process is labor intensive, involving both VA and affiliate staff to accurately reconcile payments. To address the workload demands, the OAA is developing an online tool that will automate aspects of the tracking process. Also, to ensure adequate staffing, the OAA is in the process of implementing an office optimization project, providing standardized position descriptions, an organizational chart, and staffing levels for DEO offices in VA facilities.

 

 

Conclusions

This report describes the key policies and principles of VA GME financing, highlighting the essential similarities and differences between VA and CMS. Neither the VA nor CMS regulations allow for reimbursement for > 1 FTE position per resident, a principle that underpins the assignment of resident rotations and federal funding for GME and are similar with respect to reimbursement for patient care activities, didactics, research, orientation, and scholarly activity. While reimbursable activities in the VA require physical presence and care of veteran patients, CMS also limits reimbursement to resident activities in the hospital and approved other settings if the hospital is paying for resident salary and benefits in these settings. The VA provides some flexibility for offsite activities including didactics and, in specific circumstances, remote care of veteran patients (eg, teleradiology).

The VA and CMS use different GME financing models. For example, the CMS calculations for resident FTEs are complex, whereas VA calculations reimburse the salary and benefits as set by the academic affiliate. The VA process accounts for local variation in salary rates, whereas the per-resident amount set by CMS varies regionally and does not fully account for differences in the cost of living.24 Because all patients in VA facilities are veterans, VA calculations for reimbursement do not involve ratios of beds like the CMS calculations to determine a proportional share of reimbursement. The VA GME expansion tends to be more directed to VA health workforce needs than CMS, specifying the types of programs and geographic locations to address these needs.

The VA regularly reevaluates how affiliates are reimbursed for VA resident activity, balancing compliance with VA policies and the workload for VA and its affiliates. The VA obtains input from key stakeholders including DEOs, DIOs, and professional organizations such as the Association of American Medical Colleges and the Accreditation Council for Graduate Medical Education.35,36

Looking ahead, the VA is developing an online tool to improve the accuracy of affiliate reimbursement. The VA will also implement a standardized staffing model, organizational structure, and position descriptions for DEO offices. These initiatives will help reduce the burden of tracking and verifying resident activity and continue to support the 77-year partnership between VA and its affiliated institutions.

References

1. Klink KA, Albanese AP, Bope ET, Sanders KM. Veterans Affairs graduate medical education expansion addresses US physician workforce needs. Acad Med. 2022;97(8):1144-1150. doi:10.1097/ACM.0000000000004545

2. Andrus CH, Johnson K, Pierce E, Romito PJ, Hartel P, Berrios‐Guccione S, Best W. Finance modeling in the delivery of medical care in tertiary‐care hospitals in the Department of Veterans Affairs. J Surg Res. 2001;96(2):152-157. doi:10.1006/jsre.1999.5728

3. Petrakis IL, Kozal M. Academic medical centers and the U.S. Department of Veterans Affairs: a 75-year partnership influences medical education, scientific discovery, and clinical care. Acad Med. 2022;97(8):1110-1113. doi:10.1097/ACM.0000000000004734

4. Heisler EJ, Mendez BH, Mitchell A, Panangala SV, Villagrana MA. Federal support for graduate medical education: an overview (R44376). Congressional Research Service report R44376; version 11. Updated December 27, 2018. Accessed March 2, 2024. https://crsreports.congress.gov/product/pdf/R/R44376/11

5. Chang BK, Brannen JL. The Veterans Access, Choice, and Accountability Act of 2014: examining graduate medical education enhancement in the Department of Veterans Affairs. Acad Med. 2015;90(9):1196-1198. doi:10.1097/ACM.0000000000000795

6. Albanese AP, Bope ET, Sanders KM, Bowman M. The VA MISSION Act of 2018: a potential game changer for rural GME expansion and veteran health care. J Rural Health. 2020;36(1):133-136. doi:10.1111/jrh.12360

7. Lypson ML, Roberts LW. Valuing the partnership between the Veterans Health Administration and academic medicine. Acad Med. 2022;97(8):1091-1093. doi:10.1097/ACM.0000000000004748

8. Harada ND, Traylor L, Rugen KW, et al. Interprofessional transformation of clinical education: the first six years of the Veterans Affairs Centers of Excellence in Primary Care Education. J Interprof Care. 2023;37(suppl 1):S86-S94. doi:10.1080/13561820.2018.1433642

<--pagebreak-->

9. Harada ND, Rajashekara S, Sansgiry S, et al. Developing interprofessional primary care teams: alumni evaluation of the Department of Veterans Affairs Centers of Excellence in Primary Care Education Program. J Med Educ Curric Dev. 2019;6:2382120519875455. doi:10.1177/2382120519875455

10. Splaine ME, Ogrinc G, Gilman SC, et al. The Department of Veterans Affairs National Quality Scholars Fellowship Program: experience from 10 years of training quality scholars. Acad Med. 2009;84(12):1741-1748. doi:10.1097/ACM.0b013e3181bfdcef

11. Watts BV, Paull DE, Williams LC, Neily J, Hemphill RR, Brannen JL. Department of Veterans Affairs chief resident in quality and patient safety program: a model to spread change. Am J Med Qual. 2016;31(6):598-600. doi:10.1177/1062860616643403

12. He K, Whang E, Kristo G. Graduate medical education funding mechanisms, challenges, and solutions: a narrative review. Am J Surg. 2021;221(1):65-71. doi:10.1016/j.amjsurg.2020.06.007

13. Villagrana M. Medicare graduate medical education payments: an overview. Congressional Research Service report IF10960. Updated September 29, 2022. Accessed March 2, 2024. https://crsreports.congress.gov/product/pdf/IF/IF10960

14. Committee on the Governance and Financing of Graduate Medical Education; Board on Health Care Services; Institute of Medicine. Graduate Medical Education That Meets the Nation’s Health Needs. Eden J, Berwick DM, Wilensky GR, eds. Washington, DC: National Academies Press; 2014. doi:10.17226/18754

15. Physician workforce: caps on Medicare-funded graduate medical education at teaching hospitals. Report to congressional requesters. GAO-21-391. May 21, 2021. Accessed March 1, 2024. https://www.gao.gov/assets/gao-21-391.pdf

16. VA and Academic Affiliates: Who Benefits? Hearing Before the Subcommittee on Oversight and Investigations of the Committee on Veterans’ Affairs, 114th Cong, 2nd Sess (2016). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CHRG-115hhrg29685/html/CHRG-115hhrg29685.htm

17. US Department of Veterans Affairs, Office of Inspector General (OIG). Veterans Health Administration. Review of resident and part-time physician time and attendance at the Oklahoma City VA Health Care System. OIG report 17-00253-93. March 28, 2018. Accessed March 1, 2024. https://www.oversight.gov/sites/default/files/oig-reports/VAOIG-17-00253-93.pdf

18. VA health care: actions needed to improve oversight of graduate medical education reimbursement. Report to the ranking member, Committee on Veterans’ Affairs, House of Representatives. GAO-20-553. July 2020. Accessed March 1, 2024. https://www.gao.gov/assets/710/708275.pdf

19. Functions of Veterans Health Administration: in general, 38 USC §7301 (2022). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/USCODE-2022-title38/pdf/USCODE-2022-title38-partV-chap73-subchapI-sec7301.pdf

20. US Department of Veterans Affairs. Policy memorandum no. 2, policy in association of veterans’ hospitals with medical schools. January 30, 1946.

21. Veterans Health Care Expansion Act of 1973, Public Law 93-82. August 2, 1973. Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/STATUTE-87/pdf/STATUTE-87-Pg179.pdf

22. Residencies and internships, 38 USC § 7406 (2022). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/USCODE-2022-title38/pdf/USCODE-2022-title38-partV-chap74-subchapI-sec7406.pdf

23. Direct graduate medical education (DGME). Centers for Medicaid and Medicare Services. Updated December 5, 2023. Accessed March 1, 2024. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/DGME

24. Drezdzon MK, Cowley NJ, Sweeney DP, et al. Going for broke: the impact of cost of living on surgery resident stipend value. Ann Surg. 2023;278(6):1053-1059. doi:10.1097/SLA.0000000000005923

25. Special treatment: hospitals that incur indirect costs for graduate medical education programs, 42 CFR § 412.105 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec412-105.pdf

26. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1400.05, Disbursement agreements for health professions trainees appointed under 38 U.S.C. § 7406. June 2, 2021. Accessed March 1, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9293

27. Harada ND, Sanders KM, Bowman MA. Health systems education leadership: learning from the VA designated education officer role. Fed Pract. 2022;39(6):266-273. doi:10.12788/fp.0278

28. Schleiter Hitchell K, Johnson L. CMS finalizes rules for distribution of 1000 new Medicare-funded residency positions and changes to rural training track programs. J Grad Med Educ. 2022;14(2):245-249. doi:10.4300/JGME-D-22-00193.1

<--pagebreak-->

29. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1400.10, Educational cost contracts for health professions education. September 25, 2023. Accessed March 1, 2024. https://www.va.gov/VHAPUBLICATIONS/ViewPublication.asp?pub_ID=11480

30. Direct GME payments: general requirements, 42 CFR § 413.75 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec413-75.pdf

31. Direct GME payments: determination of the total number of FTE residents, 42 CFR § 413.78 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec413-78.pdf

32. US Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare financial management manual, chapter 8. Contractor procedures for provider audits. Accessed March 1, 2024. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/fin106c08.pdf

33. US Department of Health and Human Services, Office of Inspector General. CMS did not always ensure hospitals complied with Medicare reimbursement requirements for graduate medical education. OIG report A-02-17-01017. November 2018. Accessed March 1, 2024. https://oig.hhs.gov/oas/reports/region2/21701017.pdf

34. US Department of Health and Human Services, Centers for Medicare and Medicaid Services. Interns and Residents Information System (IRIS) XML format. Publication 100-20. Transmittal 11418. Change request 12724. May 19, 2022. Accessed March 1, 2024. https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/R11418OTN.pdf

35. Birnbaum AD, Byrne J, on behalf of the VA Office of Academic Affiliations. VHA Updates: Disbursement Policy and Education Cost Contracts. Presented at: American Association of Medical Colleges Webinar; June 2021. Accessed March 1, 2024. https://vimeo.com/644415670

36. Byrne JM, on behalf of the VA Office of Academic Affiliations. Disbursement procedures update for AY 23-24. Accessed March 1, 2024. https://www.va.gov/oaa/Videos/AffiliatePresentationDisbursementandEARsAY23-24.pptx

References

1. Klink KA, Albanese AP, Bope ET, Sanders KM. Veterans Affairs graduate medical education expansion addresses US physician workforce needs. Acad Med. 2022;97(8):1144-1150. doi:10.1097/ACM.0000000000004545

2. Andrus CH, Johnson K, Pierce E, Romito PJ, Hartel P, Berrios‐Guccione S, Best W. Finance modeling in the delivery of medical care in tertiary‐care hospitals in the Department of Veterans Affairs. J Surg Res. 2001;96(2):152-157. doi:10.1006/jsre.1999.5728

3. Petrakis IL, Kozal M. Academic medical centers and the U.S. Department of Veterans Affairs: a 75-year partnership influences medical education, scientific discovery, and clinical care. Acad Med. 2022;97(8):1110-1113. doi:10.1097/ACM.0000000000004734

4. Heisler EJ, Mendez BH, Mitchell A, Panangala SV, Villagrana MA. Federal support for graduate medical education: an overview (R44376). Congressional Research Service report R44376; version 11. Updated December 27, 2018. Accessed March 2, 2024. https://crsreports.congress.gov/product/pdf/R/R44376/11

5. Chang BK, Brannen JL. The Veterans Access, Choice, and Accountability Act of 2014: examining graduate medical education enhancement in the Department of Veterans Affairs. Acad Med. 2015;90(9):1196-1198. doi:10.1097/ACM.0000000000000795

6. Albanese AP, Bope ET, Sanders KM, Bowman M. The VA MISSION Act of 2018: a potential game changer for rural GME expansion and veteran health care. J Rural Health. 2020;36(1):133-136. doi:10.1111/jrh.12360

7. Lypson ML, Roberts LW. Valuing the partnership between the Veterans Health Administration and academic medicine. Acad Med. 2022;97(8):1091-1093. doi:10.1097/ACM.0000000000004748

8. Harada ND, Traylor L, Rugen KW, et al. Interprofessional transformation of clinical education: the first six years of the Veterans Affairs Centers of Excellence in Primary Care Education. J Interprof Care. 2023;37(suppl 1):S86-S94. doi:10.1080/13561820.2018.1433642

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9. Harada ND, Rajashekara S, Sansgiry S, et al. Developing interprofessional primary care teams: alumni evaluation of the Department of Veterans Affairs Centers of Excellence in Primary Care Education Program. J Med Educ Curric Dev. 2019;6:2382120519875455. doi:10.1177/2382120519875455

10. Splaine ME, Ogrinc G, Gilman SC, et al. The Department of Veterans Affairs National Quality Scholars Fellowship Program: experience from 10 years of training quality scholars. Acad Med. 2009;84(12):1741-1748. doi:10.1097/ACM.0b013e3181bfdcef

11. Watts BV, Paull DE, Williams LC, Neily J, Hemphill RR, Brannen JL. Department of Veterans Affairs chief resident in quality and patient safety program: a model to spread change. Am J Med Qual. 2016;31(6):598-600. doi:10.1177/1062860616643403

12. He K, Whang E, Kristo G. Graduate medical education funding mechanisms, challenges, and solutions: a narrative review. Am J Surg. 2021;221(1):65-71. doi:10.1016/j.amjsurg.2020.06.007

13. Villagrana M. Medicare graduate medical education payments: an overview. Congressional Research Service report IF10960. Updated September 29, 2022. Accessed March 2, 2024. https://crsreports.congress.gov/product/pdf/IF/IF10960

14. Committee on the Governance and Financing of Graduate Medical Education; Board on Health Care Services; Institute of Medicine. Graduate Medical Education That Meets the Nation’s Health Needs. Eden J, Berwick DM, Wilensky GR, eds. Washington, DC: National Academies Press; 2014. doi:10.17226/18754

15. Physician workforce: caps on Medicare-funded graduate medical education at teaching hospitals. Report to congressional requesters. GAO-21-391. May 21, 2021. Accessed March 1, 2024. https://www.gao.gov/assets/gao-21-391.pdf

16. VA and Academic Affiliates: Who Benefits? Hearing Before the Subcommittee on Oversight and Investigations of the Committee on Veterans’ Affairs, 114th Cong, 2nd Sess (2016). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CHRG-115hhrg29685/html/CHRG-115hhrg29685.htm

17. US Department of Veterans Affairs, Office of Inspector General (OIG). Veterans Health Administration. Review of resident and part-time physician time and attendance at the Oklahoma City VA Health Care System. OIG report 17-00253-93. March 28, 2018. Accessed March 1, 2024. https://www.oversight.gov/sites/default/files/oig-reports/VAOIG-17-00253-93.pdf

18. VA health care: actions needed to improve oversight of graduate medical education reimbursement. Report to the ranking member, Committee on Veterans’ Affairs, House of Representatives. GAO-20-553. July 2020. Accessed March 1, 2024. https://www.gao.gov/assets/710/708275.pdf

19. Functions of Veterans Health Administration: in general, 38 USC §7301 (2022). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/USCODE-2022-title38/pdf/USCODE-2022-title38-partV-chap73-subchapI-sec7301.pdf

20. US Department of Veterans Affairs. Policy memorandum no. 2, policy in association of veterans’ hospitals with medical schools. January 30, 1946.

21. Veterans Health Care Expansion Act of 1973, Public Law 93-82. August 2, 1973. Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/STATUTE-87/pdf/STATUTE-87-Pg179.pdf

22. Residencies and internships, 38 USC § 7406 (2022). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/USCODE-2022-title38/pdf/USCODE-2022-title38-partV-chap74-subchapI-sec7406.pdf

23. Direct graduate medical education (DGME). Centers for Medicaid and Medicare Services. Updated December 5, 2023. Accessed March 1, 2024. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/DGME

24. Drezdzon MK, Cowley NJ, Sweeney DP, et al. Going for broke: the impact of cost of living on surgery resident stipend value. Ann Surg. 2023;278(6):1053-1059. doi:10.1097/SLA.0000000000005923

25. Special treatment: hospitals that incur indirect costs for graduate medical education programs, 42 CFR § 412.105 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec412-105.pdf

26. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1400.05, Disbursement agreements for health professions trainees appointed under 38 U.S.C. § 7406. June 2, 2021. Accessed March 1, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9293

27. Harada ND, Sanders KM, Bowman MA. Health systems education leadership: learning from the VA designated education officer role. Fed Pract. 2022;39(6):266-273. doi:10.12788/fp.0278

28. Schleiter Hitchell K, Johnson L. CMS finalizes rules for distribution of 1000 new Medicare-funded residency positions and changes to rural training track programs. J Grad Med Educ. 2022;14(2):245-249. doi:10.4300/JGME-D-22-00193.1

<--pagebreak-->

29. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1400.10, Educational cost contracts for health professions education. September 25, 2023. Accessed March 1, 2024. https://www.va.gov/VHAPUBLICATIONS/ViewPublication.asp?pub_ID=11480

30. Direct GME payments: general requirements, 42 CFR § 413.75 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec413-75.pdf

31. Direct GME payments: determination of the total number of FTE residents, 42 CFR § 413.78 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec413-78.pdf

32. US Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare financial management manual, chapter 8. Contractor procedures for provider audits. Accessed March 1, 2024. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/fin106c08.pdf

33. US Department of Health and Human Services, Office of Inspector General. CMS did not always ensure hospitals complied with Medicare reimbursement requirements for graduate medical education. OIG report A-02-17-01017. November 2018. Accessed March 1, 2024. https://oig.hhs.gov/oas/reports/region2/21701017.pdf

34. US Department of Health and Human Services, Centers for Medicare and Medicaid Services. Interns and Residents Information System (IRIS) XML format. Publication 100-20. Transmittal 11418. Change request 12724. May 19, 2022. Accessed March 1, 2024. https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/R11418OTN.pdf

35. Birnbaum AD, Byrne J, on behalf of the VA Office of Academic Affiliations. VHA Updates: Disbursement Policy and Education Cost Contracts. Presented at: American Association of Medical Colleges Webinar; June 2021. Accessed March 1, 2024. https://vimeo.com/644415670

36. Byrne JM, on behalf of the VA Office of Academic Affiliations. Disbursement procedures update for AY 23-24. Accessed March 1, 2024. https://www.va.gov/oaa/Videos/AffiliatePresentationDisbursementandEARsAY23-24.pptx

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0424 FED GME</fileName> <TBEID>0C02F40B.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F40B</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20240408T144514</firstPublished> <LastPublished>20240408T144514</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240408T144514</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>John M. Byrne, DOa; Paul B. Greenberg, MDb,c; Karen M. Sanders, MDa,d; Andrea D. Birnbaum, MD, PhDa,e; Erin L. Patel, PsyD, ABPPa; and Ryan M. Scilla, MDa,f</bylineText> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>The US Department of Veterans Affairs (VA) has partnered with academic medical centers and programs since 1946 to provide clinical training for physician reside</metaDescription> <articlePDF/> <teaserImage/> <title>Graduate Medical Education Financing in the US Department of Veterans Affairs</title> <deck/> <eyebrow>Program Profile</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>April</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>4</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>4473</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>April 2024</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Program Profile | 4473<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> </sections> <topics> <term canonical="true">27442</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Graduate Medical Education Financing in the US Department of Veterans Affairs</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background:</b> The US Department of Veterans Affairs (VA) partners with 250 sponsors of graduate medical education (GME), annually providing $850 million for 11,000 full-time equivalent resident positions that support veteran patient care and provide educational opportunities for trainees from affiliated academic programs. Knowledge of VA GME financing is vital to maintain these partnerships.<br/><br/><b>Observations: </b>In response to increased scrutiny from several federal oversight bodies, the VA revised its GME reimbursement policy and procedures, including implementing new resident tracking and auditing mechanisms. This article describes the VA GME reimbursement policies and procedures and, to facilitate understanding, compares GME financing policies of the VA and Centers for Medicare and Medicaid Services. Similarities include counting full-time equivalent positions for reimbursable resident activities (eg, patient care and didactics) and ensuring reimbursement is limited to 1 payment per resident. Differences include funding of resident salaries and benefits, indirect funding to support education, and the calculations to determine reimbursement.<br/><br/><b>Conclusions: </b>The VA continues to refine its GME financing policies and procedures to maintain compliance with laws and regulations, and to provide accurate reimbursement to academic affiliates. This endeavor is essential to support the vital GME partnerships between the VA and its affiliate institutions.</p> <p><span class="Drop">T</span>he US Department of Veterans Affairs (VA) has partnered with academic medical centers and programs since 1946 to provide clinical training for physician residents. Ranking second in federal graduate medical education (GME) funding to the Centers for Medicare and Medicaid Services (CMS), the $850 million VA GME budget annually reimburses &gt; 250 GME-sponsoring institutions (affiliates) of 8000 GME programs for the clinical training of 49,000 individual residents rotating through &gt; 11,000 full-time equivalent (FTE) positions.<sup>1</sup> The VA also distributes $1.6 billion to VA facilities to offset the costs of conducting health professions education (HPE) (eg, facility infrastructure, salary support for VA instructors and preceptors, education office administration, and instructional equipment).<sup>2</sup> The VA financial and educational contributions account for payment of 11% of resident positions nationally and allow academic medical centers to be less reliant on CMS GME funding.<sup>3,4</sup> The VA contributions also provide opportunities for GME expansion,<sup>1,5,6</sup> educational innovations,<sup>5,7</sup> interprofessional and team-based care,<sup>8,9</sup> and quality and safety training.<sup>10,11</sup> The Table provides a comparison of CMS and VA GME reimbursability based on activity.</p> <p>GME financing is complex, particularly the formulaic approach used by CMS, the details of which are often obscured in federal regulations. Due to this complexity and the $16 billion CMS GME budget, academic publications have focused on CMS GME financing while not fully explaining the VA GME policies and processes.<sup>4,12-14</sup> By comparison, the VA GME financing model is relatively straightforward and governed by different statues and VA regulations, yet sharing some of the same principles as CMS regulations. Given the challenges in CMS reimbursement to fully support the cost of resident education, as well as the educational opportunities at the VA, the VA designs its reimbursement model to assure that affiliates receive appropriate payments.<sup>4,12,15</sup> To ensure the continued success of VA GME partnerships, knowledge of VA GME financing has become increasingly important for designated institutional officers (DIOs) and residency program directors, particularly in light of recent investigations into oversight of the VA’s reimbursement to academic affiliates.<sup><scaps>16-18</scaps></sup> This report describes VA GME reimbursement and, where applicable, VA and CMS reimbursement policies are compared to highlight similarities, differences, and common principles.</p> <h2>VA AUTHORITY </h2> <p>While the VA’s primary mission is “to provide a complete hospital medical service for the medical care and treatment of veterans,”<sup> </sup>early VA leaders recognized the importance of affiliating with the nation’s academic institutions.<sup>19</sup> In 1946, the VA Policy Memorandum Number 2 established a partnership between the VA and the academic medical community.<sup>20</sup> Additional legislation authorized specific agreements with academic affiliates for the central administration of salary and benefits for residents rotating at VA facilities. This process, known as disbursement, is an alternative payroll mechanism whereby the VA reimburses the academic affiliate for resident salary and benefits and the affiliate acts as the disbursing agent, issuing paychecks to residents.<sup>21,22</sup></p> <h2>Resident FUNDING</h2> <p>By policy, with rare exceptions, the VA does not sponsor residency programs due to the challenges of providing an appropriate patient mix of age, sex, and medical conditions to meet accreditation standards.<sup>4</sup> Nearly all VA reimbursements are for residents in affiliate-sponsored programs, while just 1% pays for residents in legacy, VA-sponsored residency programs at 2 VA facilities. The VA budget for resident (including fellows) salary and benefits is managed by the VA Office of Academic Affiliations (OAA), the national VA office responsible for oversight, policy, and funding of VA HPE programs.</p> <h3>Resident Salaries and Benefits</h3> <p>VA funding of resident salary and benefits are analogous with CMS direct GME (DGME), which is designed to cover resident salary and benefits costs.<sup>4,14,23</sup> CMS DGME payments depend on a hospital’s volume of CMS inpatients and are based on a statutory formula, which uses the hospital’s resident FTE positions, the per-resident amount, and Medicare’s share of inpatient beds (Medicare patient load) to determine payments.<sup>12</sup> The per-resident amount is set by statute, varies geographically, and is calculated by dividing the hospital’s allowable costs of GME (percentage of CMS inpatient days) divided by the number of residents.<sup>12,24</sup></p> <p>By comparison, the VA GME payment reimburses for each FTE based on the salary and benefits rate set by the academic affiliate. Reimbursement is calculated based on resident time spent at the VA multiplied by a daily salary rate. The daily salary rate is determined by dividing the resident’s total compensation (salary and benefits) by the number of calendar days in an academic year. Resident time spent at the VA facility is determined by obtaining rotation schedules provided by the academic affiliate and verifying resident clinical and educational activity during scheduled rotations.</p> <h3>Indirect Medical Education Funding</h3> <p>In addition to resident salary and benefits, funds to offset the cost of conducting HPE are provided to VA facilities. These funds are intended to improve and maintain necessary infrastructure for all HPE programs not just GME, including education office administration needs, teaching costs (ie, a portion of VA preceptors salary), and instructional equipment.</p> <p>The Veterans Equitable Resource Allocation (VERA) is a national budgeting process for VA medical facilities that funds facility operational needs such as staff salary and benefits, infrastructure, and equipment.<sup>2</sup> The education portion of the VERA, the VERA Education Support Component (VESC), is not managed by the OAA, but rather is distributed through the VERA model to the general budget of VA facilities hosting HPE (Figure). VESC funding in the VA budget is based on labor mapping of physician time spent in education; other labor mapping categories include clinical care, research, and administration. VA facility VESC funding is calculated based on the number of paid health profession trainees (HPTs) from all professions, apportioned according to the number of FTEs for physician residents and VA-paid HPTs in other disciplines. In fiscal year 2024, VA facilities received $115,812 for each physician resident FTE position and $84,906 for each VA-paid, non-GME FTE position.<br/><br/>The VESC is like CMS's indirect GME funding, termed Indirect Medical Education (IME), an additional payment for each Medicare patient discharged reflecting teaching hospitals’ higher patient care costs relative to nonteaching hospitals. Described elsewhere, IME is calculated using a resident-to-bed ratio and a multiplier, which is set by statute.<sup>4,25</sup> While IME can be used for reimbursement for some resident clinical and educational activities(eg, research), VA VESC funds cannot be used for such activities and are part of the general facility budget and appropriated per the discretion of the medical facility director.</p> <h2>ESTABLISHING GME PARTNERSHIPS</h2> <p>An affiliation agreement establishes the administrative and legal requirements for educational relationships with academic affiliates and includes standards for conducting HPE, responsibilities for accreditation standards, program leadership, faculty, resources, supervision, academic policies, and procedures. The VA uses standardized affiliation agreement templates that have been vetted with accrediting bodies and the VA Office of General Counsel.</p> <p>A disbursement agreement authorizes the VA to reimburse affiliates for resident salary and benefits for VA clinical and educational activities. The disbursement agreement details the fiscal arrangements (eg, payment in advance vs arrears, salary, and benefit rates, leave) for the reimbursement payments. Veterans Health Administration (VHA) Directive 1400.05 provides the policy and procedures for calculating reimbursement for HPT educational activities.<sup>26<br/><br/></sup>The VA facility designated education officer (DEO) oversees all HPE programs and coordinates the affiliation and disbursement agreement processes.<sup>27</sup> The DEO, affiliate DIO, residency program director, and VA residency site director determine the physician resident FTE positions assigned to a VA facility based on educational objectives and availability of educational resources at the VA facility, such as patient care opportunities, faculty supervisors, space, and equipment. The VA facility requests for resident FTE positions are submitted to the OAA by the facility DEO.<br/><br/>Once GME FTE positions are approved by the OAA, VA facilities work with their academic affiliate to submit the physician resident salary and benefit rate. Affiliate DIOs attest to the accuracy of the salary rate schedule and the local DEO submits the budget request to the OAA. Upon approval, the funds are transferred to the VA facility each fiscal year, which begins October 1. DEOs report quarterly to the OAA both budget needs and excesses based on variations in the approved FTEs due to additional VA rotations, physician resident attrition, or reassignment.</p> <h3>Resident Position Allocation </h3> <p>VA GME financing provides flexibility through periodic needs assessments and expansion initiatives. In August and December, DEOs collaborate with an academic affiliate to submit reports to the OAA confirming their projected GME needs for the next academic year. Additional positions requests are reviewed by the OAA; funding depends on budget and the educational justification. The OAA periodically issues GME expansion requests for proposal, which typically arise from legislation to address specific VA workforce needs. The VA facility DEO and affiliate GME leaders collaborate to apply for additional positions. For example, a VA GME expansion under the Veterans Access, Choice, and Accountability Act of 2014 added 1500 GME positions in 8 years for critically needed specialties and in rural and underserved areas.<sup>5</sup> The Maintaining Internal Systems and Strengthening Outside Networks (MISSION) Act of 2018 authorized a pilot program for VA to fund residents at non-VA facilities with priority for Indian Health Services, Tribes and Tribal Organizations, Federally Qualified Health Centers, and US Department of Defense facilities to provide access to veterans in underserved areas.<sup>6</sup></p> <p>The VA GME financing system has flexibility to meet local needs for additional resident positions and to address broader VA workforce gaps through targeted expansion. Generally, CMS does not fund positions to address workforce needs, place residents in specific geographic areas, or require the training of certain types of residents.<sup>4</sup> However, the Consolidated Appropriations Act of 2021 has provided the opportunity to address rural workforce needs.<sup>28</sup></p> <h3>Reimbursement</h3> <p>The VA provides reimbursement for clinical and educational activities performed in VA facilities for the benefit of veterans as well as research, didactics, meetings and conferences, annual and sick leave, and orientation. The VA also may provide reimbursement for educational activities that occur off VA grounds (eg, the VA proportional share of a residency program’s didactic sessions). The VA does not reimburse for affiliate clinical duties or administrative costs, although a national policy allows VA facilities to reimburse affiliates for some GME overhead costs.<sup>29</sup></p> <p>CMS similarly reimburses for residency training time spent in patient care activities as well as orientation activities, didactics, leave, and, in some cases, research.<sup>4,30,31</sup> CMS makes payments to hospitals, which may include sponsoring institutions and Medicare-eligible participating training sites.<sup>4,30,31</sup> For both the VA and CMS, residents may not be counted twice for reimbursement by 2 federal agencies; in other words, a resident may not count for &gt; 1 FTE.<sup>4,30-32</sup></p> <h3>GME Oversight </h3> <p>VA GME funding came under significant scrutiny. At a 2016 House Veterans Affairs Committee hearing, Representative Phil Roe, MD (R-Tennessee), noted that no process existed at many VA facilities for “determining trainee presence” and that many VA medical centers had “difficulty tracking resident rotations”<sup>16</sup> A VA Office of the Inspector General investigation recommended that the VA implement policies and procedures to improve oversight to “ensure residents are fully participating in educational activities” and that the VA is “paying the correct amount” to the affiliate.<sup>17 </sup>A 2020 General Accountability Office report outlined unclear policy guidance, incomplete tracking of resident activities, and improper fiscal processes for reimbursement and reconciliation of affiliate invoices.<sup>18</sup></p> <p>In response, the OAA created an oversight and compliance unit, revised VHA Directive 1400.05 (the policy for disbursement), and improved resident tracking procedures.<sup>26</sup> The standard operating procedure that accompanied VHA Directive 1400.05 provides detailed information for the DEO and VA facility staff for tracking resident clinical and educational activities. FTE counts are essential to both VA and CMS for accurate reimbursement. The eAppendix (available online at doi:10.12788/fp.0472) and the Table provide a guide to reimbursable activities in the VA for the calculation of reimbursement, with a comparison to CMS.<sup>33,34</sup> The OAA in cooperation with other VA staff and officers periodically conducts audits to assess compliance with disbursement policy and affiliate reimbursement accuracy.<br/><br/>In the VA, resident activities are captured on the VA Educational Activity Record, a standardized spreadsheet to track activities and calculate reimbursement. Each VA facility hosting resident physicians manually records resident activity by the half-day. This process is labor intensive, involving both VA and affiliate staff to accurately reconcile payments. To address the workload demands, the OAA is developing an online tool that will automate aspects of the tracking process. Also, to ensure adequate staffing, the OAA is in the process of implementing an office optimization project, providing standardized position descriptions, an organizational chart, and staffing levels for DEO offices in VA facilities.</p> <h2>Conclusions</h2> <p>This report describes the key policies and principles of VA GME financing, highlighting the essential similarities and differences between VA and CMS. Neither the VA nor CMS regulations allow for reimbursement for &gt; 1 FTE position per resident, a principle that underpins the assignment of resident rotations and federal funding for GME and are similar with respect to reimbursement for patient care activities, didactics, research, orientation, and scholarly activity. While reimbursable activities in the VA require physical presence and care of veteran patients, CMS also limits reimbursement to resident activities in the hospital and approved other settings if the hospital is paying for resident salary and benefits in these settings. The VA provides some flexibility for offsite activities including didactics and, in specific circumstances, remote care of veteran patients (eg, teleradiology).</p> <p>The VA and CMS use different GME financing models. For example, the CMS calculations for resident FTEs are complex, whereas VA calculations reimburse the salary and benefits as set by the academic affiliate. The VA process accounts for local variation in salary rates, whereas the per-resident amount set by CMS varies regionally and does not fully account for differences in the cost of living.<sup>24</sup> Because all patients in VA facilities are veterans, VA calculations for reimbursement do not involve ratios of beds like the CMS calculations to determine a proportional share of reimbursement. The VA GME expansion tends to be more directed to VA health workforce needs than CMS, specifying the types of programs and geographic locations to address these needs.<br/><br/>The VA regularly reevaluates how affiliates are reimbursed for VA resident activity, balancing compliance with VA policies and the workload for VA and its affiliates. The VA obtains input from key stakeholders including DEOs, DIOs, and professional organizations such as the Association of American Medical Colleges and the Accreditation Council for Graduate Medical Education.<sup>35,36<br/><br/></sup>Looking ahead, the VA is developing an online tool to improve the accuracy of affiliate reimbursement. The VA will also implement a standardized staffing model, organizational structure, and position descriptions for DEO offices. These initiatives will help reduce the burden of tracking and verifying resident activity and continue to support the 77-year partnership between VA and its affiliated institutions.</p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>Office of Academic Affiliations, Veterans Health Administration, Department of Veterans Affairs, Washington, DC<br/><br/><sup>b</sup>VA Providence Health Care System, Rhode Island<br/><br/><sup>c</sup>The Warren Alpert Medical School of Brown University, Providence, Rhode Island<br/><br/><sup>d</sup>Virginia Commonwealth University, Richmond<br/><br/><sup>e</sup>Northwestern University Feinberg School of Medicine, Chicago, Illinois<br/><br/><sup>f</sup>University of Maryland School of Medicine, Baltimore</em> </p> <p class="isub">Author disclosures</p> <p> <em>The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <p class="isub">Disclaimer</p> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner</i>, Frontline Medical Communications Inc., the US Government, or any of its agencies.</em> </p> <p class="isub">Ethics and consent</p> <p> <em>This report is a program description and did not involve collection of data from human or animal subjects.</em> </p> <p class="isub">References</p> <p class="reference"> 1. Klink KA, Albanese AP, Bope ET, Sanders KM. Veterans Affairs graduate medical education expansion addresses US physician workforce needs. <i>Acad Med.</i> 2022;97(8):1144-1150. doi:10.1097/ACM.0000000000004545<br/><br/> 2. Andrus CH, Johnson K, Pierce E, Romito PJ, Hartel P, Berrios‐Guccione S, Best W. Finance modeling in the delivery of medical care in tertiary‐care hospitals in the Department of Veterans Affairs. <i>J Surg Res</i>. 2001;96(2):152-157. doi:10.1006/jsre.1999.5728<br/><br/> 3. Petrakis IL, Kozal M. Academic medical centers and the U.S. Department of Veterans Affairs: a 75-year partnership influences medical education, scientific discovery, and clinical care. <i>Acad Med</i>. 2022;97(8):1110-1113. doi:10.1097/ACM.0000000000004734<br/><br/> 4. Heisler EJ, Mendez BH, Mitchell A, Panangala SV, Villagrana MA. Federal support for graduate medical education: an overview (R44376). Congressional Research Service report R44376; version 11. Updated December 27, 2018. Accessed March 2, 2024. https://crsreports.congress.gov/product/pdf/R/R44376/11 <br/><br/> 5. Chang BK, Brannen JL. The Veterans Access, Choice, and Accountability Act of 2014: examining graduate medical education enhancement in the Department of Veterans Affairs. <i>Acad Med</i>. 2015;90(9):1196-1198. doi:10.1097/ACM.0000000000000795<br/><br/> 6. Albanese AP, Bope ET, Sanders KM, Bowman M. The VA MISSION Act of 2018: a potential game changer for rural GME expansion and veteran health care.<i> J Rural Health</i>. 2020;36(1):133-136. doi:10.1111/jrh.12360<br/><br/> 7. Lypson ML, Roberts LW. Valuing the partnership between the Veterans Health Administration and academic medicine. <i>Acad Med.</i> 2022;97(8):1091-1093. doi:10.1097/ACM.0000000000004748<br/><br/> 8. Harada ND, Traylor L, Rugen KW, et al. Interprofessional transformation of clinical education: the first six years of the Veterans Affairs Centers of Excellence in Primary Care Education. <i>J Interprof Care.</i> 2023;37(suppl 1):S86-S94. doi:10.1080/13561820.2018.1433642</p> <p class="reference"> 9. Harada ND, Rajashekara S, Sansgiry S, et al. Developing interprofessional primary care teams: alumni evaluation of the Department of Veterans Affairs Centers of Excellence in Primary Care Education Program. <i>J Med Educ Curric Dev.</i> 2019;6:2382120519875455. doi:10.1177/2382120519875455<br/><br/>10. Splaine ME, Ogrinc G, Gilman SC, et al. The Department of Veterans Affairs National Quality Scholars Fellowship Program: experience from 10 years of training quality scholars. <i>Acad Med.</i> 2009;84(12):1741-1748. doi:10.1097/ACM.0b013e3181bfdcef<br/><br/>11. Watts BV, Paull DE, Williams LC, Neily J, Hemphill RR, Brannen JL. Department of Veterans Affairs chief resident in quality and patient safety program: a model to spread change. <i>Am J Med Qual.</i> 2016;31(6):598-600. doi:10.1177/1062860616643403<br/><br/>12. He K, Whang E, Kristo G. Graduate medical education funding mechanisms, challenges, and solutions: a narrative review. <i>Am J Surg</i>. 2021;221(1):65-71. doi:10.1016/j.amjsurg.2020.06.007<br/><br/>13. Villagrana M. Medicare graduate medical education payments: an overview. Congressional Research Service report IF10960. Updated September 29, 2022. Accessed March 2, 2024. https://crsreports.congress.gov/product/pdf/IF/IF10960<br/><br/>14. Committee on the Governance and Financing of Graduate Medical Education; Board on Health Care Services; Institute of Medicine. <i>Graduate Medical Education That Meets the Nation’s Health Needs</i>. Eden J, Berwick DM, Wilensky GR, eds. Washington, DC: National Academies Press; 2014. doi:10.17226/18754<br/><br/>15. Physician workforce: caps on Medicare-funded graduate medical education at teaching hospitals. Report to congressional requesters. GAO-21-391. May 21, 2021. Accessed March 1, 2024. https://www.gao.gov/assets/gao-21-391.pdf<br/><br/>16. <i>VA and Academic Affiliates: Who Benefits? Hearing Before the Subcommittee on Oversight and Investigations of the Committee on Veterans’ Affairs</i>, 114th Cong, 2nd Sess (2016). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CHRG-115hhrg29685/html/CHRG-115hhrg29685.htm<br/><br/>17. US Department of Veterans Affairs, Office of Inspector General (OIG). Veterans Health Administration. Review of resident and part-time physician time and attendance at the Oklahoma City VA Health Care System. OIG report 17-00253-93. March 28, 2018. Accessed March 1, 2024. https://www.oversight.gov/sites/default/files/oig-reports/VAOIG-17-00253-93.pdf<br/><br/>18. VA health care: actions needed to improve oversight of graduate medical education reimbursement. Report to the ranking member, Committee on Veterans’ Affairs, House of Representatives. GAO-20-553. July 2020. Accessed March 1, 2024. https://www.gao.gov/assets/710/708275.pdf</p> <p class="reference">19. Functions of Veterans Health Administration: in general, 38 USC §7301 (2022). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/USCODE-2022-title38/pdf/USCODE-2022-title38-partV-chap73-subchapI-sec7301.pdf <br/><br/>20. US Department of Veterans Affairs. Policy memorandum no. 2, policy in association of veterans’ hospitals with medical schools. January 30, 1946. <br/><br/>21. Veterans Health Care Expansion Act of 1973, Public Law 93-82. August 2, 1973. Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/STATUTE-87/pdf/STATUTE-87-Pg179.pdf<br/><br/>22. Residencies and internships, 38 USC § 7406 (2022). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/USCODE-2022-title38/pdf/USCODE-2022-title38-partV-chap74-subchapI-sec7406.pdf <br/><br/>23. Direct graduate medical education (DGME). Centers for Medicaid and Medicare Services. Updated December 5, 2023. Accessed March 1, 2024. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/DGME<br/><br/>24. Drezdzon MK, Cowley NJ, Sweeney DP, et al. Going for broke: the impact of cost of living on surgery resident stipend value. <i>Ann Surg. </i>2023;278(6):1053-1059. doi:10.1097/SLA.0000000000005923<br/><br/>25. Special treatment: hospitals that incur indirect costs for graduate medical education programs, 42 CFR § 412.105 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec412-105.pdf<br/><br/>26. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1400.05, Disbursement agreements for health professions trainees appointed under 38 U.S.C. § 7406. June 2, 2021. Accessed March 1, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9293<br/><br/>27. Harada ND, Sanders KM, Bowman MA. Health systems education leadership: learning from the VA designated education officer role. <i>Fed Pract.</i> 2022;39(6):266-273. doi:10.12788/fp.0278<br/><br/>28. Schleiter Hitchell K, Johnson L. CMS finalizes rules for distribution of 1000 new Medicare-funded residency positions and changes to rural training track programs. <i>J Grad Med Educ</i>. 2022;14(2):245-249. doi:10.4300/JGME-D-22-00193.1</p> <p class="reference">29. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1400.10, Educational cost contracts for health professions education. September 25, 2023. Accessed March 1, 2024. https://www.va.gov/VHAPUBLICATIONS/ViewPublication.asp?pub_ID=11480<br/><br/>30. Direct GME payments: general requirements, 42 CFR § 413.75 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec413-75.pdf<br/><br/>31. Direct GME payments: determination of the total number of FTE residents, 42 CFR § 413.78 (2023). Accessed March 1, 2024. https://www.govinfo.gov/content/pkg/CFR-2023-title42-vol2/pdf/CFR-2023-title42-vol2-sec413-78.pdf<br/><br/>32. US Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare financial management manual, chapter 8. Contractor procedures for provider audits. Accessed March 1, 2024. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/fin106c08.pdf<br/><br/>33. US Department of Health and Human Services, Office of Inspector General. CMS did not always ensure hospitals complied with Medicare reimbursement requirements for graduate medical education. OIG report A-02-17-01017. November 2018. Accessed March 1, 2024. https://oig.hhs.gov/oas/reports/region2/21701017.pdf<br/><br/>34. US Department of Health and Human Services, Centers for Medicare and Medicaid Services. Interns and Residents Information System (IRIS) XML format. Publication 100-20. Transmittal 11418. Change request 12724. May 19, 2022. Accessed March 1, 2024. https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/R11418OTN.pdf<br/><br/>35. Birnbaum AD, Byrne J, on behalf of the VA Office of Academic Affiliations. <i>VHA Updates: Disbursement Policy and Education Cost Contracts</i>. Presented at: American Association of Medical Colleges Webinar; June 2021. Accessed March 1, 2024. https://vimeo.com/644415670<br/><br/>36. Byrne JM, on behalf of the VA Office of Academic Affiliations. Disbursement procedures update for AY 23-24. Accessed March 1, 2024. https://www.va.gov/oaa/Videos/AffiliatePresentationDisbursementandEARsAY23-24.pptx</p> </itemContent> </newsItem> </itemSet></root>
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Preparing Veterans Health Administration Psychologists to Meet the Complex Needs of Aging Veterans

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Mon, 04/01/2024 - 23:39

The Veterans Health Administration (VHA) is understaffed for clinical psychologists who have specialty training in geriatrics (ie, geropsychologists) to meet the needs of aging veterans. Though only 16.8% of US adults are aged ≥ 65 years,1 this age group comprises 45.9% of patients within the VHA.2 The needs of older adults are complex and warrant specialized services from mental health clinicians trained to understand lifespan developmental processes, biological changes associated with aging, and changes in psychosocial functioning.

Older veterans (aged ≥ 65 years) present with higher rates of combined medical and mental health diagnoses compared to both younger veterans and older adults who are not veterans.3 Nearly 1 of 5 (18.1%) older veterans who use VHA services have confirmed mental health diagnoses, and an additional 25.5% have documented mental health concerns without a formal diagnosis in their health record.4 The clinical presentations of older veterans frequently differ from younger adults and include greater complexity. For example, older veterans face an increased risk of cognitive impairment compared to the general population, due in part to higher prevalence of posttraumatic stress, which doubles their risk of developing dementia.5 Additional examples of multicomplexity among older veterans may include co-occurring medical and psychiatric diagnoses, the presence of delirium, social isolation/loneliness, and concerns related to polypharmacy. These complex presentations result in significant challenges for mental health clinicians in areas like assessment (eg, accuracy of case conceptualization), intervention (eg, selection and prioritization), and consultation (eg, coordination among multiple medical and mental health specialists).

Older veterans also present with substantial resilience. Research has found that aging veterans exposed to trauma during their military service often review their memories and past experiences, which is known as later-adulthood trauma reengagement.6 Through this normative life review process, veterans engage with memories and experiences from their past that they previously avoided, which could lead to posttraumatic growth for some. Unfortunately, others may experience an increase in psychological distress. Mental health clinicians with specialty expertise and training in aging and lifespan development can facilitate positive outcomes to reduce distress.7

The United States in general, and the VHA specifically, face a growing shortage of geriatric mental health clinicians. In a 2015 American Psychological Association survey, 1528 of 4109 respondents (37.2%) reported they frequently or very frequently administered care to older adults, yet only 49 respondents (1.2%) reported geropsychology as their specialty.8 According to the National Provider Registry, 660 clinicians self-identified as geropsychologists (ie, those who self-reported “psychologist: adult development and aging” as an NPI Healthcare Provider taxonomy code) in the US, representing < 1% of all doctoral level psychologists.9 The number of psychologists who obtain board certification from the American Board of Geropsychology is even lower (only 112 clinicians as of February 2024).10 Many psychologists within the VHA treat older veterans in integrated health settings such as primary care, home-based primary care, community living centers, or behavioral health care, but many lack formal training in geropsychology.

The Geriatric Scholars Program (GSP) was developed in 2008 to address the training gap and provide education in geriatrics to VHA clinicians that treat older veterans, particularly in rural areas.11,12 The GSP initially focused on primary care physicians, nurse practitioners, physician assistants, and pharmacists. It was later expanded to include other disciplines (ie, social work, rehabilitation therapists, and psychiatrists). In 2013, the GSP – Psychology Track (GSP-P) was developed with funding from the VHA Offices of Rural Health and Geriatrics and Extended Care specifically for psychologists.

figure_1.png

This article describes the multicomponent longitudinal GSP-P, which has evolved to meet the target audience’s ongoing needs for knowledge, skills, and opportunities to refine practice behaviors. GSP-P received the 2020 Award for Excellence in Geropsychology Training from the Council of Professional Geropsychology Training Programs. GSP-P has grown within the context of the larger GSP and aligns with the other existing elective learning opportunities (Figure 1).

 

 

Program description

Introductory Course

table.png

Psychologist subject matter experts (SMEs) developed an intensive course in geropsychology in the absence of a similar course in the geriatric medicine board review curriculum. SMEs reviewed the guidelines for practice by professional organizations like the Pikes Peak Geropsychology Competencies,which outline knowledge and skills in various domains.13 SMEs integrated this review with findings from a needs assessment for postlicensed VHA psychology staff in 4 health care systems, drafted a syllabus, and circulated it to geropsychology experts for feedback. The resulting multiday course covered general mental health as well as topics particularly salient for mental health clinicians treating older veterans including suicide prevention and posttraumatic stress disorder (PTSD).14 This Geropsychology Competencies Review Course was piloted in 1 region initially before being offered nationally in 2014. The previously published evaluation findings demonstrated significant improvements from precourse to 3 months postcourse in confidence and knowledge in 4 key areas of geropsychology: General knowledge about adult development and aging, assessment, intervention, and consultation.15 These domains align with the Pikes Peak Geropsychology Competencies and are measured by a subset of items from the Geropsychology Knowledge and Skills Assessment Tool.13,16 As of October 2023, 8 introductory courses have been held with 173 participants (Table).

Quality Improvement

Introductory course attendees also participate in an intensive day-long interactive workshop in quality improvement (QI). After completing these trainings, they apply what they have learned at their home facility by embarking on a QI project related to geriatrics. The QI projects reinforce learning and initiate practice changes not only for attendees but at times the larger health care system. Topics are selected by scholars in response to the needs they observe in their clinics. Recent GSP projects include efforts to increase screenings for depression and anxiety, improve adherence to VHA dementia policy, increase access to virtual care, and increase referrals to programs such as whole health or cognitive behavioral therapy for insomnia, a first-line treatment for insomnia in older adults.17 Another project targeted the improvement of referrals to the Compassionate Contact Corps in an effort to reduce social isolation and loneliness among older veterans.18 Evaluations demonstrate significant improvement in scholars’ confidence in related program development and management from precourse to 3 months postcourse.15

Webinars

The Addressing Geriatric Mental Health webinar series was created to introduce learners to topics that could not be covered in the introductory course. Topics were suggested by the expert reviewers of the curriculum or identified by the scholars themselves (eg, chronic pain, sexuality, or serious mental illness). A secondary function of the webinars was to reach a broader audience. Over time, scholars and webinar attendees requested opportunities to explore topics in greater depth (eg, PTSD later in life). These requests led the webinars to focus on annual themes.

figure_2.png

The series is open to all disciplines of geriatric scholars, VHA staff, and non-VHA staff through the Veterans Affairs Talent Management System and the TRAIN Learning Network (train.org). Attendance for the 37 webinars was captured from logins to the virtual learning platform and may underestimate attendance if a group attended on a single screen. Average attendance increased from 157 attendees/webinar in 2015 to 418 attendees/webinar in 2023 (Figure 2). This may have been related to the increase in virtual learning during the COVID-19 pandemic, but represents a 166% increase in audience from the inaugural year of the series.

Advanced Learning Opportunities

To invest in the ongoing growth and development of introductory course graduates, GSP-P developed and offered an advanced workshop in 2019. This multiday workshop focused on further enhancement of geropsychology competencies, with an emphasis on treating older veterans with mental and physical comorbidities. Didactics and experiential learning exercises led by SMEs covered topics such as adjusting to chronic illness, capacity assessment, PTSD, insomnia and sleep changes, chronic pain, and psychological interventions in palliative care and hospice settings. Evaluation findings demonstrated significant improvements from precourse to 6 months postcourse in confidence and knowledge as defined by the Pikes Peak Geropsychology Competencies.19

To facilitate ongoing and individually tailored learning following the advanced workshop, scholars also developed and executed independent learning plans (ILPs) during a 6-month window with consultation from an experienced geropsychologist. Fifteen of 19 scholars (78.9%) completed ILPs with an average of 3 learning goals listed. After completing the ILPs, scholars endorsed their clinical and/or personal usefulness, citing increased confidence, enhanced skills for use with patients with complex needs, personal fulfillment, and career advancement. Most scholars noted ILPs were feasible and learning resources were accessible. Overall, the evaluation found ILPs to be a valuable way to enhance psychologists’ learning and effectiveness in treating older veterans with complex health needs.20

 

 

Clinical Practica

All geriatric scholars who completed the program have additional opportunities for professional development through practicum experiences focused on specific clinical approaches to the care of older veterans, such as dementia care, pain management, geriatric assessment, and palliative care. These practica provide scholars with individualized learning experiences in an individualized or small group setting and may be conducted either in-person or virtually.

In response to an expressed need from those who completed the program, the GSP-P planning committee collaborated with an SME to develop a virtual practicum to assess patients’ decision making capacity. Evaluating capacities among older adults is a common request, yet clinicians report little to no formal training in how to conceptualize and approach these complex questions.21,22 Utilizing an evidence-informed and structured approach promotes the balancing of an older adult’s autonomy and professional ethics. Learning capacity evaluation skills could better position psychologists to not only navigate complex ethical, legal, and clinical situations, but also serve as expert consultants to interdisciplinary teams. This virtual practicum was initiated in 2022 and to date has included 10 scholars. The practicum includes multiple modalities of learning: (1) self-directed review of core concepts; (2) attendance at 4 capacity didactics focused on introduction to evaluating capacities, medical consent and decision making, financial decision making and management, and independent living; and (3) participation in 5 group consultations on capacity evaluations conducted at their home sites. During these group consultations, additional case examples were shared to reinforce capacity concepts.

Discussion

The objective of GSP-P is to enhance geropsychology practice competencies among VHA psychologists given the outsized representation of older adults within the VHA system and their complex care needs. The curricula have significantly evolved to accomplish this, expanding the reach and investing in the continuing growth and development of scholars.

There are several elements that set GSP apart from other geriatric and geropsychology continuing medical education programs. The first is that the training is veteran focused, allowing us to discuss the unique impact military service has on aging. Similarly, because all scholars work within the integrated health care system, we can introduce and review key resources and programs that benefit all veterans and their families/care partners across the system. Through the GSP, the VA invests in ongoing professional development. Scholars can participate in additional experiential practica, webinars, and advanced workshops tailored to their individual learning needs. Lastly, the GSP works to create a community among its scholars where they can not only continue to consult with presenters/instructors, but also one another. A planned future direction for the GSP-P is to incorporate quarterly office hours and discussions for alumni to develop an increased sense of community. This may strengthen commitment to the overall VA mission, leading to increased retainment of talent who now have the knowledge, skills, and confidence to care for aging veterans.

Limitations

GSP is limited by its available funding. Additionally, the number of participants who can enroll each year in GSP-P (not including webinars) is capped by policy. Another limitation is the number of QI coaches available to mentor scholars on their projects.

 

 

Conclusions

Outcomes of GSP-P have been extremely favorable. Following participation in the program, we have found a significant increase in confidence in geropsychology practice among clinicians, as well as enhanced knowledge and skills across competency domains.15,19 We have observed rising attendance in our annual webinar series and graduates of our introductory courses participate in subsequent trainings (eg, advanced workshop or virtual practicum). Several graduates of GSP-P have become board certified in geropsychology by the American Board of Geropsychology and many proceed to supervise geropsychology-focused clinical rotations for psychology practicum students, predoctoral interns, and postdoctoral fellows. This suggests that the reach of GSP-P programming may extend farther than reported in this article.

The needs of aging veterans have also changed based on cohort differences, as the population of World War II and Korean War era veterans has declined and the number of older Vietnam era veterans has grown. We expect different challenges with older Gulf War and post-9/11 era veterans. For instance, 17% of troops deployed to Iraq or Afghanistan following 9/11 experienced mild traumatic brain injury (TBI), and 59% of those experienced > 1 mild TBI.23 Research indicates that younger post-9/11 veterans have a 3-fold risk of developing early onset dementia after experiencing a TBI.24 Therefore, even though post-9/11 veterans are not older in terms of chronological age, some may experience symptoms and conditions more often occurring in older veterans. As a result, it would be beneficial for clinicians to learn about the presentation and treatment of geriatric conditions such as dementia.

Moving forward, the GSP-P should identify potential opportunities to collaborate with the non-VHA mental health community–which also faces a shortage of geriatric mental health clinicians–to extend educational opportunities to improve care for veterans in all settings (eg, cosponsor training opportunities open to both VHA and non-VHA clinicians).8,25 Many aging veterans may receive portions of their health care outside the VHA, particularly those who reside in rural areas. Additionally, as veterans age, so do their support systems (eg, family members, friends, spouses, caregivers, and even clinicians), most of whom will receive care outside of the VHA. Community education collaborations will not only improve the care of older veterans, but also the care of older adults in the general population.

Promising directions include the adoption of the GSP model in other health care settings. Recently, Indian Health Service has adapted the model, beginning with primary care clinicians and pharmacists and is beginning to expand to other disciplines. Additional investments in VHA workforce training include the availability of geropsychology internship and fellowship training opportunities through the Office of Academic Affiliations, which provide earlier opportunities to specialize in geropsychology. Continued investment in both prelicensure and postpsychology licensure training efforts are needed within the VHA to meet the geriatric mental health needs of veterans.

Acknowledgments

The authors wish to acknowledge Terri Huh, PhD, for her contributions to the development and initiation of the GSP-P. The authors also appreciate the collaboration and quality initiative training led by Carol Callaway-Lane, DNP, ACNP-BC, and her team.

References

1. Caplan Z, Rabe M; US Department of Commerce, US Census Bureau. The Older Population: 2020 (Census Brief No. C2020BR-07). May 2023. Accessed February 27, 2024. https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-07.pdf

2. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. VA benefits & health care utilization. Updated February 2023. Accessed February 27, 2024. https://www.va.gov/vetdata/docs/pocketcards/fy2023q2.PDF

3. O’Malley KA, Vinson L, Pless Kaiser A, Sager Z, Hinrichs K. Mental health and aging veterans: How the Veterans Health Administration meets the needs of aging veterans. Public Policy Aging Rep. 2020;30(1):19-23. doi:10.1093/ppar/prz027

4. Greenberg G, Hoff R. FY 2021 Older Adult (65+ on October 1st) Veteran Data Sheet: National, VISN, and Healthcare System Tables. West Haven, CT: U.S. Department of Veterans Affairs, Northeast Program Evaluation Center. 2022.

5. Yaffe K, Vittinghoff E, Lindquist K, et al. Posttraumatic stress disorder and risk of dementia among US veterans. Arch Gen Psychiatry. 2010;67(6):608-613. doi:10.1001/archgenpsychiatry.2010.61

6. Davison EH, Kaiser AP, Spiro A 3rd, Moye J, King LA, King DW. From late-onset stress symptomatology to later-adulthood trauma reengagement in aging combat veterans: Taking a broader view. Gerontologist. 2016;56(1):14-21. doi:10.1093/geront/gnv097

7. Kaiser AP, Boyle JT, Bamonti PM, O’Malley K, Moye J. Development, adaptation, and clinical implementation of the Later-Adulthood Trauma Reengagement (LATR) group intervention for older veterans. Psychol Serv. 2023;20(4):863-875. doi:10.1037/ser0000736

8. Moye J, Karel MJ, Stamm KE, et al. Workforce analysis of psychological practice with older adults: Growing crisis requires urgent action. Train Educ Prof Psychol. 2019;13(1):46-55. doi:10.1037/tep0000206

9. Stamm K, Lin L, Conroy J. Critical needs in geropsychology. Monitor on Psychology. 2021;52(4):21.

10. American Board of Geropsychology. Specialists. 2024. Accessed February 6, 2024. https://abgero.org/board-members/specialists/

11. Kramer BJ. The VA Geriatric Scholars Program. Fed Pract. 2015;32(5):46-48. 

12. Kramer BJ, Creekmur B, Howe JL, et al. Veterans Affairs Geriatric Scholars Program: Enhancing existing primary care clinician skills in caring for older veterans. J Am Geriatr Soc. 2016;64(11):2343-2348. doi:10.1111/jgs.14382

13. Knight BG, Karel MJ, Hinrichsen GA, Qualls SH, Duffy M. Pikes Peak model for training in professional geropsychology. Am Psychol. 2009;64(3):205-14. doi:10.1037/a0015059

14. Huh JWT, Rodriguez R, Gould CE, R Brunskill S, Melendez L, Kramer BJ. Developing a program to increase geropsychology competencies of Veterans Health Administration (VHA) psychologists. Gerontol Geriatr Educ. 2020;41(4):463-479. doi:10.1080/02701960.2018.1491402

15. Huh JWT, Rodriguez RL, Gregg JJ, Scales AN, Kramer BJ, Gould CE. Improving geropsychology competencies of Veterans Affairs psychologists. J Am Geriatr Soc. 2021;69(3):798-805. doi:10.1111/jgs.17029

16. Karel MJ, Emery EE, Molinari V; CoPGTP Task Force on the Assessment of Geropsychology Competencies. Development of a tool to evaluate geropsychology knowledge and skill competencies. Int Psychogeriatr. 2010;22(6):886-896. doi:10.1017/S1041610209991736

17. Morgenthaler T, Kramer M, Alessi C, et al. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An American Academy of Sleep Medicine report. Sleep. 2006;29(11):1415-1419.

18. Sullivan J, Gualtieri L, Campbell M, Davila H, Pendergast J, Taylor P. VA Compassionate Contact Corps: a phone-based intervention for veterans interested in speaking with peers. Innov Aging. 2021;5(Suppl 1):204. doi:10.1093/geroni/igab046.788

19. Gregg JJ, Rodriguez RL, Mehta PS, Kramer BJ, Gould CE. Enhancing specialty training in geropsychology competencies: an evaluation of a VA Geriatric Scholars Program advanced topics workshop. Gerontol Geriatr Educ. 2023;44(3):329-338. doi:10.1080/02701960.2022.2069764

20. Gould CE, Rodriguez RL, Gregg J, Mehta PS, Kramer J. Mentored independent learning plans among psychologists: a mixed methods investigation. J Amer Geriatr Soc. 2023;71(S1):S53.

21. Mullaly E, Kinsella G, Berberovic N, et al. Assessment of decision-making capacity: exploration of common practices among neuropsychologists. Aust Psychol. 2007;42:178-186. doi:10.1080/00050060601187142

22. Seyfried L, Ryan KA, Kim SYH. Assessment of decision-making capacity: Views and experiences of consultation psychiatrists. Psychosomatics. 2013;54(2):115-123. doi:10.1016/j.psym.2012.08.001

23. Wilk JE, Herrell RK, Wynn GH, Riviere LA, Hoge CW. Mild traumatic brain injury (concussion), posttraumatic stress disorder, and depression in U.S. soldiers involved in combat deployments: association with postdeployment symptoms. Psychosom Med. 2012;74(3):249-257. doi:10.1097/PSY.0b013e318244c604

24. Kennedy E, Panahi S, Stewart IJ, et al. Traumatic brain injury and early onset dementia in post 9-11 veterans. Brain Inj. 2022;36(5):620-627.doi:10.1080/02699052.2022.2033846

25. Merz CC, Koh D, Sakai EY, et al. The big shortage: Geropsychologists discuss facilitators and barriers to working in the field of aging. Transl Issues Psychol Sci. 2017;3(4):388-399. doi:10.1037/tps0000137

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Christine E. Gould, PhD, ABPP-geroa,b; Rachel L. Rodriguez, PhD, MPH, ABPP-geroc; Jeffrey J. Gregg, PhDc,d; Kyle Page, PhD, ABPP-geroe; Luis Melendez, MPA, MSf; Joseph R. Douglasf; Johnny Lewisa; B. Josea Kramer, PhDf,g

Correspondence:  Christine Gould  (christine.gould@va.gov)

aVA Palo Alto Health Care System, Geriatric Research Education and Clinical Center, California

bStanford University School of Medicine, Department of Psychiatry and Behavioral Services, Palo Alto, California

cDurham VA Health Care System, Mental and Behavioral Health Service, North Carolina

dDuke University, Department of Medicine, Division of Geriatrics, Durham, North Carolina

eEdward Hines, Jr. VA Hospital, Mental Health Service Line, Hines, Illinois

fVA Greater Los Angeles Health Care System, Greater Los Angeles Geriatric Research Education and Clinical Center, California

gDavid Geffen School of Medicine at University of California, Los Angeles, Division of Geriatric Medicine, California

Author disclosures

The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This was part of an ongoing evaluation of an educational activity as approved by the VA Greater Los Angeles Health Care System.

Funding/Support

The project was funded by the US Department of Veterans Affairs Office of Rural Health as a Promising Practice grant award as well as the US Department of Veterans Affairs Office of Geriatrics and Extended Care as a Mentored Partnership grant award (PI: Kramer).

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Christine E. Gould, PhD, ABPP-geroa,b; Rachel L. Rodriguez, PhD, MPH, ABPP-geroc; Jeffrey J. Gregg, PhDc,d; Kyle Page, PhD, ABPP-geroe; Luis Melendez, MPA, MSf; Joseph R. Douglasf; Johnny Lewisa; B. Josea Kramer, PhDf,g

Correspondence:  Christine Gould  (christine.gould@va.gov)

aVA Palo Alto Health Care System, Geriatric Research Education and Clinical Center, California

bStanford University School of Medicine, Department of Psychiatry and Behavioral Services, Palo Alto, California

cDurham VA Health Care System, Mental and Behavioral Health Service, North Carolina

dDuke University, Department of Medicine, Division of Geriatrics, Durham, North Carolina

eEdward Hines, Jr. VA Hospital, Mental Health Service Line, Hines, Illinois

fVA Greater Los Angeles Health Care System, Greater Los Angeles Geriatric Research Education and Clinical Center, California

gDavid Geffen School of Medicine at University of California, Los Angeles, Division of Geriatric Medicine, California

Author disclosures

The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This was part of an ongoing evaluation of an educational activity as approved by the VA Greater Los Angeles Health Care System.

Funding/Support

The project was funded by the US Department of Veterans Affairs Office of Rural Health as a Promising Practice grant award as well as the US Department of Veterans Affairs Office of Geriatrics and Extended Care as a Mentored Partnership grant award (PI: Kramer).

Author and Disclosure Information

Christine E. Gould, PhD, ABPP-geroa,b; Rachel L. Rodriguez, PhD, MPH, ABPP-geroc; Jeffrey J. Gregg, PhDc,d; Kyle Page, PhD, ABPP-geroe; Luis Melendez, MPA, MSf; Joseph R. Douglasf; Johnny Lewisa; B. Josea Kramer, PhDf,g

Correspondence:  Christine Gould  (christine.gould@va.gov)

aVA Palo Alto Health Care System, Geriatric Research Education and Clinical Center, California

bStanford University School of Medicine, Department of Psychiatry and Behavioral Services, Palo Alto, California

cDurham VA Health Care System, Mental and Behavioral Health Service, North Carolina

dDuke University, Department of Medicine, Division of Geriatrics, Durham, North Carolina

eEdward Hines, Jr. VA Hospital, Mental Health Service Line, Hines, Illinois

fVA Greater Los Angeles Health Care System, Greater Los Angeles Geriatric Research Education and Clinical Center, California

gDavid Geffen School of Medicine at University of California, Los Angeles, Division of Geriatric Medicine, California

Author disclosures

The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This was part of an ongoing evaluation of an educational activity as approved by the VA Greater Los Angeles Health Care System.

Funding/Support

The project was funded by the US Department of Veterans Affairs Office of Rural Health as a Promising Practice grant award as well as the US Department of Veterans Affairs Office of Geriatrics and Extended Care as a Mentored Partnership grant award (PI: Kramer).

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The Veterans Health Administration (VHA) is understaffed for clinical psychologists who have specialty training in geriatrics (ie, geropsychologists) to meet the needs of aging veterans. Though only 16.8% of US adults are aged ≥ 65 years,1 this age group comprises 45.9% of patients within the VHA.2 The needs of older adults are complex and warrant specialized services from mental health clinicians trained to understand lifespan developmental processes, biological changes associated with aging, and changes in psychosocial functioning.

Older veterans (aged ≥ 65 years) present with higher rates of combined medical and mental health diagnoses compared to both younger veterans and older adults who are not veterans.3 Nearly 1 of 5 (18.1%) older veterans who use VHA services have confirmed mental health diagnoses, and an additional 25.5% have documented mental health concerns without a formal diagnosis in their health record.4 The clinical presentations of older veterans frequently differ from younger adults and include greater complexity. For example, older veterans face an increased risk of cognitive impairment compared to the general population, due in part to higher prevalence of posttraumatic stress, which doubles their risk of developing dementia.5 Additional examples of multicomplexity among older veterans may include co-occurring medical and psychiatric diagnoses, the presence of delirium, social isolation/loneliness, and concerns related to polypharmacy. These complex presentations result in significant challenges for mental health clinicians in areas like assessment (eg, accuracy of case conceptualization), intervention (eg, selection and prioritization), and consultation (eg, coordination among multiple medical and mental health specialists).

Older veterans also present with substantial resilience. Research has found that aging veterans exposed to trauma during their military service often review their memories and past experiences, which is known as later-adulthood trauma reengagement.6 Through this normative life review process, veterans engage with memories and experiences from their past that they previously avoided, which could lead to posttraumatic growth for some. Unfortunately, others may experience an increase in psychological distress. Mental health clinicians with specialty expertise and training in aging and lifespan development can facilitate positive outcomes to reduce distress.7

The United States in general, and the VHA specifically, face a growing shortage of geriatric mental health clinicians. In a 2015 American Psychological Association survey, 1528 of 4109 respondents (37.2%) reported they frequently or very frequently administered care to older adults, yet only 49 respondents (1.2%) reported geropsychology as their specialty.8 According to the National Provider Registry, 660 clinicians self-identified as geropsychologists (ie, those who self-reported “psychologist: adult development and aging” as an NPI Healthcare Provider taxonomy code) in the US, representing < 1% of all doctoral level psychologists.9 The number of psychologists who obtain board certification from the American Board of Geropsychology is even lower (only 112 clinicians as of February 2024).10 Many psychologists within the VHA treat older veterans in integrated health settings such as primary care, home-based primary care, community living centers, or behavioral health care, but many lack formal training in geropsychology.

The Geriatric Scholars Program (GSP) was developed in 2008 to address the training gap and provide education in geriatrics to VHA clinicians that treat older veterans, particularly in rural areas.11,12 The GSP initially focused on primary care physicians, nurse practitioners, physician assistants, and pharmacists. It was later expanded to include other disciplines (ie, social work, rehabilitation therapists, and psychiatrists). In 2013, the GSP – Psychology Track (GSP-P) was developed with funding from the VHA Offices of Rural Health and Geriatrics and Extended Care specifically for psychologists.

figure_1.png

This article describes the multicomponent longitudinal GSP-P, which has evolved to meet the target audience’s ongoing needs for knowledge, skills, and opportunities to refine practice behaviors. GSP-P received the 2020 Award for Excellence in Geropsychology Training from the Council of Professional Geropsychology Training Programs. GSP-P has grown within the context of the larger GSP and aligns with the other existing elective learning opportunities (Figure 1).

 

 

Program description

Introductory Course

table.png

Psychologist subject matter experts (SMEs) developed an intensive course in geropsychology in the absence of a similar course in the geriatric medicine board review curriculum. SMEs reviewed the guidelines for practice by professional organizations like the Pikes Peak Geropsychology Competencies,which outline knowledge and skills in various domains.13 SMEs integrated this review with findings from a needs assessment for postlicensed VHA psychology staff in 4 health care systems, drafted a syllabus, and circulated it to geropsychology experts for feedback. The resulting multiday course covered general mental health as well as topics particularly salient for mental health clinicians treating older veterans including suicide prevention and posttraumatic stress disorder (PTSD).14 This Geropsychology Competencies Review Course was piloted in 1 region initially before being offered nationally in 2014. The previously published evaluation findings demonstrated significant improvements from precourse to 3 months postcourse in confidence and knowledge in 4 key areas of geropsychology: General knowledge about adult development and aging, assessment, intervention, and consultation.15 These domains align with the Pikes Peak Geropsychology Competencies and are measured by a subset of items from the Geropsychology Knowledge and Skills Assessment Tool.13,16 As of October 2023, 8 introductory courses have been held with 173 participants (Table).

Quality Improvement

Introductory course attendees also participate in an intensive day-long interactive workshop in quality improvement (QI). After completing these trainings, they apply what they have learned at their home facility by embarking on a QI project related to geriatrics. The QI projects reinforce learning and initiate practice changes not only for attendees but at times the larger health care system. Topics are selected by scholars in response to the needs they observe in their clinics. Recent GSP projects include efforts to increase screenings for depression and anxiety, improve adherence to VHA dementia policy, increase access to virtual care, and increase referrals to programs such as whole health or cognitive behavioral therapy for insomnia, a first-line treatment for insomnia in older adults.17 Another project targeted the improvement of referrals to the Compassionate Contact Corps in an effort to reduce social isolation and loneliness among older veterans.18 Evaluations demonstrate significant improvement in scholars’ confidence in related program development and management from precourse to 3 months postcourse.15

Webinars

The Addressing Geriatric Mental Health webinar series was created to introduce learners to topics that could not be covered in the introductory course. Topics were suggested by the expert reviewers of the curriculum or identified by the scholars themselves (eg, chronic pain, sexuality, or serious mental illness). A secondary function of the webinars was to reach a broader audience. Over time, scholars and webinar attendees requested opportunities to explore topics in greater depth (eg, PTSD later in life). These requests led the webinars to focus on annual themes.

figure_2.png

The series is open to all disciplines of geriatric scholars, VHA staff, and non-VHA staff through the Veterans Affairs Talent Management System and the TRAIN Learning Network (train.org). Attendance for the 37 webinars was captured from logins to the virtual learning platform and may underestimate attendance if a group attended on a single screen. Average attendance increased from 157 attendees/webinar in 2015 to 418 attendees/webinar in 2023 (Figure 2). This may have been related to the increase in virtual learning during the COVID-19 pandemic, but represents a 166% increase in audience from the inaugural year of the series.

Advanced Learning Opportunities

To invest in the ongoing growth and development of introductory course graduates, GSP-P developed and offered an advanced workshop in 2019. This multiday workshop focused on further enhancement of geropsychology competencies, with an emphasis on treating older veterans with mental and physical comorbidities. Didactics and experiential learning exercises led by SMEs covered topics such as adjusting to chronic illness, capacity assessment, PTSD, insomnia and sleep changes, chronic pain, and psychological interventions in palliative care and hospice settings. Evaluation findings demonstrated significant improvements from precourse to 6 months postcourse in confidence and knowledge as defined by the Pikes Peak Geropsychology Competencies.19

To facilitate ongoing and individually tailored learning following the advanced workshop, scholars also developed and executed independent learning plans (ILPs) during a 6-month window with consultation from an experienced geropsychologist. Fifteen of 19 scholars (78.9%) completed ILPs with an average of 3 learning goals listed. After completing the ILPs, scholars endorsed their clinical and/or personal usefulness, citing increased confidence, enhanced skills for use with patients with complex needs, personal fulfillment, and career advancement. Most scholars noted ILPs were feasible and learning resources were accessible. Overall, the evaluation found ILPs to be a valuable way to enhance psychologists’ learning and effectiveness in treating older veterans with complex health needs.20

 

 

Clinical Practica

All geriatric scholars who completed the program have additional opportunities for professional development through practicum experiences focused on specific clinical approaches to the care of older veterans, such as dementia care, pain management, geriatric assessment, and palliative care. These practica provide scholars with individualized learning experiences in an individualized or small group setting and may be conducted either in-person or virtually.

In response to an expressed need from those who completed the program, the GSP-P planning committee collaborated with an SME to develop a virtual practicum to assess patients’ decision making capacity. Evaluating capacities among older adults is a common request, yet clinicians report little to no formal training in how to conceptualize and approach these complex questions.21,22 Utilizing an evidence-informed and structured approach promotes the balancing of an older adult’s autonomy and professional ethics. Learning capacity evaluation skills could better position psychologists to not only navigate complex ethical, legal, and clinical situations, but also serve as expert consultants to interdisciplinary teams. This virtual practicum was initiated in 2022 and to date has included 10 scholars. The practicum includes multiple modalities of learning: (1) self-directed review of core concepts; (2) attendance at 4 capacity didactics focused on introduction to evaluating capacities, medical consent and decision making, financial decision making and management, and independent living; and (3) participation in 5 group consultations on capacity evaluations conducted at their home sites. During these group consultations, additional case examples were shared to reinforce capacity concepts.

Discussion

The objective of GSP-P is to enhance geropsychology practice competencies among VHA psychologists given the outsized representation of older adults within the VHA system and their complex care needs. The curricula have significantly evolved to accomplish this, expanding the reach and investing in the continuing growth and development of scholars.

There are several elements that set GSP apart from other geriatric and geropsychology continuing medical education programs. The first is that the training is veteran focused, allowing us to discuss the unique impact military service has on aging. Similarly, because all scholars work within the integrated health care system, we can introduce and review key resources and programs that benefit all veterans and their families/care partners across the system. Through the GSP, the VA invests in ongoing professional development. Scholars can participate in additional experiential practica, webinars, and advanced workshops tailored to their individual learning needs. Lastly, the GSP works to create a community among its scholars where they can not only continue to consult with presenters/instructors, but also one another. A planned future direction for the GSP-P is to incorporate quarterly office hours and discussions for alumni to develop an increased sense of community. This may strengthen commitment to the overall VA mission, leading to increased retainment of talent who now have the knowledge, skills, and confidence to care for aging veterans.

Limitations

GSP is limited by its available funding. Additionally, the number of participants who can enroll each year in GSP-P (not including webinars) is capped by policy. Another limitation is the number of QI coaches available to mentor scholars on their projects.

 

 

Conclusions

Outcomes of GSP-P have been extremely favorable. Following participation in the program, we have found a significant increase in confidence in geropsychology practice among clinicians, as well as enhanced knowledge and skills across competency domains.15,19 We have observed rising attendance in our annual webinar series and graduates of our introductory courses participate in subsequent trainings (eg, advanced workshop or virtual practicum). Several graduates of GSP-P have become board certified in geropsychology by the American Board of Geropsychology and many proceed to supervise geropsychology-focused clinical rotations for psychology practicum students, predoctoral interns, and postdoctoral fellows. This suggests that the reach of GSP-P programming may extend farther than reported in this article.

The needs of aging veterans have also changed based on cohort differences, as the population of World War II and Korean War era veterans has declined and the number of older Vietnam era veterans has grown. We expect different challenges with older Gulf War and post-9/11 era veterans. For instance, 17% of troops deployed to Iraq or Afghanistan following 9/11 experienced mild traumatic brain injury (TBI), and 59% of those experienced > 1 mild TBI.23 Research indicates that younger post-9/11 veterans have a 3-fold risk of developing early onset dementia after experiencing a TBI.24 Therefore, even though post-9/11 veterans are not older in terms of chronological age, some may experience symptoms and conditions more often occurring in older veterans. As a result, it would be beneficial for clinicians to learn about the presentation and treatment of geriatric conditions such as dementia.

Moving forward, the GSP-P should identify potential opportunities to collaborate with the non-VHA mental health community–which also faces a shortage of geriatric mental health clinicians–to extend educational opportunities to improve care for veterans in all settings (eg, cosponsor training opportunities open to both VHA and non-VHA clinicians).8,25 Many aging veterans may receive portions of their health care outside the VHA, particularly those who reside in rural areas. Additionally, as veterans age, so do their support systems (eg, family members, friends, spouses, caregivers, and even clinicians), most of whom will receive care outside of the VHA. Community education collaborations will not only improve the care of older veterans, but also the care of older adults in the general population.

Promising directions include the adoption of the GSP model in other health care settings. Recently, Indian Health Service has adapted the model, beginning with primary care clinicians and pharmacists and is beginning to expand to other disciplines. Additional investments in VHA workforce training include the availability of geropsychology internship and fellowship training opportunities through the Office of Academic Affiliations, which provide earlier opportunities to specialize in geropsychology. Continued investment in both prelicensure and postpsychology licensure training efforts are needed within the VHA to meet the geriatric mental health needs of veterans.

Acknowledgments

The authors wish to acknowledge Terri Huh, PhD, for her contributions to the development and initiation of the GSP-P. The authors also appreciate the collaboration and quality initiative training led by Carol Callaway-Lane, DNP, ACNP-BC, and her team.

The Veterans Health Administration (VHA) is understaffed for clinical psychologists who have specialty training in geriatrics (ie, geropsychologists) to meet the needs of aging veterans. Though only 16.8% of US adults are aged ≥ 65 years,1 this age group comprises 45.9% of patients within the VHA.2 The needs of older adults are complex and warrant specialized services from mental health clinicians trained to understand lifespan developmental processes, biological changes associated with aging, and changes in psychosocial functioning.

Older veterans (aged ≥ 65 years) present with higher rates of combined medical and mental health diagnoses compared to both younger veterans and older adults who are not veterans.3 Nearly 1 of 5 (18.1%) older veterans who use VHA services have confirmed mental health diagnoses, and an additional 25.5% have documented mental health concerns without a formal diagnosis in their health record.4 The clinical presentations of older veterans frequently differ from younger adults and include greater complexity. For example, older veterans face an increased risk of cognitive impairment compared to the general population, due in part to higher prevalence of posttraumatic stress, which doubles their risk of developing dementia.5 Additional examples of multicomplexity among older veterans may include co-occurring medical and psychiatric diagnoses, the presence of delirium, social isolation/loneliness, and concerns related to polypharmacy. These complex presentations result in significant challenges for mental health clinicians in areas like assessment (eg, accuracy of case conceptualization), intervention (eg, selection and prioritization), and consultation (eg, coordination among multiple medical and mental health specialists).

Older veterans also present with substantial resilience. Research has found that aging veterans exposed to trauma during their military service often review their memories and past experiences, which is known as later-adulthood trauma reengagement.6 Through this normative life review process, veterans engage with memories and experiences from their past that they previously avoided, which could lead to posttraumatic growth for some. Unfortunately, others may experience an increase in psychological distress. Mental health clinicians with specialty expertise and training in aging and lifespan development can facilitate positive outcomes to reduce distress.7

The United States in general, and the VHA specifically, face a growing shortage of geriatric mental health clinicians. In a 2015 American Psychological Association survey, 1528 of 4109 respondents (37.2%) reported they frequently or very frequently administered care to older adults, yet only 49 respondents (1.2%) reported geropsychology as their specialty.8 According to the National Provider Registry, 660 clinicians self-identified as geropsychologists (ie, those who self-reported “psychologist: adult development and aging” as an NPI Healthcare Provider taxonomy code) in the US, representing < 1% of all doctoral level psychologists.9 The number of psychologists who obtain board certification from the American Board of Geropsychology is even lower (only 112 clinicians as of February 2024).10 Many psychologists within the VHA treat older veterans in integrated health settings such as primary care, home-based primary care, community living centers, or behavioral health care, but many lack formal training in geropsychology.

The Geriatric Scholars Program (GSP) was developed in 2008 to address the training gap and provide education in geriatrics to VHA clinicians that treat older veterans, particularly in rural areas.11,12 The GSP initially focused on primary care physicians, nurse practitioners, physician assistants, and pharmacists. It was later expanded to include other disciplines (ie, social work, rehabilitation therapists, and psychiatrists). In 2013, the GSP – Psychology Track (GSP-P) was developed with funding from the VHA Offices of Rural Health and Geriatrics and Extended Care specifically for psychologists.

figure_1.png

This article describes the multicomponent longitudinal GSP-P, which has evolved to meet the target audience’s ongoing needs for knowledge, skills, and opportunities to refine practice behaviors. GSP-P received the 2020 Award for Excellence in Geropsychology Training from the Council of Professional Geropsychology Training Programs. GSP-P has grown within the context of the larger GSP and aligns with the other existing elective learning opportunities (Figure 1).

 

 

Program description

Introductory Course

table.png

Psychologist subject matter experts (SMEs) developed an intensive course in geropsychology in the absence of a similar course in the geriatric medicine board review curriculum. SMEs reviewed the guidelines for practice by professional organizations like the Pikes Peak Geropsychology Competencies,which outline knowledge and skills in various domains.13 SMEs integrated this review with findings from a needs assessment for postlicensed VHA psychology staff in 4 health care systems, drafted a syllabus, and circulated it to geropsychology experts for feedback. The resulting multiday course covered general mental health as well as topics particularly salient for mental health clinicians treating older veterans including suicide prevention and posttraumatic stress disorder (PTSD).14 This Geropsychology Competencies Review Course was piloted in 1 region initially before being offered nationally in 2014. The previously published evaluation findings demonstrated significant improvements from precourse to 3 months postcourse in confidence and knowledge in 4 key areas of geropsychology: General knowledge about adult development and aging, assessment, intervention, and consultation.15 These domains align with the Pikes Peak Geropsychology Competencies and are measured by a subset of items from the Geropsychology Knowledge and Skills Assessment Tool.13,16 As of October 2023, 8 introductory courses have been held with 173 participants (Table).

Quality Improvement

Introductory course attendees also participate in an intensive day-long interactive workshop in quality improvement (QI). After completing these trainings, they apply what they have learned at their home facility by embarking on a QI project related to geriatrics. The QI projects reinforce learning and initiate practice changes not only for attendees but at times the larger health care system. Topics are selected by scholars in response to the needs they observe in their clinics. Recent GSP projects include efforts to increase screenings for depression and anxiety, improve adherence to VHA dementia policy, increase access to virtual care, and increase referrals to programs such as whole health or cognitive behavioral therapy for insomnia, a first-line treatment for insomnia in older adults.17 Another project targeted the improvement of referrals to the Compassionate Contact Corps in an effort to reduce social isolation and loneliness among older veterans.18 Evaluations demonstrate significant improvement in scholars’ confidence in related program development and management from precourse to 3 months postcourse.15

Webinars

The Addressing Geriatric Mental Health webinar series was created to introduce learners to topics that could not be covered in the introductory course. Topics were suggested by the expert reviewers of the curriculum or identified by the scholars themselves (eg, chronic pain, sexuality, or serious mental illness). A secondary function of the webinars was to reach a broader audience. Over time, scholars and webinar attendees requested opportunities to explore topics in greater depth (eg, PTSD later in life). These requests led the webinars to focus on annual themes.

figure_2.png

The series is open to all disciplines of geriatric scholars, VHA staff, and non-VHA staff through the Veterans Affairs Talent Management System and the TRAIN Learning Network (train.org). Attendance for the 37 webinars was captured from logins to the virtual learning platform and may underestimate attendance if a group attended on a single screen. Average attendance increased from 157 attendees/webinar in 2015 to 418 attendees/webinar in 2023 (Figure 2). This may have been related to the increase in virtual learning during the COVID-19 pandemic, but represents a 166% increase in audience from the inaugural year of the series.

Advanced Learning Opportunities

To invest in the ongoing growth and development of introductory course graduates, GSP-P developed and offered an advanced workshop in 2019. This multiday workshop focused on further enhancement of geropsychology competencies, with an emphasis on treating older veterans with mental and physical comorbidities. Didactics and experiential learning exercises led by SMEs covered topics such as adjusting to chronic illness, capacity assessment, PTSD, insomnia and sleep changes, chronic pain, and psychological interventions in palliative care and hospice settings. Evaluation findings demonstrated significant improvements from precourse to 6 months postcourse in confidence and knowledge as defined by the Pikes Peak Geropsychology Competencies.19

To facilitate ongoing and individually tailored learning following the advanced workshop, scholars also developed and executed independent learning plans (ILPs) during a 6-month window with consultation from an experienced geropsychologist. Fifteen of 19 scholars (78.9%) completed ILPs with an average of 3 learning goals listed. After completing the ILPs, scholars endorsed their clinical and/or personal usefulness, citing increased confidence, enhanced skills for use with patients with complex needs, personal fulfillment, and career advancement. Most scholars noted ILPs were feasible and learning resources were accessible. Overall, the evaluation found ILPs to be a valuable way to enhance psychologists’ learning and effectiveness in treating older veterans with complex health needs.20

 

 

Clinical Practica

All geriatric scholars who completed the program have additional opportunities for professional development through practicum experiences focused on specific clinical approaches to the care of older veterans, such as dementia care, pain management, geriatric assessment, and palliative care. These practica provide scholars with individualized learning experiences in an individualized or small group setting and may be conducted either in-person or virtually.

In response to an expressed need from those who completed the program, the GSP-P planning committee collaborated with an SME to develop a virtual practicum to assess patients’ decision making capacity. Evaluating capacities among older adults is a common request, yet clinicians report little to no formal training in how to conceptualize and approach these complex questions.21,22 Utilizing an evidence-informed and structured approach promotes the balancing of an older adult’s autonomy and professional ethics. Learning capacity evaluation skills could better position psychologists to not only navigate complex ethical, legal, and clinical situations, but also serve as expert consultants to interdisciplinary teams. This virtual practicum was initiated in 2022 and to date has included 10 scholars. The practicum includes multiple modalities of learning: (1) self-directed review of core concepts; (2) attendance at 4 capacity didactics focused on introduction to evaluating capacities, medical consent and decision making, financial decision making and management, and independent living; and (3) participation in 5 group consultations on capacity evaluations conducted at their home sites. During these group consultations, additional case examples were shared to reinforce capacity concepts.

Discussion

The objective of GSP-P is to enhance geropsychology practice competencies among VHA psychologists given the outsized representation of older adults within the VHA system and their complex care needs. The curricula have significantly evolved to accomplish this, expanding the reach and investing in the continuing growth and development of scholars.

There are several elements that set GSP apart from other geriatric and geropsychology continuing medical education programs. The first is that the training is veteran focused, allowing us to discuss the unique impact military service has on aging. Similarly, because all scholars work within the integrated health care system, we can introduce and review key resources and programs that benefit all veterans and their families/care partners across the system. Through the GSP, the VA invests in ongoing professional development. Scholars can participate in additional experiential practica, webinars, and advanced workshops tailored to their individual learning needs. Lastly, the GSP works to create a community among its scholars where they can not only continue to consult with presenters/instructors, but also one another. A planned future direction for the GSP-P is to incorporate quarterly office hours and discussions for alumni to develop an increased sense of community. This may strengthen commitment to the overall VA mission, leading to increased retainment of talent who now have the knowledge, skills, and confidence to care for aging veterans.

Limitations

GSP is limited by its available funding. Additionally, the number of participants who can enroll each year in GSP-P (not including webinars) is capped by policy. Another limitation is the number of QI coaches available to mentor scholars on their projects.

 

 

Conclusions

Outcomes of GSP-P have been extremely favorable. Following participation in the program, we have found a significant increase in confidence in geropsychology practice among clinicians, as well as enhanced knowledge and skills across competency domains.15,19 We have observed rising attendance in our annual webinar series and graduates of our introductory courses participate in subsequent trainings (eg, advanced workshop or virtual practicum). Several graduates of GSP-P have become board certified in geropsychology by the American Board of Geropsychology and many proceed to supervise geropsychology-focused clinical rotations for psychology practicum students, predoctoral interns, and postdoctoral fellows. This suggests that the reach of GSP-P programming may extend farther than reported in this article.

The needs of aging veterans have also changed based on cohort differences, as the population of World War II and Korean War era veterans has declined and the number of older Vietnam era veterans has grown. We expect different challenges with older Gulf War and post-9/11 era veterans. For instance, 17% of troops deployed to Iraq or Afghanistan following 9/11 experienced mild traumatic brain injury (TBI), and 59% of those experienced > 1 mild TBI.23 Research indicates that younger post-9/11 veterans have a 3-fold risk of developing early onset dementia after experiencing a TBI.24 Therefore, even though post-9/11 veterans are not older in terms of chronological age, some may experience symptoms and conditions more often occurring in older veterans. As a result, it would be beneficial for clinicians to learn about the presentation and treatment of geriatric conditions such as dementia.

Moving forward, the GSP-P should identify potential opportunities to collaborate with the non-VHA mental health community–which also faces a shortage of geriatric mental health clinicians–to extend educational opportunities to improve care for veterans in all settings (eg, cosponsor training opportunities open to both VHA and non-VHA clinicians).8,25 Many aging veterans may receive portions of their health care outside the VHA, particularly those who reside in rural areas. Additionally, as veterans age, so do their support systems (eg, family members, friends, spouses, caregivers, and even clinicians), most of whom will receive care outside of the VHA. Community education collaborations will not only improve the care of older veterans, but also the care of older adults in the general population.

Promising directions include the adoption of the GSP model in other health care settings. Recently, Indian Health Service has adapted the model, beginning with primary care clinicians and pharmacists and is beginning to expand to other disciplines. Additional investments in VHA workforce training include the availability of geropsychology internship and fellowship training opportunities through the Office of Academic Affiliations, which provide earlier opportunities to specialize in geropsychology. Continued investment in both prelicensure and postpsychology licensure training efforts are needed within the VHA to meet the geriatric mental health needs of veterans.

Acknowledgments

The authors wish to acknowledge Terri Huh, PhD, for her contributions to the development and initiation of the GSP-P. The authors also appreciate the collaboration and quality initiative training led by Carol Callaway-Lane, DNP, ACNP-BC, and her team.

References

1. Caplan Z, Rabe M; US Department of Commerce, US Census Bureau. The Older Population: 2020 (Census Brief No. C2020BR-07). May 2023. Accessed February 27, 2024. https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-07.pdf

2. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. VA benefits & health care utilization. Updated February 2023. Accessed February 27, 2024. https://www.va.gov/vetdata/docs/pocketcards/fy2023q2.PDF

3. O’Malley KA, Vinson L, Pless Kaiser A, Sager Z, Hinrichs K. Mental health and aging veterans: How the Veterans Health Administration meets the needs of aging veterans. Public Policy Aging Rep. 2020;30(1):19-23. doi:10.1093/ppar/prz027

4. Greenberg G, Hoff R. FY 2021 Older Adult (65+ on October 1st) Veteran Data Sheet: National, VISN, and Healthcare System Tables. West Haven, CT: U.S. Department of Veterans Affairs, Northeast Program Evaluation Center. 2022.

5. Yaffe K, Vittinghoff E, Lindquist K, et al. Posttraumatic stress disorder and risk of dementia among US veterans. Arch Gen Psychiatry. 2010;67(6):608-613. doi:10.1001/archgenpsychiatry.2010.61

6. Davison EH, Kaiser AP, Spiro A 3rd, Moye J, King LA, King DW. From late-onset stress symptomatology to later-adulthood trauma reengagement in aging combat veterans: Taking a broader view. Gerontologist. 2016;56(1):14-21. doi:10.1093/geront/gnv097

7. Kaiser AP, Boyle JT, Bamonti PM, O’Malley K, Moye J. Development, adaptation, and clinical implementation of the Later-Adulthood Trauma Reengagement (LATR) group intervention for older veterans. Psychol Serv. 2023;20(4):863-875. doi:10.1037/ser0000736

8. Moye J, Karel MJ, Stamm KE, et al. Workforce analysis of psychological practice with older adults: Growing crisis requires urgent action. Train Educ Prof Psychol. 2019;13(1):46-55. doi:10.1037/tep0000206

9. Stamm K, Lin L, Conroy J. Critical needs in geropsychology. Monitor on Psychology. 2021;52(4):21.

10. American Board of Geropsychology. Specialists. 2024. Accessed February 6, 2024. https://abgero.org/board-members/specialists/

11. Kramer BJ. The VA Geriatric Scholars Program. Fed Pract. 2015;32(5):46-48. 

12. Kramer BJ, Creekmur B, Howe JL, et al. Veterans Affairs Geriatric Scholars Program: Enhancing existing primary care clinician skills in caring for older veterans. J Am Geriatr Soc. 2016;64(11):2343-2348. doi:10.1111/jgs.14382

13. Knight BG, Karel MJ, Hinrichsen GA, Qualls SH, Duffy M. Pikes Peak model for training in professional geropsychology. Am Psychol. 2009;64(3):205-14. doi:10.1037/a0015059

14. Huh JWT, Rodriguez R, Gould CE, R Brunskill S, Melendez L, Kramer BJ. Developing a program to increase geropsychology competencies of Veterans Health Administration (VHA) psychologists. Gerontol Geriatr Educ. 2020;41(4):463-479. doi:10.1080/02701960.2018.1491402

15. Huh JWT, Rodriguez RL, Gregg JJ, Scales AN, Kramer BJ, Gould CE. Improving geropsychology competencies of Veterans Affairs psychologists. J Am Geriatr Soc. 2021;69(3):798-805. doi:10.1111/jgs.17029

16. Karel MJ, Emery EE, Molinari V; CoPGTP Task Force on the Assessment of Geropsychology Competencies. Development of a tool to evaluate geropsychology knowledge and skill competencies. Int Psychogeriatr. 2010;22(6):886-896. doi:10.1017/S1041610209991736

17. Morgenthaler T, Kramer M, Alessi C, et al. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An American Academy of Sleep Medicine report. Sleep. 2006;29(11):1415-1419.

18. Sullivan J, Gualtieri L, Campbell M, Davila H, Pendergast J, Taylor P. VA Compassionate Contact Corps: a phone-based intervention for veterans interested in speaking with peers. Innov Aging. 2021;5(Suppl 1):204. doi:10.1093/geroni/igab046.788

19. Gregg JJ, Rodriguez RL, Mehta PS, Kramer BJ, Gould CE. Enhancing specialty training in geropsychology competencies: an evaluation of a VA Geriatric Scholars Program advanced topics workshop. Gerontol Geriatr Educ. 2023;44(3):329-338. doi:10.1080/02701960.2022.2069764

20. Gould CE, Rodriguez RL, Gregg J, Mehta PS, Kramer J. Mentored independent learning plans among psychologists: a mixed methods investigation. J Amer Geriatr Soc. 2023;71(S1):S53.

21. Mullaly E, Kinsella G, Berberovic N, et al. Assessment of decision-making capacity: exploration of common practices among neuropsychologists. Aust Psychol. 2007;42:178-186. doi:10.1080/00050060601187142

22. Seyfried L, Ryan KA, Kim SYH. Assessment of decision-making capacity: Views and experiences of consultation psychiatrists. Psychosomatics. 2013;54(2):115-123. doi:10.1016/j.psym.2012.08.001

23. Wilk JE, Herrell RK, Wynn GH, Riviere LA, Hoge CW. Mild traumatic brain injury (concussion), posttraumatic stress disorder, and depression in U.S. soldiers involved in combat deployments: association with postdeployment symptoms. Psychosom Med. 2012;74(3):249-257. doi:10.1097/PSY.0b013e318244c604

24. Kennedy E, Panahi S, Stewart IJ, et al. Traumatic brain injury and early onset dementia in post 9-11 veterans. Brain Inj. 2022;36(5):620-627.doi:10.1080/02699052.2022.2033846

25. Merz CC, Koh D, Sakai EY, et al. The big shortage: Geropsychologists discuss facilitators and barriers to working in the field of aging. Transl Issues Psychol Sci. 2017;3(4):388-399. doi:10.1037/tps0000137

References

1. Caplan Z, Rabe M; US Department of Commerce, US Census Bureau. The Older Population: 2020 (Census Brief No. C2020BR-07). May 2023. Accessed February 27, 2024. https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-07.pdf

2. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. VA benefits & health care utilization. Updated February 2023. Accessed February 27, 2024. https://www.va.gov/vetdata/docs/pocketcards/fy2023q2.PDF

3. O’Malley KA, Vinson L, Pless Kaiser A, Sager Z, Hinrichs K. Mental health and aging veterans: How the Veterans Health Administration meets the needs of aging veterans. Public Policy Aging Rep. 2020;30(1):19-23. doi:10.1093/ppar/prz027

4. Greenberg G, Hoff R. FY 2021 Older Adult (65+ on October 1st) Veteran Data Sheet: National, VISN, and Healthcare System Tables. West Haven, CT: U.S. Department of Veterans Affairs, Northeast Program Evaluation Center. 2022.

5. Yaffe K, Vittinghoff E, Lindquist K, et al. Posttraumatic stress disorder and risk of dementia among US veterans. Arch Gen Psychiatry. 2010;67(6):608-613. doi:10.1001/archgenpsychiatry.2010.61

6. Davison EH, Kaiser AP, Spiro A 3rd, Moye J, King LA, King DW. From late-onset stress symptomatology to later-adulthood trauma reengagement in aging combat veterans: Taking a broader view. Gerontologist. 2016;56(1):14-21. doi:10.1093/geront/gnv097

7. Kaiser AP, Boyle JT, Bamonti PM, O’Malley K, Moye J. Development, adaptation, and clinical implementation of the Later-Adulthood Trauma Reengagement (LATR) group intervention for older veterans. Psychol Serv. 2023;20(4):863-875. doi:10.1037/ser0000736

8. Moye J, Karel MJ, Stamm KE, et al. Workforce analysis of psychological practice with older adults: Growing crisis requires urgent action. Train Educ Prof Psychol. 2019;13(1):46-55. doi:10.1037/tep0000206

9. Stamm K, Lin L, Conroy J. Critical needs in geropsychology. Monitor on Psychology. 2021;52(4):21.

10. American Board of Geropsychology. Specialists. 2024. Accessed February 6, 2024. https://abgero.org/board-members/specialists/

11. Kramer BJ. The VA Geriatric Scholars Program. Fed Pract. 2015;32(5):46-48. 

12. Kramer BJ, Creekmur B, Howe JL, et al. Veterans Affairs Geriatric Scholars Program: Enhancing existing primary care clinician skills in caring for older veterans. J Am Geriatr Soc. 2016;64(11):2343-2348. doi:10.1111/jgs.14382

13. Knight BG, Karel MJ, Hinrichsen GA, Qualls SH, Duffy M. Pikes Peak model for training in professional geropsychology. Am Psychol. 2009;64(3):205-14. doi:10.1037/a0015059

14. Huh JWT, Rodriguez R, Gould CE, R Brunskill S, Melendez L, Kramer BJ. Developing a program to increase geropsychology competencies of Veterans Health Administration (VHA) psychologists. Gerontol Geriatr Educ. 2020;41(4):463-479. doi:10.1080/02701960.2018.1491402

15. Huh JWT, Rodriguez RL, Gregg JJ, Scales AN, Kramer BJ, Gould CE. Improving geropsychology competencies of Veterans Affairs psychologists. J Am Geriatr Soc. 2021;69(3):798-805. doi:10.1111/jgs.17029

16. Karel MJ, Emery EE, Molinari V; CoPGTP Task Force on the Assessment of Geropsychology Competencies. Development of a tool to evaluate geropsychology knowledge and skill competencies. Int Psychogeriatr. 2010;22(6):886-896. doi:10.1017/S1041610209991736

17. Morgenthaler T, Kramer M, Alessi C, et al. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An American Academy of Sleep Medicine report. Sleep. 2006;29(11):1415-1419.

18. Sullivan J, Gualtieri L, Campbell M, Davila H, Pendergast J, Taylor P. VA Compassionate Contact Corps: a phone-based intervention for veterans interested in speaking with peers. Innov Aging. 2021;5(Suppl 1):204. doi:10.1093/geroni/igab046.788

19. Gregg JJ, Rodriguez RL, Mehta PS, Kramer BJ, Gould CE. Enhancing specialty training in geropsychology competencies: an evaluation of a VA Geriatric Scholars Program advanced topics workshop. Gerontol Geriatr Educ. 2023;44(3):329-338. doi:10.1080/02701960.2022.2069764

20. Gould CE, Rodriguez RL, Gregg J, Mehta PS, Kramer J. Mentored independent learning plans among psychologists: a mixed methods investigation. J Amer Geriatr Soc. 2023;71(S1):S53.

21. Mullaly E, Kinsella G, Berberovic N, et al. Assessment of decision-making capacity: exploration of common practices among neuropsychologists. Aust Psychol. 2007;42:178-186. doi:10.1080/00050060601187142

22. Seyfried L, Ryan KA, Kim SYH. Assessment of decision-making capacity: Views and experiences of consultation psychiatrists. Psychosomatics. 2013;54(2):115-123. doi:10.1016/j.psym.2012.08.001

23. Wilk JE, Herrell RK, Wynn GH, Riviere LA, Hoge CW. Mild traumatic brain injury (concussion), posttraumatic stress disorder, and depression in U.S. soldiers involved in combat deployments: association with postdeployment symptoms. Psychosom Med. 2012;74(3):249-257. doi:10.1097/PSY.0b013e318244c604

24. Kennedy E, Panahi S, Stewart IJ, et al. Traumatic brain injury and early onset dementia in post 9-11 veterans. Brain Inj. 2022;36(5):620-627.doi:10.1080/02699052.2022.2033846

25. Merz CC, Koh D, Sakai EY, et al. The big shortage: Geropsychologists discuss facilitators and barriers to working in the field of aging. Transl Issues Psychol Sci. 2017;3(4):388-399. doi:10.1037/tps0000137

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0424 FED MH Older Vets</fileName> <TBEID>0C02F383.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F383</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20240401T113611</firstPublished> <LastPublished>20240401T113611</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240401T113611</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>Christine E. Gould, PhD, ABPP-geroa,b; Rachel L. Rodriguez, PhD, MPH, ABPP-geroc; Jeffrey J. Gregg, PhDc,d;Kyle Page, PhD, ABPP-geroe; Luis Melendez, MPA, MSf; Joseph R. Douglasf; Johnny Lewisa; B. Josea Kramer, PhDf,g</bylineText> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>The Veterans Health Administration (VHA) is understaffed for clinical psychologists who have specialty training in geriatrics (ie, geropsychologists) to meet th</metaDescription> <articlePDF/> <teaserImage/> <title>Preparing Veterans Health Administration Psychologists to Meet the Complex Needs of Aging Veterans</title> <deck/> <eyebrow>Program Profile</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>April</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>4</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>4473</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>April 2024</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Program Profile | 4473<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> </sections> <topics> <term canonical="true">248</term> <term>38029</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Preparing Veterans Health Administration Psychologists to Meet the Complex Needs of Aging Veterans</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background</b>: There are significant workforce shortages for geriatric mental health care. The imbalance is particularly pronounced in the Veterans Health Administration (VHA) due to the large number of aging veterans receiving care. Workforce-based educational programs are needed to train existing clinicians to meet the mental health needs of aging veterans.<br/><br/><b>Observations</b>: This article describes an expansion of the Geriatric Scholars Program to train VHA psychologists to care for aging veterans. The multicomponent program includes an introductory course and opportunities to apply geriatric knowledge and skills through quality improvement initiatives. The Geriatric Scholars Program-Psychology Track evolved to incorporate ongoing specialized elective learning opportunities for scholars. A webinar series extends the educational programs to reach the entire VHA workforce.<b>Conclusions</b>: The Geriatric Scholars Program-Psychology Track represents a longitudinal educational approach to training VHA psychologists in clinical geropsychology. Other community-based organizations can use this model to construct and implement similar programs.</p> <p>The Veterans Health Administration (VHA) is understaffed for clinical psychologists who have specialty training in geriatrics (ie, geropsychologists) to meet the needs of aging veterans. Though only 16.8% of US adults are aged ≥ 65 years,<sup>1</sup> this age group comprises 45.9%<i> </i>of patients within the VHA.<sup>2</sup> The needs of older adults are complex and warrant specialized services from mental health clinicians trained to understand lifespan developmental processes, biological changes associated with aging, and changes in psychosocial functioning.</p> <p>Older veterans (aged ≥ 65 years) present with higher rates of combined medical and mental health diagnoses compared to both younger veterans and older adults who are not veterans.<sup>3 </sup>Nearly 1 of 5 (18.1%) older veterans who use VHA services have confirmed mental health diagnoses, and an additional 25.5% have documented mental health concerns without a formal diagnosis in their health record.<sup>4</sup> The clinical presentations of older veterans frequently differ from younger adults and include greater complexity. For example, older veterans face an increased risk of cognitive impairment compared to the general population, due in part to higher prevalence of posttraumatic stress, which doubles their risk of developing dementia.<sup>5</sup> Additional examples of multicomplexity among older veterans may include co-occurring medical and psychiatric diagnoses, the presence of delirium, social isolation/loneliness, and concerns related to polypharmacy. These complex presentations result in significant challenges for mental health clinicians in areas like assessment (eg, accuracy of case conceptualization), intervention (eg, selection and prioritization), and consultation (eg, coordination among multiple medical and mental health specialists).<br/><br/>Older veterans also present with substantial resilience. Research has found that aging veterans exposed to trauma during their military service often review their memories and past experiences, which is known as later-adulthood trauma reengagement.<sup>6</sup> Through this normative life review process, veterans engage with memories and experiences from their past that they previously avoided, which could lead to posttraumatic growth for some. Unfortunately, others may experience an increase in psychological distress. Mental health clinicians with specialty expertise and training in aging and lifespan development can facilitate positive outcomes to reduce distress.<sup>7<br/><br/></sup>The United States in general, and the VHA specifically, face a growing shortage of geriatric mental health clinicians. <hl name="33562"/>In a 2015 American Psychological Association survey, 1528 of 4109 respondents (37.2%) reported they frequently or very frequently administered care to older adults, yet only 49 respondents (1.2%) reported geropsychology as their specialty.<sup>8</sup> According to the National Provider Registry, 660 clinicians self-identified as geropsychologists (ie, those who self-reported “psychologist: adult development and aging” as an NPI Healthcare Provider taxonomy code) in the US, representing &lt; 1% of all doctoral level psychologists.<sup>9</sup> The number of psychologists who obtain board certification from the American Board of Geropsychology is even lower (only 112 clinicians as of February 2024).<sup>10</sup> Many psychologists within the VHA treat older veterans in integrated health settings such as primary care, home-based primary care, community living centers, or behavioral health care, but many lack formal training in geropsychology. The Geriatric Scholars Program (GSP) was<b> </b>developed in 2008 to address the training gap and provide education in geriatrics to VHA clinicians that treat older veterans, particularly in rural areas.<sup>11,12</sup> The GSP initially focused on primary care physicians, nurse practitioners, physician assistants, and pharmacists. It was later expanded to include other disciplines (ie, social work, rehabilitation therapists, and psychiatrists). In 2013, the GSP – Psychology Track (GSP-P) was developed with funding from the VHA Offices of Rural Health and Geriatrics and Extended Care specifically for psychologists. <br/><br/>This article describes the multicomponent longitudinal GSP-P, which has evolved to meet the target audience’s ongoing needs for knowledge, skills, and opportunities to refine practice behaviors. GSP-P received the 2020 Award for Excellence in Geropsychology Training from the Council of Professional Geropsychology Training Programs. GSP-P has grown within the context of the larger GSP and aligns with the other existing elective learning opportunities (Figure 1).</p> <h2>Program description</h2> <h3>Introductory Course</h3> <p>Psychologist subject matter experts (SMEs) developed an intensive course in geropsychology in the absence of a similar course in the geriatric medicine board review curriculum. SMEs reviewed the guidelines for practice by professional organizations like the Pikes Peak Geropsychology Competencies,<sup> </sup>which outline knowledge and skills in various domains.<sup>13</sup> SMEs integrated this review with findings from a needs assessment for postlicensed VHA psychology staff in 4 health care systems, drafted a syllabus, and circulated it to geropsychology experts for feedback. The resulting multiday course covered general mental health as well as topics particularly salient for mental health clinicians treating older veterans including suicide prevention and posttraumatic stress disorder (PTSD).<sup>14</sup> This Geropsychology Competencies Review Course was piloted in 1 region initially before being offered nationally in 2014. <hl name="33564"/><hl name="33565"/>The previously published evaluation findings demonstrated significant improvements from precourse to 3 months postcourse in confidence and knowledge in 4 key areas of geropsychology: General knowledge about adult development and aging, assessment, intervention, and consultation.<sup>15</sup> These domains align with the Pikes Peak Geropsychology Competencies and are measured by a subset of items from the Geropsychology Knowledge and Skills Assessment Tool.<sup>13,16</sup> As of October 2023, 8 introductory courses have been held with 173 participants (Table).</p> <h3>Quality Improvement</h3> <p>Introductory course attendees also participate in an intensive day-long interactive workshop in quality improvement (QI). After completing these trainings, they apply what they have learned at their home facility by embarking on a QI project related to geriatrics. The QI projects reinforce learning and initiate practice changes not only for attendees but at times the larger health care system. Topics are selected by scholars in response to the needs they observe in their clinics. Recent GSP projects include efforts to increase screenings for depression and anxiety, improve adherence to VHA dementia policy, increase access to virtual care, and increase referrals to programs such as whole health or cognitive behavioral therapy for insomnia, a first-line treatment for insomnia in older adults.<sup>17</sup> Another project targeted the improvement of referrals to the Compassionate Contact Corps in an effort to reduce social isolation and loneliness among older veterans.<sup>18</sup> Evaluations demonstrate significant improvement in scholars’ confidence in related program development and management from precourse to 3 months postcourse.<sup>15</sup></p> <h3>Webinars</h3> <p>The Addressing Geriatric Mental Health webinar series was created to introduce learners to topics that could not be covered in the introductory course. Topics were suggested by the expert reviewers of the curriculum or identified by the scholars themselves (eg, chronic pain, sexuality, or serious mental illness). A secondary function of the webinars was to reach a broader audience. Over time, scholars and webinar attendees requested opportunities to explore topics in greater depth (eg, PTSD later in life). These requests led the webinars to focus on annual themes.</p> <p>The series is open to all disciplines of geriatric scholars, VHA staff, and non-VHA staff through the Veterans Affairs Talent Management System and the <a href="http://www.TRAIN.org">TRAIN Learning Network (train.org</a>). Attendance for the 37 webinars was captured from logins to the virtual learning platform and may underestimate attendance if a group attended on a single screen. Average attendance increased from 157 attendees/webinar in 2015 to 418 attendees/webinar in 2023 (Figure 2). This may have been related to the increase in virtual learning during the COVID-19 pandemic, but represents a 166% increase in audience from the inaugural year of the series. </p> <h3>Advanced Learning Opportunities</h3> <p>To invest in the ongoing growth and development of introductory course graduates, GSP-P developed and offered an advanced workshop in 2019. This multiday workshop focused on further enhancement of geropsychology competencies, with an emphasis on treating older veterans with mental and physical comorbidities. Didactics and experiential learning exercises led by SMEs covered topics such as adjusting to chronic illness, capacity assessment, PTSD, insomnia and sleep changes, chronic pain, and psychological interventions in palliative care and hospice settings. Evaluation findings demonstrated significant improvements from precourse to 6 months postcourse in confidence and knowledge as <hl name="33566"/>defined by the Pikes Peak Geropsychology Competencies.<sup>19</sup></p> <p>To facilitate ongoing and individually tailored learning following the advanced workshop, scholars also developed and executed independent learning plans (ILPs) during a 6-month window with consultation from an experienced geropsychologist. Fifteen of 19 scholars (78.9%) completed ILPs with an average of 3 learning goals listed. After completing the ILPs, scholars endorsed their clinical and/or personal usefulness, citing increased confidence, enhanced skills for use with patients with complex needs, personal fulfillment, and career advancement. Most scholars noted ILPs were feasible and learning resources were accessible. Overall, the evaluation found ILPs to be a valuable way to enhance psychologists’ learning and effectiveness in treating older veterans with complex health needs.<sup>20</sup></p> <h3>Clinical Practica</h3> <p>All geriatric scholars who completed the program have additional opportunities for professional development through practicum experiences focused on specific clinical approaches to the care of older veterans, such as dementia care, pain management, geriatric assessment, and palliative care. These practica provide scholars with individualized learning experiences in an individualized or small group setting and may be conducted either in-person or virtually.</p> <p>In response to an expressed need from those who completed the program, the GSP-P planning committee collaborated with an SME to develop a virtual practicum to assess patients’ decision making capacity. Evaluating capacities among older adults is a common request, yet clinicians report little to no formal training in how to conceptualize and approach these complex questions.<sup>21,22</sup> Utilizing an evidence-informed and structured approach promotes the balancing of an older adult’s autonomy and professional ethics. Learning capacity evaluation skills could better position psychologists to not only navigate complex ethical, legal, and clinical situations, but also serve as expert consultants to interdisciplinary teams. This virtual practicum was initiated in 2022 and to date has included 10 scholars. The practicum includes multiple modalities of learning: (1) self-directed review of core concepts; (2) attendance at 4 capacity didactics focused on introduction to evaluating capacities, medical consent and decision making, financial decision making and management, and independent living; and (3) participation in 5 group consultations on capacity evaluations conducted at their home sites. During these group consultations, additional case examples were shared to reinforce capacity concepts.</p> <h2>Discussion</h2> <p>The objective of GSP-P is to enhance geropsychology practice competencies among VHA psychologists given the outsized representation of older adults within the VHA system and their complex care needs. The curricula have significantly evolved to accomplish this, expanding the reach and investing in the continuing growth and development of scholars. </p> <p>There are several elements that set GSP apart from other geriatric and geropsychology continuing medical education programs. The first is that the training is veteran focused, allowing us to discuss the unique impact military service has on aging. Similarly, because all scholars work within the integrated health care system, we can introduce and review key resources and programs that benefit all veterans and their families/care partners across the system. Through the GSP, the VA invests in ongoing professional development. Scholars can participate in additional experiential practica, webinars, and advanced workshops tailored to their individual learning needs. Lastly, the GSP works to create a community among its scholars where they can not only continue to consult with presenters/instructors, but also one another. A planned future direction for the GSP-P is to incorporate quarterly office hours and discussions for alumni to develop an increased sense of community. This may strengthen commitment to the overall VA mission, leading to increased retainment of talent who now have the knowledge, skills, and confidence to care for aging veterans. </p> <h3>Limitations</h3> <p>GSP is limited by its available funding. Additionally, the number of participants who can enroll each year in GSP-P (not including webinars) is capped by policy. Another limitation is the number of QI coaches available to mentor scholars on their projects.</p> <h2>Conclusions</h2> <p>Outcomes of GSP-P have been extremely favorable. Following participation in the program, we have found a significant increase in confidence in geropsychology practice among clinicians, as well as enhanced knowledge and skills across competency domains.<sup>15,19 </sup>We have observed rising attendance in our annual webinar series and graduates of our introductory courses participate in subsequent trainings (eg, advanced workshop or virtual practicum). Several graduates of GSP-P have become board certified in geropsychology by the American Board of Geropsychology and many proceed to supervise geropsychology-focused clinical rotations for psychology practicum students, predoctoral interns, and postdoctoral fellows. This suggests that the reach of GSP-P programming may extend farther than reported in this article. </p> <p>The needs of aging veterans have also changed based on cohort differences, as the population of World War II and Korean War era veterans has declined and the number of older Vietnam era veterans has grown. We expect different challenges with older Gulf War and post-9/11 era veterans. For instance, 17% of troops deployed to Iraq or Afghanistan following 9/11 experienced mild traumatic brain injury (TBI), and 59% of those experienced &gt; 1 mild TBI.<sup>23</sup> Research indicates that younger post-9/11 veterans have a 3-fold risk of developing early onset dementia after experiencing a TBI.<sup>24</sup> Therefore, even though post-9/11 veterans are not older in terms of chronological age, some may experience symptoms and conditions more often occurring in older veterans. As a result, it would be beneficial for clinicians to learn about the presentation and treatment of geriatric conditions such as dementia. <br/><br/>Moving forward, the GSP-P should identify potential opportunities to collaborate with the non-VHA mental health community–which also faces a shortage of geriatric mental health clinicians–to extend educational opportunities to improve care for veterans in all settings (eg, cosponsor training opportunities open to both VHA and non-VHA clinicians).<sup>8,25</sup> Many aging veterans may receive portions of their health care outside the VHA, particularly those who reside in rural areas. Additionally, as veterans age, so do their support systems (eg, family members, friends, spouses, caregivers, and even clinicians), most of whom will receive care outside of the VHA. Community education collaborations will not only improve the care of older veterans, but also the care of older adults in the general population. <hl name="33567"/><br/><br/>Promising directions include the adoption of the GSP model in other health care settings. Recently, Indian Health Service has adapted the model, beginning with primary care clinicians and pharmacists and is beginning to expand to other disciplines. Additional investments in VHA workforce training include the availability of geropsychology internship and fellowship training opportunities through the Office of Academic Affiliations, which provide earlier opportunities to specialize in geropsychology. Continued investment in both prelicensure and postpsychology licensure training efforts are needed within the VHA to meet the geriatric mental health needs of veterans. </p> <p class="isub">Acknowledgments</p> <p> <em>The authors wish to acknowledge Terri Huh, PhD, for her contributions to the development and initiation of the GSP-P. The authors also appreciate the collaboration and quality initiative training led by Carol Callaway-Lane, DNP, ACNP-BC, and her team. </em> </p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>VA Palo Alto Health Care System, Geriatric Research Education and Clinical Center, California<br/><br/><sup>b</sup>Stanford University School of Medicine, Department of Psychiatry and Behavioral Services, Palo Alto, California<br/><br/><sup>c</sup>Durham VA Health Care System, Mental and Behavioral Health Service, North Carolina<br/><br/><sup>d</sup>Duke University, Department of Medicine, Division of Geriatrics, Durham, North Carolina<br/><br/><sup>e</sup>Edward Hines, Jr. VA Hospital, Mental Health Service Line, Hines, Illinois<br/><br/><sup>f</sup>VA Greater Los Angeles Health Care System, Greater Los Angeles Geriatric Research Education and Clinical Center, California<br/><br/><sup>g</sup>David Geffen School of Medicine at University of California, Los Angeles, Division of Geriatric Medicine, California</em> </p> <p class="isub">Author disclosures</p> <p> <em>The authors report no actual or potential conflicts of interest with regard to this article. </em> </p> <p class="isub">Disclaimer</p> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner,</i> Frontline Medical Communications Inc., the US Government, or any of its agencies.</em> </p> <p class="isub">Ethics and consent</p> <p> <em>This was part of an ongoing evaluation of an educational activity as approved by the VA Greater Los Angeles Health Care System.</em> </p> <p class="isub">Funding/Support</p> <p> <em>The project was funded by the US Department of Veterans Affairs Office of Rural Health as a Promising Practice grant award as well as the US Department of Veterans Affairs Office of Geriatrics and Extended Care as a Mentored Partnership grant award (PI: Kramer).</em> </p> <h2><hl name="33568"/>References </h2> <p class="reference"> 1. Caplan Z, Rabe M; US Department of Commerce, US Census Bureau. The Older Population: 2020 (Census Brief No. C2020BR-07). May 2023. Accessed February 27, 2024. https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-07.pdf<br/><br/> 2. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. VA benefits &amp; health care utilization. Updated February 2023. Accessed February 27, 2024. https://www.va.gov/vetdata/docs/pocketcards/fy2023q2.PDF<br/><br/> 3. O’Malley KA, Vinson L, Pless Kaiser A, Sager Z, Hinrichs K. Mental health and aging veterans: How the Veterans Health Administration meets the needs of aging veterans. <i>Public Policy Aging Rep</i>. 2020;30(1):19-23. doi:10.1093/ppar/prz027<br/><br/> 4. Greenberg G, Hoff R. <i>FY 2021 Older Adult (65+ on October 1st) Veteran Data Sheet: National, VISN, and Healthcare System Tables</i>. <span class="cf01">West Haven, CT: U.S. Department of Veterans Affairs, Northeast Program Evaluation Center.</span> 2022.<br/><br/> 5. Yaffe K, Vittinghoff E, Lindquist K, et al. Posttraumatic stress disorder and risk of dementia among US veterans. <i>Arch Gen Psychiatry. </i>2010;67(6):608-613. doi:10.1001/archgenpsychiatry.2010.61<br/><br/> 6. Davison EH, Kaiser AP, Spiro A 3rd, Moye J, King LA, King DW. From late-onset stress symptomatology to later-adulthood trauma reengagement in aging combat veterans: Taking a broader view. <i>Gerontologist</i>. 2016;56(1):14-21. doi:10.1093/geront/gnv097<br/><br/> 7. Kaiser AP, Boyle JT, Bamonti PM, O’Malley K, Moye J. Development, adaptation, and clinical implementation of the Later-Adulthood Trauma Reengagement (LATR) group intervention for older veterans. <i>Psychol Serv</i>. 2023;20(4):863-875. doi:10.1037/ser0000736</p> <p class="reference"> 8. Moye J, Karel MJ, Stamm KE, et al. Workforce analysis of psychological practice with older adults: Growing crisis requires urgent action. <i>Train Educ Prof Psychol</i>. 2019;13(1):46-55. doi:10.1037/tep0000206<br/><br/> 9. Stamm K, Lin L, Conroy J. Critical needs in geropsychology. <i>Monitor on Psychology</i>. 2021;52(4):21.<br/><br/>10. American Board of Geropsychology. Specialists. 2024. Accessed February 6, 2024. https://abgero.org/board-members/specialists/<br/><br/>11. Kramer BJ. The VA Geriatric Scholars Program. <i>Fed Pract</i>. 2015;32(5):46-48. <br/><br/>12. Kramer BJ, Creekmur B, Howe JL, et al. Veterans Affairs Geriatric Scholars Program: Enhancing existing primary care clinician skills in caring for older veterans. <i>J Am Geriatr Soc</i>. 2016;64(11):2343-2348. doi:10.1111/jgs.14382<br/><br/>13. Knight BG, Karel MJ, Hinrichsen GA, Qualls SH, Duffy M. Pikes Peak model for training in professional geropsychology. <i>Am Psychol</i>. 2009;64(3):205-14. doi:10.1037/a0015059<br/><br/>14. Huh JWT, Rodriguez R, Gould CE, R Brunskill S, Melendez L, Kramer BJ. Developing a program to increase geropsychology competencies of Veterans Health Administration (VHA) psychologists. <i>Gerontol Geriatr Educ</i>. 2020;41(4):463-479. doi:10.1080/02701960.2018.1491402<br/><br/>15. Huh JWT, Rodriguez RL, Gregg JJ, Scales AN, Kramer BJ, Gould CE. Improving geropsychology competencies of Veterans Affairs psychologists. <i>J Am Geriatr Soc</i>. 2021;69(3):798-805. doi:10.1111/jgs.17029<br/><br/>16. Karel MJ, Emery EE, Molinari V; CoPGTP Task Force on the Assessment of Geropsychology Competencies. Development of a tool to evaluate geropsychology knowledge and skill competencies. <i>Int Psychogeriatr</i>. 2010;22(6):886-896. doi:10.1017/S1041610209991736<br/><br/>17. Morgenthaler T, Kramer M, Alessi C, et al. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An American Academy of Sleep Medicine report. <i>Sleep</i>. 2006;29(11):1415-1419.<br/><br/>18. Sullivan J, Gualtieri L, Campbell M, Davila H, Pendergast J, Taylor P. VA Compassionate Contact Corps: a phone-based intervention for veterans interested in speaking with peers. <i>Innov Aging. </i>2021;5(Suppl 1):204. doi:10.1093/geroni/igab046.788<br/><br/>19. Gregg JJ, Rodriguez RL, Mehta PS, Kramer BJ, Gould CE. Enhancing specialty training in geropsychology competencies: an evaluation of a VA Geriatric Scholars Program advanced topics workshop. <i>Gerontol Geriatr Educ</i>. 2023;44(3):329-338. doi:10.1080/02701960.2022.2069764 <br/><br/>20. Gould CE, Rodriguez RL, Gregg J, Mehta PS, Kramer J. Mentored independent learning plans among psychologists: a mixed methods investigation. <i>J Amer Geriatr Soc. </i>2023;71(S1):S53.<i> </i> <br/><br/>21. Mullaly E, Kinsella G, Berberovic N, et al. Assessment of decision-making capacity: exploration of common practices among neuropsychologists<i>. Aust Psychol</i>. 2007;42:178-186. doi:10.1080/00050060601187142<br/><br/>22. Seyfried L, Ryan KA, Kim SYH. Assessment of decision-making capacity: Views and experiences of consultation psychiatrists. <i>Psychosomatics</i>. 2013;54(2):115-123. doi:10.1016/j.psym.2012.08.001<br/><br/>23. Wilk JE, Herrell RK, Wynn GH, Riviere LA, Hoge CW. Mild traumatic brain injury (concussion), posttraumatic stress disorder, and depression in U.S. soldiers involved in combat deployments: association with postdeployment symptoms. <i>Psychosom Med</i>. 2012;74(3):249-257. doi:10.1097/PSY.0b013e318244c604<br/><br/>24. Kennedy E, Panahi S, Stewart IJ, et al. Traumatic brain injury and early onset dementia in post 9-11 veterans. <i>Brain Inj</i>. 2022;36(5):620-627.doi:10.1080/02699052.2022.2033846<br/><br/>25. Merz CC, Koh D, Sakai EY, et al. The big shortage: Geropsychologists discuss facilitators and barriers to working in the field of aging. <i>Transl Issues Psychol Sci</i>. 2017;3(4):388-399. doi:10.1037/tps0000137</p> </itemContent> </newsItem> </itemSet></root>
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A Pharmacist-Led Process to Monitor Discrepant Urine Drug Screen Results

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Thu, 03/07/2024 - 13:56

Urine drug screen (UDS) monitoring is a common risk-mitigation strategy tool for prescribing controlled substances.1-3 Not only is UDS monitoring highlighted by clinical practice guidelines for opioid prescribing for chronic pain,1,2 it has also been suggested as best practice for benzodiazepines3 and a consideration for other controlled substances. Monitoring UDSs helps confirm adherence to the prescribed treatment regimen while also screening for substance use that may increase patient risk.

UDS results can be complex and have profound implications for the patient’s treatment plan. Drug metabolites for opioids are particularly complicated; for example, synthetic and semisynthetic opioids are not detected on routine opiate immunoassays.4 This may lead a clinician to falsely assume the patient is not taking their fentanyl or tramadol medication as directed—or potentially even diverting—in the face of a negative opiate result.5 Routine UDSs are also subject to the pitfall of false-positive results due to coprescribed medications; for example, bupropion can lead to a false-positive amphetamine result, whereas sertraline can lead to a false-positive benzodiazepine result.6 Retrospective reviews of clinician behavior surrounding UDS interpretation have demonstrated knowledge gaps and inconsistent communication practices with patients.7,8

Given the complexity of UDS interpretation and its close relationship with medications, pharmacists are positioned to play an important role in the process. Pharmacists are embedded in pain-management teams and involved in prescription drug monitoring programs (PDMPs) for many health systems. The Veterans Health Administration (VHA) has supported the hiring of pain management, opioid safety, and PDMP coordinators (PMOP) at its facilities to provide clinical pain-management guidance, support national initiatives, and uphold legislative requirements.9 In many facilities, a pharmacist is hired specifically for these positions.

Clinical dashboards have been used by pharmacists in a variety of settings.10-13 They allow clinicians at a broad level to target interventions needed across a patient population, then produce a list of actionable patients to facilitate delivery of that intervention on an individual level.13 Between 2021 and 2022, a clinical dashboard to review potentially discrepant UDS results was made available for use at US Department of Veterans Affairs (VA) medical centers. Evidence exists in primary and specialty care settings that implementation of an opioid-prescribing clinical dashboard improves completion rates of risk-mitigation strategies such as UDS and opioid treatment agreements.14,15 To our knowledge there is no published research on the use and outcomes of a clinical dashboard that allows users to efficiently review discrepant UDS results when compared to a list of currently prescribed medications.

Given the availability of the UDS dashboard at the VA Black Hills Health Care System (VABHHCS) in South Dakota and the hiring of a PMOP coordinator pharmacist, the aim of this quality improvement project was 2-fold: to implement a pharmacist-led process to monitor the UDS dashboard for potentially discrepant results and to describe the quantity and types of interventions made by the clinical pharmacist leading this process.

 

 

Quality Improvement Project

A clinical UDS dashboard was created by the VA Northwest Health Network and made available for use at VHA sites between 2021 and 2022. The UDS dashboard is housed on a secure, Power BI Report Server (Microsoft), with access restricted to only those with patient health data privileges. The dashboard identifies all local patients with a UDS that returned with a potential discrepancy, defined as an unexpected positive result (eg, a detected substance not recently prescribed or documented on the patient’s medication list) and/or an unexpected negative result (eg, a prescribed substance not detected). The UDS dashboard identifies these discrepancies by comparing the patient’s current medication list (both VHA and non-VHA) to their UDS results.

The UDS dashboard displays a summary of UDSs performed, unexpected negative results, unexpected positive results, and potential discrepancies. The user may also specify the laboratory type and time frame of interest to limit displayed results. The user can then view patient-specific data for any category. Among the data are the patient’s UDS results and the completion date, detected (or nondetected) substance(s), ordering clinician, associated medication(s) with last fill date and days’ supply, and whether a confirmatory test has been performed in the past year.

VABHHCS uses an extended UDS immunoassay (PROFILE-V, MEDTOX Diagnostics) that reports on 11 substances: opiates, oxycodone, buprenorphine, methadone, amphetamines, methamphetamine, barbiturates, benzodiazepines, cocaine metabolites, cannabinoids (tetrahydrocannabinol [THC]), and phencyclidine. These substances appear on the UDS dashboard. The project protocol initially included monitoring for tramadol but that was later removed because it was not available with this UDS immunoassay.

Pharmacist Process

Either the PMOP coordinator or pharmacy resident monitored the UDS dashboard weekly. Any patients identified as having a potential discrepancy were reviewed. If the discrepancy was determined to be significant, the PMOP coordinator or pharmacy resident would review the patient electronic health record. If warranted, the patient was contacted and asked about newly prescribed medications, missed and recent medication doses, and illicit substance use. Potential interventions during in-depth review included: (1) discussing future actions with the primary care clinician and/or prescriber of the controlled substance; (2) ordering a confirmatory test on the original urine sample; (3) evaluating for sources of potential false-positive results; (4) completing an updated PDMP if not performed within the past year; (5) referring patients for substance use disorder treatment or counseling; or (6) consulting the local narcotics review committee. A progress note was entered into the electronic health record with the findings and any actions taken, and an alert for the primary care clinician and/or prescriber of the controlled substance.

Implementation and Analysis

This quality improvement project spanned 16 weeks from June 2022 through September 2022. Any patient with a UDS that returned with a significant discrepancy was reviewed. The primary outcome was interventions made by the PMOP coordinator or pharmacy resident, as well as time taken to perform the in-depth review of each patient. Patient demographics were also collected. The protocol for this project was approved by the VABHHCS pharmacy and therapeutics committee and was determined to meet guidelines for a nonresearch quality improvement project.

 

 

Results

table_1.png

From June 2022 through September 2022, 700 UDSs were performed at VABHHCS with 278 (39.7%) patients identified as having a potential discrepancy based on UDS results. Sixty patients (8.6%) had significant discrepancies that warranted in-depth review. The most common reasons for determining whether a potential discrepancy was not significant included unexpected negatives due to documented non-VA medications no longer being prescribed, unexpected positives due to recent expiration of a controlled substance prescription the patient was still taking, or unexpected positives due to the detection of a substance for which the clinician was already aware. During the 16-week study period, the mean number of patients warranting in-depth review was 4 per week.

table_2.png

The patients were predominantly male with a mean age of 61 years, and most (87%) were prescribed at least 1 controlled substance (mean, 1.1), primarily opioids for pain management (Table 1). Most patients had recent substance risk mitigation with UDS (56%) and PDMP (65%) checks within the past year. Of the 60 patients reviewed with significant UDS discrepancies, 50% had a history of discrepant UDS results. Of the 60 UDS discrepancies, there were 37 unexpected positive results (62%), 17 unexpected negative results (28%), and 10 patients with both positive and negative results (17%). THC was the most frequently detected substance, followed by opiates, benzodiazepines, and amphetamines (Table 2).

table_3.png

Each in-depth review with interventions by the PMOP coordinator or pharmacy resident lasted a mean of 14 minutes (Table 3). Five patients were successfully contacted for an interview and 7 patients could not be contacted. The ordering clinician of the UDS sometimes had contacted these patients prior to the PMOP coordinator or pharmacy resident reviewing the UDS dashboard, eliminating the need for additional follow-up.

The most common pharmacist intervention was discussing future actions with the primary care clinician and/or prescriber of the controlled substance (n = 39; 65%). These conversations resulted in actions such as ordering a repeat UDS with confirmatory testing at a future date or agreeing that the clinician would discuss the results and subsequent actions with the patient at an upcoming visit. Pharmacist interventions also included 25 PDMP queries (42%) and 9 orders of confirmatory UDS on the original urine sample (15%). Only 1 patient was evaluated by the narcotics review committee, which resulted in a controlled substance flag being placed on their profile. No patients were referred to substance use disorder treatment or counseling. It was offered to and declined by 1 patient, and 3 patients were already engaged in these services.

Medication therapies that could contribute to false-positive results were also evaluated. Fourteen patients who tested positive for THC had a prescription for a nonsteroidal anti-inflammatory drug or proton-pump inhibitor, which could have created a false-positive result.6 One patient who tested positive for amphetamines had a prescription for phentermine.16 No other potential false-positive results were identified.

 

 

Discussion

Findings of this project illustrate that the use of a clinical pharmacist to monitor a dashboard of discrepant UDS results created opportunities for collaboration with clinicians and impacted confirmatory testing and PDMP monitoring practices.

At the local level, the process had numerous benefits. First, it was a reasonable amount of workload to generate pharmacist interventions: the PMOP coordinator conducted an average of 4 in-depth reviews weekly, each lasting about 14 minutes. Thus, the UDS dashboard allowed the PMOP coordinator to actively surveil all incoming UDS results for potential discrepancies in about 1 hour each week. Pairing the automation of the UDS dashboard with the clinical judgment of the PMOP coordinator seemed to maximize efficiency. VABHHCS provides primary and secondary medical and surgical care to a rural population of approximately 20,000 patients across 5 states; the time required at facilities that serve a higher volume of patients may be greater.

Second, the project served as an opportunity for the PMOP coordinator to provide case-specific clinician education on UDS monitoring. As medication experts, pharmacists can apply their medication-related knowledge to UDS interpretation. This includes understanding drug metabolism and classification and how they apply to UDS results, as well as recognizing medication therapies that could contribute to false-positive UDS results. Research suggests that clinicians may have gaps in their knowledge and may welcome pharmacist assistance in interpreting UDS results.7,8

Third, the project helped improve rates of confirmatory testing for those with unexpected positive UDS results. Confirmatory testing should be strongly considered if positive results would have significant implications on the future course of treatment.4 The PMOP coordinator ordered a confirmatory test on 9 patients using the same urine sample used to conduct the initial UDS, minimizing the burden on the patient and laboratory staff. Confirmatory testing was limited by the laboratory’s sample retention period; if the need for confirmatory testing was not recognized soon enough, the sample would no longer be available for retesting. Health systems may consider the use of reflexive confirmatory testing with UDS as an alternative approach, although this may come at an additional cost and may not be warranted in many cases (eg, only 39.7% of all potential discrepancies were deemed as significant within our project).

There were notable incidental findings in our quality improvement project. Among patients with a significant discrepancy on UDS, 50% had a history of ≥ 1 discrepant UDS result. This further emphasizes the importance of appropriate use and interpretation of UDS monitoring for all clinicians, as this may prevent prolonged and potentially inappropriate treatment regimens. Secondly, rates of mental health diagnoses among those with a significant UDS discrepancy seemed relatively high compared to population-level data. For example, among veterans, the overall lifetime prevalence of posttraumatic stress disorder is estimated to be 8.0%; in our project, 35% of patients with a significant UDS discrepancy had a posttraumatic stress disorder diagnosis.17 This relationship may be an area of further study.

Lastly, it was surprising that the overall rates of UDS and PDMP checks within the past year were 56% and 65%, respectively. VABHHCS requires veterans on controlled substances to have these risk-mitigation strategies performed annually, so our suspicion is that many were falling out due to having been most recently evaluated 12 to 16 months prior. This may represent a limitation of our data-collection method, which reviewed only the previous 12 months.

 

 

Limitations

This project was carried out over a period of only 4 months. As a result, only 60 patients received an in-depth review from the PMOP coordinator. Second, the timeliness of the intervention seemed crucial, as delayed in-depth reviews resulted in fewer opportunities to order confirmatory tests or collaborate with clinicians prior to devising an updated plan. Additionally, our process called for UDS dashboard monitoring once a week. Given that the laboratory held samples for only 48 hours, twice- or thrice-weekly review of the UDS dashboard would have allowed for more confirmatory testing, along with more immediate clinician collaboration. Most importantly, the outcomes of this project are only presented via descriptive statistics and without the results of any comparison group, making it impossible to draw firm conclusions about this approach compared to standard-care processes.

Conclusions

This quality improvement project has proven to be valuable at VABHHCS and we intend to continue this pharmacist-led process to monitor the UDS dashboard. VABHHCS leadership are also discussing UDS practices more broadly to further enhance patient management. Within the VA, the PMOP coordinator—charged with being the local coordinator of appropriate pain management and opioid safety practices—is well positioned to assume these responsibilities. Outside of the VA, a pain-management clinical pharmacist or any pharmacist embedded within primary care could similarly perform these duties. Previous literature regarding the implementation of clinical dashboards suggests that with the appropriate software engineering teams and infrastructure, this tool could also be feasibly developed and implemented at other health systems relatively quickly.14

Overall, a pharmacist-led process to efficiently monitor a dashboard of discrepant UDS results led to opportunities for collaboration with clinicians and positively impacted confirmatory testing and PDMP monitoring at a rural VA health system.

Acknowledgments

The authors express their gratitude to Patrick Spoutz, PharmD, BCPS, VISN 20 Pharmacist Executive, for introducing and sharing the UDS dashboard with our team.

References

1. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. MMWR Recomm Rep. 2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1

2. US Department of Defense, US Department of Veterans Affairs. VA/DoD clinical practice guidelines for the use of opioids in the management of chronic pain. Version 4.0. Published 2002. Accessed January 22, 2024. https://www.healthquality.va.gov/guidelines/Pain/cot/VADoDOpioidsCPG.pdf

3. Champion C, Kameg BN. Best practices in benzodiazepine prescribing and management in primary care. Nurse Pract. 2021;46(3):30-36.doi:10.1097/01.NPR.0000733684.24949.19

4. Kale N. Urine drug tests: ordering and interpretation. Am Fam Physician. 2019;99(1):33-39.

5. Gillespie E, Cunningham JM, Indovina KA. Interpretation of the urine drug screen. The Hospitalist. May 2, 2022. Accessed January 19, 2024. https://www.the-hospitalist.org/hospitalist/article/32085/interpreting-diagnostic-tests/interpretation-of-the-urine-drug-screen/

6. Schwebach A, Ball J. Urine drug screening: minimizing false-positives and false-negatives to optimize patient care. US Pharm. 2016;41(8):26-30.

7. Starrels JL, Fox AD, Kunins HV, Cunningham CO. They don’t know what they don’t know: internal medicine residents’ knowledge and confidence in urine drug test interpretation for patients with chronic pain. J Gen Intern Med. 2012;27(11):1521-1527. doi:10.1007/s11606-012-2165-7

8. Chua I, Petrides AK, Schiff GD, et al. Provider misinterpretation, documentation, and follow-up of definitive urine drug testing results. J Gen Intern Med. 2020;35(1):283-290. doi:10.1007/s11606-019-05514-5

9. US Department of Veterans Affairs, Veterans Health Administration. VHA Pain Management, Opioid Safety, and Prescription Drug Monitoring Program (PMOP) National Program Field Roles and Responsibilities Manual. October 2021 (V1).[Source not verified]

10. Dorsch MP, Chen CS, Allen AL, et al. Nationwide implementation of a population management dashboard for monitoring direct oral anticoagulants: insights from the Veterans Affairs Health System. Circ Cardiovasc Qual Outcomes. 2023;16(2):e009256. doi:10.1161/CIRCOUTCOMES.122.009256

11. Hu AM, Pepin MJ, Hashem MG, et al. Development of a specialty medication clinical dashboard to improve tumor necrosis factor-α inhibitor safety and adherence monitoring. Am J Health Syst Pharm. 2022;79(8):683-688. doi:10.1093/ajhp/zxab454

12. Homsted FAE, Magee CE, Nesin N. Population health management in a small health system: impact of controlled substance stewardship in a patient-centered medical home. Am J Health Syst Pharm. 2017;74(18):1468-1475. doi:10.2146/ajhp161032

13. US Department of Veterans Affairs, Veterans Health Administration, Pharmacy Benefits (PBM) Services, Clinical Pharmacy Practice Office. Fact Sheet: CPS Role in Population Health Management. 2019. [Source not verified]

14. Anderson D, Zlateva I, Khatri K, Ciaburri N. Using health information technology to improve adherence to opioid prescribing guidelines in primary care. Clin J Pain. 2015;31(6):573-579. doi:10.1097/AJP.0000000000000177

15. Wang EJ, Helgesen R, Johr CR, Lacko HS, Ashburn MA, Merkel PA. Targeted program in an academic rheumatology practice to improve compliance with opioid prescribing guidelines for the treatment of chronic pain. Arthritis Care Res (Hoboken). 2021;73(10):1425-1429. doi:10.1002/acr.24354

16. Moeller KE, Kissack JC, Atayee RS, Lee KC. Clinical interpretation of urine drug tests: what clinicians need to know about urine drug screens. Mayo Clin Proc. 2017;92(5):774-796. doi:10.1016/j.mayocp.2016.12.007

17. Wisco BE, Marx BP, Wolf EJ, Miller MW, Southwick SM, Pietrzak RH. Posttraumatic stress disorder in the US veteran population: results from the National Health and Resilience in Veterans Study. J Clin Psychiatry. 2014;75(12):1338-46. doi:10.4088/JCP.14m09328

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Author and Disclosure Information

Joseph Berendse, PharmD, BCPS, BCACPa,b; Olivia Sharp, PharmDb; Whitney Hutchison, PharmDb;  Harrison Johnson, PharmD, MHAb

Correspondence:  Joseph Berendse  (joseph.berendse@sdstate.edu)

aSouth Dakota State University College of Pharmacy & Allied Health Professions, Brookings

bVeterans Affairs Black Hills Health Care System, Fort Meade, South Dakota

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The protocol for this project was approved by the Veterans Affairs Black Hills Health Care System pharmacy and therapeutics committee in May 2022 and was determined to meet guidelines for a nonresearch quality improvement project.

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Author and Disclosure Information

Joseph Berendse, PharmD, BCPS, BCACPa,b; Olivia Sharp, PharmDb; Whitney Hutchison, PharmDb;  Harrison Johnson, PharmD, MHAb

Correspondence:  Joseph Berendse  (joseph.berendse@sdstate.edu)

aSouth Dakota State University College of Pharmacy & Allied Health Professions, Brookings

bVeterans Affairs Black Hills Health Care System, Fort Meade, South Dakota

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The protocol for this project was approved by the Veterans Affairs Black Hills Health Care System pharmacy and therapeutics committee in May 2022 and was determined to meet guidelines for a nonresearch quality improvement project.

Author and Disclosure Information

Joseph Berendse, PharmD, BCPS, BCACPa,b; Olivia Sharp, PharmDb; Whitney Hutchison, PharmDb;  Harrison Johnson, PharmD, MHAb

Correspondence:  Joseph Berendse  (joseph.berendse@sdstate.edu)

aSouth Dakota State University College of Pharmacy & Allied Health Professions, Brookings

bVeterans Affairs Black Hills Health Care System, Fort Meade, South Dakota

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The protocol for this project was approved by the Veterans Affairs Black Hills Health Care System pharmacy and therapeutics committee in May 2022 and was determined to meet guidelines for a nonresearch quality improvement project.

Article PDF
Article PDF

Urine drug screen (UDS) monitoring is a common risk-mitigation strategy tool for prescribing controlled substances.1-3 Not only is UDS monitoring highlighted by clinical practice guidelines for opioid prescribing for chronic pain,1,2 it has also been suggested as best practice for benzodiazepines3 and a consideration for other controlled substances. Monitoring UDSs helps confirm adherence to the prescribed treatment regimen while also screening for substance use that may increase patient risk.

UDS results can be complex and have profound implications for the patient’s treatment plan. Drug metabolites for opioids are particularly complicated; for example, synthetic and semisynthetic opioids are not detected on routine opiate immunoassays.4 This may lead a clinician to falsely assume the patient is not taking their fentanyl or tramadol medication as directed—or potentially even diverting—in the face of a negative opiate result.5 Routine UDSs are also subject to the pitfall of false-positive results due to coprescribed medications; for example, bupropion can lead to a false-positive amphetamine result, whereas sertraline can lead to a false-positive benzodiazepine result.6 Retrospective reviews of clinician behavior surrounding UDS interpretation have demonstrated knowledge gaps and inconsistent communication practices with patients.7,8

Given the complexity of UDS interpretation and its close relationship with medications, pharmacists are positioned to play an important role in the process. Pharmacists are embedded in pain-management teams and involved in prescription drug monitoring programs (PDMPs) for many health systems. The Veterans Health Administration (VHA) has supported the hiring of pain management, opioid safety, and PDMP coordinators (PMOP) at its facilities to provide clinical pain-management guidance, support national initiatives, and uphold legislative requirements.9 In many facilities, a pharmacist is hired specifically for these positions.

Clinical dashboards have been used by pharmacists in a variety of settings.10-13 They allow clinicians at a broad level to target interventions needed across a patient population, then produce a list of actionable patients to facilitate delivery of that intervention on an individual level.13 Between 2021 and 2022, a clinical dashboard to review potentially discrepant UDS results was made available for use at US Department of Veterans Affairs (VA) medical centers. Evidence exists in primary and specialty care settings that implementation of an opioid-prescribing clinical dashboard improves completion rates of risk-mitigation strategies such as UDS and opioid treatment agreements.14,15 To our knowledge there is no published research on the use and outcomes of a clinical dashboard that allows users to efficiently review discrepant UDS results when compared to a list of currently prescribed medications.

Given the availability of the UDS dashboard at the VA Black Hills Health Care System (VABHHCS) in South Dakota and the hiring of a PMOP coordinator pharmacist, the aim of this quality improvement project was 2-fold: to implement a pharmacist-led process to monitor the UDS dashboard for potentially discrepant results and to describe the quantity and types of interventions made by the clinical pharmacist leading this process.

 

 

Quality Improvement Project

A clinical UDS dashboard was created by the VA Northwest Health Network and made available for use at VHA sites between 2021 and 2022. The UDS dashboard is housed on a secure, Power BI Report Server (Microsoft), with access restricted to only those with patient health data privileges. The dashboard identifies all local patients with a UDS that returned with a potential discrepancy, defined as an unexpected positive result (eg, a detected substance not recently prescribed or documented on the patient’s medication list) and/or an unexpected negative result (eg, a prescribed substance not detected). The UDS dashboard identifies these discrepancies by comparing the patient’s current medication list (both VHA and non-VHA) to their UDS results.

The UDS dashboard displays a summary of UDSs performed, unexpected negative results, unexpected positive results, and potential discrepancies. The user may also specify the laboratory type and time frame of interest to limit displayed results. The user can then view patient-specific data for any category. Among the data are the patient’s UDS results and the completion date, detected (or nondetected) substance(s), ordering clinician, associated medication(s) with last fill date and days’ supply, and whether a confirmatory test has been performed in the past year.

VABHHCS uses an extended UDS immunoassay (PROFILE-V, MEDTOX Diagnostics) that reports on 11 substances: opiates, oxycodone, buprenorphine, methadone, amphetamines, methamphetamine, barbiturates, benzodiazepines, cocaine metabolites, cannabinoids (tetrahydrocannabinol [THC]), and phencyclidine. These substances appear on the UDS dashboard. The project protocol initially included monitoring for tramadol but that was later removed because it was not available with this UDS immunoassay.

Pharmacist Process

Either the PMOP coordinator or pharmacy resident monitored the UDS dashboard weekly. Any patients identified as having a potential discrepancy were reviewed. If the discrepancy was determined to be significant, the PMOP coordinator or pharmacy resident would review the patient electronic health record. If warranted, the patient was contacted and asked about newly prescribed medications, missed and recent medication doses, and illicit substance use. Potential interventions during in-depth review included: (1) discussing future actions with the primary care clinician and/or prescriber of the controlled substance; (2) ordering a confirmatory test on the original urine sample; (3) evaluating for sources of potential false-positive results; (4) completing an updated PDMP if not performed within the past year; (5) referring patients for substance use disorder treatment or counseling; or (6) consulting the local narcotics review committee. A progress note was entered into the electronic health record with the findings and any actions taken, and an alert for the primary care clinician and/or prescriber of the controlled substance.

Implementation and Analysis

This quality improvement project spanned 16 weeks from June 2022 through September 2022. Any patient with a UDS that returned with a significant discrepancy was reviewed. The primary outcome was interventions made by the PMOP coordinator or pharmacy resident, as well as time taken to perform the in-depth review of each patient. Patient demographics were also collected. The protocol for this project was approved by the VABHHCS pharmacy and therapeutics committee and was determined to meet guidelines for a nonresearch quality improvement project.

 

 

Results

table_1.png

From June 2022 through September 2022, 700 UDSs were performed at VABHHCS with 278 (39.7%) patients identified as having a potential discrepancy based on UDS results. Sixty patients (8.6%) had significant discrepancies that warranted in-depth review. The most common reasons for determining whether a potential discrepancy was not significant included unexpected negatives due to documented non-VA medications no longer being prescribed, unexpected positives due to recent expiration of a controlled substance prescription the patient was still taking, or unexpected positives due to the detection of a substance for which the clinician was already aware. During the 16-week study period, the mean number of patients warranting in-depth review was 4 per week.

table_2.png

The patients were predominantly male with a mean age of 61 years, and most (87%) were prescribed at least 1 controlled substance (mean, 1.1), primarily opioids for pain management (Table 1). Most patients had recent substance risk mitigation with UDS (56%) and PDMP (65%) checks within the past year. Of the 60 patients reviewed with significant UDS discrepancies, 50% had a history of discrepant UDS results. Of the 60 UDS discrepancies, there were 37 unexpected positive results (62%), 17 unexpected negative results (28%), and 10 patients with both positive and negative results (17%). THC was the most frequently detected substance, followed by opiates, benzodiazepines, and amphetamines (Table 2).

table_3.png

Each in-depth review with interventions by the PMOP coordinator or pharmacy resident lasted a mean of 14 minutes (Table 3). Five patients were successfully contacted for an interview and 7 patients could not be contacted. The ordering clinician of the UDS sometimes had contacted these patients prior to the PMOP coordinator or pharmacy resident reviewing the UDS dashboard, eliminating the need for additional follow-up.

The most common pharmacist intervention was discussing future actions with the primary care clinician and/or prescriber of the controlled substance (n = 39; 65%). These conversations resulted in actions such as ordering a repeat UDS with confirmatory testing at a future date or agreeing that the clinician would discuss the results and subsequent actions with the patient at an upcoming visit. Pharmacist interventions also included 25 PDMP queries (42%) and 9 orders of confirmatory UDS on the original urine sample (15%). Only 1 patient was evaluated by the narcotics review committee, which resulted in a controlled substance flag being placed on their profile. No patients were referred to substance use disorder treatment or counseling. It was offered to and declined by 1 patient, and 3 patients were already engaged in these services.

Medication therapies that could contribute to false-positive results were also evaluated. Fourteen patients who tested positive for THC had a prescription for a nonsteroidal anti-inflammatory drug or proton-pump inhibitor, which could have created a false-positive result.6 One patient who tested positive for amphetamines had a prescription for phentermine.16 No other potential false-positive results were identified.

 

 

Discussion

Findings of this project illustrate that the use of a clinical pharmacist to monitor a dashboard of discrepant UDS results created opportunities for collaboration with clinicians and impacted confirmatory testing and PDMP monitoring practices.

At the local level, the process had numerous benefits. First, it was a reasonable amount of workload to generate pharmacist interventions: the PMOP coordinator conducted an average of 4 in-depth reviews weekly, each lasting about 14 minutes. Thus, the UDS dashboard allowed the PMOP coordinator to actively surveil all incoming UDS results for potential discrepancies in about 1 hour each week. Pairing the automation of the UDS dashboard with the clinical judgment of the PMOP coordinator seemed to maximize efficiency. VABHHCS provides primary and secondary medical and surgical care to a rural population of approximately 20,000 patients across 5 states; the time required at facilities that serve a higher volume of patients may be greater.

Second, the project served as an opportunity for the PMOP coordinator to provide case-specific clinician education on UDS monitoring. As medication experts, pharmacists can apply their medication-related knowledge to UDS interpretation. This includes understanding drug metabolism and classification and how they apply to UDS results, as well as recognizing medication therapies that could contribute to false-positive UDS results. Research suggests that clinicians may have gaps in their knowledge and may welcome pharmacist assistance in interpreting UDS results.7,8

Third, the project helped improve rates of confirmatory testing for those with unexpected positive UDS results. Confirmatory testing should be strongly considered if positive results would have significant implications on the future course of treatment.4 The PMOP coordinator ordered a confirmatory test on 9 patients using the same urine sample used to conduct the initial UDS, minimizing the burden on the patient and laboratory staff. Confirmatory testing was limited by the laboratory’s sample retention period; if the need for confirmatory testing was not recognized soon enough, the sample would no longer be available for retesting. Health systems may consider the use of reflexive confirmatory testing with UDS as an alternative approach, although this may come at an additional cost and may not be warranted in many cases (eg, only 39.7% of all potential discrepancies were deemed as significant within our project).

There were notable incidental findings in our quality improvement project. Among patients with a significant discrepancy on UDS, 50% had a history of ≥ 1 discrepant UDS result. This further emphasizes the importance of appropriate use and interpretation of UDS monitoring for all clinicians, as this may prevent prolonged and potentially inappropriate treatment regimens. Secondly, rates of mental health diagnoses among those with a significant UDS discrepancy seemed relatively high compared to population-level data. For example, among veterans, the overall lifetime prevalence of posttraumatic stress disorder is estimated to be 8.0%; in our project, 35% of patients with a significant UDS discrepancy had a posttraumatic stress disorder diagnosis.17 This relationship may be an area of further study.

Lastly, it was surprising that the overall rates of UDS and PDMP checks within the past year were 56% and 65%, respectively. VABHHCS requires veterans on controlled substances to have these risk-mitigation strategies performed annually, so our suspicion is that many were falling out due to having been most recently evaluated 12 to 16 months prior. This may represent a limitation of our data-collection method, which reviewed only the previous 12 months.

 

 

Limitations

This project was carried out over a period of only 4 months. As a result, only 60 patients received an in-depth review from the PMOP coordinator. Second, the timeliness of the intervention seemed crucial, as delayed in-depth reviews resulted in fewer opportunities to order confirmatory tests or collaborate with clinicians prior to devising an updated plan. Additionally, our process called for UDS dashboard monitoring once a week. Given that the laboratory held samples for only 48 hours, twice- or thrice-weekly review of the UDS dashboard would have allowed for more confirmatory testing, along with more immediate clinician collaboration. Most importantly, the outcomes of this project are only presented via descriptive statistics and without the results of any comparison group, making it impossible to draw firm conclusions about this approach compared to standard-care processes.

Conclusions

This quality improvement project has proven to be valuable at VABHHCS and we intend to continue this pharmacist-led process to monitor the UDS dashboard. VABHHCS leadership are also discussing UDS practices more broadly to further enhance patient management. Within the VA, the PMOP coordinator—charged with being the local coordinator of appropriate pain management and opioid safety practices—is well positioned to assume these responsibilities. Outside of the VA, a pain-management clinical pharmacist or any pharmacist embedded within primary care could similarly perform these duties. Previous literature regarding the implementation of clinical dashboards suggests that with the appropriate software engineering teams and infrastructure, this tool could also be feasibly developed and implemented at other health systems relatively quickly.14

Overall, a pharmacist-led process to efficiently monitor a dashboard of discrepant UDS results led to opportunities for collaboration with clinicians and positively impacted confirmatory testing and PDMP monitoring at a rural VA health system.

Acknowledgments

The authors express their gratitude to Patrick Spoutz, PharmD, BCPS, VISN 20 Pharmacist Executive, for introducing and sharing the UDS dashboard with our team.

Urine drug screen (UDS) monitoring is a common risk-mitigation strategy tool for prescribing controlled substances.1-3 Not only is UDS monitoring highlighted by clinical practice guidelines for opioid prescribing for chronic pain,1,2 it has also been suggested as best practice for benzodiazepines3 and a consideration for other controlled substances. Monitoring UDSs helps confirm adherence to the prescribed treatment regimen while also screening for substance use that may increase patient risk.

UDS results can be complex and have profound implications for the patient’s treatment plan. Drug metabolites for opioids are particularly complicated; for example, synthetic and semisynthetic opioids are not detected on routine opiate immunoassays.4 This may lead a clinician to falsely assume the patient is not taking their fentanyl or tramadol medication as directed—or potentially even diverting—in the face of a negative opiate result.5 Routine UDSs are also subject to the pitfall of false-positive results due to coprescribed medications; for example, bupropion can lead to a false-positive amphetamine result, whereas sertraline can lead to a false-positive benzodiazepine result.6 Retrospective reviews of clinician behavior surrounding UDS interpretation have demonstrated knowledge gaps and inconsistent communication practices with patients.7,8

Given the complexity of UDS interpretation and its close relationship with medications, pharmacists are positioned to play an important role in the process. Pharmacists are embedded in pain-management teams and involved in prescription drug monitoring programs (PDMPs) for many health systems. The Veterans Health Administration (VHA) has supported the hiring of pain management, opioid safety, and PDMP coordinators (PMOP) at its facilities to provide clinical pain-management guidance, support national initiatives, and uphold legislative requirements.9 In many facilities, a pharmacist is hired specifically for these positions.

Clinical dashboards have been used by pharmacists in a variety of settings.10-13 They allow clinicians at a broad level to target interventions needed across a patient population, then produce a list of actionable patients to facilitate delivery of that intervention on an individual level.13 Between 2021 and 2022, a clinical dashboard to review potentially discrepant UDS results was made available for use at US Department of Veterans Affairs (VA) medical centers. Evidence exists in primary and specialty care settings that implementation of an opioid-prescribing clinical dashboard improves completion rates of risk-mitigation strategies such as UDS and opioid treatment agreements.14,15 To our knowledge there is no published research on the use and outcomes of a clinical dashboard that allows users to efficiently review discrepant UDS results when compared to a list of currently prescribed medications.

Given the availability of the UDS dashboard at the VA Black Hills Health Care System (VABHHCS) in South Dakota and the hiring of a PMOP coordinator pharmacist, the aim of this quality improvement project was 2-fold: to implement a pharmacist-led process to monitor the UDS dashboard for potentially discrepant results and to describe the quantity and types of interventions made by the clinical pharmacist leading this process.

 

 

Quality Improvement Project

A clinical UDS dashboard was created by the VA Northwest Health Network and made available for use at VHA sites between 2021 and 2022. The UDS dashboard is housed on a secure, Power BI Report Server (Microsoft), with access restricted to only those with patient health data privileges. The dashboard identifies all local patients with a UDS that returned with a potential discrepancy, defined as an unexpected positive result (eg, a detected substance not recently prescribed or documented on the patient’s medication list) and/or an unexpected negative result (eg, a prescribed substance not detected). The UDS dashboard identifies these discrepancies by comparing the patient’s current medication list (both VHA and non-VHA) to their UDS results.

The UDS dashboard displays a summary of UDSs performed, unexpected negative results, unexpected positive results, and potential discrepancies. The user may also specify the laboratory type and time frame of interest to limit displayed results. The user can then view patient-specific data for any category. Among the data are the patient’s UDS results and the completion date, detected (or nondetected) substance(s), ordering clinician, associated medication(s) with last fill date and days’ supply, and whether a confirmatory test has been performed in the past year.

VABHHCS uses an extended UDS immunoassay (PROFILE-V, MEDTOX Diagnostics) that reports on 11 substances: opiates, oxycodone, buprenorphine, methadone, amphetamines, methamphetamine, barbiturates, benzodiazepines, cocaine metabolites, cannabinoids (tetrahydrocannabinol [THC]), and phencyclidine. These substances appear on the UDS dashboard. The project protocol initially included monitoring for tramadol but that was later removed because it was not available with this UDS immunoassay.

Pharmacist Process

Either the PMOP coordinator or pharmacy resident monitored the UDS dashboard weekly. Any patients identified as having a potential discrepancy were reviewed. If the discrepancy was determined to be significant, the PMOP coordinator or pharmacy resident would review the patient electronic health record. If warranted, the patient was contacted and asked about newly prescribed medications, missed and recent medication doses, and illicit substance use. Potential interventions during in-depth review included: (1) discussing future actions with the primary care clinician and/or prescriber of the controlled substance; (2) ordering a confirmatory test on the original urine sample; (3) evaluating for sources of potential false-positive results; (4) completing an updated PDMP if not performed within the past year; (5) referring patients for substance use disorder treatment or counseling; or (6) consulting the local narcotics review committee. A progress note was entered into the electronic health record with the findings and any actions taken, and an alert for the primary care clinician and/or prescriber of the controlled substance.

Implementation and Analysis

This quality improvement project spanned 16 weeks from June 2022 through September 2022. Any patient with a UDS that returned with a significant discrepancy was reviewed. The primary outcome was interventions made by the PMOP coordinator or pharmacy resident, as well as time taken to perform the in-depth review of each patient. Patient demographics were also collected. The protocol for this project was approved by the VABHHCS pharmacy and therapeutics committee and was determined to meet guidelines for a nonresearch quality improvement project.

 

 

Results

table_1.png

From June 2022 through September 2022, 700 UDSs were performed at VABHHCS with 278 (39.7%) patients identified as having a potential discrepancy based on UDS results. Sixty patients (8.6%) had significant discrepancies that warranted in-depth review. The most common reasons for determining whether a potential discrepancy was not significant included unexpected negatives due to documented non-VA medications no longer being prescribed, unexpected positives due to recent expiration of a controlled substance prescription the patient was still taking, or unexpected positives due to the detection of a substance for which the clinician was already aware. During the 16-week study period, the mean number of patients warranting in-depth review was 4 per week.

table_2.png

The patients were predominantly male with a mean age of 61 years, and most (87%) were prescribed at least 1 controlled substance (mean, 1.1), primarily opioids for pain management (Table 1). Most patients had recent substance risk mitigation with UDS (56%) and PDMP (65%) checks within the past year. Of the 60 patients reviewed with significant UDS discrepancies, 50% had a history of discrepant UDS results. Of the 60 UDS discrepancies, there were 37 unexpected positive results (62%), 17 unexpected negative results (28%), and 10 patients with both positive and negative results (17%). THC was the most frequently detected substance, followed by opiates, benzodiazepines, and amphetamines (Table 2).

table_3.png

Each in-depth review with interventions by the PMOP coordinator or pharmacy resident lasted a mean of 14 minutes (Table 3). Five patients were successfully contacted for an interview and 7 patients could not be contacted. The ordering clinician of the UDS sometimes had contacted these patients prior to the PMOP coordinator or pharmacy resident reviewing the UDS dashboard, eliminating the need for additional follow-up.

The most common pharmacist intervention was discussing future actions with the primary care clinician and/or prescriber of the controlled substance (n = 39; 65%). These conversations resulted in actions such as ordering a repeat UDS with confirmatory testing at a future date or agreeing that the clinician would discuss the results and subsequent actions with the patient at an upcoming visit. Pharmacist interventions also included 25 PDMP queries (42%) and 9 orders of confirmatory UDS on the original urine sample (15%). Only 1 patient was evaluated by the narcotics review committee, which resulted in a controlled substance flag being placed on their profile. No patients were referred to substance use disorder treatment or counseling. It was offered to and declined by 1 patient, and 3 patients were already engaged in these services.

Medication therapies that could contribute to false-positive results were also evaluated. Fourteen patients who tested positive for THC had a prescription for a nonsteroidal anti-inflammatory drug or proton-pump inhibitor, which could have created a false-positive result.6 One patient who tested positive for amphetamines had a prescription for phentermine.16 No other potential false-positive results were identified.

 

 

Discussion

Findings of this project illustrate that the use of a clinical pharmacist to monitor a dashboard of discrepant UDS results created opportunities for collaboration with clinicians and impacted confirmatory testing and PDMP monitoring practices.

At the local level, the process had numerous benefits. First, it was a reasonable amount of workload to generate pharmacist interventions: the PMOP coordinator conducted an average of 4 in-depth reviews weekly, each lasting about 14 minutes. Thus, the UDS dashboard allowed the PMOP coordinator to actively surveil all incoming UDS results for potential discrepancies in about 1 hour each week. Pairing the automation of the UDS dashboard with the clinical judgment of the PMOP coordinator seemed to maximize efficiency. VABHHCS provides primary and secondary medical and surgical care to a rural population of approximately 20,000 patients across 5 states; the time required at facilities that serve a higher volume of patients may be greater.

Second, the project served as an opportunity for the PMOP coordinator to provide case-specific clinician education on UDS monitoring. As medication experts, pharmacists can apply their medication-related knowledge to UDS interpretation. This includes understanding drug metabolism and classification and how they apply to UDS results, as well as recognizing medication therapies that could contribute to false-positive UDS results. Research suggests that clinicians may have gaps in their knowledge and may welcome pharmacist assistance in interpreting UDS results.7,8

Third, the project helped improve rates of confirmatory testing for those with unexpected positive UDS results. Confirmatory testing should be strongly considered if positive results would have significant implications on the future course of treatment.4 The PMOP coordinator ordered a confirmatory test on 9 patients using the same urine sample used to conduct the initial UDS, minimizing the burden on the patient and laboratory staff. Confirmatory testing was limited by the laboratory’s sample retention period; if the need for confirmatory testing was not recognized soon enough, the sample would no longer be available for retesting. Health systems may consider the use of reflexive confirmatory testing with UDS as an alternative approach, although this may come at an additional cost and may not be warranted in many cases (eg, only 39.7% of all potential discrepancies were deemed as significant within our project).

There were notable incidental findings in our quality improvement project. Among patients with a significant discrepancy on UDS, 50% had a history of ≥ 1 discrepant UDS result. This further emphasizes the importance of appropriate use and interpretation of UDS monitoring for all clinicians, as this may prevent prolonged and potentially inappropriate treatment regimens. Secondly, rates of mental health diagnoses among those with a significant UDS discrepancy seemed relatively high compared to population-level data. For example, among veterans, the overall lifetime prevalence of posttraumatic stress disorder is estimated to be 8.0%; in our project, 35% of patients with a significant UDS discrepancy had a posttraumatic stress disorder diagnosis.17 This relationship may be an area of further study.

Lastly, it was surprising that the overall rates of UDS and PDMP checks within the past year were 56% and 65%, respectively. VABHHCS requires veterans on controlled substances to have these risk-mitigation strategies performed annually, so our suspicion is that many were falling out due to having been most recently evaluated 12 to 16 months prior. This may represent a limitation of our data-collection method, which reviewed only the previous 12 months.

 

 

Limitations

This project was carried out over a period of only 4 months. As a result, only 60 patients received an in-depth review from the PMOP coordinator. Second, the timeliness of the intervention seemed crucial, as delayed in-depth reviews resulted in fewer opportunities to order confirmatory tests or collaborate with clinicians prior to devising an updated plan. Additionally, our process called for UDS dashboard monitoring once a week. Given that the laboratory held samples for only 48 hours, twice- or thrice-weekly review of the UDS dashboard would have allowed for more confirmatory testing, along with more immediate clinician collaboration. Most importantly, the outcomes of this project are only presented via descriptive statistics and without the results of any comparison group, making it impossible to draw firm conclusions about this approach compared to standard-care processes.

Conclusions

This quality improvement project has proven to be valuable at VABHHCS and we intend to continue this pharmacist-led process to monitor the UDS dashboard. VABHHCS leadership are also discussing UDS practices more broadly to further enhance patient management. Within the VA, the PMOP coordinator—charged with being the local coordinator of appropriate pain management and opioid safety practices—is well positioned to assume these responsibilities. Outside of the VA, a pain-management clinical pharmacist or any pharmacist embedded within primary care could similarly perform these duties. Previous literature regarding the implementation of clinical dashboards suggests that with the appropriate software engineering teams and infrastructure, this tool could also be feasibly developed and implemented at other health systems relatively quickly.14

Overall, a pharmacist-led process to efficiently monitor a dashboard of discrepant UDS results led to opportunities for collaboration with clinicians and positively impacted confirmatory testing and PDMP monitoring at a rural VA health system.

Acknowledgments

The authors express their gratitude to Patrick Spoutz, PharmD, BCPS, VISN 20 Pharmacist Executive, for introducing and sharing the UDS dashboard with our team.

References

1. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. MMWR Recomm Rep. 2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1

2. US Department of Defense, US Department of Veterans Affairs. VA/DoD clinical practice guidelines for the use of opioids in the management of chronic pain. Version 4.0. Published 2002. Accessed January 22, 2024. https://www.healthquality.va.gov/guidelines/Pain/cot/VADoDOpioidsCPG.pdf

3. Champion C, Kameg BN. Best practices in benzodiazepine prescribing and management in primary care. Nurse Pract. 2021;46(3):30-36.doi:10.1097/01.NPR.0000733684.24949.19

4. Kale N. Urine drug tests: ordering and interpretation. Am Fam Physician. 2019;99(1):33-39.

5. Gillespie E, Cunningham JM, Indovina KA. Interpretation of the urine drug screen. The Hospitalist. May 2, 2022. Accessed January 19, 2024. https://www.the-hospitalist.org/hospitalist/article/32085/interpreting-diagnostic-tests/interpretation-of-the-urine-drug-screen/

6. Schwebach A, Ball J. Urine drug screening: minimizing false-positives and false-negatives to optimize patient care. US Pharm. 2016;41(8):26-30.

7. Starrels JL, Fox AD, Kunins HV, Cunningham CO. They don’t know what they don’t know: internal medicine residents’ knowledge and confidence in urine drug test interpretation for patients with chronic pain. J Gen Intern Med. 2012;27(11):1521-1527. doi:10.1007/s11606-012-2165-7

8. Chua I, Petrides AK, Schiff GD, et al. Provider misinterpretation, documentation, and follow-up of definitive urine drug testing results. J Gen Intern Med. 2020;35(1):283-290. doi:10.1007/s11606-019-05514-5

9. US Department of Veterans Affairs, Veterans Health Administration. VHA Pain Management, Opioid Safety, and Prescription Drug Monitoring Program (PMOP) National Program Field Roles and Responsibilities Manual. October 2021 (V1).[Source not verified]

10. Dorsch MP, Chen CS, Allen AL, et al. Nationwide implementation of a population management dashboard for monitoring direct oral anticoagulants: insights from the Veterans Affairs Health System. Circ Cardiovasc Qual Outcomes. 2023;16(2):e009256. doi:10.1161/CIRCOUTCOMES.122.009256

11. Hu AM, Pepin MJ, Hashem MG, et al. Development of a specialty medication clinical dashboard to improve tumor necrosis factor-α inhibitor safety and adherence monitoring. Am J Health Syst Pharm. 2022;79(8):683-688. doi:10.1093/ajhp/zxab454

12. Homsted FAE, Magee CE, Nesin N. Population health management in a small health system: impact of controlled substance stewardship in a patient-centered medical home. Am J Health Syst Pharm. 2017;74(18):1468-1475. doi:10.2146/ajhp161032

13. US Department of Veterans Affairs, Veterans Health Administration, Pharmacy Benefits (PBM) Services, Clinical Pharmacy Practice Office. Fact Sheet: CPS Role in Population Health Management. 2019. [Source not verified]

14. Anderson D, Zlateva I, Khatri K, Ciaburri N. Using health information technology to improve adherence to opioid prescribing guidelines in primary care. Clin J Pain. 2015;31(6):573-579. doi:10.1097/AJP.0000000000000177

15. Wang EJ, Helgesen R, Johr CR, Lacko HS, Ashburn MA, Merkel PA. Targeted program in an academic rheumatology practice to improve compliance with opioid prescribing guidelines for the treatment of chronic pain. Arthritis Care Res (Hoboken). 2021;73(10):1425-1429. doi:10.1002/acr.24354

16. Moeller KE, Kissack JC, Atayee RS, Lee KC. Clinical interpretation of urine drug tests: what clinicians need to know about urine drug screens. Mayo Clin Proc. 2017;92(5):774-796. doi:10.1016/j.mayocp.2016.12.007

17. Wisco BE, Marx BP, Wolf EJ, Miller MW, Southwick SM, Pietrzak RH. Posttraumatic stress disorder in the US veteran population: results from the National Health and Resilience in Veterans Study. J Clin Psychiatry. 2014;75(12):1338-46. doi:10.4088/JCP.14m09328

References

1. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. MMWR Recomm Rep. 2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1

2. US Department of Defense, US Department of Veterans Affairs. VA/DoD clinical practice guidelines for the use of opioids in the management of chronic pain. Version 4.0. Published 2002. Accessed January 22, 2024. https://www.healthquality.va.gov/guidelines/Pain/cot/VADoDOpioidsCPG.pdf

3. Champion C, Kameg BN. Best practices in benzodiazepine prescribing and management in primary care. Nurse Pract. 2021;46(3):30-36.doi:10.1097/01.NPR.0000733684.24949.19

4. Kale N. Urine drug tests: ordering and interpretation. Am Fam Physician. 2019;99(1):33-39.

5. Gillespie E, Cunningham JM, Indovina KA. Interpretation of the urine drug screen. The Hospitalist. May 2, 2022. Accessed January 19, 2024. https://www.the-hospitalist.org/hospitalist/article/32085/interpreting-diagnostic-tests/interpretation-of-the-urine-drug-screen/

6. Schwebach A, Ball J. Urine drug screening: minimizing false-positives and false-negatives to optimize patient care. US Pharm. 2016;41(8):26-30.

7. Starrels JL, Fox AD, Kunins HV, Cunningham CO. They don’t know what they don’t know: internal medicine residents’ knowledge and confidence in urine drug test interpretation for patients with chronic pain. J Gen Intern Med. 2012;27(11):1521-1527. doi:10.1007/s11606-012-2165-7

8. Chua I, Petrides AK, Schiff GD, et al. Provider misinterpretation, documentation, and follow-up of definitive urine drug testing results. J Gen Intern Med. 2020;35(1):283-290. doi:10.1007/s11606-019-05514-5

9. US Department of Veterans Affairs, Veterans Health Administration. VHA Pain Management, Opioid Safety, and Prescription Drug Monitoring Program (PMOP) National Program Field Roles and Responsibilities Manual. October 2021 (V1).[Source not verified]

10. Dorsch MP, Chen CS, Allen AL, et al. Nationwide implementation of a population management dashboard for monitoring direct oral anticoagulants: insights from the Veterans Affairs Health System. Circ Cardiovasc Qual Outcomes. 2023;16(2):e009256. doi:10.1161/CIRCOUTCOMES.122.009256

11. Hu AM, Pepin MJ, Hashem MG, et al. Development of a specialty medication clinical dashboard to improve tumor necrosis factor-α inhibitor safety and adherence monitoring. Am J Health Syst Pharm. 2022;79(8):683-688. doi:10.1093/ajhp/zxab454

12. Homsted FAE, Magee CE, Nesin N. Population health management in a small health system: impact of controlled substance stewardship in a patient-centered medical home. Am J Health Syst Pharm. 2017;74(18):1468-1475. doi:10.2146/ajhp161032

13. US Department of Veterans Affairs, Veterans Health Administration, Pharmacy Benefits (PBM) Services, Clinical Pharmacy Practice Office. Fact Sheet: CPS Role in Population Health Management. 2019. [Source not verified]

14. Anderson D, Zlateva I, Khatri K, Ciaburri N. Using health information technology to improve adherence to opioid prescribing guidelines in primary care. Clin J Pain. 2015;31(6):573-579. doi:10.1097/AJP.0000000000000177

15. Wang EJ, Helgesen R, Johr CR, Lacko HS, Ashburn MA, Merkel PA. Targeted program in an academic rheumatology practice to improve compliance with opioid prescribing guidelines for the treatment of chronic pain. Arthritis Care Res (Hoboken). 2021;73(10):1425-1429. doi:10.1002/acr.24354

16. Moeller KE, Kissack JC, Atayee RS, Lee KC. Clinical interpretation of urine drug tests: what clinicians need to know about urine drug screens. Mayo Clin Proc. 2017;92(5):774-796. doi:10.1016/j.mayocp.2016.12.007

17. Wisco BE, Marx BP, Wolf EJ, Miller MW, Southwick SM, Pietrzak RH. Posttraumatic stress disorder in the US veteran population: results from the National Health and Resilience in Veterans Study. J Clin Psychiatry. 2014;75(12):1338-46. doi:10.4088/JCP.14m09328

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All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> </sections> <topics> <term canonical="true">27442</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>A Pharmacist-Led Process to Monitor Discrepant Urine Drug Screen Results</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background: </b>A urine drug screen (UDS) is a common risk-mitigation strategy tool for prescribing controlled substances, particularly opioids. Due to their complexity, UDS results can be misinterpreted and thereby have profound impacts on the patient-clinician relationship. From 2021 to 2022, a clinical dashboard to review potentially discrepant UDS results—based on a comparison of the results to the patient’s medication list—was made available by the Veterans Health Administration.<br/><br/><b>Methods:</b> This quality improvement project implemented a process for weekly clinical pharmacist reviews of the UDS dashboard. Significant discrepant UDS results were reviewed in depth. From June 2022 through September 2022, 700 UDSs were performed and 60 patients had significant discrepancies that warranted in-depth review. <br/><br/><b>Results: </b>Pharmacist interventions during the review included 39 collaborations with medication prescribers to discuss follow up (65%), 25 queries to a prescription drug monitoring program (42%), and 9 confirmatory UDS on the original sample (15%). In-depth reviews were required for about 4 patients weekly, with a mean length of 14 minutes.<br/><br/><b>Conclusions: </b>A pharmacist-led process to monitor discrepant UDS results led to opportunities for collaboration with prescribers and positively impacted confirmatory testing at a rural veterans affairs health system. </p> <p><span class="Drop">U</span> rine drug screen (UDS) monitoring is a common risk-mitigation strategy tool for prescribing controlled substances.<sup>1-3</sup> Not only is UDS monitoring highlighted by clinical practice guidelines for opioid prescribing for chronic pain,<sup>1,2</sup> it has also been suggested as best practice for benzodiazepines<sup>3</sup> and a consideration for other controlled substances. Monitoring UDSs helps confirm adherence to the prescribed treatment regimen while also screening for substance use that may increase patient risk.</p> <p>UDS results can be complex and have profound implications for the patient’s treatment plan. Drug metabolites for opioids are particularly complicated; for example, synthetic and semisynthetic opioids are not detected on routine opiate immunoassays.<sup>4</sup> This may lead a clinician to falsely assume the patient is not taking their fentanyl or tramadol medication as directed—or potentially even diverting—in the face of a negative opiate result.<sup>5</sup> Routine UDSs are also subject to the pitfall of false-positive results due to coprescribed medications; for example, bupropion can lead to a false-positive amphetamine result, whereas sertraline can lead to a false-positive benzodiazepine result.<sup>6</sup> Retrospective reviews of clinician behavior surrounding UDS interpretation have demonstrated knowledge gaps and inconsistent communication practices with patients.<sup>7,8<br/><br/></sup>Given the complexity of UDS interpretation and its close relationship with medications, pharmacists are positioned to play an important role in the process. Pharmacists are embedded in pain-management teams and involved in prescription drug monitoring programs (PDMPs) for many health systems. The Veterans Health Administration (VHA) has supported the hiring of pain management, opioid safety, and PDMP coordinators (PMOP) at its facilities to provide clinical pain-management guidance, support national initiatives, and uphold legislative requirements.<sup>9</sup> In many facilities, a pharmacist is hired specifically for these positions.<br/><br/>Clinical dashboards have been used by pharmacists in a variety of settings.<sup>10-13</sup> They allow clinicians at a broad level to target interventions needed across a patient population, then produce a list of actionable patients to facilitate delivery of that intervention on an individual level.<sup>13</sup> Between 2021 and 2022, a clinical dashboard to review potentially discrepant UDS results was made available for use at US Department of Veterans Affairs (VA) medical centers. Evidence exists in primary and specialty care settings that implementation of an opioid-prescribing clinical dashboard improves completion rates of risk-mitigation strategies such as UDS and opioid treatment agreements.<sup>14,15</sup> To our knowledge there is no published research on the use and outcomes of a clinical dashboard that allows users to efficiently review discrepant UDS results when compared to a list of currently prescribed medications. <br/><br/>Given the availability of the UDS dashboard at the VA Black Hills Health Care System (VABHHCS) in South Dakota and the hiring of a PMOP coordinator pharmacist, the aim of this quality improvement project was 2-fold: to implement a pharmacist-led process to monitor the UDS dashboard for potentially discrepant results and to describe the quantity and types of interventions made by the clinical pharmacist leading this process.</p> <h2>Quality Improvement Project</h2> <p>A clinical UDS dashboard was created by the VA Northwest Health Network and made available for use at VHA sites between 2021 and 2022. The UDS dashboard is housed on a secure, Power BI Report Server (Microsoft), with access restricted to only those with patient health data privileges. The dashboard identifies all local patients with a UDS that returned with a potential discrepancy, defined as an unexpected positive result (eg, a detected substance not recently prescribed or documented on the patient’s medication list) and/or an unexpected negative result (eg, a prescribed substance not detected). The UDS dashboard identifies these discrepancies by comparing the patient’s current medication list (both VHA and non-VHA) to their UDS results. </p> <p>The UDS dashboard displays a summary of UDSs performed, unexpected negative results, unexpected positive results, and potential discrepancies. The user may also specify the laboratory type and time frame of interest to limit displayed results. The user can then view patient-specific data for any category. Among the data are the patient’s UDS results and the completion date, detected (or nondetected) substance(s), ordering clinician, associated medication(s) with last fill date and days’ supply, and whether a confirmatory test has been performed in the past year.<br/><br/>VABHHCS uses an extended UDS immunoassay (PROFILE-V, MEDTOX Diagnostics) that reports on 11 substances: opiates, oxycodone, buprenorphine, methadone, amphetamines, methamphetamine, barbiturates, benzodiazepines, cocaine metabolites, cannabinoids (tetrahydrocannabinol [THC]), and phencyclidine. These substances appear on the UDS dashboard. The project protocol initially included monitoring for tramadol but that was later removed because it was not available with this UDS immunoassay.</p> <h3>Pharmacist Process</h3> <p>Either the PMOP coordinator or pharmacy resident monitored the UDS dashboard weekly. Any patients identified as having a potential discrepancy were reviewed. If the discrepancy was determined to be significant, the PMOP coordinator or pharmacy resident would review the patient electronic health record. If warranted, the patient was contacted and asked about newly prescribed medications, missed and recent medication doses, and illicit substance use. Potential interventions during in-depth review included: (1) discussing future actions with the primary care clinician and/or prescriber of the controlled substance; (2) ordering a confirmatory test on the original urine sample; (3) evaluating for sources of potential false-positive results; (4) completing an updated PDMP if not performed within the past year; (5) referring patients for substance use disorder treatment or counseling; or (6) consulting the local narcotics review committee. A progress note was entered into the electronic health record with the findings and any actions taken, and an alert for the primary care clinician and/or prescriber of the controlled substance.</p> <h3>Implementation and Analysis</h3> <p>This quality improvement project spanned 16 weeks from June 2022 through September 2022. Any patient with a UDS that returned with a significant discrepancy was reviewed. The primary outcome was interventions made by the PMOP coordinator or pharmacy resident, as well as time taken to perform the in-depth review of each patient. Patient demographics were also collected. The protocol for this project was approved by the VABHHCS pharmacy and therapeutics committee and was determined to meet guidelines for a nonresearch quality improvement project.</p> <h2>Results</h2> <p>From June 2022 through September 2022, 700 UDSs were performed at VABHHCS with 278 (39.7%) patients identified as having a potential discrepancy based on UDS results. Sixty patients (8.6%)<b> </b>had significant discrepancies that warranted in-depth review. The most common reasons for determining whether a potential discrepancy was not significant included unexpected negatives due to documented non-VA medications no longer being prescribed, unexpected positives due to recent expiration of a controlled substance prescription the patient was still taking, or unexpected positives due to the detection of a substance for which the clinician was already aware. During the 16-week study period, the mean number of patients warranting in-depth review was 4 per week. </p> <p>The patients were predominantly male with a mean age of 61 years, and most (87%) were prescribed at least 1 controlled substance (mean, 1.1), primarily opioids for pain management (Table 1). Most patients had recent substance risk mitigation with UDS (56%) and PDMP (65%) checks within the past year. Of the 60 patients reviewed with significant UDS discrepancies, 50% had a history of discrepant UDS results. Of the 60 UDS discrepancies, there were 37 unexpected positive results (62%), 17 unexpected negative results (28%), and 10 patients with both positive and negative results (17%). THC was the most frequently detected substance, followed by opiates, benzodiazepines, and amphetamines (Table 2). <br/><br/>Each in-depth review with interventions by the PMOP coordinator or pharmacy resident lasted a mean of 14 minutes (Table 3). Five patients were successfully contacted for an interview and 7 patients could not be contacted. The ordering clinician of the UDS sometimes had contacted these patients prior to the PMOP coordinator or pharmacy resident reviewing the UDS dashboard, eliminating the need for additional follow-up.<br/><br/>The most common pharmacist intervention was discussing future actions with the primary care clinician and/or prescriber of the controlled substance (n = 39; 65%). These conversations resulted in actions such as ordering a repeat UDS with confirmatory testing at a future date or agreeing that the clinician would discuss the results and subsequent actions with the patient at an upcoming visit. Pharmacist interventions also included 25 PDMP queries (42%) and 9 orders of confirmatory UDS on the original urine sample (15%). Only 1 patient was evaluated by the narcotics review committee, which resulted in a controlled substance flag being placed on their profile. No patients were referred to substance use disorder treatment or counseling. It was offered to and declined by 1 patient, and 3 patients were already engaged in these services.<br/><br/>Medication therapies that could contribute to false-positive results were also evaluated. Fourteen patients who tested positive for THC had a prescription for a nonsteroidal anti-inflammatory drug or proton-pump inhibitor, which could have created a false-positive result.<sup>6</sup> One patient who tested positive for amphetamines had a prescription for phentermine.<sup>16</sup> No other potential false-positive results were identified.</p> <h2>Discussion</h2> <p>Findings of this project illustrate that the use of a clinical pharmacist to monitor a dashboard of discrepant UDS results created opportunities for collaboration with clinicians and impacted confirmatory testing and PDMP monitoring practices. </p> <p>At the local level, the process had numerous benefits. First, it was a reasonable amount of workload to generate pharmacist interventions: the PMOP coordinator conducted an average of 4 in-depth reviews weekly, each lasting about 14 minutes. Thus, the UDS dashboard allowed the PMOP coordinator to actively surveil all incoming UDS results for potential discrepancies in about 1 hour each week. Pairing the automation of the UDS dashboard with the clinical judgment of the PMOP coordinator seemed to maximize efficiency. VABHHCS provides primary and secondary medical and surgical care to a rural population of approximately 20,000 patients across 5 states; the time required at facilities that serve a higher volume of patients may be greater. <br/><br/>Second, the project served as an opportunity for the PMOP coordinator to provide case-specific clinician education on UDS monitoring. As medication experts, pharmacists can apply their medication-related knowledge to UDS interpretation. This includes understanding drug metabolism and classification and how they apply to UDS results, as well as recognizing medication therapies that could contribute to false-positive UDS results. Research suggests that clinicians may have gaps in their knowledge and may welcome pharmacist assistance in interpreting UDS results.<sup>7,8</sup><br/><br/>Third, the project helped improve rates of confirmatory testing for those with unexpected positive UDS results. Confirmatory testing should be strongly considered if positive results would have significant implications on the future course of treatment.<sup>4</sup> The PMOP coordinator ordered a confirmatory test on 9 patients using the same urine sample used to conduct the initial UDS, minimizing the burden on the patient and laboratory staff. Confirmatory testing was limited by the laboratory’s sample retention period; if the need for confirmatory testing was not recognized soon enough, the sample would no longer be available for retesting. Health systems may consider the use of reflexive confirmatory testing with UDS as an alternative approach, although this may come at an additional cost and may not be warranted in many cases (eg, only 39.7% of all potential discrepancies were deemed as significant within our project). <br/><br/>There were notable incidental findings in our quality improvement project. Among patients with a significant discrepancy on UDS, 50% had a history of ≥ 1 discrepant UDS result. This further emphasizes the importance of appropriate use and interpretation of UDS monitoring for all clinicians, as this may prevent prolonged and potentially inappropriate treatment regimens. Secondly, rates of mental health diagnoses among those with a significant UDS discrepancy seemed relatively high compared to population-level data. For example, among veterans, the overall lifetime prevalence of posttraumatic stress disorder is estimated to be 8.0%; in our project, 35% of patients with a significant UDS discrepancy had a posttraumatic stress disorder diagnosis.<sup>17</sup> This relationship may be an area of further study.<br/><br/>Lastly, it was surprising that the overall rates of UDS and PDMP checks within the past year were 56% and 65%, respectively. VABHHCS requires veterans on controlled substances to have these risk-mitigation strategies performed annually, so our suspicion is that many were falling out due to having been most recently evaluated 12 to 16 months prior. This may represent a limitation of our data-collection method, which reviewed only the previous 12 months.</p> <h3>Limitations</h3> <p>This project was carried out over a period of only 4 months. As a result, only 60 patients received an in-depth review from the PMOP coordinator. Second, the timeliness of the intervention seemed crucial, as delayed in-depth reviews resulted in fewer opportunities to order confirmatory tests or collaborate with clinicians prior to devising an updated plan. Additionally, our process called for UDS dashboard monitoring once a week. Given that the laboratory held samples for only 48 hours, twice- or thrice-weekly review of the UDS dashboard would have allowed for more confirmatory testing, along with more immediate clinician collaboration. Most importantly, the outcomes of this project are only presented via descriptive statistics and without the results of any comparison group, making it impossible to draw firm conclusions about this approach compared to standard-care processes.</p> <h2>Conclusions</h2> <p>This quality improvement project has proven to be valuable at VABHHCS and we intend to continue this pharmacist-led process to monitor the UDS dashboard. VABHHCS leadership are also discussing UDS practices more broadly to further enhance patient management. Within the VA, the PMOP coordinator—charged with being the local coordinator of appropriate pain management and opioid safety practices—is well positioned to assume these responsibilities. Outside of the VA, a pain-management clinical pharmacist or any pharmacist embedded within primary care could similarly perform these duties. Previous literature regarding the implementation of clinical dashboards suggests that with the appropriate software engineering teams and infrastructure, this tool could also be feasibly developed and implemented at other health systems relatively quickly.<sup>14</sup> </p> <p>Overall, a pharmacist-led process to efficiently monitor a dashboard of discrepant UDS results led to opportunities for collaboration with clinicians and positively impacted confirmatory testing and PDMP monitoring at a rural VA health system. </p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>South Dakota State University College of Pharmacy &amp; Allied Health Professions, Brookings<br/><br/><sup>b</sup>Veterans Affairs Black Hills Health Care System, Fort Meade, South Dakota</em> </p> <p class="isub">Acknowledgments</p> <p> <em>The authors express their gratitude to Patrick Spoutz, PharmD, BCPS, VISN 20 Pharmacist Executive, for introducing and sharing the UDS dashboard with our team.</em> </p> <p class="isub">Author disclosures</p> <p> <em>The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <p class="isub">Disclaimer</p> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner, </i>Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.</em> </p> <p class="isub">Ethics and consent</p> <p> <em>The protocol for this project was approved by the Veterans Affairs Black Hills Health Care System pharmacy and therapeutics committee in May 2022 and was determined to meet guidelines for a nonresearch quality improvement project.</em> </p> <h2>References </h2> <p class="reference"> 1. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. <i>MMWR Recomm Rep</i>. 2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1<br/><br/> 2. US Department of Defense, US Department of Veterans Affairs. VA/DoD clinical practice guidelines for the use of opioids in the management of chronic pain. Version 4.0. Published 2002. Accessed January 22, 2024. https://www.healthquality.va.gov/guidelines/Pain/cot/VADoDOpioidsCPG.pdf <br/><br/> 3. Champion C, Kameg BN. Best practices in benzodiazepine prescribing and management in primary care. <i>Nurse Pract</i>. 2021;46(3):30-36.doi:10.1097/01.NPR.0000733684.24949.19<br/><br/> 4. Kale N. Urine drug tests: ordering and interpretation. <i>Am Fam Physician</i>. 2019;99(1):33-39.<br/><br/> 5. Gillespie E, Cunningham JM, Indovina KA. Interpretation of the urine drug screen. <i>The Hospitalist</i>. May 2, 2022. Accessed January 19, 2024. https://www.the-hospitalist.org/hospitalist/article/32085/interpreting-diagnostic-tests/interpretation-of-the-urine-drug-screen/<br/><br/> 6. Schwebach A, Ball J. Urine drug screening: minimizing false-positives and false-negatives to optimize patient care. <i>US Pharm</i>. 2016;41(8):26-30.<br/><br/> 7. Starrels JL, Fox AD, Kunins HV, Cunningham CO. They don’t know what they don’t know: internal medicine residents’ knowledge and confidence in urine drug test interpretation for patients with chronic pain. <i>J Gen Intern Med</i>. 2012;27(11):1521-1527. doi:10.1007/s11606-012-2165-7<br/><br/> 8. Chua I, Petrides AK, Schiff GD, et al. Provider misinterpretation, documentation, and follow-up of definitive urine drug testing results. <i>J Gen Intern Med</i>. 2020;35(1):283-290. doi:10.1007/s11606-019-05514-5<br/><br/> 9. US Department of Veterans Affairs, Veterans Health Administration. VHA Pain Management, Opioid Safety, and Prescription Drug Monitoring Program (PMOP) National Program Field Roles and Responsibilities Manual. October 2021 (V1).[Source not verified] <br/><br/>10. Dorsch MP, Chen CS, Allen AL, et al. Nationwide implementation of a population management dashboard for monitoring direct oral anticoagulants: insights from the Veterans Affairs Health System. <i>Circ Cardiovasc Qual Outcomes</i>. 2023;16(2):e009256. doi:10.1161/CIRCOUTCOMES.122.009256<br/><br/>11. Hu AM, Pepin MJ, Hashem MG, et al. Development of a specialty medication clinical dashboard to improve tumor necrosis factor-α inhibitor safety and adherence monitoring. <i>Am J Health Syst Pharm</i>. 2022;79(8):683-688. doi:10.1093/ajhp/zxab454<br/><br/>12. Homsted FAE, Magee CE, Nesin N. Population health management in a small health system: impact of controlled substance stewardship in a patient-centered medical home. <i>Am J Health Syst Pharm</i>. 2017;74(18):1468-1475. doi:10.2146/ajhp161032<br/><br/>13. US Department of Veterans Affairs, Veterans Health Administration, Pharmacy Benefits (PBM) Services, Clinical Pharmacy Practice Office. Fact Sheet: CPS Role in Population Health Management. 2019. [Source not verified]<br/><br/>14. Anderson D, Zlateva I, Khatri K, Ciaburri N. Using health information technology to improve adherence to opioid prescribing guidelines in primary care. <i>Clin J Pain</i>. 2015;31(6):573-579. doi:10.1097/AJP.0000000000000177<br/><br/>15. Wang EJ, Helgesen R, Johr CR, Lacko HS, Ashburn MA, Merkel PA. Targeted program in an academic rheumatology practice to improve compliance with opioid prescribing guidelines for the treatment of chronic pain. <i>Arthritis Care Res (Hoboken)</i>. 2021;73(10):1425-1429. doi:10.1002/acr.24354<br/><br/>16. Moeller KE, Kissack JC, Atayee RS, Lee KC. Clinical interpretation of urine drug tests: what clinicians need to know about urine drug screens. <i>Mayo Clin Proc</i>. 2017;92(5):774-796. doi:10.1016/j.mayocp.2016.12.007<br/><br/>17. Wisco BE, Marx BP, Wolf EJ, Miller MW, Southwick SM, Pietrzak RH. Posttraumatic stress disorder in the US veteran population: results from the National Health and Resilience in Veterans Study. <i>J Clin Psychiatry</i>. 2014;75(12):1338-46. doi:10.4088/JCP.14m09328 </p> </itemContent> </newsItem> </itemSet></root>
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Diabetes Basic Training Program: Empowering Veterans for Wellness

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Thu, 03/07/2024 - 11:50

More than 37 million Americans (11.3%) have diabetes mellitus (DM), and 90% to 95% are diagnosed with type 2 DM, including nearly 1 in 4 veterans receiving Veterans Health Administration (VHA) care.1,2 DM is associated with serious negative health outcomes, including cardiovascular disease and subsequent complications as well as significant health care system utilization and cost.1,3

Group interventions have been identified as a possible method of improving DM outcomes. For example, shared medical appointments (SMAs) have been identified by the VHA as holding promise for improving care and efficiency for DM and other common health conditions.4 Although the precise structure and SMA process for managing DM has been noted to be heterogeneous, the appointment is typically led by an interdisciplinary health care team and includes individualized assessment including medication review and adjustment, group education, and troubleshooting challenges with management in a group format.5 Research suggests that DM SMAs are a worthwhile treatment approach.5 Several studies have found that SMAs were associated with decreased hemoglobin A1c (Hb A1c) levels and improvement in overall disease complications and severity.6

The high degree of SMA heterogeneity and lack of detailed description of structure and process of SMAs studied has made meta-analysis and other synthesis of the literature difficult.5 Consequently, there is inadequate empirically supported guidance for clinicians and health care organizations on how to best implement SMAs and similar group-based treatments. Edelman and colleagues recommended that future research should focus on more consistent and standardized intervention structures and real-world patient- and staff-centered outcomes to address gaps in the literature.5 They noted that a mental health professional was utilized in only a minority of SMAs studied.5 Additionally, we noted a paucity of studies examining patient satisfaction with SMAs.

Another group-based intervention found to be effective in improving DM outcomes is the 6-session Stanford Diabetes Self-Management Program (DSMP), a workshop led in part by trained peers with DM. The sessions focus on educating patients on DM care and self-management tools. The workshop encourages active practice in building DM self-management skills and confidence. DSMP participation has been associated with improvement in DM-related outcomes, including Hb A1c levels, amount of exercise, and medication adherence.7

While SMAs and DSMP have been shown to enhance clinical outcomes, they provide differing types of patient support. SMAs allow for frequent interaction with a health care professional (HCP) and less emphasis on behavioral health interventions. DSMPs include behavioral health professionals and peer leaders and emphasize higher levels of psychosocial support, but do not offer access to clinicians. It is possible that combining these interventions could result in better outcomes than what either could provide on their own.

In 2018, the Cincinnati Veterans Affairs Medical Center (VAMC) in Ohio offered Diabetes Basic Training, a structured DM intervention. Patients enrolled in the program participated in a 9-week intervention that included 3 SMAs and 6 DSMP sessions. During the SMAs, a clinical psychologist or psychology postdoctoral fellow skilled in motivational interviewing facilitated the group to enhance patient engagement and empowerment for improved self-management. In addition, patients participated in structured DSMP groups with an emphasis on action-planning, often surrounding nutrition, physical activity, and other health behavior change information reviewed during the SMAs.

 

 

Design and Referral

figure.png

Self-management programs for chronic health conditions are often underutilized. Although HCPs may wish to connect veterans with available programs, time constraints may limit opportunities for detailed discussions with patients about specific aspects of each program. To simplify this process, a 2-hour orientation program was offered that explained individual and group DM self-management options (Figure). During this initial visit, patients met with an interdisciplinary care team (registered dietician, diabetes nurse practitioner, and behavioral health specialist) and were informed about Diabetes Basic Training, DM clinical care practices, and other related resources available at the Cincinnati VAMC (eg, cooking classes, food pantry). Patients received individualized referral recommendations and were urged to consult with their primary care practitioner to finalize their treatment plan.

Shared Medical Appointments

Diabetes Basic Training interventions had an average of 6 to 8 veterans participating in the weekly groups. The first, fifth, and final weeks were SMAs in which an interdisciplinary team collaboratively provided group-based health care for DM. The team consisted of a registered nurse, a prescriber (eg, nurse practitioner), a moderator (eg, psychologist), and a content expert (eg, nutritionist). Before each SMA began, the nurse checked-in patients in the SMA room and collected heart rate and blood pressure, and performed a diabetic foot check. Each SMA consisted of introductions, group-driven discussions (facilitated by an HCP) and troubleshooting DM self-management challenges. During group discussions, the prescriber initiated a 1-on-1 discussion with each patient in a private office regarding their recent laboratory results, medication regimen, and other aspects of DM care. The patient’s medications were refilled and/or adjusted as needed and other orders and referrals were submitted. If a patient had a medical question, the prescriber and moderator engaged the entire group so all individuals could benefit from generating and hearing answers. When discussion slowed, education was provided on topics generated by the group. Frequent topics included challenges managing DM, concerns, how DM impacted daily life and relationships, and sharing successes. As needed, HCPs spoke individually with patients following the SMA. Patients were sometimes asked, but never required, to do homework consistent with standard DM care (eg, recording what they eat or blood sugar levels). Each SMA session lasted about 2 hours.

Diabetes Self-Management Program

The second, third, fourth, sixth, seventh, and eighth weeks of the program were devoted to the DSMP. These sessions were delivered primarily by veteran peers who received appropriate training, observation, and certification. Each 2-hour educational program provided ample practice in many fundamental self-management skills, such as decision making, problem solving, and action planning. Patients were asked, but never required, to practice related skills during the sessions and to create weekly action plans to be completed between sessions that typically involved increasing exercise or improving diet. Patients were encouraged to follow up with HCPs at SMAs when they had questions requiring HCP expertise. If participants had more immediate concerns regarding their treatment plan and/or medications, they contacted their primary care practitioner prior to the next SMA.

As a part of participation in the program, psychosocial and health data and Hb A1c levels at baseline (the closest level to 90 days prior to start) and follow-up (the closest level to 90 days after the final session) were collected.8 In addition, Problem Areas in Diabetes (PAID), Patient Activation Measure (PAM)-13, and Diabetes Self-Management Questionnaire (DSMQ) were administered at 3 points: during the orientation, in the first week, and in the ninth week of the program.

PAID, a 20-item self-report questionnaire designed to capture emotional distress related to having DM, is a valid and reliable scale able to detect changes over time when used in intervention studies.9,10 PAM-13 is a 13-item measure designed to assess patient knowledge, skill, and confidence in the self-management of health or chronic conditions based on the original PAM.11,12 Scores fall into 1 of 4 activation levels, ranging from low levels of confidence and knowledge of health management to high levels of being proactive with one’s care. The PAM-13 has been widely used within health psychology, including research among adults with multiple chronic conditions, individuals with DM or osteoarthritis, and within primary care.13-15 The DSMQ is a statistically reliable and valid instrument that allows for user-friendly assessment of self-care behaviors associated with glycemic control.16-18

 

 

Observations

All measures were collected as part of traditional clinical care, and we present initial program evaluation data to demonstrate potential effectiveness of the clinic model. Paired samples t tests were used to examine differences between baseline and follow-up measures for the 24 veteran participants. The age of participants who completed the program ranged from 42 to 74 years (mean, 68 years); 29% of participants were Black veterans and 12% were female. Examination of clinical outcomes indicated that veterans reported significant increases in activation levels for managing their health increasing from a baseline mean (SD) 62.1 (12.3) to 68.4 (14.5) at follow up (t[23] = 2.15, P = .04). Hb A1c levels trended downward from a mean (SD) 8.6% (1.3) at baseline to 8.2% (1.2) at 90-day follow up (t[21] 1.05, P = .30). Similar nonsignificant trends in PAID scores were seen for pre- and postprogram reductions in emotional distress related to having DM from a mean (SD) 7.9 (5.0) at baseline to 6.3 (5.1) (t[18] = 11.51, P = .15), and enhanced self-management of glucose with a mean (SD) 6.5 (1.5) at baseline to 6.8 (1.3) at follow up (t[19] = 0.52, P = .61). The trends found in this study show promising outcomes for this pilot group-based DM treatment, though the small sample size (N = 24) limits statistical power. These findings support further exploration and expansion of interdisciplinary health programs supporting veteran self-management.

Discussion

DM is a condition of epidemic proportions that causes substantial negative health outcomes and costs at a national level. Current standards of DM care do not appear to be reversing these trends. Wider implementation of group-based treatment for DM could improve efficiency of care, increase access to quality care, and reduce burden on individual HCPs.

The VHA continues the transformation of its care system, which shifts toward a patient-centered, proactive focus on veteran well-being. This new whole health approach integrates conventional medical treatment with veteran self-empowerment in the pursuit of health goals based on individual veteran’s identified values.19 This approach emphasizes peer-led explorations of veterans’ aspirations, purpose, and individual mission, personalized health planning, and use of whole health coaches and well-being programs, with both allopathic and complementary and integrative clinical care centered around veterans’ identified goals and priorities.20

Including a program like Diabetes Basic Training as a part of whole health programming could offer several benefits. Diabetes Basic Training is unique in its integration of more traditional SMA structure with psychosocial interventions including values identification and motivational interviewing strategies to enhance patient engagement. Veterans can learn from each other’s experiences and concerns, leading to better DM management knowledge and skills. The group nature of the sessions enhances opportunities for emotional support and reduced isolation, as well as peer accountability for maintaining medication adherence.

By meeting with HCPs from multiple disciplines, veterans are exposed to different perspectives on self-management techniques, including behavioral approaches for overcoming barriers to behavior change. Clinicians have more time to engage with patients, building stronger relationships and trust. SMAs are cost-efficient and time efficient, allowing HCPs to see multiple patients at once, reducing wait times and increasing the number of patients treated in a given time frame.

The COVID-19 pandemic temporarily impacted the ongoing expansion of the program, when so many services were shifted from in-person to virtual classes. Due to staffing and other logistic issues, our pilot program was suspended during that time, but plans to resume the program by early 2024 are moving forward.

CONCLUSIONS

The Diabetes Basic Training program serves as a successful model for implementation within a VAMC. Although the number of veterans with complete data available for analysis was small, the trends exhibited in the preliminary outcome data are promising. We encourage other VAMCs to replicate this program with a larger participant base and evaluate its impact on veteran health outcomes. Next steps include comparing the clinical data from treatment as usual with outcomes from DM group participants. As the program resumes, we will reinitiate recruitment efforts to increase HCP referrals to this program.

References

1. National Institute of Diabetes and Digestive and Kidney Diseases. Diabetes Statistics. Updated February 2023. Accessed January 22, 2024. https://www.niddk.nih.gov/health-information/health-statistics/diabetes-statistics

2. US Department of Veterans Affairs, Office of Research and Development. VA research on diabetes. www.research.va.gov. Updated January 15, 2023. Accessed January 22, 2024. https://www.research.va.gov/topics/diabetes.cfm

3. Halter JB, Musi N, McFarland Horne F, et al. Diabetes and cardiovascular disease in older adults: current status and future directions. Diabetes. 2014;63(8):2578-2589. doi:10.2337/db14-0020

4. Kirsh S, Watts S, Schaub K, et al. VA shared medical appointments for patients with diabetes: maximizing patient and provider expertise to strengthen care management. Updated December 2010. Accessed January 22, 2024. https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1513366&FileName=VA244-14-R-0025-011.pdf

5. Edelman D, Gierisch JM, McDuffie JR, Oddone E, Williams JW Jr. Shared medical appointments for patients with diabetes mellitus: a systematic review. J Gen Intern Med. 2015;30(1):99-106. doi:10.1007/s11606-014-2978-7

6. Watts SA, Strauss GJ, Pascuzzi K, et al. Shared medical appointments for patients with diabetes: glycemic reduction in high-risk patients. J Am Assoc Nurse Pract. 2015;27(8):450-456. doi:10.1002/2327-6924.12200

7. Lorig K, Ritter PL, Turner RM, English K, Laurent DD, Greenberg J. Benefits of diabetes self-management for health plan members: a 6-month translation study. J Med Internet Res. 2016;18(6):e164. Published 2016 Jun 24. doi:10.2196/jmir.5568

8. Gilstrap LG, Chernew ME, Nguyen CA, et al. Association between clinical practice group adherence to quality measures and adverse outcomes among adult patients with diabetes. JAMA Netw Open. 2019;2(8):e199139. Published 2019 Aug 2. doi:10.1001/jamanetworkopen.2019.9139

9. Venkataraman K, Tan LS, Bautista DC, et al. Psychometric properties of the Problem Areas in Diabetes (PAID) instrument in Singapore. PLoS One. 2015;10(9):e0136759. Published 2015 Sep 3. doi:10.1371/journal.pone.0136759

10. Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire. Diabet Med. 2003;20(1):69-72. doi:10.1046/j.1464-5491.2003.00832.x

11. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005;40(6 Pt 1):1918-1930. doi:10.1111/j.1475-6773.2005.00438.x

12. Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004;39(4 Pt 1):1005-1026. doi:10.1111/j.1475-6773.2004.00269.x

13. Ahn YH, Yi CH, Ham OK, Kim BJ. Psychometric properties of the Korean version of the “Patient Activation Measure 13” (PAM13-K) in patients with osteoarthritis. Eval Health Prof. 2015;38(2):255-264. doi:10.1177/0163278714540915

14. Brenk-Franz K, Hibbard JH, Herrmann WJ, et al. Validation of the German version of the patient activation measure 13 (PAM13-D) in an international multicentre study of primary care patients. PLoS One. 2013;8(9):e74786. Published 2013 Sep 30. doi:10.1371/journal.pone.0074786

15. Zill JM, Dwinger S, Kriston L, Rohenkohl A, Härter M, Dirmaier J. Psychometric evaluation of the German version of the Patient Activation Measure (PAM13). BMC Public Health. 2013;13:1027. Published 2013 Oct 30. doi:10.1186/1471-2458-13-1027

16. Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013;11:138. Published 2013 Aug 13. doi:10.1186/1477-7525-11-138

17. Schmitt A, Reimer A, Hermanns N, et al. assessing diabetes self-management with the Diabetes Self-Management Questionnaire (DSMQ) can help analyse behavioural problems related to reduced glycaemic control. PLoS One. 2016;11(3):e0150774. Published 2016 Mar 3. doi:10.1371/journal.pone.0150774

18. Bukhsh A, Lee SWH, Pusparajah P, Schmitt A, Khan TM. Psychometric properties of the Diabetes Self-Management Questionnaire (DSMQ) in Urdu. Health Qual Life Outcomes. 2017;15(1):200. Published 2017 Oct 12. doi:10.1186/s12955-017-0776-8

19. Krejci LP, Carter K, Gaudet T. Whole health: the vision and implementation of personalized, proactive, patient-driven health care for veterans. Med Care. 2014;52(12 Suppl 5):S5-S8. doi:10.1097/MLR.0000000000000226

20. Bokhour BG, Haun JN, Hyde J, Charns M, Kligler B. Transforming the Veterans Affairs to a whole health system of care: time for action and research. Med Care. 2020;58(4):295-300. doi:10.1097/MLR.0000000000001316

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Correspondence:  Jennifer E. Phillips  (phillipsj15@xavier.edu)

aXavier University, Cincinnati, Ohio

bVeterans Affairs Cincinnati Healthcare System, Ohio

cSouth Carolina Department of Mental Health, Columbia

dVeterans Affairs Indiana Healthcare System, Indianapolis

eSt. Elizabeth Healthcare, Cincinnati, Ohio

fHealthSource of Ohio, Loveland

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

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This project was approved by the Cincinnati Veterans Affairs Medical Center Research and Development Committee.

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Correspondence:  Jennifer E. Phillips  (phillipsj15@xavier.edu)

aXavier University, Cincinnati, Ohio

bVeterans Affairs Cincinnati Healthcare System, Ohio

cSouth Carolina Department of Mental Health, Columbia

dVeterans Affairs Indiana Healthcare System, Indianapolis

eSt. Elizabeth Healthcare, Cincinnati, Ohio

fHealthSource of Ohio, Loveland

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The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

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This project was approved by the Cincinnati Veterans Affairs Medical Center Research and Development Committee.

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Jennifer E. Phillips, PhDa; Alli Duncan, MAa; Brock Partlow, PsyDb; Olivia Robinson, PsyDc; Hideki Scherb, PsyDd; Jalean Heikenfeld, APRNe;  Michael Bruner, PsyDf; Shari Frensemeier, PhDb

Correspondence:  Jennifer E. Phillips  (phillipsj15@xavier.edu)

aXavier University, Cincinnati, Ohio

bVeterans Affairs Cincinnati Healthcare System, Ohio

cSouth Carolina Department of Mental Health, Columbia

dVeterans Affairs Indiana Healthcare System, Indianapolis

eSt. Elizabeth Healthcare, Cincinnati, Ohio

fHealthSource of Ohio, Loveland

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Ethics and consent

This project was approved by the Cincinnati Veterans Affairs Medical Center Research and Development Committee.

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More than 37 million Americans (11.3%) have diabetes mellitus (DM), and 90% to 95% are diagnosed with type 2 DM, including nearly 1 in 4 veterans receiving Veterans Health Administration (VHA) care.1,2 DM is associated with serious negative health outcomes, including cardiovascular disease and subsequent complications as well as significant health care system utilization and cost.1,3

Group interventions have been identified as a possible method of improving DM outcomes. For example, shared medical appointments (SMAs) have been identified by the VHA as holding promise for improving care and efficiency for DM and other common health conditions.4 Although the precise structure and SMA process for managing DM has been noted to be heterogeneous, the appointment is typically led by an interdisciplinary health care team and includes individualized assessment including medication review and adjustment, group education, and troubleshooting challenges with management in a group format.5 Research suggests that DM SMAs are a worthwhile treatment approach.5 Several studies have found that SMAs were associated with decreased hemoglobin A1c (Hb A1c) levels and improvement in overall disease complications and severity.6

The high degree of SMA heterogeneity and lack of detailed description of structure and process of SMAs studied has made meta-analysis and other synthesis of the literature difficult.5 Consequently, there is inadequate empirically supported guidance for clinicians and health care organizations on how to best implement SMAs and similar group-based treatments. Edelman and colleagues recommended that future research should focus on more consistent and standardized intervention structures and real-world patient- and staff-centered outcomes to address gaps in the literature.5 They noted that a mental health professional was utilized in only a minority of SMAs studied.5 Additionally, we noted a paucity of studies examining patient satisfaction with SMAs.

Another group-based intervention found to be effective in improving DM outcomes is the 6-session Stanford Diabetes Self-Management Program (DSMP), a workshop led in part by trained peers with DM. The sessions focus on educating patients on DM care and self-management tools. The workshop encourages active practice in building DM self-management skills and confidence. DSMP participation has been associated with improvement in DM-related outcomes, including Hb A1c levels, amount of exercise, and medication adherence.7

While SMAs and DSMP have been shown to enhance clinical outcomes, they provide differing types of patient support. SMAs allow for frequent interaction with a health care professional (HCP) and less emphasis on behavioral health interventions. DSMPs include behavioral health professionals and peer leaders and emphasize higher levels of psychosocial support, but do not offer access to clinicians. It is possible that combining these interventions could result in better outcomes than what either could provide on their own.

In 2018, the Cincinnati Veterans Affairs Medical Center (VAMC) in Ohio offered Diabetes Basic Training, a structured DM intervention. Patients enrolled in the program participated in a 9-week intervention that included 3 SMAs and 6 DSMP sessions. During the SMAs, a clinical psychologist or psychology postdoctoral fellow skilled in motivational interviewing facilitated the group to enhance patient engagement and empowerment for improved self-management. In addition, patients participated in structured DSMP groups with an emphasis on action-planning, often surrounding nutrition, physical activity, and other health behavior change information reviewed during the SMAs.

 

 

Design and Referral

figure.png

Self-management programs for chronic health conditions are often underutilized. Although HCPs may wish to connect veterans with available programs, time constraints may limit opportunities for detailed discussions with patients about specific aspects of each program. To simplify this process, a 2-hour orientation program was offered that explained individual and group DM self-management options (Figure). During this initial visit, patients met with an interdisciplinary care team (registered dietician, diabetes nurse practitioner, and behavioral health specialist) and were informed about Diabetes Basic Training, DM clinical care practices, and other related resources available at the Cincinnati VAMC (eg, cooking classes, food pantry). Patients received individualized referral recommendations and were urged to consult with their primary care practitioner to finalize their treatment plan.

Shared Medical Appointments

Diabetes Basic Training interventions had an average of 6 to 8 veterans participating in the weekly groups. The first, fifth, and final weeks were SMAs in which an interdisciplinary team collaboratively provided group-based health care for DM. The team consisted of a registered nurse, a prescriber (eg, nurse practitioner), a moderator (eg, psychologist), and a content expert (eg, nutritionist). Before each SMA began, the nurse checked-in patients in the SMA room and collected heart rate and blood pressure, and performed a diabetic foot check. Each SMA consisted of introductions, group-driven discussions (facilitated by an HCP) and troubleshooting DM self-management challenges. During group discussions, the prescriber initiated a 1-on-1 discussion with each patient in a private office regarding their recent laboratory results, medication regimen, and other aspects of DM care. The patient’s medications were refilled and/or adjusted as needed and other orders and referrals were submitted. If a patient had a medical question, the prescriber and moderator engaged the entire group so all individuals could benefit from generating and hearing answers. When discussion slowed, education was provided on topics generated by the group. Frequent topics included challenges managing DM, concerns, how DM impacted daily life and relationships, and sharing successes. As needed, HCPs spoke individually with patients following the SMA. Patients were sometimes asked, but never required, to do homework consistent with standard DM care (eg, recording what they eat or blood sugar levels). Each SMA session lasted about 2 hours.

Diabetes Self-Management Program

The second, third, fourth, sixth, seventh, and eighth weeks of the program were devoted to the DSMP. These sessions were delivered primarily by veteran peers who received appropriate training, observation, and certification. Each 2-hour educational program provided ample practice in many fundamental self-management skills, such as decision making, problem solving, and action planning. Patients were asked, but never required, to practice related skills during the sessions and to create weekly action plans to be completed between sessions that typically involved increasing exercise or improving diet. Patients were encouraged to follow up with HCPs at SMAs when they had questions requiring HCP expertise. If participants had more immediate concerns regarding their treatment plan and/or medications, they contacted their primary care practitioner prior to the next SMA.

As a part of participation in the program, psychosocial and health data and Hb A1c levels at baseline (the closest level to 90 days prior to start) and follow-up (the closest level to 90 days after the final session) were collected.8 In addition, Problem Areas in Diabetes (PAID), Patient Activation Measure (PAM)-13, and Diabetes Self-Management Questionnaire (DSMQ) were administered at 3 points: during the orientation, in the first week, and in the ninth week of the program.

PAID, a 20-item self-report questionnaire designed to capture emotional distress related to having DM, is a valid and reliable scale able to detect changes over time when used in intervention studies.9,10 PAM-13 is a 13-item measure designed to assess patient knowledge, skill, and confidence in the self-management of health or chronic conditions based on the original PAM.11,12 Scores fall into 1 of 4 activation levels, ranging from low levels of confidence and knowledge of health management to high levels of being proactive with one’s care. The PAM-13 has been widely used within health psychology, including research among adults with multiple chronic conditions, individuals with DM or osteoarthritis, and within primary care.13-15 The DSMQ is a statistically reliable and valid instrument that allows for user-friendly assessment of self-care behaviors associated with glycemic control.16-18

 

 

Observations

All measures were collected as part of traditional clinical care, and we present initial program evaluation data to demonstrate potential effectiveness of the clinic model. Paired samples t tests were used to examine differences between baseline and follow-up measures for the 24 veteran participants. The age of participants who completed the program ranged from 42 to 74 years (mean, 68 years); 29% of participants were Black veterans and 12% were female. Examination of clinical outcomes indicated that veterans reported significant increases in activation levels for managing their health increasing from a baseline mean (SD) 62.1 (12.3) to 68.4 (14.5) at follow up (t[23] = 2.15, P = .04). Hb A1c levels trended downward from a mean (SD) 8.6% (1.3) at baseline to 8.2% (1.2) at 90-day follow up (t[21] 1.05, P = .30). Similar nonsignificant trends in PAID scores were seen for pre- and postprogram reductions in emotional distress related to having DM from a mean (SD) 7.9 (5.0) at baseline to 6.3 (5.1) (t[18] = 11.51, P = .15), and enhanced self-management of glucose with a mean (SD) 6.5 (1.5) at baseline to 6.8 (1.3) at follow up (t[19] = 0.52, P = .61). The trends found in this study show promising outcomes for this pilot group-based DM treatment, though the small sample size (N = 24) limits statistical power. These findings support further exploration and expansion of interdisciplinary health programs supporting veteran self-management.

Discussion

DM is a condition of epidemic proportions that causes substantial negative health outcomes and costs at a national level. Current standards of DM care do not appear to be reversing these trends. Wider implementation of group-based treatment for DM could improve efficiency of care, increase access to quality care, and reduce burden on individual HCPs.

The VHA continues the transformation of its care system, which shifts toward a patient-centered, proactive focus on veteran well-being. This new whole health approach integrates conventional medical treatment with veteran self-empowerment in the pursuit of health goals based on individual veteran’s identified values.19 This approach emphasizes peer-led explorations of veterans’ aspirations, purpose, and individual mission, personalized health planning, and use of whole health coaches and well-being programs, with both allopathic and complementary and integrative clinical care centered around veterans’ identified goals and priorities.20

Including a program like Diabetes Basic Training as a part of whole health programming could offer several benefits. Diabetes Basic Training is unique in its integration of more traditional SMA structure with psychosocial interventions including values identification and motivational interviewing strategies to enhance patient engagement. Veterans can learn from each other’s experiences and concerns, leading to better DM management knowledge and skills. The group nature of the sessions enhances opportunities for emotional support and reduced isolation, as well as peer accountability for maintaining medication adherence.

By meeting with HCPs from multiple disciplines, veterans are exposed to different perspectives on self-management techniques, including behavioral approaches for overcoming barriers to behavior change. Clinicians have more time to engage with patients, building stronger relationships and trust. SMAs are cost-efficient and time efficient, allowing HCPs to see multiple patients at once, reducing wait times and increasing the number of patients treated in a given time frame.

The COVID-19 pandemic temporarily impacted the ongoing expansion of the program, when so many services were shifted from in-person to virtual classes. Due to staffing and other logistic issues, our pilot program was suspended during that time, but plans to resume the program by early 2024 are moving forward.

CONCLUSIONS

The Diabetes Basic Training program serves as a successful model for implementation within a VAMC. Although the number of veterans with complete data available for analysis was small, the trends exhibited in the preliminary outcome data are promising. We encourage other VAMCs to replicate this program with a larger participant base and evaluate its impact on veteran health outcomes. Next steps include comparing the clinical data from treatment as usual with outcomes from DM group participants. As the program resumes, we will reinitiate recruitment efforts to increase HCP referrals to this program.

More than 37 million Americans (11.3%) have diabetes mellitus (DM), and 90% to 95% are diagnosed with type 2 DM, including nearly 1 in 4 veterans receiving Veterans Health Administration (VHA) care.1,2 DM is associated with serious negative health outcomes, including cardiovascular disease and subsequent complications as well as significant health care system utilization and cost.1,3

Group interventions have been identified as a possible method of improving DM outcomes. For example, shared medical appointments (SMAs) have been identified by the VHA as holding promise for improving care and efficiency for DM and other common health conditions.4 Although the precise structure and SMA process for managing DM has been noted to be heterogeneous, the appointment is typically led by an interdisciplinary health care team and includes individualized assessment including medication review and adjustment, group education, and troubleshooting challenges with management in a group format.5 Research suggests that DM SMAs are a worthwhile treatment approach.5 Several studies have found that SMAs were associated with decreased hemoglobin A1c (Hb A1c) levels and improvement in overall disease complications and severity.6

The high degree of SMA heterogeneity and lack of detailed description of structure and process of SMAs studied has made meta-analysis and other synthesis of the literature difficult.5 Consequently, there is inadequate empirically supported guidance for clinicians and health care organizations on how to best implement SMAs and similar group-based treatments. Edelman and colleagues recommended that future research should focus on more consistent and standardized intervention structures and real-world patient- and staff-centered outcomes to address gaps in the literature.5 They noted that a mental health professional was utilized in only a minority of SMAs studied.5 Additionally, we noted a paucity of studies examining patient satisfaction with SMAs.

Another group-based intervention found to be effective in improving DM outcomes is the 6-session Stanford Diabetes Self-Management Program (DSMP), a workshop led in part by trained peers with DM. The sessions focus on educating patients on DM care and self-management tools. The workshop encourages active practice in building DM self-management skills and confidence. DSMP participation has been associated with improvement in DM-related outcomes, including Hb A1c levels, amount of exercise, and medication adherence.7

While SMAs and DSMP have been shown to enhance clinical outcomes, they provide differing types of patient support. SMAs allow for frequent interaction with a health care professional (HCP) and less emphasis on behavioral health interventions. DSMPs include behavioral health professionals and peer leaders and emphasize higher levels of psychosocial support, but do not offer access to clinicians. It is possible that combining these interventions could result in better outcomes than what either could provide on their own.

In 2018, the Cincinnati Veterans Affairs Medical Center (VAMC) in Ohio offered Diabetes Basic Training, a structured DM intervention. Patients enrolled in the program participated in a 9-week intervention that included 3 SMAs and 6 DSMP sessions. During the SMAs, a clinical psychologist or psychology postdoctoral fellow skilled in motivational interviewing facilitated the group to enhance patient engagement and empowerment for improved self-management. In addition, patients participated in structured DSMP groups with an emphasis on action-planning, often surrounding nutrition, physical activity, and other health behavior change information reviewed during the SMAs.

 

 

Design and Referral

figure.png

Self-management programs for chronic health conditions are often underutilized. Although HCPs may wish to connect veterans with available programs, time constraints may limit opportunities for detailed discussions with patients about specific aspects of each program. To simplify this process, a 2-hour orientation program was offered that explained individual and group DM self-management options (Figure). During this initial visit, patients met with an interdisciplinary care team (registered dietician, diabetes nurse practitioner, and behavioral health specialist) and were informed about Diabetes Basic Training, DM clinical care practices, and other related resources available at the Cincinnati VAMC (eg, cooking classes, food pantry). Patients received individualized referral recommendations and were urged to consult with their primary care practitioner to finalize their treatment plan.

Shared Medical Appointments

Diabetes Basic Training interventions had an average of 6 to 8 veterans participating in the weekly groups. The first, fifth, and final weeks were SMAs in which an interdisciplinary team collaboratively provided group-based health care for DM. The team consisted of a registered nurse, a prescriber (eg, nurse practitioner), a moderator (eg, psychologist), and a content expert (eg, nutritionist). Before each SMA began, the nurse checked-in patients in the SMA room and collected heart rate and blood pressure, and performed a diabetic foot check. Each SMA consisted of introductions, group-driven discussions (facilitated by an HCP) and troubleshooting DM self-management challenges. During group discussions, the prescriber initiated a 1-on-1 discussion with each patient in a private office regarding their recent laboratory results, medication regimen, and other aspects of DM care. The patient’s medications were refilled and/or adjusted as needed and other orders and referrals were submitted. If a patient had a medical question, the prescriber and moderator engaged the entire group so all individuals could benefit from generating and hearing answers. When discussion slowed, education was provided on topics generated by the group. Frequent topics included challenges managing DM, concerns, how DM impacted daily life and relationships, and sharing successes. As needed, HCPs spoke individually with patients following the SMA. Patients were sometimes asked, but never required, to do homework consistent with standard DM care (eg, recording what they eat or blood sugar levels). Each SMA session lasted about 2 hours.

Diabetes Self-Management Program

The second, third, fourth, sixth, seventh, and eighth weeks of the program were devoted to the DSMP. These sessions were delivered primarily by veteran peers who received appropriate training, observation, and certification. Each 2-hour educational program provided ample practice in many fundamental self-management skills, such as decision making, problem solving, and action planning. Patients were asked, but never required, to practice related skills during the sessions and to create weekly action plans to be completed between sessions that typically involved increasing exercise or improving diet. Patients were encouraged to follow up with HCPs at SMAs when they had questions requiring HCP expertise. If participants had more immediate concerns regarding their treatment plan and/or medications, they contacted their primary care practitioner prior to the next SMA.

As a part of participation in the program, psychosocial and health data and Hb A1c levels at baseline (the closest level to 90 days prior to start) and follow-up (the closest level to 90 days after the final session) were collected.8 In addition, Problem Areas in Diabetes (PAID), Patient Activation Measure (PAM)-13, and Diabetes Self-Management Questionnaire (DSMQ) were administered at 3 points: during the orientation, in the first week, and in the ninth week of the program.

PAID, a 20-item self-report questionnaire designed to capture emotional distress related to having DM, is a valid and reliable scale able to detect changes over time when used in intervention studies.9,10 PAM-13 is a 13-item measure designed to assess patient knowledge, skill, and confidence in the self-management of health or chronic conditions based on the original PAM.11,12 Scores fall into 1 of 4 activation levels, ranging from low levels of confidence and knowledge of health management to high levels of being proactive with one’s care. The PAM-13 has been widely used within health psychology, including research among adults with multiple chronic conditions, individuals with DM or osteoarthritis, and within primary care.13-15 The DSMQ is a statistically reliable and valid instrument that allows for user-friendly assessment of self-care behaviors associated with glycemic control.16-18

 

 

Observations

All measures were collected as part of traditional clinical care, and we present initial program evaluation data to demonstrate potential effectiveness of the clinic model. Paired samples t tests were used to examine differences between baseline and follow-up measures for the 24 veteran participants. The age of participants who completed the program ranged from 42 to 74 years (mean, 68 years); 29% of participants were Black veterans and 12% were female. Examination of clinical outcomes indicated that veterans reported significant increases in activation levels for managing their health increasing from a baseline mean (SD) 62.1 (12.3) to 68.4 (14.5) at follow up (t[23] = 2.15, P = .04). Hb A1c levels trended downward from a mean (SD) 8.6% (1.3) at baseline to 8.2% (1.2) at 90-day follow up (t[21] 1.05, P = .30). Similar nonsignificant trends in PAID scores were seen for pre- and postprogram reductions in emotional distress related to having DM from a mean (SD) 7.9 (5.0) at baseline to 6.3 (5.1) (t[18] = 11.51, P = .15), and enhanced self-management of glucose with a mean (SD) 6.5 (1.5) at baseline to 6.8 (1.3) at follow up (t[19] = 0.52, P = .61). The trends found in this study show promising outcomes for this pilot group-based DM treatment, though the small sample size (N = 24) limits statistical power. These findings support further exploration and expansion of interdisciplinary health programs supporting veteran self-management.

Discussion

DM is a condition of epidemic proportions that causes substantial negative health outcomes and costs at a national level. Current standards of DM care do not appear to be reversing these trends. Wider implementation of group-based treatment for DM could improve efficiency of care, increase access to quality care, and reduce burden on individual HCPs.

The VHA continues the transformation of its care system, which shifts toward a patient-centered, proactive focus on veteran well-being. This new whole health approach integrates conventional medical treatment with veteran self-empowerment in the pursuit of health goals based on individual veteran’s identified values.19 This approach emphasizes peer-led explorations of veterans’ aspirations, purpose, and individual mission, personalized health planning, and use of whole health coaches and well-being programs, with both allopathic and complementary and integrative clinical care centered around veterans’ identified goals and priorities.20

Including a program like Diabetes Basic Training as a part of whole health programming could offer several benefits. Diabetes Basic Training is unique in its integration of more traditional SMA structure with psychosocial interventions including values identification and motivational interviewing strategies to enhance patient engagement. Veterans can learn from each other’s experiences and concerns, leading to better DM management knowledge and skills. The group nature of the sessions enhances opportunities for emotional support and reduced isolation, as well as peer accountability for maintaining medication adherence.

By meeting with HCPs from multiple disciplines, veterans are exposed to different perspectives on self-management techniques, including behavioral approaches for overcoming barriers to behavior change. Clinicians have more time to engage with patients, building stronger relationships and trust. SMAs are cost-efficient and time efficient, allowing HCPs to see multiple patients at once, reducing wait times and increasing the number of patients treated in a given time frame.

The COVID-19 pandemic temporarily impacted the ongoing expansion of the program, when so many services were shifted from in-person to virtual classes. Due to staffing and other logistic issues, our pilot program was suspended during that time, but plans to resume the program by early 2024 are moving forward.

CONCLUSIONS

The Diabetes Basic Training program serves as a successful model for implementation within a VAMC. Although the number of veterans with complete data available for analysis was small, the trends exhibited in the preliminary outcome data are promising. We encourage other VAMCs to replicate this program with a larger participant base and evaluate its impact on veteran health outcomes. Next steps include comparing the clinical data from treatment as usual with outcomes from DM group participants. As the program resumes, we will reinitiate recruitment efforts to increase HCP referrals to this program.

References

1. National Institute of Diabetes and Digestive and Kidney Diseases. Diabetes Statistics. Updated February 2023. Accessed January 22, 2024. https://www.niddk.nih.gov/health-information/health-statistics/diabetes-statistics

2. US Department of Veterans Affairs, Office of Research and Development. VA research on diabetes. www.research.va.gov. Updated January 15, 2023. Accessed January 22, 2024. https://www.research.va.gov/topics/diabetes.cfm

3. Halter JB, Musi N, McFarland Horne F, et al. Diabetes and cardiovascular disease in older adults: current status and future directions. Diabetes. 2014;63(8):2578-2589. doi:10.2337/db14-0020

4. Kirsh S, Watts S, Schaub K, et al. VA shared medical appointments for patients with diabetes: maximizing patient and provider expertise to strengthen care management. Updated December 2010. Accessed January 22, 2024. https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1513366&FileName=VA244-14-R-0025-011.pdf

5. Edelman D, Gierisch JM, McDuffie JR, Oddone E, Williams JW Jr. Shared medical appointments for patients with diabetes mellitus: a systematic review. J Gen Intern Med. 2015;30(1):99-106. doi:10.1007/s11606-014-2978-7

6. Watts SA, Strauss GJ, Pascuzzi K, et al. Shared medical appointments for patients with diabetes: glycemic reduction in high-risk patients. J Am Assoc Nurse Pract. 2015;27(8):450-456. doi:10.1002/2327-6924.12200

7. Lorig K, Ritter PL, Turner RM, English K, Laurent DD, Greenberg J. Benefits of diabetes self-management for health plan members: a 6-month translation study. J Med Internet Res. 2016;18(6):e164. Published 2016 Jun 24. doi:10.2196/jmir.5568

8. Gilstrap LG, Chernew ME, Nguyen CA, et al. Association between clinical practice group adherence to quality measures and adverse outcomes among adult patients with diabetes. JAMA Netw Open. 2019;2(8):e199139. Published 2019 Aug 2. doi:10.1001/jamanetworkopen.2019.9139

9. Venkataraman K, Tan LS, Bautista DC, et al. Psychometric properties of the Problem Areas in Diabetes (PAID) instrument in Singapore. PLoS One. 2015;10(9):e0136759. Published 2015 Sep 3. doi:10.1371/journal.pone.0136759

10. Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire. Diabet Med. 2003;20(1):69-72. doi:10.1046/j.1464-5491.2003.00832.x

11. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005;40(6 Pt 1):1918-1930. doi:10.1111/j.1475-6773.2005.00438.x

12. Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004;39(4 Pt 1):1005-1026. doi:10.1111/j.1475-6773.2004.00269.x

13. Ahn YH, Yi CH, Ham OK, Kim BJ. Psychometric properties of the Korean version of the “Patient Activation Measure 13” (PAM13-K) in patients with osteoarthritis. Eval Health Prof. 2015;38(2):255-264. doi:10.1177/0163278714540915

14. Brenk-Franz K, Hibbard JH, Herrmann WJ, et al. Validation of the German version of the patient activation measure 13 (PAM13-D) in an international multicentre study of primary care patients. PLoS One. 2013;8(9):e74786. Published 2013 Sep 30. doi:10.1371/journal.pone.0074786

15. Zill JM, Dwinger S, Kriston L, Rohenkohl A, Härter M, Dirmaier J. Psychometric evaluation of the German version of the Patient Activation Measure (PAM13). BMC Public Health. 2013;13:1027. Published 2013 Oct 30. doi:10.1186/1471-2458-13-1027

16. Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013;11:138. Published 2013 Aug 13. doi:10.1186/1477-7525-11-138

17. Schmitt A, Reimer A, Hermanns N, et al. assessing diabetes self-management with the Diabetes Self-Management Questionnaire (DSMQ) can help analyse behavioural problems related to reduced glycaemic control. PLoS One. 2016;11(3):e0150774. Published 2016 Mar 3. doi:10.1371/journal.pone.0150774

18. Bukhsh A, Lee SWH, Pusparajah P, Schmitt A, Khan TM. Psychometric properties of the Diabetes Self-Management Questionnaire (DSMQ) in Urdu. Health Qual Life Outcomes. 2017;15(1):200. Published 2017 Oct 12. doi:10.1186/s12955-017-0776-8

19. Krejci LP, Carter K, Gaudet T. Whole health: the vision and implementation of personalized, proactive, patient-driven health care for veterans. Med Care. 2014;52(12 Suppl 5):S5-S8. doi:10.1097/MLR.0000000000000226

20. Bokhour BG, Haun JN, Hyde J, Charns M, Kligler B. Transforming the Veterans Affairs to a whole health system of care: time for action and research. Med Care. 2020;58(4):295-300. doi:10.1097/MLR.0000000000001316

References

1. National Institute of Diabetes and Digestive and Kidney Diseases. Diabetes Statistics. Updated February 2023. Accessed January 22, 2024. https://www.niddk.nih.gov/health-information/health-statistics/diabetes-statistics

2. US Department of Veterans Affairs, Office of Research and Development. VA research on diabetes. www.research.va.gov. Updated January 15, 2023. Accessed January 22, 2024. https://www.research.va.gov/topics/diabetes.cfm

3. Halter JB, Musi N, McFarland Horne F, et al. Diabetes and cardiovascular disease in older adults: current status and future directions. Diabetes. 2014;63(8):2578-2589. doi:10.2337/db14-0020

4. Kirsh S, Watts S, Schaub K, et al. VA shared medical appointments for patients with diabetes: maximizing patient and provider expertise to strengthen care management. Updated December 2010. Accessed January 22, 2024. https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1513366&FileName=VA244-14-R-0025-011.pdf

5. Edelman D, Gierisch JM, McDuffie JR, Oddone E, Williams JW Jr. Shared medical appointments for patients with diabetes mellitus: a systematic review. J Gen Intern Med. 2015;30(1):99-106. doi:10.1007/s11606-014-2978-7

6. Watts SA, Strauss GJ, Pascuzzi K, et al. Shared medical appointments for patients with diabetes: glycemic reduction in high-risk patients. J Am Assoc Nurse Pract. 2015;27(8):450-456. doi:10.1002/2327-6924.12200

7. Lorig K, Ritter PL, Turner RM, English K, Laurent DD, Greenberg J. Benefits of diabetes self-management for health plan members: a 6-month translation study. J Med Internet Res. 2016;18(6):e164. Published 2016 Jun 24. doi:10.2196/jmir.5568

8. Gilstrap LG, Chernew ME, Nguyen CA, et al. Association between clinical practice group adherence to quality measures and adverse outcomes among adult patients with diabetes. JAMA Netw Open. 2019;2(8):e199139. Published 2019 Aug 2. doi:10.1001/jamanetworkopen.2019.9139

9. Venkataraman K, Tan LS, Bautista DC, et al. Psychometric properties of the Problem Areas in Diabetes (PAID) instrument in Singapore. PLoS One. 2015;10(9):e0136759. Published 2015 Sep 3. doi:10.1371/journal.pone.0136759

10. Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire. Diabet Med. 2003;20(1):69-72. doi:10.1046/j.1464-5491.2003.00832.x

11. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005;40(6 Pt 1):1918-1930. doi:10.1111/j.1475-6773.2005.00438.x

12. Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004;39(4 Pt 1):1005-1026. doi:10.1111/j.1475-6773.2004.00269.x

13. Ahn YH, Yi CH, Ham OK, Kim BJ. Psychometric properties of the Korean version of the “Patient Activation Measure 13” (PAM13-K) in patients with osteoarthritis. Eval Health Prof. 2015;38(2):255-264. doi:10.1177/0163278714540915

14. Brenk-Franz K, Hibbard JH, Herrmann WJ, et al. Validation of the German version of the patient activation measure 13 (PAM13-D) in an international multicentre study of primary care patients. PLoS One. 2013;8(9):e74786. Published 2013 Sep 30. doi:10.1371/journal.pone.0074786

15. Zill JM, Dwinger S, Kriston L, Rohenkohl A, Härter M, Dirmaier J. Psychometric evaluation of the German version of the Patient Activation Measure (PAM13). BMC Public Health. 2013;13:1027. Published 2013 Oct 30. doi:10.1186/1471-2458-13-1027

16. Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013;11:138. Published 2013 Aug 13. doi:10.1186/1477-7525-11-138

17. Schmitt A, Reimer A, Hermanns N, et al. assessing diabetes self-management with the Diabetes Self-Management Questionnaire (DSMQ) can help analyse behavioural problems related to reduced glycaemic control. PLoS One. 2016;11(3):e0150774. Published 2016 Mar 3. doi:10.1371/journal.pone.0150774

18. Bukhsh A, Lee SWH, Pusparajah P, Schmitt A, Khan TM. Psychometric properties of the Diabetes Self-Management Questionnaire (DSMQ) in Urdu. Health Qual Life Outcomes. 2017;15(1):200. Published 2017 Oct 12. doi:10.1186/s12955-017-0776-8

19. Krejci LP, Carter K, Gaudet T. Whole health: the vision and implementation of personalized, proactive, patient-driven health care for veterans. Med Care. 2014;52(12 Suppl 5):S5-S8. doi:10.1097/MLR.0000000000000226

20. Bokhour BG, Haun JN, Hyde J, Charns M, Kligler B. Transforming the Veterans Affairs to a whole health system of care: time for action and research. Med Care. 2020;58(4):295-300. doi:10.1097/MLR.0000000000001316

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0324 FED Diabetes</fileName> <TBEID>0C02F23B.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F23B</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20240302T212657</firstPublished> <LastPublished>20240302T212657</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240302T212657</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText/> <bylineFull/> <bylineTitleText> Jennifer E. Phillips, PhD a ; Alli Duncan, MA a ; Brock Partlow, PsyD b ; Olivia Robinson, PsyD c ; Hideki Scherb, PsyD d ; Jalean Heikenfeld, APRN e ; Michael Bruner, PsyD f ; Shari Frensemeier, PhD b </bylineTitleText> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>More than 37 million Americans (11.3%) have diabetes mellitus (DM), and 90% to 95% are diagnosed with type 2 DM, including nearly 1 in 4 veterans receiving Vete</metaDescription> <articlePDF/> <teaserImage/> <title>Diabetes Basic Training Program: Empowering Veterans for Wellness</title> <deck/> <eyebrow>Program Profile</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>March</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>3</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>4473</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>March 2024</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Program Profile | 4473<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> </sections> <topics> <term canonical="true">205</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Diabetes Basic Training Program: Empowering Veterans for Wellness</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background:</b> Diabetes impacts 1 in 4 patients in the Veterans Health Administration and is associated with serious negative health consequences in addition to high health care system utilization and cost. The Cincinnati Veterans Affairs Medical Center developed Diabetes Basic Training, a 9-week intervention that blends medical consultation with group support and training in self-management strategies for enhancing patient motivation and empowerment. <br/><br/><b>Observations:</b> Diabetes Basic Training combined 3 monthly shared medical appointments and 6<b> </b>Diabetes Self-Management Program sessions led in part by trained peers with diabetes. Diabetes Self-Management Program sessions focus on educating patients on diabetes and self-management tools and encourage active practice in building self-management skills and confidence. During shared medical appointments, a clinical psychologist or psychology postdoctoral fellow skilled in motivational interviewing facilitated the group to enhance patient motivation and empowerment for improved diabetes self-management.<br/><br/><b>Conclusions:</b> This novel program combined 2 types of group appointments to provide veterans with access to health care professionals and education on diabetes self-management. Preliminary results suggest the need for larger studies and that these programs may be beneficial in a veteran population.</p> <p><span class="Drop">M</span>ore than 37 million Americans (11.3%) have diabetes mellitus (DM), and 90% to 95% are diagnosed with type 2 DM, including nearly 1 in 4 veterans receiving Veterans Health Administration (VHA) care.<sup>1,2</sup> DM is associated with serious negative health outcomes, including cardiovascular disease and subsequent complications as well as significant health care system utilization and cost.<sup>1,3</sup></p> <p>Group interventions have been identified as a possible method of improving DM outcomes. For example, shared medical appointments (SMAs) have been identified by the VHA as holding promise for improving care and efficiency for DM and other common health conditions.<sup>4</sup> Although the precise structure and SMA process for managing DM has been noted to be heterogeneous, the appointment is typically led by an interdisciplinary health care team and includes individualized assessment including medication review and adjustment, group education, and troubleshooting challenges with management in a group format.<sup>5</sup> Research suggests that DM SMAs are a worthwhile treatment approach.<sup>5</sup> Several studies have found that SMAs were associated with decreased hemoglobin A<sub>1c </sub>(Hb A<sub>1c</sub>) levels and improvement in overall disease complications and severity.<sup>6<br/><br/></sup>The high degree of SMA heterogeneity and lack of detailed description of structure and process of SMAs studied has made meta-analysis and other synthesis of the literature difficult.<sup>5</sup> Consequently, there is inadequate empirically supported guidance for clinicians and health care organizations on how to best implement SMAs and similar group-based treatments. Edelman and colleagues recommended that future research should focus on more consistent and standardized intervention structures and real-world patient- and staff-centered outcomes to address gaps in the literature.<sup>5</sup> They noted that a mental health professional was utilized in only a minority of SMAs studied.<sup>5</sup> Additionally, we noted a paucity of studies examining patient satisfaction with SMAs. <br/><br/>Another group-based intervention found to be effective in improving DM outcomes is the 6-session Stanford Diabetes Self-Management Program (DSMP), a workshop led in part by trained peers with DM. The sessions focus on educating patients on DM care and self-management tools. The workshop encourages active practice in building DM self-management skills and confidence. DSMP participation has been associated with improvement in DM-related outcomes, including Hb A<sub>1c </sub>levels, amount of exercise, and medication adherence.<sup>7 <br/><br/></sup>While SMAs and DSMP have been shown to enhance clinical outcomes, they provide differing types of patient support. SMAs allow for frequent interaction with a health care professional (HCP) and less emphasis on behavioral health interventions. DSMPs include behavioral health professionals and peer leaders and emphasize higher levels of psychosocial support, but do not offer access to clinicians. It is possible that combining these interventions could result in better outcomes than what either could provide on their own.<br/><br/>In 2018, the Cincinnati Veterans Affairs Medical Center (VAMC) in Ohio offered Diabetes Basic Training, a structured DM intervention. Patients enrolled in the program participated in a 9-week intervention that included 3<b> </b>SMAs and 6<b> </b>DSMP sessions. During the SMAs, a clinical psychologist or psychology postdoctoral fellow skilled in motivational interviewing facilitated the group to enhance patient engagement and empowerment for improved self-management. In addition, patients participated in structured DSMP groups with an emphasis on action-planning, often surrounding nutrition, physical activity, and other health behavior change information reviewed during the SMAs.</p> <h2>design and referral</h2> <p>Self-management programs for chronic health conditions are often underutilized. Although HCPs may wish to connect veterans with available programs, time constraints may limit opportunities for detailed discussions with patients about specific aspects of each program. To simplify this process, a 2-hour orientation program was offered that explained individual and group DM self-management options (Figure). During this initial visit, patients met with an interdisciplinary care team (registered dietician, diabetes nurse practitioner, and behavioral health specialist) and were informed about Diabetes Basic Training, DM clinical care practices, and other related resources available at the Cincinnati VAMC (eg, cooking classes, food pantry). Patients received individualized referral recommendations and were urged to consult with their primary care practitioner to finalize their treatment plan. </p> <h3>Shared Medical Appointments</h3> <p>Diabetes Basic Training interventions had an average of 6 to 8 veterans participating in the weekly groups. The first, fifth, and final weeks were SMAs in which an interdisciplinary team collaboratively provided group-based health care for DM. The team consisted of a registered nurse, a prescriber (eg, nurse practitioner), a moderator (eg, psychologist), and a content expert (eg, nutritionist). Before each SMA began, the nurse checked-in patients in the SMA room and collected heart rate and blood pressure, and performed a diabetic foot check. Each SMA consisted of introductions, group-driven discussions (facilitated by an HCP) and troubleshooting DM self-management challenges. During group discussions, the prescriber initiated a 1-on-1 discussion with each patient in a private office regarding their recent laboratory results, medication regimen, and other aspects of DM care. The patient’s medications were refilled and/or adjusted as needed and other orders and referrals were submitted. If a patient had a medical question, the prescriber and moderator engaged the entire group so all individuals could benefit from generating and hearing answers. When discussion slowed, education was provided on topics generated by the group. Frequent topics included challenges managing DM, concerns, how DM impacted daily life and relationships, and sharing successes. As needed, HCPs spoke individually with patients following the SMA. Patients were sometimes asked, but never required, to do homework consistent with standard DM care (eg, recording what they eat or blood sugar levels). Each SMA session lasted about 2 hours. </p> <h3>Diabetes Self-Management Program</h3> <p>The second, third, fourth, sixth, seventh, and eighth weeks of the program were devoted to the DSMP. These sessions were delivered primarily by veteran peers who received appropriate training, observation, and certification. Each 2-hour educational program provided ample practice in many fundamental self-management skills, such as decision making, problem solving, and action planning. Patients were asked, but never required, to practice related skills during the sessions and to create weekly action plans to be completed between sessions that typically involved increasing exercise or improving diet. Patients were encouraged to follow up with HCPs at SMAs when they had questions requiring HCP expertise. If participants had more immediate concerns regarding their treatment plan and/or medications, they contacted their primary care practitioner prior to the next SMA. </p> <p>As a part of participation in the program, psychosocial and health data and Hb A<sub>1c </sub>levels at baseline (the closest level to 90 days prior to start) and follow-up (the closest level to 90 days after the final session) were collected.<sup>8</sup> In addition, Problem Areas in Diabetes (PAID), Patient Activation Measure (PAM)-13, and Diabetes Self-Management Questionnaire (DSMQ) were administered at 3 points: during the orientation, in the first week, and in the ninth week of the program. <br/><br/>PAID, a 20-item self-report questionnaire designed to capture <hl name="33674"/>emotional distress related to having DM, is a valid and reliable scale able to detect changes over time when used in intervention studies.<sup>9,10</sup> PAM-13 is a 13-item measure designed to assess patient knowledge, skill, and confidence in the self-management of health or chronic conditions based on the original PAM.<sup>11,12</sup> Scores fall into 1 of 4 activation levels, ranging from low levels of confidence and knowledge of health management to high levels of being proactive with one’s care. The PAM-13 has been widely used within health psychology, including research among adults with multiple chronic conditions, individuals with DM or osteoarthritis, and within primary care.<sup>13-15</sup> The DSMQ is a statistically reliable and valid instrument that allows for user-friendly assessment of self-care behaviors associated with glycemic control.<sup>16-18</sup></p> <h2>Observations</h2> <p>All measures were collected as part of traditional clinical care, and we present initial program evaluation data to demonstrate potential effectiveness of the clinic model. Paired samples <i>t</i> tests were used to examine differences between baseline and follow-up measures for the 24 veteran participants. The age of participants who completed the program ranged from 42 to 74 years (mean, 68 years); 29% of participants were Black veterans and 12% were female. Examination of clinical outcomes indicated that veterans reported significant increases in activation levels for managing their health increasing from a baseline mean (SD) 62.1 (12.3) to 68.4 (14.5) at follow up (t[23] = 2.15, <i>P</i> = .04). Hb A<sub>1c</sub> levels trended downward from a mean (SD) 8.6% (1.3) at baseline to 8.2% (1.2) at 90-day follow up (t[21] 1.05, <i>P</i> = .30). Similar nonsignificant trends in PAID scores were seen for pre- and postprogram reductions in emotional distress related to having DM from a mean (SD) 7.9 (5.0) at baseline to 6.3 (5.1) (t[18] = 11.51, <i>P</i> = .15), and enhanced self-management of glucose with a mean (SD) 6.5 (1.5) at baseline to 6.8 (1.3) at follow up (t[19] = 0.52, <i>P</i> = .61). The trends found in this study show promising outcomes for this pilot group-based DM treatment, though the small sample size (N = 24) limits statistical power. These findings support further exploration and expansion of interdisciplinary health programs supporting veteran self-management. </p> <h2>Discussion</h2> <p>DM is a condition of epidemic proportions that causes substantial negative health outcomes and costs at a national level. Current standards of DM care do not appear to be reversing these trends. Wider implementation of group-based treatment for DM could improve efficiency of care, increase access to quality care, and reduce burden on individual HCPs. </p> <p>The VHA continues the transformation of its care system, which shifts toward a patient-centered, proactive focus on veteran well-being. This new whole health approach integrates conventional medical treatment with veteran self-empowerment in the pursuit of health goals based on individual veteran’s identified values.<sup>19</sup> This approach emphasizes peer-led explorations of veterans’ aspirations, purpose, and individual mission, personalized health planning, and use of whole health coaches and well-being programs, with both allopathic and complementary and integrative clinical care centered around veterans’ identified goals and priorities.<sup>20</sup> <br/><br/>Including a program like Diabetes Basic Training as a part of whole health programming could offer several benefits. Diabetes Basic Training is unique in its integration of more traditional SMA structure with psychosocial interventions including values identification and motivational interviewing strategies to enhance patient engagement. Veterans can learn from each other’s experiences and concerns, leading to better DM management knowledge and skills. The group nature of the sessions enhances opportunities for emotional support and reduced isolation, as well as peer accountability for maintaining medication adherence. <br/><br/>By meeting with HCPs from multiple disciplines, veterans are exposed to different perspectives on self-management techniques, including behavioral approaches for overcoming barriers to behavior change. Clinicians have more time to engage with patients, building stronger relationships and trust. SMAs are cost-efficient and time efficient, allowing HCPs to see multiple patients at once, reducing wait times and increasing the number of patients treated in a given time frame. <br/><br/>The COVID-19 pandemic temporarily impacted the ongoing expansion of the program, when so many services were shifted from in-person to virtual classes. Due to staffing and other logistic issues, our pilot program was suspended during that time, but plans to resume the program by early 2024 are moving forward. </p> <h2>CONCLUSIONS</h2> <p>The Diabetes Basic Training program serves as a successful model for implementation within a VAMC. Although the number of veterans with complete data available for analysis was small, the trends exhibited in the preliminary outcome data are promising. We encourage other VAMCs to replicate this program with a larger participant base and evaluate its impact on veteran health outcomes. Next steps include comparing the clinical data from treatment as usual with outcomes from DM group participants. As the program resumes, we will reinitiate recruitment efforts to increase HCP referrals to this program. </p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>Xavier University, Cincinnati, Ohio<br/><br/><sup>b</sup>Veterans Affairs Cincinnati Healthcare System, Ohio<br/><br/><sup>c</sup>South Carolina Department of Mental Health, Columbia<br/><br/><sup>d</sup>Veterans Affairs Indiana Healthcare System, Indianapolis<br/><br/><sup>e</sup>St. Elizabeth Healthcare, Cincinnati, Ohio<br/><br/><sup>f</sup>HealthSource of Ohio, Loveland</em> </p> <p class="isub">Author disclosures </p> <p> <em>The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <p class="isub">Disclaimer</p> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner</i>, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. </em> </p> <p class="isub">Ethics and consent</p> <p> <em>This project was approved by the Cincinnati Veterans Affairs Medical Center Research and Development Committee.</em> </p> <h2>References</h2> <p class="reference"> 1. National Institute of Diabetes and Digestive and Kidney Diseases. Diabetes Statistics. Updated February 2023. Accessed January 22, 2024. https://www.niddk.nih.gov/health-information/health-statistics/diabetes-statistics<br/><br/> 2. US Department of Veterans Affairs, Office of Research and Development. VA research on diabetes. www.research.va.gov. Updated January 15, 2023. Accessed January 22, 2024. https://www.research.va.gov/topics/diabetes.cfm<br/><br/> 3. Halter JB, Musi N, McFarland Horne F, et al. Diabetes and cardiovascular disease in older adults: current status and future directions. <i>Diabetes</i>. 2014;63(8):2578-2589. doi:10.2337/db14-0020<br/><br/> 4. Kirsh S, Watts S, Schaub K, et al. VA shared medical appointments for patients with diabetes: maximizing patient and provider expertise to strengthen care management. Updated December 2010. Accessed January 22, 2024. https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1513366&amp;FileName=VA244-14-R-0025-011.pdf<br/><br/> 5. Edelman D, Gierisch JM, McDuffie JR, Oddone E, Williams JW Jr. Shared medical appointments for patients with diabetes mellitus: a systematic review. <i>J Gen Intern Med</i>. 2015;30(1):99-106. doi:10.1007/s11606-014-2978-7<br/><br/> 6. Watts SA, Strauss GJ, Pascuzzi K, et al. Shared medical appointments for patients with diabetes: glycemic reduction in high-risk patients. <i>J Am Assoc Nurse Pract</i>. 2015;27(8):450-456. doi:10.1002/2327-6924.12200<br/><br/> 7. Lorig K, Ritter PL, Turner RM, English K, Laurent DD, Greenberg J. Benefits of diabetes self-management for health plan members: a 6-month translation study. <i>J Med Internet Res</i>. 2016;18(6):e164. Published 2016 Jun 24. doi:10.2196/jmir.5568<br/><br/> 8. Gilstrap LG, Chernew ME, Nguyen CA, et al. Association between clinical practice group adherence to quality measures and adverse outcomes among adult patients with diabetes. <i>JAMA Netw Open</i>. 2019;2(8):e199139. Published 2019 Aug 2. doi:10.1001/jamanetworkopen.2019.9139<br/><br/> 9. Venkataraman K, Tan LS, Bautista DC, et al. Psychometric properties of the Problem Areas in Diabetes (PAID) instrument in Singapore. <i>PLoS One</i>. 2015;10(9):e0136759. Published 2015 Sep 3. doi:10.1371/journal.pone.0136759<br/><br/>10. Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire. <i>Diabet Med</i>. 2003;20(1):69-72. doi:10.1046/j.1464-5491.2003.00832.x<br/><br/>11. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. <i>Health Serv Res</i>. 2005;40(6 Pt 1):1918-1930. doi:10.1111/j.1475-6773.2005.00438.x <br/><br/>12. Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. <i>Health Serv Res</i>. 2004;39(4 Pt 1):1005-1026. doi:10.1111/j.1475-6773.2004.00269.x<br/><br/>13. Ahn YH, Yi CH, Ham OK, Kim BJ. Psychometric properties of the Korean version of the “Patient Activation Measure 13” (PAM13-K) in patients with osteoarthritis. <i>Eval Health Prof</i>. 2015;38(2):255-264. doi:10.1177/0163278714540915<br/><br/>14. Brenk-Franz K, Hibbard JH, Herrmann WJ, et al. Validation of the German version of the patient activation measure 13 (PAM13-D) in an international multicentre study of primary care patients. <i>PLoS One</i>. 2013;8(9):e74786. Published 2013 Sep 30. doi:10.1371/journal.pone.0074786<br/><br/>15. Zill JM, Dwinger S, Kriston L, Rohenkohl A, Härter M, Dirmaier J. Psychometric evaluation of the German version of the Patient Activation Measure (PAM13). <i>BMC Public Health</i>. 2013;13:1027. Published 2013 Oct 30. doi:10.1186/1471-2458-13-1027<br/><br/>16. Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. <i>Health Qual Life Outcomes</i>. 2013;11:138. Published 2013 Aug 13. doi:10.1186/1477-7525-11-138<br/><br/>17. Schmitt A, Reimer A, Hermanns N, et al. assessing diabetes self-management with the Diabetes Self-Management Questionnaire (DSMQ) can help analyse behavioural problems related to reduced glycaemic control. <i>PLoS One</i>. 2016;11(3):e0150774. Published 2016 Mar 3. doi:10.1371/journal.pone.0150774<br/><br/>18. Bukhsh A, Lee SWH, Pusparajah P, Schmitt A, Khan TM. Psychometric properties of the Diabetes Self-Management Questionnaire (DSMQ) in Urdu. <i>Health Qual Life Outcomes</i>. 2017;15(1):200. Published 2017 Oct 12. doi:10.1186/s12955-017-0776-8<br/><br/>19. Krejci LP, Carter K, Gaudet T. Whole health: the vision and implementation of personalized, proactive, patient-driven health care for veterans. <i>Med Care</i>. 2014;52(12 Suppl 5):S5-S8. doi:10.1097/MLR.0000000000000226<br/><br/>20. Bokhour BG, Haun JN, Hyde J, Charns M, Kligler B. Transforming the Veterans Affairs to a whole health system of care: time for action and research. <i>Med Care</i>. 2020;58(4):295-300. doi:10.1097/MLR.0000000000001316</p> </itemContent> </newsItem> </itemSet></root>
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Reducing or Discontinuing Insulin or Sulfonylurea When Initiating a Glucagon-like Peptide-1 Agonist

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Sat, 02/03/2024 - 22:32

Hypoglycemia and weight gain are well-known adverse effects that can result from insulin and sulfonylureas in patients with type 2 diabetes mellitus (T2DM).1,2 Insulin and sulfonylurea medications can cause additional weight gain in patients who are overweight or obese, which can increase the burden of diabetes therapy with added medications, raise the risk of hypoglycemia complications, and raise atherosclerotic cardiovascular disease risk factors.3 Although increasing the insulin or sulfonylurea dose is an option health care practitioners or pharmacists have, this approach can increase the risk of hypoglycemia, especially in older adults, such as the veteran population, which could lead to complications, such as falls.2

Previous studies focusing on hypoglycemic events in patients with T2DM showed that glucagon-like peptide-1 (GLP-1) agonist monotherapy has a low incidence of a hypoglycemic events. However, when a GLP-1 agonist is combined with insulin or sulfonylureas, patients have an increased chance of a hypoglycemic event.3-8 According to the prescribing information for semaglutide, 1.6% to 3.8% of patients on a GLP-1 agonist monotherapy reported a documented symptomatic hypoglycemic event (blood glucose ≤ 70 mg/dL), based on semaglutide dosing. 9 Patients on combination therapy of a GLP-1 agonist and basal insulin and a GLP-1 agonist and a sulfonylurea reported a documented symptomatic hypoglycemic event ranging from 16.7% to 29.8% and 17.3% to 24.4%, respectively.9 The incidences of hypoglycemia thus dramatically increase with combination therapy of a GLP-1 agonist plus insulin or a sulfonylurea.

When adding a GLP-1 agonist to insulin or a sulfonylurea, clinicians must be mindful of the increased risk of hypoglycemia. Per the warnings and precautions in the prescribing information of GLP-1 agonists, concomitant use with insulin or a sulfonylurea may increase the risk of hypoglycemia, and reducing the dose of insulin or a sulfonylurea may be necessary.9-11 According to the American College of Cardiology guidelines, when starting a GLP-1 agonist, the insulin dose should be decreased by about 20% in patients with a well-controlled hemoglobin A1c (HbA1c).12

This study aimed to determine the percentage of patients who required dose reductions or discontinuations of insulin and sulfonylureas with the addition of a GLP-1 agonist. Understanding necessary dose reductions or discontinuations of these concomitant diabetes agents can assist pharmacists in preventing hypoglycemia and minimizing weight gain.

Methods

This clinical review was a single-center, retrospective chart review of patients prescribed a GLP-1 agonist while on insulin or a sulfonylurea between January 1, 2019, and September 30, 2022, at the Wilkes-Barre Veterans Affairs Medical Center (WBVAMC) in Pennsylvania and managed in a pharmacist-led patient aligned care team (PACT) clinic. It was determined by the US Department of Veterans Affairs Office of Research and Development that an institutional review board or other review committee approval was not needed for this nonresearch Veterans Health Administration quality assurance and improvement project. Patients aged ≥ 18 years were included in this study. Patients were excluded if they were not on insulin or a sulfonylurea when starting a GLP-1 agonist, started a GLP-1 agonist outside of the retrospective chart review dates, or were prescribed a GLP-1 agonist by anyone other than a pharmacist in their PACT clinic. This included if a GLP-1 agonist was prescribed by a primary care physician, endocrinologist, or someone outside the VA system.

The primary study outcomes were to determine the percentage of patients with a dose reduction of insulin or sulfonylurea and discontinuation of insulin or a sulfonylurea at intervals of 0 (baseline), 3, 6, and 12 months. Secondary outcomes included changes in HbA1c and body weight measured at the same intervals of 0 (baseline), 3, 6, and 12 months.
Data were collected using the VA Computerized Patient Record System (CPRS) and stored in a locked spreadsheet. Descriptive statistics were used to analyze the data. Patient data included the number of patients on insulin or a sulfonylurea when initiating a GLP-1 agonist, the percentage of patients started on a certain GLP-1 agonist (dulaglutide, liraglutide, exenatide, and semaglutide), and the percentage of patients with a baseline HbA1c of < 8%, 8% to 10%, and > 10%. The GLP-1 agonist formulary was adjusted during the time of this retrospective chart review. Patients who were not on semaglutide were switched over if they were on another GLP-1 agonist as semaglutide became the preferred GLP-1 agonist.

Patients were considered to have a dose reduction or discontinuation of insulin or a sulfonylurea if the dose or medication they were on decreased or was discontinued permanently within 12 months of starting a GLP-1 agonist. For example, if a patient who was administering 10 units of insulin daily was decreased to 8 but later increased back to 10, this was not counted as a dose reduction. If a patient discontinued insulin or a sulfonylurea and then restarted it within 12 months of initiating a GLP-1 agonist, this was not counted as a discontinuation.

 

 

Results

This retrospective review included 136 patients; 96 patients taking insulin and 54 taking a sulfonylurea when they started a GLP-1 agonist. Fourteen patients were on both. Criteria for use, which are clinical criteria to determine if a patient is eligible for the use of a given medication, are used within the VA. The inclusion criteria for a patient initiating a GLP-1 agonist is that the patient must have atherosclerotic cardiovascular disease or chronic kidney disease with the patient receiving metformin (unless unable to use metformin) and empagliflozin (unless unable to use empagliflozin).

table.png

The baseline mean age and weight for the patient population in this retrospective chart review was 70.7 years and 238.2 lb, respectively. Ninety-six patients (70.6%) were started on semaglutide, 27 (19.9%) on dulaglutide, 12 (8.8%) on liraglutide, and 1 (0.7%) on exenatide. The mean HbA1c when patients initiated a GLP-1 agonist was 8.6%. When starting a GLP-1 agonist, 34 patients (25.0%) had an HbA1c < 8%, 89 (65.4%) had an HbA1c between 8% to 10%, and 13 (9.6%) had an HbA1c > 10% (Table).

figure.png

For the primary results, 25 patients (26.0%) had a dose reduction of insulin when they started a GLP-1 agonist, and 55 patients (57.3%) had at least 1 insulin dose reduction within the year follow-up. Seven patients (13.0%) had a dose reduction of a sulfonylurea when they started a GLP-1 agonist, and 16 patients (29.6%) had at least 1 dose reduction of a sulfonylurea within the year follow-up. Six patients (6.3%) discontinued insulin use when they initially started a GLP-1 agonist, and 14 patients (14.6%) discontinued insulin use within the year follow-up. Eleven patients (20.4%) discontinued sulfonylurea use when they initially started a GLP-1 agonist, and 21 patients (38.9%) discontinued sulfonylurea use within the year follow-up (Figure).

Fourteen patients were on both insulin and a sulfonylurea. Two patients (14.3%) had a dose reduction of insulin when they started a GLP-1 agonist, and 5 (35.7%) had ≥ 1 insulin dose reduction within the year follow-up. Three patients (21.4%) had a dose reduction of a sulfonylurea when they started a GLP-1 agonist, and 6 (42.9%) had ≥ 1 dose reduction of a sulfonylurea within the year follow-up. Seven patients (50.0%) discontinued sulfonylurea and 3 (21.4%) discontinued insulin at any time throughout the year. The majority of the discontinuations were at the initial start of GLP-1 agonist therapy.

The mean HbA1c for patients on GLP-1 agonist was 8.6% at baseline, 8.0% at 0 to 3 months, 7.6% at 3 to 6 months, and 7.5% at 12 months. Patients experienced a mean HbA1c reduction of 1.1%. The mean weight when a GLP-1 agonist was started was 238.2 lb, 236.0 lb at 0 to 3 months, 223.8 lb at 3 to 6 months, and 224.3 lb after 12 months. Study participants lost a mean weight of 13.9 lb while on a GLP-1 agonist.

Discussion

While this study did not examine why there were dose reductions or discontinuations, we can hypothesize that insulin or sulfonylureas were reduced or discontinued due to a myriad of reasons, such as prophylactic dosing per guidelines, patients having a hypoglycemic event, or pharmacists anticipating potential low blood glucose trends. Also, there could have been numerous reasons GLP-1 agonists were started in patients on insulin or a sulfonylurea, such as HbA1c not being within goal range, cardiovascular benefits (reduce risk of stroke, heart attack, and death), weight loss, and renal protection, such as preventing albuminuria.13,14

This retrospective chart review found a large proportion of patients had a dose reduction of insulin (57.3%) or sulfonylurea (29.6%). The percentage of patients with a dose reduction was potentially underestimated as patients were not counted if they discontinued insulin or sulfonylurea. Concomitant use of GLP-1 agonists with insulin or a sulfonylurea may increase the risk of hypoglycemia and reducing the dose of insulin or a sulfonylurea may be necessary.9-11 The dose reductions in this study show that pharmacists within pharmacy-led PACT clinics monitor for or attempt to prevent hypoglycemia, which aligns with the prescribing information of GLP-1 agonists. While increasing the insulin or sulfonylurea dose is an option for patients, this approach can increase the risk of hypoglycemia, especially in an older population, like this one with a mean age > 70 years. The large proportions of patients with dose reductions or insulin and sulfonylurea discontinuations suggest that pharmacists may need to take a more cautious approach when initiating a GLP-1 agonist to prevent adverse health outcomes related to low blood sugar for older adults, such as falls and fractures.

Insulin was discontinued in 20.4% of patients and sulfonylurea was discontinued in 38.9% of patients within 12 months after starting a GLP-1 agonist. When a patient was on both insulin and a sulfonylurea, the percentage of patients who discontinued insulin (21.4%) or a sulfonylurea (50.0%) was higher compared with patients just on insulin (14.6%) or a sulfonylurea (38.9%) alone. Patients on both insulin and a sulfonylurea may need closer monitoring due to a higher incidence of discontinuations when these diabetes agents are administered in combination.

 

 

Within 12 months of patients receiving a GLP-1 agonist, the mean HbA1c reduction was 1.1%, which is comparable to other GLP-1 agonist clinical trials. For semaglutide 0.5 mg and 1.0 mg dosages, the mean HbA1c reduction was 1.4% and 1.6%, respectively.9 For dulaglutide 0.75 mg and 1.5 mg dosages, the mean HbA1c reduction ranged from 0.7% to 1.6% and 0.8% to 1.6%, respectively.10 For liraglutide 1.8 mg dosage, the mean HbA1c reduction ranged from 1.0% to 1.5%.11 The mean weight loss in this study was 13.9 lb. Along with HbA1c, weight loss in this review was comparable to other GLP-1 agonist clinical trials. Patients administering semaglutide lost up to 14 lb, patients taking dulaglutide lost up to 10.1 lb, and patients on liraglutide lost on average 6.2 lb.9-11 Even with medications such as insulin and sulfonylurea that have the side effects of hypoglycemia and weight gain, adding a GLP-1 agonist showed a reduction in HbA1c and weight loss relatively similar to previous clinical trials.

A study on the effects of adding semaglutide to insulin regimens in March 2023 by Meyer and colleagues displayed similar results to this retrospective chart review. That study concluded that there was blood glucose improvement (HbA1c reduction of 1.3%) in patients after 6 months despite a decrease in the insulin dose. Also, patients lost a mean weight of 11 lb during the 6-month trial.3 This retrospective chart review at the WBVAMC adds to the body of research that supports potential reductions or discontinuations of insulin and/or sulfonylureas with the addition of a GLP-1 agonist.

Limitations

Several limitations of this study should be considered when evaluating the results. This review was comprised of a mostly older, male population, which results in a low generalizability to organizations other than VA medical centers. In addition, this study only evaluated patients on a GLP-1 agonist followed in a pharmacist-led PACT clinic. This study excluded patients who were prescribed a GLP-1 agonist by an endocrinologist or a pharmacist at one of the community-based outpatient clinics affiliated with WBVAMC, or a pharmacist or clinician outside the VA. The sole focus of this study was patients in a pharmacist-led VAMC clinic. Not all patient data may have been included in the study. If a patient did not have an appointment at baseline, 3, 6, and 12 months or did not obtain laboratory tests, HbA1c and weights were not recorded. Data were collected during the COVID-19 pandemic and in-person appointments were potentially switched to phone or video appointments. There were many instances during this chart review where a weight was not recorded at each time interval. Also, this study did not consider any other diabetes medications the patient was taking. There were many instances where the patient was taking metformin and/or sodium-glucose cotransporter-2 (SGLT-2) inhibitors. These medications along with diet could have affected the weight results as metformin is weight neutral and SGLT-2 inhibitors promote weight loss.15 Lastly, this study did not evaluate the amount of insulin reduced, only if there was a dose reduction or discontinuation of insulin and/or a sulfonylurea.

Conclusions

Dose reductions and a discontinuation of insulin or a sulfonylurea with the addition of a GLP-1 agonist may be needed. Patients on both insulin and a sulfonylurea may need closer monitoring due to the higher incidences of discontinuations compared with patients on just 1 of these agents. Dose reductions or discontinuations of these diabetic agents can promote positive patient outcomes, such as preventing hypoglycemia, minimizing weight gain, increasing weight loss, and reducing HbA1c levels.

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the Wilkes-Barre Veterans Affairs Medical Center in Pennsylvania.

References

1. ElSayed NA, Aleppo G, Aroda VR, et al. 8. Obesity and weight management for the prevention and treatment of type 2 diabetes: standards of care in diabetes-2023. Diabetes Care. 2023;46(suppl 1):S128-S139. doi:10.2337/dc23-S008

2. ElSayed NA, Aleppo G, Aroda VE, et al. Older adults: standards of care in diabetes-2023. Diabetes Care. 2023;46(suppl 1):S216-S229. doi:10.2337/dc23-S013

3. Meyer J, Dreischmeier E, Lehmann M, Phelan J. The effects of adding semaglutide to high daily dose insulin regimens in patients with type 2 diabetes. Ann Pharmacother. 2023;57(3):241-250. doi:10.1177/10600280221107381

4. Rodbard HW, Lingvay I, Reed J, et al. Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): a randomized, controlled trial. J Clin Endocrinol Metab. 2018;103(6):2291-2301. doi:10.1210/jc.2018-00070

5. Anderson SL, Trujillo JM. Basal insulin use with GLP-1 receptor agonists. Diabetes Spectr. 2016;29(3):152-160. doi:10.2337/diaspect.29.3.152

6. Castek SL, Healey LC, Kania DS, Vernon VP, Dawson AJ. Assessment of glucagon-like peptide-1 receptor agonists in veterans taking basal/bolus insulin regimens. Fed Pract. 2022;39(suppl 5):S18-S23. doi:10.12788/fp.0317

7. Chen M, Vider E, Plakogiannis R. Insulin dosage adjustments after initiation of GLP-1 receptor agonists in patients with type 2 diabetes. J Pharm Pract. 2022;35(4):511-517. doi:10.1177/0897190021993625

8. Seino Y, Min KW, Niemoeller E, Takami A; EFC10887 GETGOAL-L Asia Study Investigators. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab. 2012;14(10):910-917. doi:10.1111/j.1463-1326.2012.01618.x.

9. Ozempic (semaglutide) injection. Package insert. Novo Nordisk Inc; 2022. https://www.ozempic.com/prescribing-information.html

10. Trulicity (dulaglutide) injection. Prescribing information. Lilly and Company; 2022. Accessed December 20, 2023. https://pi.lilly.com/us/trulicity-uspi.pdf

11. Victoza (liraglutide) injection. Prescribing information. Novo Nordisk Inc; 2022. Accessed December 20, 2023. https://www.novo-pi.com/victoza.pdf

12. Das SR, Everett BM, Birtcher KK, et al. 2020 expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2020;76(9):1117-1145. doi:10.1016/j.jacc.2020.05.037

13. Granata A, Maccarrone R, Anzaldi M, et al. GLP-1 receptor agonists and renal outcomes in patients with diabetes mellitus type 2 and diabetic kidney disease: state of the art. Clin Kidney J. 2022;15(9):1657-1665. Published 2022 Mar 12. doi:10.1093/ckj/sfac069

14. Marx N, Husain M, Lehrke M, Verma S, Sattar N. GLP-1 receptor agonists for the reduction of atherosclerotic cardiovascular risk in patients with type 2 diabetes. Circulation. 2022;146(24):1882-1894. doi:10.1161/CIRCULATIONAHA.122.059595

15. Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022;65(12):1925-1966. doi:10.1007/s00125-022-05787-2

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Emily Herron, PharmDa; Joseph Cencetti, PharmD, BCACP, CLSa; James Matis, PharmDa

Correspondence: Emily Herron (emily.herron@va.gov)

aWilkes-Barre Veterans Affairs Medical Center, Pennsylvania

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

It was determined that this project description approval by an institutional review board or other review committee was not needed. The project was a nonresearch Veteran Health Administration operations activity.

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Author and Disclosure Information

Emily Herron, PharmDa; Joseph Cencetti, PharmD, BCACP, CLSa; James Matis, PharmDa

Correspondence: Emily Herron (emily.herron@va.gov)

aWilkes-Barre Veterans Affairs Medical Center, Pennsylvania

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

It was determined that this project description approval by an institutional review board or other review committee was not needed. The project was a nonresearch Veteran Health Administration operations activity.

Author and Disclosure Information

Emily Herron, PharmDa; Joseph Cencetti, PharmD, BCACP, CLSa; James Matis, PharmDa

Correspondence: Emily Herron (emily.herron@va.gov)

aWilkes-Barre Veterans Affairs Medical Center, Pennsylvania

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

It was determined that this project description approval by an institutional review board or other review committee was not needed. The project was a nonresearch Veteran Health Administration operations activity.

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Article PDF

Hypoglycemia and weight gain are well-known adverse effects that can result from insulin and sulfonylureas in patients with type 2 diabetes mellitus (T2DM).1,2 Insulin and sulfonylurea medications can cause additional weight gain in patients who are overweight or obese, which can increase the burden of diabetes therapy with added medications, raise the risk of hypoglycemia complications, and raise atherosclerotic cardiovascular disease risk factors.3 Although increasing the insulin or sulfonylurea dose is an option health care practitioners or pharmacists have, this approach can increase the risk of hypoglycemia, especially in older adults, such as the veteran population, which could lead to complications, such as falls.2

Previous studies focusing on hypoglycemic events in patients with T2DM showed that glucagon-like peptide-1 (GLP-1) agonist monotherapy has a low incidence of a hypoglycemic events. However, when a GLP-1 agonist is combined with insulin or sulfonylureas, patients have an increased chance of a hypoglycemic event.3-8 According to the prescribing information for semaglutide, 1.6% to 3.8% of patients on a GLP-1 agonist monotherapy reported a documented symptomatic hypoglycemic event (blood glucose ≤ 70 mg/dL), based on semaglutide dosing. 9 Patients on combination therapy of a GLP-1 agonist and basal insulin and a GLP-1 agonist and a sulfonylurea reported a documented symptomatic hypoglycemic event ranging from 16.7% to 29.8% and 17.3% to 24.4%, respectively.9 The incidences of hypoglycemia thus dramatically increase with combination therapy of a GLP-1 agonist plus insulin or a sulfonylurea.

When adding a GLP-1 agonist to insulin or a sulfonylurea, clinicians must be mindful of the increased risk of hypoglycemia. Per the warnings and precautions in the prescribing information of GLP-1 agonists, concomitant use with insulin or a sulfonylurea may increase the risk of hypoglycemia, and reducing the dose of insulin or a sulfonylurea may be necessary.9-11 According to the American College of Cardiology guidelines, when starting a GLP-1 agonist, the insulin dose should be decreased by about 20% in patients with a well-controlled hemoglobin A1c (HbA1c).12

This study aimed to determine the percentage of patients who required dose reductions or discontinuations of insulin and sulfonylureas with the addition of a GLP-1 agonist. Understanding necessary dose reductions or discontinuations of these concomitant diabetes agents can assist pharmacists in preventing hypoglycemia and minimizing weight gain.

Methods

This clinical review was a single-center, retrospective chart review of patients prescribed a GLP-1 agonist while on insulin or a sulfonylurea between January 1, 2019, and September 30, 2022, at the Wilkes-Barre Veterans Affairs Medical Center (WBVAMC) in Pennsylvania and managed in a pharmacist-led patient aligned care team (PACT) clinic. It was determined by the US Department of Veterans Affairs Office of Research and Development that an institutional review board or other review committee approval was not needed for this nonresearch Veterans Health Administration quality assurance and improvement project. Patients aged ≥ 18 years were included in this study. Patients were excluded if they were not on insulin or a sulfonylurea when starting a GLP-1 agonist, started a GLP-1 agonist outside of the retrospective chart review dates, or were prescribed a GLP-1 agonist by anyone other than a pharmacist in their PACT clinic. This included if a GLP-1 agonist was prescribed by a primary care physician, endocrinologist, or someone outside the VA system.

The primary study outcomes were to determine the percentage of patients with a dose reduction of insulin or sulfonylurea and discontinuation of insulin or a sulfonylurea at intervals of 0 (baseline), 3, 6, and 12 months. Secondary outcomes included changes in HbA1c and body weight measured at the same intervals of 0 (baseline), 3, 6, and 12 months.
Data were collected using the VA Computerized Patient Record System (CPRS) and stored in a locked spreadsheet. Descriptive statistics were used to analyze the data. Patient data included the number of patients on insulin or a sulfonylurea when initiating a GLP-1 agonist, the percentage of patients started on a certain GLP-1 agonist (dulaglutide, liraglutide, exenatide, and semaglutide), and the percentage of patients with a baseline HbA1c of < 8%, 8% to 10%, and > 10%. The GLP-1 agonist formulary was adjusted during the time of this retrospective chart review. Patients who were not on semaglutide were switched over if they were on another GLP-1 agonist as semaglutide became the preferred GLP-1 agonist.

Patients were considered to have a dose reduction or discontinuation of insulin or a sulfonylurea if the dose or medication they were on decreased or was discontinued permanently within 12 months of starting a GLP-1 agonist. For example, if a patient who was administering 10 units of insulin daily was decreased to 8 but later increased back to 10, this was not counted as a dose reduction. If a patient discontinued insulin or a sulfonylurea and then restarted it within 12 months of initiating a GLP-1 agonist, this was not counted as a discontinuation.

 

 

Results

This retrospective review included 136 patients; 96 patients taking insulin and 54 taking a sulfonylurea when they started a GLP-1 agonist. Fourteen patients were on both. Criteria for use, which are clinical criteria to determine if a patient is eligible for the use of a given medication, are used within the VA. The inclusion criteria for a patient initiating a GLP-1 agonist is that the patient must have atherosclerotic cardiovascular disease or chronic kidney disease with the patient receiving metformin (unless unable to use metformin) and empagliflozin (unless unable to use empagliflozin).

table.png

The baseline mean age and weight for the patient population in this retrospective chart review was 70.7 years and 238.2 lb, respectively. Ninety-six patients (70.6%) were started on semaglutide, 27 (19.9%) on dulaglutide, 12 (8.8%) on liraglutide, and 1 (0.7%) on exenatide. The mean HbA1c when patients initiated a GLP-1 agonist was 8.6%. When starting a GLP-1 agonist, 34 patients (25.0%) had an HbA1c < 8%, 89 (65.4%) had an HbA1c between 8% to 10%, and 13 (9.6%) had an HbA1c > 10% (Table).

figure.png

For the primary results, 25 patients (26.0%) had a dose reduction of insulin when they started a GLP-1 agonist, and 55 patients (57.3%) had at least 1 insulin dose reduction within the year follow-up. Seven patients (13.0%) had a dose reduction of a sulfonylurea when they started a GLP-1 agonist, and 16 patients (29.6%) had at least 1 dose reduction of a sulfonylurea within the year follow-up. Six patients (6.3%) discontinued insulin use when they initially started a GLP-1 agonist, and 14 patients (14.6%) discontinued insulin use within the year follow-up. Eleven patients (20.4%) discontinued sulfonylurea use when they initially started a GLP-1 agonist, and 21 patients (38.9%) discontinued sulfonylurea use within the year follow-up (Figure).

Fourteen patients were on both insulin and a sulfonylurea. Two patients (14.3%) had a dose reduction of insulin when they started a GLP-1 agonist, and 5 (35.7%) had ≥ 1 insulin dose reduction within the year follow-up. Three patients (21.4%) had a dose reduction of a sulfonylurea when they started a GLP-1 agonist, and 6 (42.9%) had ≥ 1 dose reduction of a sulfonylurea within the year follow-up. Seven patients (50.0%) discontinued sulfonylurea and 3 (21.4%) discontinued insulin at any time throughout the year. The majority of the discontinuations were at the initial start of GLP-1 agonist therapy.

The mean HbA1c for patients on GLP-1 agonist was 8.6% at baseline, 8.0% at 0 to 3 months, 7.6% at 3 to 6 months, and 7.5% at 12 months. Patients experienced a mean HbA1c reduction of 1.1%. The mean weight when a GLP-1 agonist was started was 238.2 lb, 236.0 lb at 0 to 3 months, 223.8 lb at 3 to 6 months, and 224.3 lb after 12 months. Study participants lost a mean weight of 13.9 lb while on a GLP-1 agonist.

Discussion

While this study did not examine why there were dose reductions or discontinuations, we can hypothesize that insulin or sulfonylureas were reduced or discontinued due to a myriad of reasons, such as prophylactic dosing per guidelines, patients having a hypoglycemic event, or pharmacists anticipating potential low blood glucose trends. Also, there could have been numerous reasons GLP-1 agonists were started in patients on insulin or a sulfonylurea, such as HbA1c not being within goal range, cardiovascular benefits (reduce risk of stroke, heart attack, and death), weight loss, and renal protection, such as preventing albuminuria.13,14

This retrospective chart review found a large proportion of patients had a dose reduction of insulin (57.3%) or sulfonylurea (29.6%). The percentage of patients with a dose reduction was potentially underestimated as patients were not counted if they discontinued insulin or sulfonylurea. Concomitant use of GLP-1 agonists with insulin or a sulfonylurea may increase the risk of hypoglycemia and reducing the dose of insulin or a sulfonylurea may be necessary.9-11 The dose reductions in this study show that pharmacists within pharmacy-led PACT clinics monitor for or attempt to prevent hypoglycemia, which aligns with the prescribing information of GLP-1 agonists. While increasing the insulin or sulfonylurea dose is an option for patients, this approach can increase the risk of hypoglycemia, especially in an older population, like this one with a mean age > 70 years. The large proportions of patients with dose reductions or insulin and sulfonylurea discontinuations suggest that pharmacists may need to take a more cautious approach when initiating a GLP-1 agonist to prevent adverse health outcomes related to low blood sugar for older adults, such as falls and fractures.

Insulin was discontinued in 20.4% of patients and sulfonylurea was discontinued in 38.9% of patients within 12 months after starting a GLP-1 agonist. When a patient was on both insulin and a sulfonylurea, the percentage of patients who discontinued insulin (21.4%) or a sulfonylurea (50.0%) was higher compared with patients just on insulin (14.6%) or a sulfonylurea (38.9%) alone. Patients on both insulin and a sulfonylurea may need closer monitoring due to a higher incidence of discontinuations when these diabetes agents are administered in combination.

 

 

Within 12 months of patients receiving a GLP-1 agonist, the mean HbA1c reduction was 1.1%, which is comparable to other GLP-1 agonist clinical trials. For semaglutide 0.5 mg and 1.0 mg dosages, the mean HbA1c reduction was 1.4% and 1.6%, respectively.9 For dulaglutide 0.75 mg and 1.5 mg dosages, the mean HbA1c reduction ranged from 0.7% to 1.6% and 0.8% to 1.6%, respectively.10 For liraglutide 1.8 mg dosage, the mean HbA1c reduction ranged from 1.0% to 1.5%.11 The mean weight loss in this study was 13.9 lb. Along with HbA1c, weight loss in this review was comparable to other GLP-1 agonist clinical trials. Patients administering semaglutide lost up to 14 lb, patients taking dulaglutide lost up to 10.1 lb, and patients on liraglutide lost on average 6.2 lb.9-11 Even with medications such as insulin and sulfonylurea that have the side effects of hypoglycemia and weight gain, adding a GLP-1 agonist showed a reduction in HbA1c and weight loss relatively similar to previous clinical trials.

A study on the effects of adding semaglutide to insulin regimens in March 2023 by Meyer and colleagues displayed similar results to this retrospective chart review. That study concluded that there was blood glucose improvement (HbA1c reduction of 1.3%) in patients after 6 months despite a decrease in the insulin dose. Also, patients lost a mean weight of 11 lb during the 6-month trial.3 This retrospective chart review at the WBVAMC adds to the body of research that supports potential reductions or discontinuations of insulin and/or sulfonylureas with the addition of a GLP-1 agonist.

Limitations

Several limitations of this study should be considered when evaluating the results. This review was comprised of a mostly older, male population, which results in a low generalizability to organizations other than VA medical centers. In addition, this study only evaluated patients on a GLP-1 agonist followed in a pharmacist-led PACT clinic. This study excluded patients who were prescribed a GLP-1 agonist by an endocrinologist or a pharmacist at one of the community-based outpatient clinics affiliated with WBVAMC, or a pharmacist or clinician outside the VA. The sole focus of this study was patients in a pharmacist-led VAMC clinic. Not all patient data may have been included in the study. If a patient did not have an appointment at baseline, 3, 6, and 12 months or did not obtain laboratory tests, HbA1c and weights were not recorded. Data were collected during the COVID-19 pandemic and in-person appointments were potentially switched to phone or video appointments. There were many instances during this chart review where a weight was not recorded at each time interval. Also, this study did not consider any other diabetes medications the patient was taking. There were many instances where the patient was taking metformin and/or sodium-glucose cotransporter-2 (SGLT-2) inhibitors. These medications along with diet could have affected the weight results as metformin is weight neutral and SGLT-2 inhibitors promote weight loss.15 Lastly, this study did not evaluate the amount of insulin reduced, only if there was a dose reduction or discontinuation of insulin and/or a sulfonylurea.

Conclusions

Dose reductions and a discontinuation of insulin or a sulfonylurea with the addition of a GLP-1 agonist may be needed. Patients on both insulin and a sulfonylurea may need closer monitoring due to the higher incidences of discontinuations compared with patients on just 1 of these agents. Dose reductions or discontinuations of these diabetic agents can promote positive patient outcomes, such as preventing hypoglycemia, minimizing weight gain, increasing weight loss, and reducing HbA1c levels.

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the Wilkes-Barre Veterans Affairs Medical Center in Pennsylvania.

Hypoglycemia and weight gain are well-known adverse effects that can result from insulin and sulfonylureas in patients with type 2 diabetes mellitus (T2DM).1,2 Insulin and sulfonylurea medications can cause additional weight gain in patients who are overweight or obese, which can increase the burden of diabetes therapy with added medications, raise the risk of hypoglycemia complications, and raise atherosclerotic cardiovascular disease risk factors.3 Although increasing the insulin or sulfonylurea dose is an option health care practitioners or pharmacists have, this approach can increase the risk of hypoglycemia, especially in older adults, such as the veteran population, which could lead to complications, such as falls.2

Previous studies focusing on hypoglycemic events in patients with T2DM showed that glucagon-like peptide-1 (GLP-1) agonist monotherapy has a low incidence of a hypoglycemic events. However, when a GLP-1 agonist is combined with insulin or sulfonylureas, patients have an increased chance of a hypoglycemic event.3-8 According to the prescribing information for semaglutide, 1.6% to 3.8% of patients on a GLP-1 agonist monotherapy reported a documented symptomatic hypoglycemic event (blood glucose ≤ 70 mg/dL), based on semaglutide dosing. 9 Patients on combination therapy of a GLP-1 agonist and basal insulin and a GLP-1 agonist and a sulfonylurea reported a documented symptomatic hypoglycemic event ranging from 16.7% to 29.8% and 17.3% to 24.4%, respectively.9 The incidences of hypoglycemia thus dramatically increase with combination therapy of a GLP-1 agonist plus insulin or a sulfonylurea.

When adding a GLP-1 agonist to insulin or a sulfonylurea, clinicians must be mindful of the increased risk of hypoglycemia. Per the warnings and precautions in the prescribing information of GLP-1 agonists, concomitant use with insulin or a sulfonylurea may increase the risk of hypoglycemia, and reducing the dose of insulin or a sulfonylurea may be necessary.9-11 According to the American College of Cardiology guidelines, when starting a GLP-1 agonist, the insulin dose should be decreased by about 20% in patients with a well-controlled hemoglobin A1c (HbA1c).12

This study aimed to determine the percentage of patients who required dose reductions or discontinuations of insulin and sulfonylureas with the addition of a GLP-1 agonist. Understanding necessary dose reductions or discontinuations of these concomitant diabetes agents can assist pharmacists in preventing hypoglycemia and minimizing weight gain.

Methods

This clinical review was a single-center, retrospective chart review of patients prescribed a GLP-1 agonist while on insulin or a sulfonylurea between January 1, 2019, and September 30, 2022, at the Wilkes-Barre Veterans Affairs Medical Center (WBVAMC) in Pennsylvania and managed in a pharmacist-led patient aligned care team (PACT) clinic. It was determined by the US Department of Veterans Affairs Office of Research and Development that an institutional review board or other review committee approval was not needed for this nonresearch Veterans Health Administration quality assurance and improvement project. Patients aged ≥ 18 years were included in this study. Patients were excluded if they were not on insulin or a sulfonylurea when starting a GLP-1 agonist, started a GLP-1 agonist outside of the retrospective chart review dates, or were prescribed a GLP-1 agonist by anyone other than a pharmacist in their PACT clinic. This included if a GLP-1 agonist was prescribed by a primary care physician, endocrinologist, or someone outside the VA system.

The primary study outcomes were to determine the percentage of patients with a dose reduction of insulin or sulfonylurea and discontinuation of insulin or a sulfonylurea at intervals of 0 (baseline), 3, 6, and 12 months. Secondary outcomes included changes in HbA1c and body weight measured at the same intervals of 0 (baseline), 3, 6, and 12 months.
Data were collected using the VA Computerized Patient Record System (CPRS) and stored in a locked spreadsheet. Descriptive statistics were used to analyze the data. Patient data included the number of patients on insulin or a sulfonylurea when initiating a GLP-1 agonist, the percentage of patients started on a certain GLP-1 agonist (dulaglutide, liraglutide, exenatide, and semaglutide), and the percentage of patients with a baseline HbA1c of < 8%, 8% to 10%, and > 10%. The GLP-1 agonist formulary was adjusted during the time of this retrospective chart review. Patients who were not on semaglutide were switched over if they were on another GLP-1 agonist as semaglutide became the preferred GLP-1 agonist.

Patients were considered to have a dose reduction or discontinuation of insulin or a sulfonylurea if the dose or medication they were on decreased or was discontinued permanently within 12 months of starting a GLP-1 agonist. For example, if a patient who was administering 10 units of insulin daily was decreased to 8 but later increased back to 10, this was not counted as a dose reduction. If a patient discontinued insulin or a sulfonylurea and then restarted it within 12 months of initiating a GLP-1 agonist, this was not counted as a discontinuation.

 

 

Results

This retrospective review included 136 patients; 96 patients taking insulin and 54 taking a sulfonylurea when they started a GLP-1 agonist. Fourteen patients were on both. Criteria for use, which are clinical criteria to determine if a patient is eligible for the use of a given medication, are used within the VA. The inclusion criteria for a patient initiating a GLP-1 agonist is that the patient must have atherosclerotic cardiovascular disease or chronic kidney disease with the patient receiving metformin (unless unable to use metformin) and empagliflozin (unless unable to use empagliflozin).

table.png

The baseline mean age and weight for the patient population in this retrospective chart review was 70.7 years and 238.2 lb, respectively. Ninety-six patients (70.6%) were started on semaglutide, 27 (19.9%) on dulaglutide, 12 (8.8%) on liraglutide, and 1 (0.7%) on exenatide. The mean HbA1c when patients initiated a GLP-1 agonist was 8.6%. When starting a GLP-1 agonist, 34 patients (25.0%) had an HbA1c < 8%, 89 (65.4%) had an HbA1c between 8% to 10%, and 13 (9.6%) had an HbA1c > 10% (Table).

figure.png

For the primary results, 25 patients (26.0%) had a dose reduction of insulin when they started a GLP-1 agonist, and 55 patients (57.3%) had at least 1 insulin dose reduction within the year follow-up. Seven patients (13.0%) had a dose reduction of a sulfonylurea when they started a GLP-1 agonist, and 16 patients (29.6%) had at least 1 dose reduction of a sulfonylurea within the year follow-up. Six patients (6.3%) discontinued insulin use when they initially started a GLP-1 agonist, and 14 patients (14.6%) discontinued insulin use within the year follow-up. Eleven patients (20.4%) discontinued sulfonylurea use when they initially started a GLP-1 agonist, and 21 patients (38.9%) discontinued sulfonylurea use within the year follow-up (Figure).

Fourteen patients were on both insulin and a sulfonylurea. Two patients (14.3%) had a dose reduction of insulin when they started a GLP-1 agonist, and 5 (35.7%) had ≥ 1 insulin dose reduction within the year follow-up. Three patients (21.4%) had a dose reduction of a sulfonylurea when they started a GLP-1 agonist, and 6 (42.9%) had ≥ 1 dose reduction of a sulfonylurea within the year follow-up. Seven patients (50.0%) discontinued sulfonylurea and 3 (21.4%) discontinued insulin at any time throughout the year. The majority of the discontinuations were at the initial start of GLP-1 agonist therapy.

The mean HbA1c for patients on GLP-1 agonist was 8.6% at baseline, 8.0% at 0 to 3 months, 7.6% at 3 to 6 months, and 7.5% at 12 months. Patients experienced a mean HbA1c reduction of 1.1%. The mean weight when a GLP-1 agonist was started was 238.2 lb, 236.0 lb at 0 to 3 months, 223.8 lb at 3 to 6 months, and 224.3 lb after 12 months. Study participants lost a mean weight of 13.9 lb while on a GLP-1 agonist.

Discussion

While this study did not examine why there were dose reductions or discontinuations, we can hypothesize that insulin or sulfonylureas were reduced or discontinued due to a myriad of reasons, such as prophylactic dosing per guidelines, patients having a hypoglycemic event, or pharmacists anticipating potential low blood glucose trends. Also, there could have been numerous reasons GLP-1 agonists were started in patients on insulin or a sulfonylurea, such as HbA1c not being within goal range, cardiovascular benefits (reduce risk of stroke, heart attack, and death), weight loss, and renal protection, such as preventing albuminuria.13,14

This retrospective chart review found a large proportion of patients had a dose reduction of insulin (57.3%) or sulfonylurea (29.6%). The percentage of patients with a dose reduction was potentially underestimated as patients were not counted if they discontinued insulin or sulfonylurea. Concomitant use of GLP-1 agonists with insulin or a sulfonylurea may increase the risk of hypoglycemia and reducing the dose of insulin or a sulfonylurea may be necessary.9-11 The dose reductions in this study show that pharmacists within pharmacy-led PACT clinics monitor for or attempt to prevent hypoglycemia, which aligns with the prescribing information of GLP-1 agonists. While increasing the insulin or sulfonylurea dose is an option for patients, this approach can increase the risk of hypoglycemia, especially in an older population, like this one with a mean age > 70 years. The large proportions of patients with dose reductions or insulin and sulfonylurea discontinuations suggest that pharmacists may need to take a more cautious approach when initiating a GLP-1 agonist to prevent adverse health outcomes related to low blood sugar for older adults, such as falls and fractures.

Insulin was discontinued in 20.4% of patients and sulfonylurea was discontinued in 38.9% of patients within 12 months after starting a GLP-1 agonist. When a patient was on both insulin and a sulfonylurea, the percentage of patients who discontinued insulin (21.4%) or a sulfonylurea (50.0%) was higher compared with patients just on insulin (14.6%) or a sulfonylurea (38.9%) alone. Patients on both insulin and a sulfonylurea may need closer monitoring due to a higher incidence of discontinuations when these diabetes agents are administered in combination.

 

 

Within 12 months of patients receiving a GLP-1 agonist, the mean HbA1c reduction was 1.1%, which is comparable to other GLP-1 agonist clinical trials. For semaglutide 0.5 mg and 1.0 mg dosages, the mean HbA1c reduction was 1.4% and 1.6%, respectively.9 For dulaglutide 0.75 mg and 1.5 mg dosages, the mean HbA1c reduction ranged from 0.7% to 1.6% and 0.8% to 1.6%, respectively.10 For liraglutide 1.8 mg dosage, the mean HbA1c reduction ranged from 1.0% to 1.5%.11 The mean weight loss in this study was 13.9 lb. Along with HbA1c, weight loss in this review was comparable to other GLP-1 agonist clinical trials. Patients administering semaglutide lost up to 14 lb, patients taking dulaglutide lost up to 10.1 lb, and patients on liraglutide lost on average 6.2 lb.9-11 Even with medications such as insulin and sulfonylurea that have the side effects of hypoglycemia and weight gain, adding a GLP-1 agonist showed a reduction in HbA1c and weight loss relatively similar to previous clinical trials.

A study on the effects of adding semaglutide to insulin regimens in March 2023 by Meyer and colleagues displayed similar results to this retrospective chart review. That study concluded that there was blood glucose improvement (HbA1c reduction of 1.3%) in patients after 6 months despite a decrease in the insulin dose. Also, patients lost a mean weight of 11 lb during the 6-month trial.3 This retrospective chart review at the WBVAMC adds to the body of research that supports potential reductions or discontinuations of insulin and/or sulfonylureas with the addition of a GLP-1 agonist.

Limitations

Several limitations of this study should be considered when evaluating the results. This review was comprised of a mostly older, male population, which results in a low generalizability to organizations other than VA medical centers. In addition, this study only evaluated patients on a GLP-1 agonist followed in a pharmacist-led PACT clinic. This study excluded patients who were prescribed a GLP-1 agonist by an endocrinologist or a pharmacist at one of the community-based outpatient clinics affiliated with WBVAMC, or a pharmacist or clinician outside the VA. The sole focus of this study was patients in a pharmacist-led VAMC clinic. Not all patient data may have been included in the study. If a patient did not have an appointment at baseline, 3, 6, and 12 months or did not obtain laboratory tests, HbA1c and weights were not recorded. Data were collected during the COVID-19 pandemic and in-person appointments were potentially switched to phone or video appointments. There were many instances during this chart review where a weight was not recorded at each time interval. Also, this study did not consider any other diabetes medications the patient was taking. There were many instances where the patient was taking metformin and/or sodium-glucose cotransporter-2 (SGLT-2) inhibitors. These medications along with diet could have affected the weight results as metformin is weight neutral and SGLT-2 inhibitors promote weight loss.15 Lastly, this study did not evaluate the amount of insulin reduced, only if there was a dose reduction or discontinuation of insulin and/or a sulfonylurea.

Conclusions

Dose reductions and a discontinuation of insulin or a sulfonylurea with the addition of a GLP-1 agonist may be needed. Patients on both insulin and a sulfonylurea may need closer monitoring due to the higher incidences of discontinuations compared with patients on just 1 of these agents. Dose reductions or discontinuations of these diabetic agents can promote positive patient outcomes, such as preventing hypoglycemia, minimizing weight gain, increasing weight loss, and reducing HbA1c levels.

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the Wilkes-Barre Veterans Affairs Medical Center in Pennsylvania.

References

1. ElSayed NA, Aleppo G, Aroda VR, et al. 8. Obesity and weight management for the prevention and treatment of type 2 diabetes: standards of care in diabetes-2023. Diabetes Care. 2023;46(suppl 1):S128-S139. doi:10.2337/dc23-S008

2. ElSayed NA, Aleppo G, Aroda VE, et al. Older adults: standards of care in diabetes-2023. Diabetes Care. 2023;46(suppl 1):S216-S229. doi:10.2337/dc23-S013

3. Meyer J, Dreischmeier E, Lehmann M, Phelan J. The effects of adding semaglutide to high daily dose insulin regimens in patients with type 2 diabetes. Ann Pharmacother. 2023;57(3):241-250. doi:10.1177/10600280221107381

4. Rodbard HW, Lingvay I, Reed J, et al. Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): a randomized, controlled trial. J Clin Endocrinol Metab. 2018;103(6):2291-2301. doi:10.1210/jc.2018-00070

5. Anderson SL, Trujillo JM. Basal insulin use with GLP-1 receptor agonists. Diabetes Spectr. 2016;29(3):152-160. doi:10.2337/diaspect.29.3.152

6. Castek SL, Healey LC, Kania DS, Vernon VP, Dawson AJ. Assessment of glucagon-like peptide-1 receptor agonists in veterans taking basal/bolus insulin regimens. Fed Pract. 2022;39(suppl 5):S18-S23. doi:10.12788/fp.0317

7. Chen M, Vider E, Plakogiannis R. Insulin dosage adjustments after initiation of GLP-1 receptor agonists in patients with type 2 diabetes. J Pharm Pract. 2022;35(4):511-517. doi:10.1177/0897190021993625

8. Seino Y, Min KW, Niemoeller E, Takami A; EFC10887 GETGOAL-L Asia Study Investigators. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab. 2012;14(10):910-917. doi:10.1111/j.1463-1326.2012.01618.x.

9. Ozempic (semaglutide) injection. Package insert. Novo Nordisk Inc; 2022. https://www.ozempic.com/prescribing-information.html

10. Trulicity (dulaglutide) injection. Prescribing information. Lilly and Company; 2022. Accessed December 20, 2023. https://pi.lilly.com/us/trulicity-uspi.pdf

11. Victoza (liraglutide) injection. Prescribing information. Novo Nordisk Inc; 2022. Accessed December 20, 2023. https://www.novo-pi.com/victoza.pdf

12. Das SR, Everett BM, Birtcher KK, et al. 2020 expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2020;76(9):1117-1145. doi:10.1016/j.jacc.2020.05.037

13. Granata A, Maccarrone R, Anzaldi M, et al. GLP-1 receptor agonists and renal outcomes in patients with diabetes mellitus type 2 and diabetic kidney disease: state of the art. Clin Kidney J. 2022;15(9):1657-1665. Published 2022 Mar 12. doi:10.1093/ckj/sfac069

14. Marx N, Husain M, Lehrke M, Verma S, Sattar N. GLP-1 receptor agonists for the reduction of atherosclerotic cardiovascular risk in patients with type 2 diabetes. Circulation. 2022;146(24):1882-1894. doi:10.1161/CIRCULATIONAHA.122.059595

15. Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022;65(12):1925-1966. doi:10.1007/s00125-022-05787-2

References

1. ElSayed NA, Aleppo G, Aroda VR, et al. 8. Obesity and weight management for the prevention and treatment of type 2 diabetes: standards of care in diabetes-2023. Diabetes Care. 2023;46(suppl 1):S128-S139. doi:10.2337/dc23-S008

2. ElSayed NA, Aleppo G, Aroda VE, et al. Older adults: standards of care in diabetes-2023. Diabetes Care. 2023;46(suppl 1):S216-S229. doi:10.2337/dc23-S013

3. Meyer J, Dreischmeier E, Lehmann M, Phelan J. The effects of adding semaglutide to high daily dose insulin regimens in patients with type 2 diabetes. Ann Pharmacother. 2023;57(3):241-250. doi:10.1177/10600280221107381

4. Rodbard HW, Lingvay I, Reed J, et al. Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): a randomized, controlled trial. J Clin Endocrinol Metab. 2018;103(6):2291-2301. doi:10.1210/jc.2018-00070

5. Anderson SL, Trujillo JM. Basal insulin use with GLP-1 receptor agonists. Diabetes Spectr. 2016;29(3):152-160. doi:10.2337/diaspect.29.3.152

6. Castek SL, Healey LC, Kania DS, Vernon VP, Dawson AJ. Assessment of glucagon-like peptide-1 receptor agonists in veterans taking basal/bolus insulin regimens. Fed Pract. 2022;39(suppl 5):S18-S23. doi:10.12788/fp.0317

7. Chen M, Vider E, Plakogiannis R. Insulin dosage adjustments after initiation of GLP-1 receptor agonists in patients with type 2 diabetes. J Pharm Pract. 2022;35(4):511-517. doi:10.1177/0897190021993625

8. Seino Y, Min KW, Niemoeller E, Takami A; EFC10887 GETGOAL-L Asia Study Investigators. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab. 2012;14(10):910-917. doi:10.1111/j.1463-1326.2012.01618.x.

9. Ozempic (semaglutide) injection. Package insert. Novo Nordisk Inc; 2022. https://www.ozempic.com/prescribing-information.html

10. Trulicity (dulaglutide) injection. Prescribing information. Lilly and Company; 2022. Accessed December 20, 2023. https://pi.lilly.com/us/trulicity-uspi.pdf

11. Victoza (liraglutide) injection. Prescribing information. Novo Nordisk Inc; 2022. Accessed December 20, 2023. https://www.novo-pi.com/victoza.pdf

12. Das SR, Everett BM, Birtcher KK, et al. 2020 expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2020;76(9):1117-1145. doi:10.1016/j.jacc.2020.05.037

13. Granata A, Maccarrone R, Anzaldi M, et al. GLP-1 receptor agonists and renal outcomes in patients with diabetes mellitus type 2 and diabetic kidney disease: state of the art. Clin Kidney J. 2022;15(9):1657-1665. Published 2022 Mar 12. doi:10.1093/ckj/sfac069

14. Marx N, Husain M, Lehrke M, Verma S, Sattar N. GLP-1 receptor agonists for the reduction of atherosclerotic cardiovascular risk in patients with type 2 diabetes. Circulation. 2022;146(24):1882-1894. doi:10.1161/CIRCULATIONAHA.122.059595

15. Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022;65(12):1925-1966. doi:10.1007/s00125-022-05787-2

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All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> <term>112</term> </sections> <topics> <term canonical="true">205</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Reducing or Discontinuing Insulin or Sulfonylurea When Initiating a Glucagon-like Peptide-1 Agonist</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background:</b> Hypoglycemia and weight gain are well-known adverse effects of insulin and sulfonylureas in patients with type 2 diabetes. Glucagon-like peptide-1 (GLP-1) agonist monotherapy has a low incidence of hypoglycemia, but when combined with insulin or sulfonylureas, patients have higher rates of hypoglycemia. <br/><br/><b>Methods:</b> The primary study outcome was to determine the percentage of patients with dose reductions or discontinuation of insulin or a sulfonylurea at baseline, 3, 6, and 12 months. Secondary outcomes included changes in hemoglobin A<sub>1c</sub> and body weight measured. This was a single-center, quality assurance, quality improvement, retrospective chart review of patients prescribed a GLP-1 agonist while on insulin and/or a sulfonylurea between January 1, 2019, and September 30, 2022, at a pharmacist-led patient aligned care team (PACT) clinic at the Wilkes-Barre Veterans Affairs Medical Center.<br/><br/><b>Results:</b> This retrospective chart review included 136 patients. Throughout 12 months of following the pharmacist-led PACT clinic, 55 patients (57.3%) had ≥ 1 insulin dose reduction, 16 patients (29.6%) had ≥ 1 dose reduction of a sulfonylurea, 14 patients (14.6%) discontinued insulin, and 21<b> </b>patients (38.9%) discontinued their sulfonylurea. <b>Conclusions:</b> Patients taking insulin and/or sulfonylurea in combination with a GLP-1 agonist may require a dose reduction or discontinuation of the diabetic agents. Patients on both insulin and sulfonylurea may need closer monitoring due to the higher incidences of discontinuations compared with patients on only 1 of these agents. Dose reductions or discontinuations of these diabetic agents can promote positive patient outcomes, such as preventing hypoglycemia, minimizing weight gain, increasing weight loss, and reducing hemoglobin A<hl name="33673"/><sub>1c</sub>.</p> <p><span class="Drop">H</span>ypoglycemia and weight gain are well-known adverse effects that can result from insulin and sulfonylureas in patients with type 2 diabetes mellitus (T2DM).<sup>1,2</sup> Insulin and sulfonylurea medications can cause additional weight gain in patients who are overweight or obese, which can increase the burden of diabetes therapy with added medications, raise the risk of hypoglycemia complications, and raise atherosclerotic cardiovascular disease risk factors.<sup>3</sup> Although increasing the insulin or sulfonylurea dose is an option health care practitioners or pharmacists have, this approach can increase the risk of hypoglycemia, especially in older adults, such as the veteran population, which could lead to complications, such as falls.<sup>2</sup> </p> <p>Previous studies focusing on hypoglycemic events in patients with T2DM showed that glucagon-like peptide-1 (GLP-1) agonist monotherapy has a low incidence of a hypoglycemic events. However, when a GLP-1 agonist is combined with insulin or sulfonylureas, patients have an increased chance of a hypoglycemic event.<sup>3-8</sup> According to the prescribing information for semaglutide, 1.6% to 3.8% of patients on a GLP-1 agonist monotherapy reported a documented symptomatic hypoglycemic event (blood glucose ≤ 70 mg/dL), based on semaglutide dosing.<sup> 9</sup> Patients on combination therapy of a GLP-1 agonist and basal insulin and a GLP-1 agonist and a sulfonylurea reported a documented symptomatic hypoglycemic event ranging from 16.7% to 29.8% and 17.3% to 24.4%, respectively.<sup>9</sup> The incidences of hypoglycemia thus dramatically increase with combination therapy of a GLP-1 agonist plus insulin or a sulfonylurea. <br/><br/>When adding a GLP-1 agonist to insulin or a sulfonylurea, clinicians must be mindful of the increased risk of hypoglycemia. Per the warnings and precautions in the prescribing information of GLP-1 agonists, concomitant use with insulin or a sulfonylurea may increase the risk of hypoglycemia, and reducing the dose of insulin or a sulfonylurea may be necessary.<sup>9-11</sup> According to the American College of Cardiology guidelines, when starting a GLP-1 agonist, the insulin dose should be decreased by about 20% in patients with a well-controlled hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>).<sup>12</sup> <br/><br/>This study aimed to determine the percentage of patients who required dose reductions or discontinuations of insulin and sulfonylureas with the addition of a GLP-1 agonist. Understanding necessary dose reductions or discontinuations of these concomitant diabetes agents can assist pharmacists in preventing hypoglycemia and minimizing weight gain. </p> <h2>Methods</h2> <p>This clinical review was a single-center, retrospective chart review of patients prescribed a GLP-1 agonist while on insulin or a sulfonylurea between January 1, 2019, and September 30, 2022, at the Wilkes-Barre Veterans Affairs Medical Center (WBVAMC) in Pennsylvania and managed in a pharmacist-led patient aligned care team (PACT) clinic. It was determined by the US Department of Veterans Affairs Office of Research and Development that an institutional review board or other review committee approval was not needed for this nonresearch Veterans Health Administration quality assurance and improvement project. Patients aged ≥ 18 years were included in this study. Patients were excluded if they were not on insulin or a sulfonylurea when starting a GLP-1 agonist, started a GLP-1 agonist outside of the retrospective chart review dates, or were prescribed a GLP-1 agonist by anyone other than a pharmacist in their PACT clinic. This included if a GLP-1 agonist was prescribed by a primary care physician, endocrinologist, or someone outside the VA system.</p> <p>The primary study outcomes were to determine the percentage of patients with a dose reduction of insulin or sulfonylurea and discontinuation of insulin or a sulfonylurea at intervals of 0 (baseline), 3, 6, and 12 months. Secondary outcomes included changes in HbA<sub>1c</sub> and body weight measured at the same intervals of 0 (baseline), 3, 6, and 12 months. <br/><br/>Data were collected using the VA Computerized Patient Record System (CPRS) and stored in a locked spreadsheet. Descriptive statistics were used to analyze the data. Patient data included the number of patients on insulin or a sulfonylurea when initiating a GLP-1 agonist, the percentage of patients started on a certain GLP-1 agonist (dulaglutide, liraglutide, exenatide, and semaglutide), and the percentage of patients with a baseline HbA<sub>1c</sub> of &lt; 8%, 8% to 10%, and &gt; 10%. The GLP-1 agonist formulary was adjusted during the time of this retrospective chart review. Patients who were not on semaglutide were switched over if they were on another GLP-1 agonist as semaglutide became the preferred GLP-1 agonist. <br/><br/>Patients were considered to have a dose reduction or discontinuation of insulin or a sulfonylurea if the dose or medication they were on decreased or was discontinued permanently within 12 months of starting a GLP-1 agonist. For example, if a patient who was administering 10 units of insulin daily was decreased to 8 but later increased back to 10, this was not counted as a dose reduction. If a patient discontinued insulin or a sulfonylurea and then restarted it within 12 months of initiating a GLP-1 agonist, this was not counted as a discontinuation. </p> <h2>Results</h2> <p>This retrospective review included 136 patients; 96 patients taking insulin and 54 taking a sulfonylurea when they started a GLP-1 agonist. Fourteen patients were on both. Criteria for use, which are clinical criteria to determine if a patient is eligible for the use of a given medication, are used within the VA. The inclusion criteria for a patient initiating a GLP-1 agonist is that the patient must have atherosclerotic cardiovascular disease or chronic kidney disease with the patient receiving metformin (unless unable to use metformin) and empagliflozin (unless unable to use empagliflozin).</p> <p>The baseline mean age and weight for the patient population in this retrospective chart review was 70.7 years and 238.2 lb, respectively. Ninety-six patients (70.6%) were started on semaglutide, 27 (19.9%) on dulaglutide, 12 (8.8%) on liraglutide, and 1 (0.7%) on exenatide. The mean HbA<sub>1c</sub> when patients initiated a GLP-1 agonist was 8.6%. When starting a GLP-1 agonist, 34 patients (25.0%) had an HbA<sub>1c</sub> &lt; 8%, 89 (65.4%) had an HbA<sub>1c</sub> between 8% to 10%, and 13 (9.6%) had an HbA<sub>1c</sub> &gt; 10% (Table).<br/><br/>For the primary results, 25 patients (26.0%) had a dose reduction of insulin when they started a GLP-1 agonist, and 55 patients (57.3%) had at least 1 insulin dose reduction within the year follow-up. Seven patients (13.0%) had a dose reduction of a sulfonylurea when they started a GLP-1 agonist, and 16 patients (29.6%) had at least 1 dose reduction of a sulfonylurea within the year follow-up. Six patients (6.3%) discontinued insulin use when they initially started a GLP-1 agonist, and 14 patients (14.6%) discontinued insulin use within the year follow-up. Eleven patients (20.4%) discontinued sulfonylurea use when they initially started a GLP-1 agonist, and 21 patients (38.9%) discontinued sulfonylurea use within the year follow-up (Figure).<br/><br/>Fourteen patients were on both insulin and a sulfonylurea. Two patients (14.3%) had a dose reduction of insulin when they started a GLP-1 agonist, and 5 (35.7%) had ≥ 1 insulin dose reduction within the year follow-up. Three patients (21.4%) had a dose reduction of a sulfonylurea when they started a GLP-1 agonist, and 6 (42.9%) had ≥ 1 dose reduction of a sulfonylurea within the year follow-up. Seven patients (50.0%) discontinued sulfonylurea and 3 (21.4%) discontinued insulin at any time throughout the year. The majority of the discontinuations were at the initial start of GLP-1 agonist therapy.<br/><br/>The mean HbA<sub>1c</sub> for patients on GLP-1 agonist was 8.6% at baseline, 8.0% at 0 to 3 months, 7.6% at 3 to 6 months, and 7.5% at 12 months. Patients experienced a mean HbA<sub>1c</sub> reduction of 1.1%. The mean weight when a GLP-1 agonist was started was 238.2 lb, 236.0 lb at 0 to 3 months, 223.8 lb at 3 to 6 months, and 224.3 lb after 12 months. Study participants lost a mean weight of 13.9 lb while on a GLP-1 agonist.</p> <h2>Discussion</h2> <p>While this study did not examine why there were dose reductions or discontinuations, we can hypothesize that insulin or sulfonylureas were reduced or discontinued due to a myriad of reasons, such as prophylactic dosing per guidelines, patients having a hypoglycemic event, or pharmacists anticipating potential low blood glucose trends. Also, there could have been numerous reasons GLP-1 agonists were started in patients on insulin or a sulfonylurea, such as HbA<sub>1c</sub> not being within goal range, cardiovascular benefits (reduce risk of stroke, heart attack, and death), weight loss, and renal protection, such as preventing albuminuria.<sup>13,14</sup></p> <p>This retrospective chart review found a large proportion of patients had a dose reduction of insulin (57.3%) or sulfonylurea (29.6%). The percentage of patients with a dose reduction was potentially underestimated as patients were not counted if they discontinued insulin or sulfonylurea. Concomitant use of GLP-1 agonists with insulin or a sulfonylurea may increase the risk of hypoglycemia and reducing the dose of insulin or a sulfonylurea may be necessary.<sup>9-11</sup> The dose reductions in this study show that pharmacists within pharmacy-led PACT clinics monitor for or attempt to prevent hypoglycemia, which aligns with the prescribing information of GLP-1 agonists. While increasing the insulin or sulfonylurea dose is an option for patients, this approach can increase the risk of hypoglycemia, especially in an older population, like this one with a mean age &gt; 70 years. The large proportions of patients with dose reductions or insulin and sulfonylurea discontinuations suggest that pharmacists may need to take a more cautious approach when initiating a GLP-1 agonist to prevent adverse health outcomes related to low blood sugar for older adults, such as falls and fractures.<br/><br/>Insulin was discontinued in 20.4% of patients and sulfonylurea was discontinued in 38.9% of patients within 12 months after starting a GLP-1 agonist. When a patient was on both insulin and a sulfonylurea, the percentage of patients who discontinued insulin (21.4%) or a sulfonylurea (50.0%) was higher compared with patients just on insulin (14.6%) or a sulfonylurea (38.9%) alone. Patients on both insulin and a sulfonylurea may need closer monitoring due to a higher incidence of discontinuations when these diabetes agents are administered in combination. <br/><br/>Within 12 months of patients receiving a GLP-1 agonist, the mean HbA<sub>1c</sub> reduction was 1.1%, which is comparable to other GLP-1 agonist clinical trials. For semaglutide 0.5 mg and 1.0 mg dosages, the mean HbA<sub>1c</sub> reduction was 1.4% and 1.6%, respectively.<sup>9</sup> For dulaglutide 0.75 mg and 1.5 mg dosages, the mean HbA<sub>1c</sub> reduction ranged from 0.7% to 1.6% and 0.8% to 1.6%, respectively.<sup>10</sup> For liraglutide 1.8 mg dosage, the mean HbA<sub>1c</sub> reduction ranged from 1.0% to 1.5%.<sup>11</sup> The mean weight loss in this study was 13.9 lb. Along with HbA<sub>1c</sub>, weight loss in this review was comparable to other GLP-1 agonist clinical trials. Patients administering semaglutide lost up to 14 lb, patients taking dulaglutide lost up to 10.1 lb, and patients on liraglutide lost on average 6.2 lb.<sup>9-11</sup> Even with medications such as insulin and sulfonylurea that have the side effects of hypoglycemia and weight gain, adding a GLP-1 agonist showed a reduction in HbA<sub>1c</sub> and weight loss relatively similar to previous clinical trials. <br/><br/>A study on the effects of adding semaglutide to insulin regimens in March 2023 by Meyer and colleagues displayed similar results to this retrospective chart review. That study concluded that there was blood glucose improvement (HbA<sub>1c</sub> reduction of 1.3%) in patients after 6 months despite a decrease in the insulin dose. Also, patients lost a mean weight of 11 lb during the 6-month trial.<sup>3</sup> This retrospective chart review at the WBVAMC adds to the body of research that supports potential reductions or discontinuations of insulin and/or sulfonylureas with the addition of a GLP-1 agonist. </p> <h3>Limitations</h3> <p>Several limitations of this study should be considered when evaluating the results. This review was comprised of a mostly older, male population, which results in a low generalizability to organizations other than VA medical centers. In addition, this study only evaluated patients on a GLP-1 agonist followed in a pharmacist-led PACT clinic. This study excluded patients who were prescribed a GLP-1 agonist by an endocrinologist or a pharmacist at one of the community-based outpatient clinics affiliated with WBVAMC, or a pharmacist or clinician outside the VA. The sole focus of this study was patients in a pharmacist-led VAMC clinic. Not all patient data may have been included in the study. If a patient did not have an appointment at baseline, 3, 6, and 12 months or did not obtain laboratory tests, HbA<sub>1c</sub> and weights were not recorded. Data were collected during the COVID-19 pandemic and in-person appointments were potentially switched to phone or video appointments. There were many instances during this chart review where a weight was not recorded at each time interval. Also, this study did not consider any other diabetes medications the patient was taking. There were many instances where the patient was taking metformin and/or sodium-glucose cotransporter-2 (SGLT-2) inhibitors. These medications along with diet could have affected the weight results as metformin is weight neutral and SGLT-2 inhibitors promote weight loss.<sup>15</sup> Lastly, this study did not evaluate the amount of insulin reduced, only if there was a dose reduction or discontinuation of insulin and/or a sulfonylurea. </p> <h2>Conclusions</h2> <p>Dose reductions and a discontinuation of insulin or a sulfonylurea with the addition of a GLP-1 agonist may be needed. Patients on both insulin and a sulfonylurea may need closer monitoring due to the higher incidences of discontinuations compared with patients on just 1 of these agents. Dose reductions or discontinuations of these diabetic agents can promote positive patient outcomes, such as preventing hypoglycemia, minimizing weight gain, increasing weight loss, and reducing HbA<sub>1c</sub> levels. </p> <h3> Acknowledgments </h3> <p> <em>This material is the result of work supported with resources and the use of facilities at the Wilkes-Barre Veterans Affairs Medical Center in Pennsylvania. </em> </p> <h3> Author affiliations </h3> <p> <em><sup>a</sup>Wilkes-Barre Veterans Affairs Medical Center, Pennsylvania</em> </p> <h3> Author disclosures </h3> <p> <em>The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article. </em> </p> <h3> Disclaimer </h3> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner</i>, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.</em> </p> <h3> Ethics and consent </h3> <p> <em>It was determined that this project description approval by an institutional review board or other review committee was not needed. The project was a nonresearch Veteran Health Administration operations activity.</em> </p> <h3> References </h3> <p class="reference"> 1. ElSayed NA, Aleppo G, Aroda VR, et al. 8. Obesity and weight management for the prevention and treatment of type 2 diabetes: standards of care in diabetes-2023. <i>Diabetes Care</i>. 2023;46(suppl 1):S128-S139. doi:10.2337/dc23-S008<br/><br/> 2. ElSayed NA, Aleppo G, Aroda VE, et al. Older adults: standards of care in diabetes-2023. <i>Diabetes Care</i>. 2023;46(suppl 1):S216-S229. doi:10.2337/dc23-S013 <br/><br/> 3. Meyer J, Dreischmeier E, Lehmann M, Phelan J. The effects of adding semaglutide to high daily dose insulin regimens in patients with type 2 diabetes. <i>Ann Pharmacother</i>. 2023;57(3):241-250. doi:10.1177/10600280221107381 <br/><br/> 4. Rodbard HW, Lingvay I, Reed J, et al. Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): a randomized, controlled trial. <i>J Clin Endocrinol Metab</i>. 2018;103(6):2291-2301. doi:10.1210/jc.2018-00070<br/><br/> 5. Anderson SL, Trujillo JM. Basal insulin use with GLP-1 receptor agonists. <i>Diabetes Spectr</i>. 2016;29(3):152-160. doi:10.2337/diaspect.29.3.152<br/><br/> 6. Castek SL, Healey LC, Kania DS, Vernon VP, Dawson AJ. Assessment of glucagon-like peptide-1 receptor agonists in veterans taking basal/bolus insulin regimens. <i>Fed Pract</i>. 2022;39(suppl 5):S18-S23. doi:10.12788/fp.0317 <br/><br/> 7. Chen M, Vider E, Plakogiannis R. Insulin dosage adjustments after initiation of GLP-1 receptor agonists in patients with type 2 diabetes. <i>J Pharm Pract</i>. 2022;35(4):511-517. doi:10.1177/0897190021993625 <br/><br/> 8. Seino Y, Min KW, Niemoeller E, Takami A; EFC10887 GETGOAL-L Asia Study Investigators. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). <i>Diabetes Obes Metab</i>. 2012;14(10):910-917. doi:10.1111/j.1463-1326.2012.01618.x. <br/><br/> 9. Ozempic (semaglutide) injection. Package insert. Novo Nordisk Inc; 2022. https://www.ozempic.com/prescribing-information.html<br/><br/>10. Trulicity (dulaglutide) injection. Prescribing information. Lilly and Company; 2022. Accessed December 20, 2023. https://pi.lilly.com/us/trulicity-uspi.pdf <br/><br/>11. Victoza (liraglutide) injection. Prescribing information. Novo Nordisk Inc; 2022. Accessed December 20, 2023. https://www.novo-pi.com/victoza.pdf<br/><br/>12. Das SR, Everett BM, Birtcher KK, et al. 2020 expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes: a report of the American College of Cardiology Solution Set Oversight Committee. <i>J Am Coll Cardiol</i>. 2020;76(9):1117-1145. doi:10.1016/j.jacc.2020.05.037 <br/><br/>13. Granata A, Maccarrone R, Anzaldi M, et al. GLP-1 receptor agonists and renal outcomes in patients with diabetes mellitus type 2 and diabetic kidney disease: state of the art. <i>Clin Kidney J</i>. 2022;15(9):1657-1665. Published 2022 Mar 12. doi:10.1093/ckj/sfac069 <br/><br/>14. Marx N, Husain M, Lehrke M, Verma S, Sattar N. GLP-1 receptor agonists for the reduction of atherosclerotic cardiovascular risk in patients with type 2 diabetes. <i>Circulation</i>. 2022;146(24):1882-1894. doi:10.1161/CIRCULATIONAHA.122.059595 <br/><br/>15. Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). <i>Diabetologia</i>. 2022;65(12):1925-1966. doi:10.1007/s00125-022-05787-2</p> </itemContent> </newsItem> </itemSet></root>
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