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The definition of “hospitalist,” according to the SHM website, is a clinician “dedicated to delivering comprehensive medical care to hospitalized patients.” For years, the hospital setting was the specialties’ identifier. But as hospitalists’ scope has expanded, and post-acute care (PAC) in the United States has grown, more hospitalists are extending their roles into this space.
PAC today is more than the traditional nursing home, according to Manoj K. Mathew, MD, SFHM, national medical director of Agilon Health in Los Angeles.
Many of those expanded settings Dr. Mathew describes emerged as a result of the Affordable Care Act. Since its enactment in 2010, the ACA has heightened providers’ focus on the “Triple Aim” of improving the patient experience (including quality and satisfaction), improving the health of populations, and reducing the per capita cost of healthcare.1 Vishal Kuchaculla, MD, New England regional post-acute medical director of Knoxville,Tenn.-based TeamHealth, says new service lines also developed as Medicare clamped down on long-term inpatient hospital stays by giving financial impetus to discharge patients as soon as possible.
“Over the last few years, there’s been a major shift from fee-for-service to risk-based payment models,” Dr. Kuchaculla says. “The government’s financial incentives are driving outcomes to improve performance initiatives.”
“Today, LTACHs can be used as substitutes for short-term acute care,” says Sean R. Muldoon, MD, MPH, FCCP, chief medical officer of Kindred Healthcare in Louisville, Ky., and former chair of SHM’s Post-Acute Care Committee. “This means that a patient can be directly admitted from their home to an LTACH. In fact, many hospice and home-care patients are referred from physicians’ offices without a preceding hospitalization.”
122259_Medicare_claims web.PNG
Hospitalists can fill a need
More hospitalists are working in PACs for a number of reasons. Dr. Mathew says PAC facilities and services have “typically lacked the clinical structure and processes to obtain the results that patients and payors expect.
“These deficits needed to be quickly remedied as patients discharged from hospitals have increased acuity and higher disease burdens,” he adds. “Hospitalists were the natural choice to fill roles requiring their expertise and experience.”
Dr. Muldoon considers the expanded scope of practice into PACs an additional layer to hospital medicine’s value proposition to the healthcare system.
“As experts in the management of inpatient populations, it’s natural for hospitalists to expand to other facilities with inpatient-like populations,” he says, noting SNFs are the most popular choice, with IRFs and LTACHs also being common places to work. Few hospitalists work in home care or hospice.
PAC settings are designed to help patients who are transitioning from an inpatient setting back to their home or other setting.
“Many patients go home after a SNF stay, while others will move to a nursing home or other longer-term care setting for the first time,” says Tiffany Radcliff, PhD, a health economist in the department of health policy and management at Texas A&M University School of Public Health in College Station. “With this in mind, hospitalists working in PAC have the opportunity to address each patient’s ongoing care needs and prepare them for their next setting. Hospitalists can manage medication or other care regimen changes that resulted from an inpatient stay, reinforce discharge instructions to the patient and their caregivers, and identify any other issues with continuing care that need to be addressed before discharge to the next care setting.”
Transitioning Care
Even if a hospitalist is not employed at a PAC, it’s important that they know something about them.
“As patients are moved downstream earlier, hospitalists are being asked to help make a judgment regarding when and where an inpatient is transitioned,” Dr. Muldoon says. As organizations move toward becoming fully risk capable, it is necessary to develop referral networks of high-quality PAC providers to achieve the best clinical outcomes, reduce readmissions, and lower costs.2“Therefore, hospitalists should have a working knowledge of the different sites of service as well as some opinion on the suitability of available options in their community,” Dr. Muldoon says. “The hospitalist can also help to educate the hospitalized patient on what to expect at a PAC.”
If a patient is inappropriately prepared for the PAC setting, it could lead to incomplete management of their condition, which ultimately could lead to readmission.
“When hospitalists know how care is provided in a PAC setting, they are better able to ensure a smoother transition of care between settings,” says Tochi Iroku-Malize, MD, MPH, MBA, FAAFP, SFHM, chair of family medicine at Northwell Health in Long Island, N.Y. “This will ultimately prevent unnecessary readmissions.”
Further, the quality metrics that hospitals and thereby hospitalists are judged by no longer end at the hospital’s exit.
“The ownership of acute-care outcomes requires extending the accountability to outside of the institution’s four walls,” Dr. Mathew says. “The inpatient team needs to place great importance on the transition of care and the subsequent quality of that care when the patient is discharged.”
Robert W. Harrington Jr., MD, SFHM, chief medical officer of Plano, Texas–based Reliant Post-Acute Care Solutions and former SHM president, says the health system landscapes are pushing HM beyond the hospitals’ walls.
How PAC settings differ from hospitals
Practicing in PAC has some important nuances that hospitalists from short-term acute care need to get accustomed to, Dr. Muldoon says. Primarily, the diagnostic capabilities are much more limited, as is the presence of high-level staffing. Further, patients are less resilient to medication changes and interventions, so changes need to be done gradually.
“Hospitalists who try to practice acute-care medicine in a PAC setting may become frustrated by the length of time it takes to do a work-up, get a consultation, and respond to a patient’s change of condition,” Dr. Muldoon says. “Nonetheless, hospitalists can overcome this once recognizing this mind shift.”
According to Dr. Harrington, another challenge hospitalists may face is the inability of the hospital’s and PAC facility’s IT platforms to exchange electronic information.
“The major vendors on both sides need to figure out an interoperability strategy,” he says. “Currently, it often takes 1-3 days to receive a new patient’s discharge summary. The summary may consist of a stack of paper that takes significant time to sort through and requires the PAC facility to perform duplicate data entry. It’s a very highly inefficient process that opens up the doors to mistakes and errors of omission and commission that can result in bad patient outcomes.”
Arif Nazir, MD, CMD, FACP, AGSF, chief medical officer of Signature HealthCARE and president of SHC Medical Partners, both in Louisville, Ky., cites additional reasons the lack of seamless communication between a hospital and PAC facility is problematic. “I see physicians order laboratory tests and investigations that were already done in the hospital because they didn’t know they were already performed or never received the results,” he says. “Similarly, I see patients continue to take medications prescribed in the hospital long term even though they were only supposed to take them short term. I’ve also seen patients come to a PAC setting from a hospital without any formal understanding of their rehabilitative period and expectations for recovery.”
What’s ahead?
Looking to the future, Surafel Tsega, MD, clinical instructor at Mount Sinai Hospital in New York, says he thinks there will be a move toward greater collaboration among inpatient and PAC facilities, particularly in the discharge process, given that hospitals have an added incentive to ensure safe transitions because reimbursement from the Centers for Medicare & Medicaid Services is tied to readmissions and there are penalties for readmission. This involves more comprehensive planning regarding “warm handoffs” (e.g., real-time discussions with PAC providers about a patient’s hospital course and plan of care upon discharge), transferring of information, and so forth.
And while it can still be challenging to identify high-risk patients or determine the intensity and duration of their care, Dr. Mathew says risk-stratification tools and care pathways are continually being refined to maximize value with the limited resources available. In addition, with an increased emphasis on employing a team approach to care, there will be better integration of non-medical services to address the social determinants of health, which play significant roles in overall health and healing.
“Working with community-based organizations for this purpose will be a valuable tool for any of the population health–based initiatives,” he says.
Dr. Muldoon says he believes healthcare reform will increasingly view an inpatient admission as something to be avoided.
“If hospitalization can’t be avoided, then it should be shortened as much as possible,” he says. “This will shift inpatient care into LTACHs, SNFs, and IRFs. Hospitalists would be wise to follow patients into those settings as traditional inpatient census is reduced. This will take a few years, so hospitalists should start now in preparing for that downstream transition of individuals who were previously inpatients.”
The cost of care, and other PAC facts and figures
The amount of money that Medicare spends on post-acute care (PAC) has been increasing. In 2012, 12.6% of Medicare beneficiaries used some form of PAC, costing $62 billion.2 That amounts to the Centers for Medicare & Medicaid Services spending close to 25% of Medicare beneficiary expenses on PAC, a 133% increase from 2001 to 2012. Among the different types, $30.4 billion was spent on skilled nursing facilities (SNFs), $18.6 billion on home health, and $13.1 billion on long-term acute care (LTAC) and acute-care rehabilitation.2
It’s also been reported that after short-term acute-care hospitalization, about one in five Medicare beneficiaries requires continued specialized treatment in one of the three typical Medicare PAC settings: inpatient rehabilitation facilities (IRFs), LTAC hospitals, and SNFs.3
What’s more, hospital readmission nearly doubles the cost of an episode, so the financial implications for organizations operating in risk-bearing arrangements are significant. In 2013, 2,213 hospitals were charged $280 million in readmission penalties.2
References
1. The role of post-acute care in new care delivery models. American Hospital Association website. Available at: http://www.aha.org/research/reports/tw/15dec-tw-postacute.pdf. Accessed Nov. 7, 2016.
2. Post-acute care integration: Today and in the future. DHG Healthcare website. Available at: http://www2.dhgllp.com/res_pubs/HCG-Post-Acute-Care-Integration.pdf. Accessed Nov. 7, 2016.
3. Overview: Post-acute care transitions toolkit. Society for Hospital Medicine website. Available at: http://www.hospitalmedicine.org/Web/Quality___Innovation/Implementation_Toolkit/pact/Overview_PACT.aspx?hkey=dea3da3c-8620-46db-a00f-89f07f021958. Accessed Nov. 10, 2016.
The definition of “hospitalist,” according to the SHM website, is a clinician “dedicated to delivering comprehensive medical care to hospitalized patients.” For years, the hospital setting was the specialties’ identifier. But as hospitalists’ scope has expanded, and post-acute care (PAC) in the United States has grown, more hospitalists are extending their roles into this space.
PAC today is more than the traditional nursing home, according to Manoj K. Mathew, MD, SFHM, national medical director of Agilon Health in Los Angeles.
Many of those expanded settings Dr. Mathew describes emerged as a result of the Affordable Care Act. Since its enactment in 2010, the ACA has heightened providers’ focus on the “Triple Aim” of improving the patient experience (including quality and satisfaction), improving the health of populations, and reducing the per capita cost of healthcare.1 Vishal Kuchaculla, MD, New England regional post-acute medical director of Knoxville,Tenn.-based TeamHealth, says new service lines also developed as Medicare clamped down on long-term inpatient hospital stays by giving financial impetus to discharge patients as soon as possible.
“Over the last few years, there’s been a major shift from fee-for-service to risk-based payment models,” Dr. Kuchaculla says. “The government’s financial incentives are driving outcomes to improve performance initiatives.”
“Today, LTACHs can be used as substitutes for short-term acute care,” says Sean R. Muldoon, MD, MPH, FCCP, chief medical officer of Kindred Healthcare in Louisville, Ky., and former chair of SHM’s Post-Acute Care Committee. “This means that a patient can be directly admitted from their home to an LTACH. In fact, many hospice and home-care patients are referred from physicians’ offices without a preceding hospitalization.”
122259_Medicare_claims web.PNG
Hospitalists can fill a need
More hospitalists are working in PACs for a number of reasons. Dr. Mathew says PAC facilities and services have “typically lacked the clinical structure and processes to obtain the results that patients and payors expect.
“These deficits needed to be quickly remedied as patients discharged from hospitals have increased acuity and higher disease burdens,” he adds. “Hospitalists were the natural choice to fill roles requiring their expertise and experience.”
Dr. Muldoon considers the expanded scope of practice into PACs an additional layer to hospital medicine’s value proposition to the healthcare system.
“As experts in the management of inpatient populations, it’s natural for hospitalists to expand to other facilities with inpatient-like populations,” he says, noting SNFs are the most popular choice, with IRFs and LTACHs also being common places to work. Few hospitalists work in home care or hospice.
PAC settings are designed to help patients who are transitioning from an inpatient setting back to their home or other setting.
“Many patients go home after a SNF stay, while others will move to a nursing home or other longer-term care setting for the first time,” says Tiffany Radcliff, PhD, a health economist in the department of health policy and management at Texas A&M University School of Public Health in College Station. “With this in mind, hospitalists working in PAC have the opportunity to address each patient’s ongoing care needs and prepare them for their next setting. Hospitalists can manage medication or other care regimen changes that resulted from an inpatient stay, reinforce discharge instructions to the patient and their caregivers, and identify any other issues with continuing care that need to be addressed before discharge to the next care setting.”
Transitioning Care
Even if a hospitalist is not employed at a PAC, it’s important that they know something about them.
“As patients are moved downstream earlier, hospitalists are being asked to help make a judgment regarding when and where an inpatient is transitioned,” Dr. Muldoon says. As organizations move toward becoming fully risk capable, it is necessary to develop referral networks of high-quality PAC providers to achieve the best clinical outcomes, reduce readmissions, and lower costs.2“Therefore, hospitalists should have a working knowledge of the different sites of service as well as some opinion on the suitability of available options in their community,” Dr. Muldoon says. “The hospitalist can also help to educate the hospitalized patient on what to expect at a PAC.”
If a patient is inappropriately prepared for the PAC setting, it could lead to incomplete management of their condition, which ultimately could lead to readmission.
“When hospitalists know how care is provided in a PAC setting, they are better able to ensure a smoother transition of care between settings,” says Tochi Iroku-Malize, MD, MPH, MBA, FAAFP, SFHM, chair of family medicine at Northwell Health in Long Island, N.Y. “This will ultimately prevent unnecessary readmissions.”
Further, the quality metrics that hospitals and thereby hospitalists are judged by no longer end at the hospital’s exit.
“The ownership of acute-care outcomes requires extending the accountability to outside of the institution’s four walls,” Dr. Mathew says. “The inpatient team needs to place great importance on the transition of care and the subsequent quality of that care when the patient is discharged.”
Robert W. Harrington Jr., MD, SFHM, chief medical officer of Plano, Texas–based Reliant Post-Acute Care Solutions and former SHM president, says the health system landscapes are pushing HM beyond the hospitals’ walls.
How PAC settings differ from hospitals
Practicing in PAC has some important nuances that hospitalists from short-term acute care need to get accustomed to, Dr. Muldoon says. Primarily, the diagnostic capabilities are much more limited, as is the presence of high-level staffing. Further, patients are less resilient to medication changes and interventions, so changes need to be done gradually.
“Hospitalists who try to practice acute-care medicine in a PAC setting may become frustrated by the length of time it takes to do a work-up, get a consultation, and respond to a patient’s change of condition,” Dr. Muldoon says. “Nonetheless, hospitalists can overcome this once recognizing this mind shift.”
According to Dr. Harrington, another challenge hospitalists may face is the inability of the hospital’s and PAC facility’s IT platforms to exchange electronic information.
“The major vendors on both sides need to figure out an interoperability strategy,” he says. “Currently, it often takes 1-3 days to receive a new patient’s discharge summary. The summary may consist of a stack of paper that takes significant time to sort through and requires the PAC facility to perform duplicate data entry. It’s a very highly inefficient process that opens up the doors to mistakes and errors of omission and commission that can result in bad patient outcomes.”
Arif Nazir, MD, CMD, FACP, AGSF, chief medical officer of Signature HealthCARE and president of SHC Medical Partners, both in Louisville, Ky., cites additional reasons the lack of seamless communication between a hospital and PAC facility is problematic. “I see physicians order laboratory tests and investigations that were already done in the hospital because they didn’t know they were already performed or never received the results,” he says. “Similarly, I see patients continue to take medications prescribed in the hospital long term even though they were only supposed to take them short term. I’ve also seen patients come to a PAC setting from a hospital without any formal understanding of their rehabilitative period and expectations for recovery.”
What’s ahead?
Looking to the future, Surafel Tsega, MD, clinical instructor at Mount Sinai Hospital in New York, says he thinks there will be a move toward greater collaboration among inpatient and PAC facilities, particularly in the discharge process, given that hospitals have an added incentive to ensure safe transitions because reimbursement from the Centers for Medicare & Medicaid Services is tied to readmissions and there are penalties for readmission. This involves more comprehensive planning regarding “warm handoffs” (e.g., real-time discussions with PAC providers about a patient’s hospital course and plan of care upon discharge), transferring of information, and so forth.
And while it can still be challenging to identify high-risk patients or determine the intensity and duration of their care, Dr. Mathew says risk-stratification tools and care pathways are continually being refined to maximize value with the limited resources available. In addition, with an increased emphasis on employing a team approach to care, there will be better integration of non-medical services to address the social determinants of health, which play significant roles in overall health and healing.
“Working with community-based organizations for this purpose will be a valuable tool for any of the population health–based initiatives,” he says.
Dr. Muldoon says he believes healthcare reform will increasingly view an inpatient admission as something to be avoided.
“If hospitalization can’t be avoided, then it should be shortened as much as possible,” he says. “This will shift inpatient care into LTACHs, SNFs, and IRFs. Hospitalists would be wise to follow patients into those settings as traditional inpatient census is reduced. This will take a few years, so hospitalists should start now in preparing for that downstream transition of individuals who were previously inpatients.”
The cost of care, and other PAC facts and figures
The amount of money that Medicare spends on post-acute care (PAC) has been increasing. In 2012, 12.6% of Medicare beneficiaries used some form of PAC, costing $62 billion.2 That amounts to the Centers for Medicare & Medicaid Services spending close to 25% of Medicare beneficiary expenses on PAC, a 133% increase from 2001 to 2012. Among the different types, $30.4 billion was spent on skilled nursing facilities (SNFs), $18.6 billion on home health, and $13.1 billion on long-term acute care (LTAC) and acute-care rehabilitation.2
It’s also been reported that after short-term acute-care hospitalization, about one in five Medicare beneficiaries requires continued specialized treatment in one of the three typical Medicare PAC settings: inpatient rehabilitation facilities (IRFs), LTAC hospitals, and SNFs.3
What’s more, hospital readmission nearly doubles the cost of an episode, so the financial implications for organizations operating in risk-bearing arrangements are significant. In 2013, 2,213 hospitals were charged $280 million in readmission penalties.2
References
1. The role of post-acute care in new care delivery models. American Hospital Association website. Available at: http://www.aha.org/research/reports/tw/15dec-tw-postacute.pdf. Accessed Nov. 7, 2016.
2. Post-acute care integration: Today and in the future. DHG Healthcare website. Available at: http://www2.dhgllp.com/res_pubs/HCG-Post-Acute-Care-Integration.pdf. Accessed Nov. 7, 2016.
3. Overview: Post-acute care transitions toolkit. Society for Hospital Medicine website. Available at: http://www.hospitalmedicine.org/Web/Quality___Innovation/Implementation_Toolkit/pact/Overview_PACT.aspx?hkey=dea3da3c-8620-46db-a00f-89f07f021958. Accessed Nov. 10, 2016.
The definition of “hospitalist,” according to the SHM website, is a clinician “dedicated to delivering comprehensive medical care to hospitalized patients.” For years, the hospital setting was the specialties’ identifier. But as hospitalists’ scope has expanded, and post-acute care (PAC) in the United States has grown, more hospitalists are extending their roles into this space.
PAC today is more than the traditional nursing home, according to Manoj K. Mathew, MD, SFHM, national medical director of Agilon Health in Los Angeles.
Many of those expanded settings Dr. Mathew describes emerged as a result of the Affordable Care Act. Since its enactment in 2010, the ACA has heightened providers’ focus on the “Triple Aim” of improving the patient experience (including quality and satisfaction), improving the health of populations, and reducing the per capita cost of healthcare.1 Vishal Kuchaculla, MD, New England regional post-acute medical director of Knoxville,Tenn.-based TeamHealth, says new service lines also developed as Medicare clamped down on long-term inpatient hospital stays by giving financial impetus to discharge patients as soon as possible.
“Over the last few years, there’s been a major shift from fee-for-service to risk-based payment models,” Dr. Kuchaculla says. “The government’s financial incentives are driving outcomes to improve performance initiatives.”
“Today, LTACHs can be used as substitutes for short-term acute care,” says Sean R. Muldoon, MD, MPH, FCCP, chief medical officer of Kindred Healthcare in Louisville, Ky., and former chair of SHM’s Post-Acute Care Committee. “This means that a patient can be directly admitted from their home to an LTACH. In fact, many hospice and home-care patients are referred from physicians’ offices without a preceding hospitalization.”
122259_Medicare_claims web.PNG
Hospitalists can fill a need
More hospitalists are working in PACs for a number of reasons. Dr. Mathew says PAC facilities and services have “typically lacked the clinical structure and processes to obtain the results that patients and payors expect.
“These deficits needed to be quickly remedied as patients discharged from hospitals have increased acuity and higher disease burdens,” he adds. “Hospitalists were the natural choice to fill roles requiring their expertise and experience.”
Dr. Muldoon considers the expanded scope of practice into PACs an additional layer to hospital medicine’s value proposition to the healthcare system.
“As experts in the management of inpatient populations, it’s natural for hospitalists to expand to other facilities with inpatient-like populations,” he says, noting SNFs are the most popular choice, with IRFs and LTACHs also being common places to work. Few hospitalists work in home care or hospice.
PAC settings are designed to help patients who are transitioning from an inpatient setting back to their home or other setting.
“Many patients go home after a SNF stay, while others will move to a nursing home or other longer-term care setting for the first time,” says Tiffany Radcliff, PhD, a health economist in the department of health policy and management at Texas A&M University School of Public Health in College Station. “With this in mind, hospitalists working in PAC have the opportunity to address each patient’s ongoing care needs and prepare them for their next setting. Hospitalists can manage medication or other care regimen changes that resulted from an inpatient stay, reinforce discharge instructions to the patient and their caregivers, and identify any other issues with continuing care that need to be addressed before discharge to the next care setting.”
Transitioning Care
Even if a hospitalist is not employed at a PAC, it’s important that they know something about them.
“As patients are moved downstream earlier, hospitalists are being asked to help make a judgment regarding when and where an inpatient is transitioned,” Dr. Muldoon says. As organizations move toward becoming fully risk capable, it is necessary to develop referral networks of high-quality PAC providers to achieve the best clinical outcomes, reduce readmissions, and lower costs.2“Therefore, hospitalists should have a working knowledge of the different sites of service as well as some opinion on the suitability of available options in their community,” Dr. Muldoon says. “The hospitalist can also help to educate the hospitalized patient on what to expect at a PAC.”
If a patient is inappropriately prepared for the PAC setting, it could lead to incomplete management of their condition, which ultimately could lead to readmission.
“When hospitalists know how care is provided in a PAC setting, they are better able to ensure a smoother transition of care between settings,” says Tochi Iroku-Malize, MD, MPH, MBA, FAAFP, SFHM, chair of family medicine at Northwell Health in Long Island, N.Y. “This will ultimately prevent unnecessary readmissions.”
Further, the quality metrics that hospitals and thereby hospitalists are judged by no longer end at the hospital’s exit.
“The ownership of acute-care outcomes requires extending the accountability to outside of the institution’s four walls,” Dr. Mathew says. “The inpatient team needs to place great importance on the transition of care and the subsequent quality of that care when the patient is discharged.”
Robert W. Harrington Jr., MD, SFHM, chief medical officer of Plano, Texas–based Reliant Post-Acute Care Solutions and former SHM president, says the health system landscapes are pushing HM beyond the hospitals’ walls.
How PAC settings differ from hospitals
Practicing in PAC has some important nuances that hospitalists from short-term acute care need to get accustomed to, Dr. Muldoon says. Primarily, the diagnostic capabilities are much more limited, as is the presence of high-level staffing. Further, patients are less resilient to medication changes and interventions, so changes need to be done gradually.
“Hospitalists who try to practice acute-care medicine in a PAC setting may become frustrated by the length of time it takes to do a work-up, get a consultation, and respond to a patient’s change of condition,” Dr. Muldoon says. “Nonetheless, hospitalists can overcome this once recognizing this mind shift.”
According to Dr. Harrington, another challenge hospitalists may face is the inability of the hospital’s and PAC facility’s IT platforms to exchange electronic information.
“The major vendors on both sides need to figure out an interoperability strategy,” he says. “Currently, it often takes 1-3 days to receive a new patient’s discharge summary. The summary may consist of a stack of paper that takes significant time to sort through and requires the PAC facility to perform duplicate data entry. It’s a very highly inefficient process that opens up the doors to mistakes and errors of omission and commission that can result in bad patient outcomes.”
Arif Nazir, MD, CMD, FACP, AGSF, chief medical officer of Signature HealthCARE and president of SHC Medical Partners, both in Louisville, Ky., cites additional reasons the lack of seamless communication between a hospital and PAC facility is problematic. “I see physicians order laboratory tests and investigations that were already done in the hospital because they didn’t know they were already performed or never received the results,” he says. “Similarly, I see patients continue to take medications prescribed in the hospital long term even though they were only supposed to take them short term. I’ve also seen patients come to a PAC setting from a hospital without any formal understanding of their rehabilitative period and expectations for recovery.”
What’s ahead?
Looking to the future, Surafel Tsega, MD, clinical instructor at Mount Sinai Hospital in New York, says he thinks there will be a move toward greater collaboration among inpatient and PAC facilities, particularly in the discharge process, given that hospitals have an added incentive to ensure safe transitions because reimbursement from the Centers for Medicare & Medicaid Services is tied to readmissions and there are penalties for readmission. This involves more comprehensive planning regarding “warm handoffs” (e.g., real-time discussions with PAC providers about a patient’s hospital course and plan of care upon discharge), transferring of information, and so forth.
And while it can still be challenging to identify high-risk patients or determine the intensity and duration of their care, Dr. Mathew says risk-stratification tools and care pathways are continually being refined to maximize value with the limited resources available. In addition, with an increased emphasis on employing a team approach to care, there will be better integration of non-medical services to address the social determinants of health, which play significant roles in overall health and healing.
“Working with community-based organizations for this purpose will be a valuable tool for any of the population health–based initiatives,” he says.
Dr. Muldoon says he believes healthcare reform will increasingly view an inpatient admission as something to be avoided.
“If hospitalization can’t be avoided, then it should be shortened as much as possible,” he says. “This will shift inpatient care into LTACHs, SNFs, and IRFs. Hospitalists would be wise to follow patients into those settings as traditional inpatient census is reduced. This will take a few years, so hospitalists should start now in preparing for that downstream transition of individuals who were previously inpatients.”
The cost of care, and other PAC facts and figures
The amount of money that Medicare spends on post-acute care (PAC) has been increasing. In 2012, 12.6% of Medicare beneficiaries used some form of PAC, costing $62 billion.2 That amounts to the Centers for Medicare & Medicaid Services spending close to 25% of Medicare beneficiary expenses on PAC, a 133% increase from 2001 to 2012. Among the different types, $30.4 billion was spent on skilled nursing facilities (SNFs), $18.6 billion on home health, and $13.1 billion on long-term acute care (LTAC) and acute-care rehabilitation.2
It’s also been reported that after short-term acute-care hospitalization, about one in five Medicare beneficiaries requires continued specialized treatment in one of the three typical Medicare PAC settings: inpatient rehabilitation facilities (IRFs), LTAC hospitals, and SNFs.3
What’s more, hospital readmission nearly doubles the cost of an episode, so the financial implications for organizations operating in risk-bearing arrangements are significant. In 2013, 2,213 hospitals were charged $280 million in readmission penalties.2
References
1. The role of post-acute care in new care delivery models. American Hospital Association website. Available at: http://www.aha.org/research/reports/tw/15dec-tw-postacute.pdf. Accessed Nov. 7, 2016.
2. Post-acute care integration: Today and in the future. DHG Healthcare website. Available at: http://www2.dhgllp.com/res_pubs/HCG-Post-Acute-Care-Integration.pdf. Accessed Nov. 7, 2016.
3. Overview: Post-acute care transitions toolkit. Society for Hospital Medicine website. Available at: http://www.hospitalmedicine.org/Web/Quality___Innovation/Implementation_Toolkit/pact/Overview_PACT.aspx?hkey=dea3da3c-8620-46db-a00f-89f07f021958. Accessed Nov. 10, 2016.
Dx Across the Skin Color Spectrum: Longitudinal Melanonychia
Longitudinal melanonychia (LM) is a pigmented linear band—brown, black, or gray—spanning the length of the nail plate due to the presence of excess melanin, which may be attributed to a benign or malignant process and may warrant further investigation.1,2 The majority of patients who present with LM are diagnosed with melanocytic activation of the nail matrix due to their inherent darker skin tone or various triggers including trauma, infection, and medications. Longitudinal melanonychia secondary to melanocytic activation often occurs spontaneously in patients with skin of color.3 Less commonly, LM is caused by a nail matrix nevus or lentigo; however, LM may arise secondary to subungual melanoma, a more dangerous cause.
A thorough clinical history including duration, recent changes in LM manifestation, nail trauma, or infection is helpful in evaluating patients with LM; however, a history of nail trauma can be misleading, as nail changes attributed to the trauma may in fact be melanoma. Irregularly spaced vertical lines of pigmentation ranging from brown to black with variations in spacing and width are characteristic of subungual melanoma.4 Nail dystrophy, granular hyperpigmentation, and Hutchinson sign (extension of pigmentation to the nail folds) also are worrisome features.5 In recent years, dermoscopy has become an important tool in the clinical examination of LM, with the development of criteria based on color and pattern recognition.5,6 Dermoscopy can be useful in screening potential candidates for biopsy. Although clinical examination and dermoscopy are essential to evaluating LM, the gold-standard diagnostic test when malignancy is suspected is a nail matrix biopsy.1,2,6,7
Epidemiology
It is not unusual for patients with darker skin tones to develop LM due to melanocytic activation of multiple nails with age. This finding can be seen in approximately 80% of African American individuals, 30% of Japanese individuals, and 50% of Hispanic individuals.2 It has even been reported that approximately 100% of Black patients older than 50 years will have evidence of LM.3
In a retrospective analysis, children presenting with LM tend to have a higher prevalence of nail matrix nevi compared to adults (56.1% [60/106] vs 34.3% [23/66]; P =.005).8 Involvement of a single digit in children is most likely indicative of a nevus; however, when an adult presents with LM in a single digit, suspicion for subungual melanoma should be raised.2,3,9
Two separate single-center retrospective studies showed the prevalence of subungual melanoma in patients presenting with melanonychia in Asia. Jin et al10 reported subungual melanoma in 6.2% (17/275) of Korean patients presenting with melanonychia at a general dermatology clinic from 2002 to 2014. Lyu et al8 studied LM in 172 Chinese patients in a dermatology clinic from 2018 to 2021 and reported 9% (6/66) of adults (aged ≥ 18 years) with subungual melanoma, with no reported cases in childhood (aged < 18 years).
Although the prevalence of subungual melanoma in patients with LM is low, it is an important diagnosis that should not be missed. In confirmed cases of subungual melanoma, two-thirds of lesions manifested as LM.3,10,11 Thus, LM arising in an adult in a single digit is more concerning for malignancy.2,3,7,9
Individuals of African and Asian descent as well as American Indian individuals are at highest risk for subungual melanoma with a poor prognosis compared to other types of melanoma, largely due to diagnosis at an advanced stage of disease.3,9 In a retrospective study of 25 patients with surgically treated subungual melanoma, the mean recurrence-free survival was 33.6 months. The recurrence-free survival was 66% at 1 year and 40% at 3 years, and the overall survival rate was 37% at 3 years.12
Key clinical features in individuals with darker skin tones
• In patients with darker skin tones, LM tends to occur on multiple nails as a result of melanocytic activation.2,13
• Several longitudinal bands may be noted on the same nail and the pigmentation of the bands may vary. With age, these longitudinal bands typically increase in number and width.13
• Pseudo-Hutchinson sign may be present due to ethnic melanosis of the proximal nail fold.13,14
• Dermoscopic findings of LM in patients with skin of color include wider bands (P = .0125), lower band brightness (P < .032), and higher frequency of changing appearance of bands (P = .0071).15
Worth noting
When patients present with LM, thorough examination of the nail plate, periungual skin, and distal pulp of all digits on all extremities with adequate lighting is important.2 Dermoscopy is useful, and a gel interface helps for examining the nail plates.7
Clinicians should be encouraged to biopsy or immediately refer patients with concerning nail unit lesions. Cases of LM most likely are benign, but if some doubt exists, the lesions should be biopsied or tracked closely with clinical and dermoscopic images, with a biopsy if changes occur.16 In conjunction with evaluation by a qualified clinician, patients also should be encouraged to take photographs, as the evolution of nail changes is a critical part of clinical decision-making on the need for a biopsy or referral.
Health disparity highlight
Despite the disproportionately high mortality rates from subungual melanoma in Black and Hispanic populations,3,9 studies often do not adequately represent these populations. Although subungual melanoma is rare, a delay in the diagnosis contributes to high morbidity and mortality rates.
1. Tosti A, Piraccini BM, de Farias DC. Dealing with melanonychia. Semin Cutan Med Surg. 2009;28:49-54. doi:10.1016/j.sder.2008.12.004
2. Piraccini BM, Dika E, Fanti PA. Tips for diagnosis and treatment of nail pigmentation with practical algorithm. Dermatol Clin. 2015;33:185-195. doi:10.1016/j.det.2014.12.002
3. Halteh P, Scher R, Artis A, et al. Assessment of patient knowledge of longitudinal melanonychia: a survey study of patients in outpatient clinics. Skin Appendage Disord. 2016;2:156-161. doi:10.1159/000452673
4. Singal A, Bisherwal K. Melanonychia: etiology, diagnosis, and treatment. Indian Dermatol J Online. 2020;11:1-11. doi:10.4103/idoj.IDOJ_167_19
5. Benati E, Ribero S, Longo C, et al. Clinical and dermoscopic clues to differentiate pigmented nail bands: an International Dermoscopy Society study. J Eur Acad Dermatol Venereol. 2017;31:732-736. doi:10.1111/jdv.13991
6. Sawada M, Yokota K, Matsumoto T, et al. Proposed classification of longitudinal melanonychia based on clinical and dermoscopic criteria. Int J Dermatol. 2014;53:581-585. doi:10.1111/ijd.12001
7. Starace M, Alessandrini A, Brandi N, et al. Use of nail dermoscopy in the management of melanonychia. Dermatol Pract Concept. 2019;9:38-43. doi:10.5826/dpc.0901a10
8. Lyu A, Hou Y, Wang Q. Retrospective analysis of longitudinal melanonychia: a Chinese experience. Front Pediatr. 2023;10:1065758. doi:10.3389/fped.2022.1065758
9. Williams NM, Obayomi AO, Diaz-Perez, JA, et al. Monodactylous longitudinal melanonychia: a sign of Bowen’s disease in skin of color. Skin Appendage Disord. 2021;7:306-310. doi:10.1159/000514221
10. Jin H, Kim JM, Kim GW, et al. Diagnostic criteria for and clinical review of melanonychia in Korean patients. J Am Acad Dermatol. 2016;74,1121-1127. doi:10.1016/j.jaad.2015.12.039
11. Halteh P, Scher R, Artis A, et al. A survey-based study of management of longitudinal melanonychia amongst attending and resident dermatologists. J Am Acad Dermatol. 2017;76:994-996. doi:10.1016/j.jaad.2016.11.053
12. LaRocca CJ, Lai L, Nelson RA, et al. Subungual melanoma: a single institution experience. Med Sci (Basel). 2021;9:57. doi:10.3390/medsci9030057
13. Baran LR, Ruben BS, Kechijian P, et al. Non‐melanoma Hutchinson’s sign: a reappraisal of this important, remarkable melanoma simulant. J Eur Acad Dermatol Venereol. 2018;32:495-501. doi:10.1111/jdv.14715
14. Sladden MJ, Mortimer NJ, Osborne JE. Longitudinal melanonychia and pseudo‐Hutchinson sign associated with amlodipine. Br J Dermatol. 2005;153:219-220. doi:10.1111/j.13652133.2005.06668.x
15. Lee DK, Chang MJ, Desai AD, et al. Clinical and dermoscopic findings of benign longitudinal melanonychia due to melanocytic activation differ by skin type and predict likelihood of nail matrix biopsy. J Am Acad Dermatol. 2022;87:792-799. doi:10.1016/j.jaad.2022.06.1165
16. Hogue L, Harvey VM. Basal cell carcinoma, squamous cell carcinoma, and cutaneous melanoma in skin of color patients. Dermatol Clin. 2019;37:519-526. doi:10.1016/j.det.2019.05.009
Longitudinal melanonychia (LM) is a pigmented linear band—brown, black, or gray—spanning the length of the nail plate due to the presence of excess melanin, which may be attributed to a benign or malignant process and may warrant further investigation.1,2 The majority of patients who present with LM are diagnosed with melanocytic activation of the nail matrix due to their inherent darker skin tone or various triggers including trauma, infection, and medications. Longitudinal melanonychia secondary to melanocytic activation often occurs spontaneously in patients with skin of color.3 Less commonly, LM is caused by a nail matrix nevus or lentigo; however, LM may arise secondary to subungual melanoma, a more dangerous cause.
A thorough clinical history including duration, recent changes in LM manifestation, nail trauma, or infection is helpful in evaluating patients with LM; however, a history of nail trauma can be misleading, as nail changes attributed to the trauma may in fact be melanoma. Irregularly spaced vertical lines of pigmentation ranging from brown to black with variations in spacing and width are characteristic of subungual melanoma.4 Nail dystrophy, granular hyperpigmentation, and Hutchinson sign (extension of pigmentation to the nail folds) also are worrisome features.5 In recent years, dermoscopy has become an important tool in the clinical examination of LM, with the development of criteria based on color and pattern recognition.5,6 Dermoscopy can be useful in screening potential candidates for biopsy. Although clinical examination and dermoscopy are essential to evaluating LM, the gold-standard diagnostic test when malignancy is suspected is a nail matrix biopsy.1,2,6,7
Epidemiology
It is not unusual for patients with darker skin tones to develop LM due to melanocytic activation of multiple nails with age. This finding can be seen in approximately 80% of African American individuals, 30% of Japanese individuals, and 50% of Hispanic individuals.2 It has even been reported that approximately 100% of Black patients older than 50 years will have evidence of LM.3
In a retrospective analysis, children presenting with LM tend to have a higher prevalence of nail matrix nevi compared to adults (56.1% [60/106] vs 34.3% [23/66]; P =.005).8 Involvement of a single digit in children is most likely indicative of a nevus; however, when an adult presents with LM in a single digit, suspicion for subungual melanoma should be raised.2,3,9
Two separate single-center retrospective studies showed the prevalence of subungual melanoma in patients presenting with melanonychia in Asia. Jin et al10 reported subungual melanoma in 6.2% (17/275) of Korean patients presenting with melanonychia at a general dermatology clinic from 2002 to 2014. Lyu et al8 studied LM in 172 Chinese patients in a dermatology clinic from 2018 to 2021 and reported 9% (6/66) of adults (aged ≥ 18 years) with subungual melanoma, with no reported cases in childhood (aged < 18 years).
Although the prevalence of subungual melanoma in patients with LM is low, it is an important diagnosis that should not be missed. In confirmed cases of subungual melanoma, two-thirds of lesions manifested as LM.3,10,11 Thus, LM arising in an adult in a single digit is more concerning for malignancy.2,3,7,9
Individuals of African and Asian descent as well as American Indian individuals are at highest risk for subungual melanoma with a poor prognosis compared to other types of melanoma, largely due to diagnosis at an advanced stage of disease.3,9 In a retrospective study of 25 patients with surgically treated subungual melanoma, the mean recurrence-free survival was 33.6 months. The recurrence-free survival was 66% at 1 year and 40% at 3 years, and the overall survival rate was 37% at 3 years.12
Key clinical features in individuals with darker skin tones
• In patients with darker skin tones, LM tends to occur on multiple nails as a result of melanocytic activation.2,13
• Several longitudinal bands may be noted on the same nail and the pigmentation of the bands may vary. With age, these longitudinal bands typically increase in number and width.13
• Pseudo-Hutchinson sign may be present due to ethnic melanosis of the proximal nail fold.13,14
• Dermoscopic findings of LM in patients with skin of color include wider bands (P = .0125), lower band brightness (P < .032), and higher frequency of changing appearance of bands (P = .0071).15
Worth noting
When patients present with LM, thorough examination of the nail plate, periungual skin, and distal pulp of all digits on all extremities with adequate lighting is important.2 Dermoscopy is useful, and a gel interface helps for examining the nail plates.7
Clinicians should be encouraged to biopsy or immediately refer patients with concerning nail unit lesions. Cases of LM most likely are benign, but if some doubt exists, the lesions should be biopsied or tracked closely with clinical and dermoscopic images, with a biopsy if changes occur.16 In conjunction with evaluation by a qualified clinician, patients also should be encouraged to take photographs, as the evolution of nail changes is a critical part of clinical decision-making on the need for a biopsy or referral.
Health disparity highlight
Despite the disproportionately high mortality rates from subungual melanoma in Black and Hispanic populations,3,9 studies often do not adequately represent these populations. Although subungual melanoma is rare, a delay in the diagnosis contributes to high morbidity and mortality rates.
Longitudinal melanonychia (LM) is a pigmented linear band—brown, black, or gray—spanning the length of the nail plate due to the presence of excess melanin, which may be attributed to a benign or malignant process and may warrant further investigation.1,2 The majority of patients who present with LM are diagnosed with melanocytic activation of the nail matrix due to their inherent darker skin tone or various triggers including trauma, infection, and medications. Longitudinal melanonychia secondary to melanocytic activation often occurs spontaneously in patients with skin of color.3 Less commonly, LM is caused by a nail matrix nevus or lentigo; however, LM may arise secondary to subungual melanoma, a more dangerous cause.
A thorough clinical history including duration, recent changes in LM manifestation, nail trauma, or infection is helpful in evaluating patients with LM; however, a history of nail trauma can be misleading, as nail changes attributed to the trauma may in fact be melanoma. Irregularly spaced vertical lines of pigmentation ranging from brown to black with variations in spacing and width are characteristic of subungual melanoma.4 Nail dystrophy, granular hyperpigmentation, and Hutchinson sign (extension of pigmentation to the nail folds) also are worrisome features.5 In recent years, dermoscopy has become an important tool in the clinical examination of LM, with the development of criteria based on color and pattern recognition.5,6 Dermoscopy can be useful in screening potential candidates for biopsy. Although clinical examination and dermoscopy are essential to evaluating LM, the gold-standard diagnostic test when malignancy is suspected is a nail matrix biopsy.1,2,6,7
Epidemiology
It is not unusual for patients with darker skin tones to develop LM due to melanocytic activation of multiple nails with age. This finding can be seen in approximately 80% of African American individuals, 30% of Japanese individuals, and 50% of Hispanic individuals.2 It has even been reported that approximately 100% of Black patients older than 50 years will have evidence of LM.3
In a retrospective analysis, children presenting with LM tend to have a higher prevalence of nail matrix nevi compared to adults (56.1% [60/106] vs 34.3% [23/66]; P =.005).8 Involvement of a single digit in children is most likely indicative of a nevus; however, when an adult presents with LM in a single digit, suspicion for subungual melanoma should be raised.2,3,9
Two separate single-center retrospective studies showed the prevalence of subungual melanoma in patients presenting with melanonychia in Asia. Jin et al10 reported subungual melanoma in 6.2% (17/275) of Korean patients presenting with melanonychia at a general dermatology clinic from 2002 to 2014. Lyu et al8 studied LM in 172 Chinese patients in a dermatology clinic from 2018 to 2021 and reported 9% (6/66) of adults (aged ≥ 18 years) with subungual melanoma, with no reported cases in childhood (aged < 18 years).
Although the prevalence of subungual melanoma in patients with LM is low, it is an important diagnosis that should not be missed. In confirmed cases of subungual melanoma, two-thirds of lesions manifested as LM.3,10,11 Thus, LM arising in an adult in a single digit is more concerning for malignancy.2,3,7,9
Individuals of African and Asian descent as well as American Indian individuals are at highest risk for subungual melanoma with a poor prognosis compared to other types of melanoma, largely due to diagnosis at an advanced stage of disease.3,9 In a retrospective study of 25 patients with surgically treated subungual melanoma, the mean recurrence-free survival was 33.6 months. The recurrence-free survival was 66% at 1 year and 40% at 3 years, and the overall survival rate was 37% at 3 years.12
Key clinical features in individuals with darker skin tones
• In patients with darker skin tones, LM tends to occur on multiple nails as a result of melanocytic activation.2,13
• Several longitudinal bands may be noted on the same nail and the pigmentation of the bands may vary. With age, these longitudinal bands typically increase in number and width.13
• Pseudo-Hutchinson sign may be present due to ethnic melanosis of the proximal nail fold.13,14
• Dermoscopic findings of LM in patients with skin of color include wider bands (P = .0125), lower band brightness (P < .032), and higher frequency of changing appearance of bands (P = .0071).15
Worth noting
When patients present with LM, thorough examination of the nail plate, periungual skin, and distal pulp of all digits on all extremities with adequate lighting is important.2 Dermoscopy is useful, and a gel interface helps for examining the nail plates.7
Clinicians should be encouraged to biopsy or immediately refer patients with concerning nail unit lesions. Cases of LM most likely are benign, but if some doubt exists, the lesions should be biopsied or tracked closely with clinical and dermoscopic images, with a biopsy if changes occur.16 In conjunction with evaluation by a qualified clinician, patients also should be encouraged to take photographs, as the evolution of nail changes is a critical part of clinical decision-making on the need for a biopsy or referral.
Health disparity highlight
Despite the disproportionately high mortality rates from subungual melanoma in Black and Hispanic populations,3,9 studies often do not adequately represent these populations. Although subungual melanoma is rare, a delay in the diagnosis contributes to high morbidity and mortality rates.
1. Tosti A, Piraccini BM, de Farias DC. Dealing with melanonychia. Semin Cutan Med Surg. 2009;28:49-54. doi:10.1016/j.sder.2008.12.004
2. Piraccini BM, Dika E, Fanti PA. Tips for diagnosis and treatment of nail pigmentation with practical algorithm. Dermatol Clin. 2015;33:185-195. doi:10.1016/j.det.2014.12.002
3. Halteh P, Scher R, Artis A, et al. Assessment of patient knowledge of longitudinal melanonychia: a survey study of patients in outpatient clinics. Skin Appendage Disord. 2016;2:156-161. doi:10.1159/000452673
4. Singal A, Bisherwal K. Melanonychia: etiology, diagnosis, and treatment. Indian Dermatol J Online. 2020;11:1-11. doi:10.4103/idoj.IDOJ_167_19
5. Benati E, Ribero S, Longo C, et al. Clinical and dermoscopic clues to differentiate pigmented nail bands: an International Dermoscopy Society study. J Eur Acad Dermatol Venereol. 2017;31:732-736. doi:10.1111/jdv.13991
6. Sawada M, Yokota K, Matsumoto T, et al. Proposed classification of longitudinal melanonychia based on clinical and dermoscopic criteria. Int J Dermatol. 2014;53:581-585. doi:10.1111/ijd.12001
7. Starace M, Alessandrini A, Brandi N, et al. Use of nail dermoscopy in the management of melanonychia. Dermatol Pract Concept. 2019;9:38-43. doi:10.5826/dpc.0901a10
8. Lyu A, Hou Y, Wang Q. Retrospective analysis of longitudinal melanonychia: a Chinese experience. Front Pediatr. 2023;10:1065758. doi:10.3389/fped.2022.1065758
9. Williams NM, Obayomi AO, Diaz-Perez, JA, et al. Monodactylous longitudinal melanonychia: a sign of Bowen’s disease in skin of color. Skin Appendage Disord. 2021;7:306-310. doi:10.1159/000514221
10. Jin H, Kim JM, Kim GW, et al. Diagnostic criteria for and clinical review of melanonychia in Korean patients. J Am Acad Dermatol. 2016;74,1121-1127. doi:10.1016/j.jaad.2015.12.039
11. Halteh P, Scher R, Artis A, et al. A survey-based study of management of longitudinal melanonychia amongst attending and resident dermatologists. J Am Acad Dermatol. 2017;76:994-996. doi:10.1016/j.jaad.2016.11.053
12. LaRocca CJ, Lai L, Nelson RA, et al. Subungual melanoma: a single institution experience. Med Sci (Basel). 2021;9:57. doi:10.3390/medsci9030057
13. Baran LR, Ruben BS, Kechijian P, et al. Non‐melanoma Hutchinson’s sign: a reappraisal of this important, remarkable melanoma simulant. J Eur Acad Dermatol Venereol. 2018;32:495-501. doi:10.1111/jdv.14715
14. Sladden MJ, Mortimer NJ, Osborne JE. Longitudinal melanonychia and pseudo‐Hutchinson sign associated with amlodipine. Br J Dermatol. 2005;153:219-220. doi:10.1111/j.13652133.2005.06668.x
15. Lee DK, Chang MJ, Desai AD, et al. Clinical and dermoscopic findings of benign longitudinal melanonychia due to melanocytic activation differ by skin type and predict likelihood of nail matrix biopsy. J Am Acad Dermatol. 2022;87:792-799. doi:10.1016/j.jaad.2022.06.1165
16. Hogue L, Harvey VM. Basal cell carcinoma, squamous cell carcinoma, and cutaneous melanoma in skin of color patients. Dermatol Clin. 2019;37:519-526. doi:10.1016/j.det.2019.05.009
1. Tosti A, Piraccini BM, de Farias DC. Dealing with melanonychia. Semin Cutan Med Surg. 2009;28:49-54. doi:10.1016/j.sder.2008.12.004
2. Piraccini BM, Dika E, Fanti PA. Tips for diagnosis and treatment of nail pigmentation with practical algorithm. Dermatol Clin. 2015;33:185-195. doi:10.1016/j.det.2014.12.002
3. Halteh P, Scher R, Artis A, et al. Assessment of patient knowledge of longitudinal melanonychia: a survey study of patients in outpatient clinics. Skin Appendage Disord. 2016;2:156-161. doi:10.1159/000452673
4. Singal A, Bisherwal K. Melanonychia: etiology, diagnosis, and treatment. Indian Dermatol J Online. 2020;11:1-11. doi:10.4103/idoj.IDOJ_167_19
5. Benati E, Ribero S, Longo C, et al. Clinical and dermoscopic clues to differentiate pigmented nail bands: an International Dermoscopy Society study. J Eur Acad Dermatol Venereol. 2017;31:732-736. doi:10.1111/jdv.13991
6. Sawada M, Yokota K, Matsumoto T, et al. Proposed classification of longitudinal melanonychia based on clinical and dermoscopic criteria. Int J Dermatol. 2014;53:581-585. doi:10.1111/ijd.12001
7. Starace M, Alessandrini A, Brandi N, et al. Use of nail dermoscopy in the management of melanonychia. Dermatol Pract Concept. 2019;9:38-43. doi:10.5826/dpc.0901a10
8. Lyu A, Hou Y, Wang Q. Retrospective analysis of longitudinal melanonychia: a Chinese experience. Front Pediatr. 2023;10:1065758. doi:10.3389/fped.2022.1065758
9. Williams NM, Obayomi AO, Diaz-Perez, JA, et al. Monodactylous longitudinal melanonychia: a sign of Bowen’s disease in skin of color. Skin Appendage Disord. 2021;7:306-310. doi:10.1159/000514221
10. Jin H, Kim JM, Kim GW, et al. Diagnostic criteria for and clinical review of melanonychia in Korean patients. J Am Acad Dermatol. 2016;74,1121-1127. doi:10.1016/j.jaad.2015.12.039
11. Halteh P, Scher R, Artis A, et al. A survey-based study of management of longitudinal melanonychia amongst attending and resident dermatologists. J Am Acad Dermatol. 2017;76:994-996. doi:10.1016/j.jaad.2016.11.053
12. LaRocca CJ, Lai L, Nelson RA, et al. Subungual melanoma: a single institution experience. Med Sci (Basel). 2021;9:57. doi:10.3390/medsci9030057
13. Baran LR, Ruben BS, Kechijian P, et al. Non‐melanoma Hutchinson’s sign: a reappraisal of this important, remarkable melanoma simulant. J Eur Acad Dermatol Venereol. 2018;32:495-501. doi:10.1111/jdv.14715
14. Sladden MJ, Mortimer NJ, Osborne JE. Longitudinal melanonychia and pseudo‐Hutchinson sign associated with amlodipine. Br J Dermatol. 2005;153:219-220. doi:10.1111/j.13652133.2005.06668.x
15. Lee DK, Chang MJ, Desai AD, et al. Clinical and dermoscopic findings of benign longitudinal melanonychia due to melanocytic activation differ by skin type and predict likelihood of nail matrix biopsy. J Am Acad Dermatol. 2022;87:792-799. doi:10.1016/j.jaad.2022.06.1165
16. Hogue L, Harvey VM. Basal cell carcinoma, squamous cell carcinoma, and cutaneous melanoma in skin of color patients. Dermatol Clin. 2019;37:519-526. doi:10.1016/j.det.2019.05.009
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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0424ED Cutis Edwards</fileName> <TBEID>0C02F3F4.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F3F4</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20240408T145344</firstPublished> <LastPublished>20240408T145344</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240408T145344</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText/> <bylineFull/> <bylineTitleText>Simultaneously published in Cutis and Federal Practitioner. doi:10.12788/cutis.0972</bylineTitleText> <USOrGlobal/> <wireDocType/> <newsDocType>(choose one)</newsDocType> <journalDocType>(choose one)</journalDocType> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>Longitudinal melanonychia (LM) is a pigmented linear band—brown, black, or gray—spanning the length of the nail plate due to the presence of excess melanin, whi</metaDescription> <articlePDF/> <teaserImage/> <title>Dx Across the Skin Color SpectrumLongitudinal Melanonychia Tristi M. Edwards, MBBS, MSc a ; Richard P. Usatine, MD b ; Candrice R. Heath, MD c</title> <deck/> <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>2951</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>Feature | 2951<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">104</term> </sections> <topics> <term canonical="true">203</term> <term>66772</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Dx Across the Skin Color SpectrumLongitudinal Melanonychia Tristi M. Edwards, MBBS, MSc a ; Richard P. Usatine, MD b ; Candrice R. Heath, MD c</title> <deck/> </itemMeta> <itemContent> <p><span class="Drop">L</span>ongitudinal melanonychia (LM) is a pigmented linear band—brown, black, or gray—spanning the length of the nail plate due to the presence of excess melanin, which may be attributed to a benign or malignant process and may warrant further investigation.<sup>1,2</sup> The majority of patients who present with LM are diagnosed with melanocytic activation of the nail matrix due to their inherent darker skin tone or various triggers including trauma, infection, and medications. Longitudinal melanonychia secondary to melanocytic activation often occurs spontaneously in patients with skin of color.<sup>3</sup> Less commonly, LM is caused by a nail matrix nevus or lentigo; however, LM may arise secondary to subungual melanoma, a more dangerous cause. </p> <p>A thorough clinical history including duration, recent changes in LM manifestation, nail trauma, or infection is helpful in evaluating patients with LM; however, a history of nail trauma can be misleading, as nail changes attributed to the trauma may in fact be melanoma. Irregularly spaced vertical lines of pigmentation ranging from brown to black with variations in spacing and width are characteristic of subungual melanoma.<sup>4</sup> Nail dystrophy, granular hyperpigmentation, and Hutchinson sign (extension of pigmentation to the nail folds) also are worrisome features.<sup>5</sup> In recent years, dermoscopy has become an important tool in the clinical examination of LM, with the development of criteria based on color and pattern recognition.<sup>5,6</sup> Dermoscopy can be useful in screening potential candidates for biopsy. Although clinical examination and dermoscopy are essential to evaluating LM, the gold-standard diagnostic test when malignancy is suspected is a nail matrix biopsy.<sup>1,2,6,7</sup></p> <h2> Epidemiology </h2> <p>It is not unusual for patients with darker skin tones to develop LM due to melanocytic activation of multiple nails with age. This finding can be seen in approximately 80% of African American individuals, 30% of Japanese individuals, and 50% of Hispanic individuals.<sup>2</sup> It has even been reported that approximately 100% of Black patients older than 50 years will have evidence of LM.<sup>3</sup></p> <p>In a retrospective analysis, children presenting with LM tend to have a higher prevalence of nail matrix nevi compared to adults (56.1% [60/106] vs 34.3% [23/66]; <i>P </i><span class="body">=</span>.005).<sup>8</sup> Involvement of a single digit in children is most likely indicative of a nevus; however, when an adult presents with LM in a single digit, suspicion for subungual melanoma should be raised.<sup>2,3,9</sup> <br/><br/>Two separate single-center retrospective studies showed the prevalence of subungual melanoma in patients presenting with melanonychia in Asia. Jin et al<sup>10</sup> reported subungual melanoma in 6.2% (17/275) of Korean patients presenting with melanonychia at a general dermatology clinic from 2002 to 2014. Lyu et al<sup>8</sup> studied LM in 172 Chinese patients in a dermatology clinic from 2018 to 2021 and reported 9% (6/66) of adults (aged ≥ 18 years) with subungual melanoma, with no reported cases in childhood (aged <span class="body">< </span>18 years).<br/><br/>Although the prevalence of subungual melanoma in patients with LM is low, it is an important diagnosis that should not be missed. In confirmed cases of subungual melanoma, two-thirds of lesions manifested as LM.<sup>3,10,11</sup> Thus, LM arising in an adult in a single digit is more concerning for malignancy.<sup>2,3,7,9</sup> <br/><br/>Individuals of African and Asian descent as well as American Indian individuals are at highest risk for subungual melanoma with a poor prognosis compared to other types of melanoma, largely due to diagnosis at an advanced stage of disease.<sup>3,9</sup> In a retrospective study of 25 patients with surgically treated subungual melanoma, the mean recurrence-free survival was 33.6 months. The recurrence-free survival was 66% at 1 year and 40% at 3 years, and the overall survival rate was 37% at 3 years.<sup>12</sup> </p> <h3>Key clinical features in individuals with darker skin tones</h3> <p>• In patients with darker skin tones, LM tends to occur on multiple nails as a result of melanocytic activation.<sup>2,13</sup> <br/><br/>• Several longitudinal bands may be noted on the same nail and the pigmentation of the bands may vary. With age, these longitudinal bands typically increase in number and width.<sup>13</sup><br/><br/>• Pseudo-Hutchinson sign may be present due to ethnic melanosis of the proximal nail fold.<sup>13,14<br/><br/></sup>• Dermoscopic findings of LM in patients with skin of color include wider bands (<i>P </i>= .0125), lower band brightness (<i>P </i>< .032), and higher frequency of changing appearance of bands (<i>P </i>= .0071).<sup>15 </sup></p> <h2> Worth noting </h2> <p>When patients present with LM, thorough examination of the nail plate, periungual skin, and distal pulp of all digits on all extremities with adequate lighting is important.<sup>2</sup> Dermoscopy is useful, and a gel interface helps for examining the nail plates.<sup>7</sup> </p> <p>Clinicians should be encouraged to biopsy or immediately refer patients with concerning nail unit lesions. Cases of LM most likely are benign, but if some doubt exists, the lesions should be biopsied or tracked closely with clinical and dermoscopic images, with a biopsy if changes occur.<sup>16</sup> In conjunction with evaluation by a qualified clinician, patients also should be encouraged to take photographs, as the evolution of nail changes is a critical part of clinical decision-making on the need for a biopsy or referral. </p> <h2> Health disparity highlight </h2> <p>Despite the disproportionately high mortality rates from subungual melanoma in Black and Hispanic populations,<sup>3,9</sup> studies often do not adequately represent these populations. Although subungual melanoma is rare, a delay in the diagnosis contributes to high morbidity and mortality rates. </p> <h3> Author affiliation </h3> <p> <em><sup>a</sup>SUNY Downstate Health Sciences University, New York<br/><br/><sup>b</sup>Family and Community Medicine and Dermatology, and Cutaneous Surgery, University of Texas Health, San Antonio<br/><br/><sup>c</sup>Department of Urban Health and Population, Science, Center for Urban Bioethics, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania</em> </p> <h2>References</h2> <p class="reference"> 1. Tosti A, Piraccini BM, de Farias DC. Dealing with melanonychia. <i>Semin Cutan Med Surg.</i> 2009;28:49-54. doi:10.1016/j.sder.2008.12.004 <br/><br/> 2. Piraccini BM, Dika E, Fanti PA. Tips for diagnosis and treatment of nail pigmentation with practical algorithm. <i>Dermatol Clin. </i>2015;33:185-195. doi:10.1016/j.det.2014.12.002 <br/><br/> 3. Halteh P, Scher R, Artis A, et al. Assessment of patient knowledge of longitudinal melanonychia: a survey study of patients in outpatient clinics.<span class="apple-converted-space"> </span><i>Skin Appendage Disord. </i><span class="apple-converted-space">2016;</span>2:156-161. doi:10.1159/000452673<br/><br/> 4. Singal A, Bisherwal K. Melanonychia: etiology, diagnosis, and treatment.<span class="apple-converted-space"> </span><i>Indian Dermatol J Online.</i><span class="apple-converted-space"> 2020;11:1-11</span>. doi:10.4103/idoj.IDOJ_167_19<br/><br/> 5. Benati E, Ribero S, Longo C, et al. Clinical and dermoscopic clues to differentiate pigmented nail bands: an International Dermoscopy Society study.<span class="apple-converted-space"> </span><i>J Eur Acad Dermatol Venereol. </i><span class="apple-converted-space">2017;</span>31:732-736. doi:10.1111/jdv.13991<br/><br/> 6. Sawada M, Yokota K, Matsumoto T, et al. Proposed classification of longitudinal melanonychia based on clinical and dermoscopic criteria.<span class="apple-converted-space"> </span><i>Int J Dermatol</i>. <span class="apple-converted-space">2014;</span>53:581-585. doi:10.1111/ijd.12001<br/><br/> 7. Starace M, Alessandrini A, Brandi N, et al. Use of nail dermoscopy in the management of melanonychia.<span class="apple-converted-space"> </span><span class="apple-converted-space"><i>Dermatol Pract Concept</i></span><span class="apple-converted-space">. 2019;</span>9:38-43. doi:10.5826/dpc.0901a10<br/><br/> 8. Lyu A, Hou Y, Wang Q. Retrospective analysis of longitudinal melanonychia: a Chinese experience.<span class="apple-converted-space"> </span><i>Front Pediatr.</i><span class="apple-converted-space"> 2023;</span>10:1065758. doi:10.3389/fped.2022.1065758<br/><br/> 9. Williams NM, Obayomi AO, Diaz-Perez, JA, et al. Monodactylous longitudinal melanonychia: a sign of Bowen’s disease in skin of color.<span class="apple-converted-space"> </span><i>Skin Appendage Disord. </i><span class="apple-converted-space">2021;</span>7:306-310. doi:10.1159/000514221<br/><br/>10. Jin H, Kim JM, Kim GW, et al. Diagnostic criteria for and clinical review of melanonychia in Korean patients.<span class="apple-converted-space"> </span><i>J Am Acad Dermatol.</i><span class="apple-converted-space"> 2016;</span>74,1121-1127. doi:10.1016/j.jaad.2015.12.039<br/><br/>11. Halteh P, Scher R, Artis A, et al. A survey-based study of management of longitudinal melanonychia amongst attending and resident dermatologists.<span class="apple-converted-space"> </span><i>J Am Acad Dermatol.</i> <span class="apple-converted-space">2017;</span>76:994-996. doi:10.1016/j.jaad.2016.11.053<br/><br/>12. LaRocca CJ, Lai L, Nelson RA, et al. Subungual melanoma: a single institution experience. <i>Med Sci (Basel)</i>. 2021;9:57. doi:10.3390/medsci9030057<br/><br/>13. Baran LR, Ruben BS, Kechijian P, et al. Non‐melanoma Hutchinson’s sign: a reappraisal of this important, remarkable melanoma simulant.<span class="apple-converted-space"> </span><i>J Eur Acad Dermatol Venereol.</i> <span class="apple-converted-space">2018;</span>32:495-501. doi:10.1111/jdv.14715<br/><br/>14. Sladden MJ, Mortimer NJ, Osborne JE. Longitudinal melanonychia and pseudo‐Hutchinson sign associated with amlodipine.<i> Br J Dermatol.</i><span class="apple-converted-space"> 2005;</span>153:219-220. doi:10.1111/j.13652133.2005.06668.x<br/><br/>15. Lee DK, Chang MJ, Desai AD, et al. Clinical and dermoscopic findings of benign longitudinal melanonychia due to melanocytic activation differ by skin type and predict likelihood of nail matrix biopsy.<span class="apple-converted-space"> </span>J<i> Am Acad Dermatol. </i><span class="apple-converted-space">2022;</span>87:792-799. doi:10.1016/j.jaad.2022.06.1165<br/><br/>16. Hogue L, Harvey VM. Basal cell carcinoma, squamous cell carcinoma, and cutaneous melanoma in skin of color patients.<span class="apple-converted-space"> </span><i>Dermatol Clin.</i><span class="apple-converted-space"> 2019;</span>37:519-526. doi:10.1016/j.det.2019.05.009</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>bio</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Age-Friendly Health Systems and Meeting the Principles of High Reliability Organizations in the VHA
The Veterans Health Administration (VHA) is the largest integrated health care system in the US, providing care to more than 9 million enrolled veterans at 1298 facilities.1 In February 2019, the VHA identified key action steps to become a high reliability organization (HRO), transforming how employees think about patient safety and care quality.2 The VHA is also working toward becoming the largest age-friendly health system in the US to be recognized by the Institute for Healthcare Improvement (IHI) for its commitment to providing care guided by the 4Ms (what matters, medication, mentation, and mobility), causing no harm, and aligning care with what matters to older veterans.3 In this article, we describe how the Age-Friendly Health Systems (AFHS) movement supports the culture shift observed in HROs.
Age-Friendly Veteran Care
By 2060, the US population of adults aged ≥ 65 years is projected to increase to about 95 million.3 In the VHA, nearly half of veteran enrollees are aged ≥ 65 years, necessitating evidence-based models of care, such as the 4Ms, to meet their complex care needs.3 Historically, the VHA has been a leader in caring for older adults, recognizing the value of age-friendly care for veterans.4 In 1975, the VHA established the Geriatric Research, Education, and Clinical Centers (GRECCs) to serve as catalysts for developing, implementing, and refining enduring models of geriatric care.4 For 5 decades, GRECCs have driven innovations related to the 4Ms.
The VHA is well positioned to be a leader in the AFHS movement, building on decades of GRECC innovations and geriatric programs that align with the 4Ms and providing specialized geriatric training for health care professionals to expand age-friendly care to new settings and health systems.4 The AFHS movement organizes the 4Ms into a simple framework for frontline staff, and the VHA has recently begun tracking 4Ms care in the electronic health record (EHR) to facilitate evaluation and continuous improvement.
AFHS use the 4Ms as a framework to be implemented in every care setting, from the emergency department to inpatient units, outpatient settings, and postacute and long-term care. By assessing and acting on each M and practicing the 4Ms collectively, all members of the care team work to improve health outcomes and prevent avoidable harm.5
The 4Ms
What matters, is the driver of this person-centered approach. Any member of the care team may initiate a what matters conversation with the older adult to understand their personal values, health goals, and care preferences. When compared with usual care, care aligned with the older adult’s health priorities has been shown to decrease the use of high-risk medications and reduce treatment burden.6 The VHA has adopted Whole Health principles of care and the Patient Priorities Care approach to identify and support what matters to veterans.7,8
Addressing polypharmacy and identifying and deprescribing potentially inappropriate medications are essential in preventing adverse drug events, drug-drug interactions, and medication nonadherence.9 In the VHA, VIONE (Vital, Important, Optional, Not indicated, Every medication has an indication) is a rapidly expanding medication deprescribing program that exemplifies HRO principles.9 VIONE provides medication management that supports shared decision making, reducing risk and improving patient safety and quality of life.9 As of June 2023, > 600,000 unique veterans have benefited from VIONE, with an average of 2.2 medications deprescribed per patient with an annual cost avoidance of > $100 million.10
Assessing and acting on mentation includes preventing, identifying, and managing depression and dementia in outpatient settings and delirium in hospital and long-term care settings.5 There are many tools and clinical reminders available in the EHR so that interdisciplinary teams can document changes to mentation and identify opportunities for continuous improvement.
Closely aligned with mentation is mobility, with evidence suggesting that regular physical activity reduces the risk of falls (preventing associated complications), maintains physical functioning, and lowers the risk of cognitive impairment and depression.5 Ensuring early, frequent, and safe mobility helps patients achieve better health outcomes and prevent injury.5 Mobility programs within the VHA include the STRIDEprogram for the inpatient setting and Gerofit for outpatient settings.11,12
HRO Principles
An HRO is a complex environment of care that experiences fewer than anticipated accidents or adverse events by (1) establishing trust among leaders and staff by balancing individual accountability with systems thinking; (2) empowering staff to lead continuous process improvements; and (3) creating an environment where employees feel safe to report harm or near misses, focusing on the reasons errors occur.13 The work of AFHS incorporates HRO principles with an emphasis on 3 elements. First, it involves interactive systems and processes needed to support 4Ms care across care settings. Second, AFHS acknowledge the complexity of age-friendly work and deference to the expertise of interdisciplinary team members. Finally, AFHS are committed to resilience by overcoming failures and challenges to implementation and long-term sustainment as a standard of practice.
Case study
The names and details in this case have been modified to protect patient privacy. It is representative of many Community Living Centers (CLCs) involved in AFHS that work to create a safe, person-centered environment for veterans.
In a CLC team workroom, 2 nurses were discussing a long-term care resident. The nurses approached the attending physician and explained that they were worried about Sgt Johnson, who seemed depressed and sometimes combative. They had noticed a change in his behavior when they helped him clean up after an episode of incontinence and were concerned that he would try to get out of bed on his own and fall. The attending physician thanked them for sharing their concerns. Sgt Johnson was a retired Army veteran who had a long, decorated military career. His chronic health conditions had led to muscle weakness, and he fell and broke a hip before this admission. He had an uneventful hip replacement but was showing signs of depression due to his limited mobility, loss of independence, and inability to live at home without additional support.
The attending physician knocked on the door of his room, sat down next to the bed, and asked, “How are you feeling today?” Sgt Johnson tersely replied, “About the same.” The physician asked, “Sgt Johnson, what matters most to you related to your recovery? What is important to you?” Sgt Johnson responded, “Feeling like a man!” The doctor replied, “So what makes you feel ‘not like a man’?” The Sgt replied, “Having to be cleaned up by the nurses and not being able to use the toilet on my own.” The physician surmised that his decline in physical functioning had a connection to his worsening depression and combativeness and said to the Sgt, “Let’s get the team together and work out a plan to get you strong enough to use a bedside commode by yourself. Let’s make that the first goal in our plan to get you back to using the toilet independently. Can you work with us on that?” He smiled and said, “Sir, yes Sir!”
At the weekly interdisciplinary team meeting, the team discussed Sgt Johnson’s wishes and the nurses’ safety concerns. The physician reported to the team what mattered to the veteran. The nurses arranged for a bedside commode and supplies to be placed in his room, encouraged and assisted him, and provided a privacy screen. The physical therapist continued to support his mobility needs, concentrating on transfers, small steps like standing and turning with a walker to get in position to use the bedside commode, and later the bathroom toilet. The psychologist addressed what matters to Sgt Johnson and his mentation, health goals, and coping strategies. The social worker provided support and counseling for the veteran and his family. The pharmacist checked his medications to be sure that none were affecting his gastrointestinal tract and his ability to move safely and do what matters to him. Knowing what mattered to Sgt Johnson was the driver of the interdisciplinary care plan to provide 4Ms care.
The team worked collaboratively with the veteran to develop and set attainable goals around toileting and regaining his dignity. This improved his overall recovery. As Sgt Johnson became more independent, his mood gradually improved and he began to participate in other activities and interact with other residents on the unit, and he did not experience any falls. By addressing the 4Ms, the interdisciplinary team coordinated efforts to provide high-quality, person-centered care. They built trust with the veteran, shared accountability, and followed HRO principles to keep the veteran safe.
Becoming an Age-Friendly HRO
Becoming an HRO is a dynamic, ever-changing process to maintain high standards, improve care quality, and cause no harm. There are 3 pillars and 5 principles that guide an HRO. The pillars are critical areas of focus and include leadership commitment, culture of safety, and continuous process improvement.14 The first of 5 HRO principles is sensitivity to operations. This is defined as an awareness of how processes and systems impact the entire organization, the downstream impact.15 Focusing on the 4Ms helps develop the capability of frontline staff to provide high-quality care for older adults while ensuring that processes are in place to support the work. The 4Ms provide an efficient way to organize interdisciplinary team meetings, provide warm handoffs using Situation-Background-Assessment-Recommendation, and standardize documentation. Involvement in the AFHS movement improves communication, care quality, and patient and staff satisfaction to meet this HRO principle.15
The second HRO principle, reluctance to simplify, ensures that direct care staff and leaders delve further into issues to find solutions.15 AFHS use the Plan-Do-Study-Act cycle to put the 4Ms into practice; this cycle helps teams test small increments of change, study their performance, and act to ensure that all 4Ms are being practiced as a set. AFHS teams are encouraged to review at least 3 months of data after implementation of the 4Ms, working to find solutions if there are gaps or issues identified.
The third principle, preoccupation with failure, refers to shared attentiveness—being prepared for the unexpected and learning from mistakes.15 The entire AFHS team shares responsibility for providing 4Ms care, where staff are empowered to report any safety concerns or close calls. The fourth principle of deference to expertise includes listening to staff who have the most knowledge for the task at hand, which aligns with the collaborative interdisciplinary teamwork of age-friendly teams.15
The final HRO principle, commitment to resilience, includes continuous learning, interdisciplinary team training, and sharing of lessons learned.15 Although IHI offers 2 levels of AFHS recognition, teams are continuously learning to improve and sustain care beyond level 2, Committed to Care Excellence recognition.16
The Table shows the VHA’s AFHS implementation strategies and the HRO principles adapted from the Joint Commission’s High Reliability Health Care Maturity Model and the IHI’s Framework for Safe, Reliable, and Effective Care. The VHA is developing a national dashboard to capture age-friendly processes and health outcome measures that address patient safety and care quality.
Conclusions
AFHS empowers VHA teams to honor veterans’ care preferences and values, supporting their independence, dignity, and quality of life across care settings. The adoption of AFHS brings evidence-based practices to the point of care by addressing common pitfalls in the care of older adults, drawing attention to, and calling for action on inappropriate medication use, physical inactivity, and assessment of the vulnerable brain. The 4Ms also serve as a framework to continuously improve care and cause zero harm, reinforcing HRO pillars and principles across the VHA, and ensuring that older adults reliably receive the evidence-based, high-quality care they deserve.
1. Veterans Health Administration. Providing healthcare for veterans. Updated June 20, 2023. Accessed June 26, 2023. https://www.va.gov/health
2. Veazie S, Peterson K, Bourne D. Evidence brief: implementation of high reliability organization principles. Washington, DC: Evidence Synthesis Program, Health Services Research and Development Service, Office of Research and Development, Department of Veterans Affairs. VA ESP Project #09-199; 2019. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/esp/high-reliability-org.cfm
3. Church K, Munro S, Shaughnessy M, Clancy C. Age-Friendly Health Systems: improving care for older adults in the Veterans Health Administration. Health Serv Res. 2023;58(suppl 1):5-8. doi:10.1111/1475-6773.14110
4. Farrell TW, Volden TA, Butler JM, et al. Age-friendly care in the Veterans Health Administration: past, present, and future. J Am Geriatr Soc. 2023;71(1):18-25. doi:10.1111/jgs.18070
5. Mate K, Fulmer T, Pelton L, et al. Evidence for the 4Ms: interactions and outcomes across the care continuum. J Aging Health. 2021;33(7-8):469-481. doi:10.1177/0898264321991658
6. Tinetti ME, Naik AD, Dindo L, et al. Association of patient priorities-aligned decision-making with patient outcomes and ambulatory health care burden among older adults with multiple chronic conditions: A nonrandomized clinical trial. JAMA Intern Med. 2019;179(12):1688-1697. doi:10.1001/jamainternmed.2019.4235
7. US Department of Veterans Affairs. What is whole health? Updated: October 31, 2023. November 30, 2023. https://www.va.gov/wholehealth
8. Patient Priorities Care. Updated 2019. Accessed November 30, 2023. https://patientprioritiescare.org
9. Battar S, Watson Dickerson KR, Sedgwick C, Cmelik T. Understanding principles of high reliability organizations through the eyes of VIONE: a clinical program to improve patient safety by deprescribing potentially inappropriate medications and reducing polypharmacy. Fed Pract. 2019;36(12):564-568.
10. VA Diffusion Marketplace. VIONE- medication optimization and polypharmacy reduction initiative. Accessed November 30, 2023. https://marketplace.va.gov/innovations/vione
11. US Department of Veterans Affairs, Office of Research and Development. STRIDE program to keep hospitalized veterans mobile. Updated November 6, 2018. Accessed November 30, 2023. https://www.research.va.gov/research_in_action/STRIDE-program-to-keep-hospitalized-Veterans-mobile.cfm
12. US Department of Veterans Affairs, VA Geriatrics and Extended Care. Gerofit: a program promoting exercise and health for older veterans. Updated August 2, 2023. Accessed November 30, 2023. https://www.va.gov/GERIATRICS/pages/gerofit_Home.asp
13. US Department of Veterans Affairs, Health Services Research and Development. VHA’s vision for a high reliability organization. Updated August 14, 2020. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/forum/summer20/default.cfm?ForumMenu=summer20-1
14. US Department of Veterans Affairs, Health Services Research and Development. Three HRO evaluation priorities. Updated August 14, 2020. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/forum/summer20/default.cfm?ForumMenu=summer20-2
15. Oster CA, Deakins S. Practical application of high-reliability principles in healthcare to optimize quality and safety outcomes. J Nurs Adm. 2018;48(1):50-55. doi:10.1097/NNA.0000000000000570
16. Institute for Healthcare Improvement. Age-Friendly Health Systems recognitions. Accessed November 30, 2023. https://www.ihi.org/Engage/Initiatives/Age-Friendly-Health-Systems/Pages/Recognition.aspx
The Veterans Health Administration (VHA) is the largest integrated health care system in the US, providing care to more than 9 million enrolled veterans at 1298 facilities.1 In February 2019, the VHA identified key action steps to become a high reliability organization (HRO), transforming how employees think about patient safety and care quality.2 The VHA is also working toward becoming the largest age-friendly health system in the US to be recognized by the Institute for Healthcare Improvement (IHI) for its commitment to providing care guided by the 4Ms (what matters, medication, mentation, and mobility), causing no harm, and aligning care with what matters to older veterans.3 In this article, we describe how the Age-Friendly Health Systems (AFHS) movement supports the culture shift observed in HROs.
Age-Friendly Veteran Care
By 2060, the US population of adults aged ≥ 65 years is projected to increase to about 95 million.3 In the VHA, nearly half of veteran enrollees are aged ≥ 65 years, necessitating evidence-based models of care, such as the 4Ms, to meet their complex care needs.3 Historically, the VHA has been a leader in caring for older adults, recognizing the value of age-friendly care for veterans.4 In 1975, the VHA established the Geriatric Research, Education, and Clinical Centers (GRECCs) to serve as catalysts for developing, implementing, and refining enduring models of geriatric care.4 For 5 decades, GRECCs have driven innovations related to the 4Ms.
The VHA is well positioned to be a leader in the AFHS movement, building on decades of GRECC innovations and geriatric programs that align with the 4Ms and providing specialized geriatric training for health care professionals to expand age-friendly care to new settings and health systems.4 The AFHS movement organizes the 4Ms into a simple framework for frontline staff, and the VHA has recently begun tracking 4Ms care in the electronic health record (EHR) to facilitate evaluation and continuous improvement.
AFHS use the 4Ms as a framework to be implemented in every care setting, from the emergency department to inpatient units, outpatient settings, and postacute and long-term care. By assessing and acting on each M and practicing the 4Ms collectively, all members of the care team work to improve health outcomes and prevent avoidable harm.5
The 4Ms
What matters, is the driver of this person-centered approach. Any member of the care team may initiate a what matters conversation with the older adult to understand their personal values, health goals, and care preferences. When compared with usual care, care aligned with the older adult’s health priorities has been shown to decrease the use of high-risk medications and reduce treatment burden.6 The VHA has adopted Whole Health principles of care and the Patient Priorities Care approach to identify and support what matters to veterans.7,8
Addressing polypharmacy and identifying and deprescribing potentially inappropriate medications are essential in preventing adverse drug events, drug-drug interactions, and medication nonadherence.9 In the VHA, VIONE (Vital, Important, Optional, Not indicated, Every medication has an indication) is a rapidly expanding medication deprescribing program that exemplifies HRO principles.9 VIONE provides medication management that supports shared decision making, reducing risk and improving patient safety and quality of life.9 As of June 2023, > 600,000 unique veterans have benefited from VIONE, with an average of 2.2 medications deprescribed per patient with an annual cost avoidance of > $100 million.10
Assessing and acting on mentation includes preventing, identifying, and managing depression and dementia in outpatient settings and delirium in hospital and long-term care settings.5 There are many tools and clinical reminders available in the EHR so that interdisciplinary teams can document changes to mentation and identify opportunities for continuous improvement.
Closely aligned with mentation is mobility, with evidence suggesting that regular physical activity reduces the risk of falls (preventing associated complications), maintains physical functioning, and lowers the risk of cognitive impairment and depression.5 Ensuring early, frequent, and safe mobility helps patients achieve better health outcomes and prevent injury.5 Mobility programs within the VHA include the STRIDEprogram for the inpatient setting and Gerofit for outpatient settings.11,12
HRO Principles
An HRO is a complex environment of care that experiences fewer than anticipated accidents or adverse events by (1) establishing trust among leaders and staff by balancing individual accountability with systems thinking; (2) empowering staff to lead continuous process improvements; and (3) creating an environment where employees feel safe to report harm or near misses, focusing on the reasons errors occur.13 The work of AFHS incorporates HRO principles with an emphasis on 3 elements. First, it involves interactive systems and processes needed to support 4Ms care across care settings. Second, AFHS acknowledge the complexity of age-friendly work and deference to the expertise of interdisciplinary team members. Finally, AFHS are committed to resilience by overcoming failures and challenges to implementation and long-term sustainment as a standard of practice.
Case study
The names and details in this case have been modified to protect patient privacy. It is representative of many Community Living Centers (CLCs) involved in AFHS that work to create a safe, person-centered environment for veterans.
In a CLC team workroom, 2 nurses were discussing a long-term care resident. The nurses approached the attending physician and explained that they were worried about Sgt Johnson, who seemed depressed and sometimes combative. They had noticed a change in his behavior when they helped him clean up after an episode of incontinence and were concerned that he would try to get out of bed on his own and fall. The attending physician thanked them for sharing their concerns. Sgt Johnson was a retired Army veteran who had a long, decorated military career. His chronic health conditions had led to muscle weakness, and he fell and broke a hip before this admission. He had an uneventful hip replacement but was showing signs of depression due to his limited mobility, loss of independence, and inability to live at home without additional support.
The attending physician knocked on the door of his room, sat down next to the bed, and asked, “How are you feeling today?” Sgt Johnson tersely replied, “About the same.” The physician asked, “Sgt Johnson, what matters most to you related to your recovery? What is important to you?” Sgt Johnson responded, “Feeling like a man!” The doctor replied, “So what makes you feel ‘not like a man’?” The Sgt replied, “Having to be cleaned up by the nurses and not being able to use the toilet on my own.” The physician surmised that his decline in physical functioning had a connection to his worsening depression and combativeness and said to the Sgt, “Let’s get the team together and work out a plan to get you strong enough to use a bedside commode by yourself. Let’s make that the first goal in our plan to get you back to using the toilet independently. Can you work with us on that?” He smiled and said, “Sir, yes Sir!”
At the weekly interdisciplinary team meeting, the team discussed Sgt Johnson’s wishes and the nurses’ safety concerns. The physician reported to the team what mattered to the veteran. The nurses arranged for a bedside commode and supplies to be placed in his room, encouraged and assisted him, and provided a privacy screen. The physical therapist continued to support his mobility needs, concentrating on transfers, small steps like standing and turning with a walker to get in position to use the bedside commode, and later the bathroom toilet. The psychologist addressed what matters to Sgt Johnson and his mentation, health goals, and coping strategies. The social worker provided support and counseling for the veteran and his family. The pharmacist checked his medications to be sure that none were affecting his gastrointestinal tract and his ability to move safely and do what matters to him. Knowing what mattered to Sgt Johnson was the driver of the interdisciplinary care plan to provide 4Ms care.
The team worked collaboratively with the veteran to develop and set attainable goals around toileting and regaining his dignity. This improved his overall recovery. As Sgt Johnson became more independent, his mood gradually improved and he began to participate in other activities and interact with other residents on the unit, and he did not experience any falls. By addressing the 4Ms, the interdisciplinary team coordinated efforts to provide high-quality, person-centered care. They built trust with the veteran, shared accountability, and followed HRO principles to keep the veteran safe.
Becoming an Age-Friendly HRO
Becoming an HRO is a dynamic, ever-changing process to maintain high standards, improve care quality, and cause no harm. There are 3 pillars and 5 principles that guide an HRO. The pillars are critical areas of focus and include leadership commitment, culture of safety, and continuous process improvement.14 The first of 5 HRO principles is sensitivity to operations. This is defined as an awareness of how processes and systems impact the entire organization, the downstream impact.15 Focusing on the 4Ms helps develop the capability of frontline staff to provide high-quality care for older adults while ensuring that processes are in place to support the work. The 4Ms provide an efficient way to organize interdisciplinary team meetings, provide warm handoffs using Situation-Background-Assessment-Recommendation, and standardize documentation. Involvement in the AFHS movement improves communication, care quality, and patient and staff satisfaction to meet this HRO principle.15
The second HRO principle, reluctance to simplify, ensures that direct care staff and leaders delve further into issues to find solutions.15 AFHS use the Plan-Do-Study-Act cycle to put the 4Ms into practice; this cycle helps teams test small increments of change, study their performance, and act to ensure that all 4Ms are being practiced as a set. AFHS teams are encouraged to review at least 3 months of data after implementation of the 4Ms, working to find solutions if there are gaps or issues identified.
The third principle, preoccupation with failure, refers to shared attentiveness—being prepared for the unexpected and learning from mistakes.15 The entire AFHS team shares responsibility for providing 4Ms care, where staff are empowered to report any safety concerns or close calls. The fourth principle of deference to expertise includes listening to staff who have the most knowledge for the task at hand, which aligns with the collaborative interdisciplinary teamwork of age-friendly teams.15
The final HRO principle, commitment to resilience, includes continuous learning, interdisciplinary team training, and sharing of lessons learned.15 Although IHI offers 2 levels of AFHS recognition, teams are continuously learning to improve and sustain care beyond level 2, Committed to Care Excellence recognition.16
The Table shows the VHA’s AFHS implementation strategies and the HRO principles adapted from the Joint Commission’s High Reliability Health Care Maturity Model and the IHI’s Framework for Safe, Reliable, and Effective Care. The VHA is developing a national dashboard to capture age-friendly processes and health outcome measures that address patient safety and care quality.
Conclusions
AFHS empowers VHA teams to honor veterans’ care preferences and values, supporting their independence, dignity, and quality of life across care settings. The adoption of AFHS brings evidence-based practices to the point of care by addressing common pitfalls in the care of older adults, drawing attention to, and calling for action on inappropriate medication use, physical inactivity, and assessment of the vulnerable brain. The 4Ms also serve as a framework to continuously improve care and cause zero harm, reinforcing HRO pillars and principles across the VHA, and ensuring that older adults reliably receive the evidence-based, high-quality care they deserve.
The Veterans Health Administration (VHA) is the largest integrated health care system in the US, providing care to more than 9 million enrolled veterans at 1298 facilities.1 In February 2019, the VHA identified key action steps to become a high reliability organization (HRO), transforming how employees think about patient safety and care quality.2 The VHA is also working toward becoming the largest age-friendly health system in the US to be recognized by the Institute for Healthcare Improvement (IHI) for its commitment to providing care guided by the 4Ms (what matters, medication, mentation, and mobility), causing no harm, and aligning care with what matters to older veterans.3 In this article, we describe how the Age-Friendly Health Systems (AFHS) movement supports the culture shift observed in HROs.
Age-Friendly Veteran Care
By 2060, the US population of adults aged ≥ 65 years is projected to increase to about 95 million.3 In the VHA, nearly half of veteran enrollees are aged ≥ 65 years, necessitating evidence-based models of care, such as the 4Ms, to meet their complex care needs.3 Historically, the VHA has been a leader in caring for older adults, recognizing the value of age-friendly care for veterans.4 In 1975, the VHA established the Geriatric Research, Education, and Clinical Centers (GRECCs) to serve as catalysts for developing, implementing, and refining enduring models of geriatric care.4 For 5 decades, GRECCs have driven innovations related to the 4Ms.
The VHA is well positioned to be a leader in the AFHS movement, building on decades of GRECC innovations and geriatric programs that align with the 4Ms and providing specialized geriatric training for health care professionals to expand age-friendly care to new settings and health systems.4 The AFHS movement organizes the 4Ms into a simple framework for frontline staff, and the VHA has recently begun tracking 4Ms care in the electronic health record (EHR) to facilitate evaluation and continuous improvement.
AFHS use the 4Ms as a framework to be implemented in every care setting, from the emergency department to inpatient units, outpatient settings, and postacute and long-term care. By assessing and acting on each M and practicing the 4Ms collectively, all members of the care team work to improve health outcomes and prevent avoidable harm.5
The 4Ms
What matters, is the driver of this person-centered approach. Any member of the care team may initiate a what matters conversation with the older adult to understand their personal values, health goals, and care preferences. When compared with usual care, care aligned with the older adult’s health priorities has been shown to decrease the use of high-risk medications and reduce treatment burden.6 The VHA has adopted Whole Health principles of care and the Patient Priorities Care approach to identify and support what matters to veterans.7,8
Addressing polypharmacy and identifying and deprescribing potentially inappropriate medications are essential in preventing adverse drug events, drug-drug interactions, and medication nonadherence.9 In the VHA, VIONE (Vital, Important, Optional, Not indicated, Every medication has an indication) is a rapidly expanding medication deprescribing program that exemplifies HRO principles.9 VIONE provides medication management that supports shared decision making, reducing risk and improving patient safety and quality of life.9 As of June 2023, > 600,000 unique veterans have benefited from VIONE, with an average of 2.2 medications deprescribed per patient with an annual cost avoidance of > $100 million.10
Assessing and acting on mentation includes preventing, identifying, and managing depression and dementia in outpatient settings and delirium in hospital and long-term care settings.5 There are many tools and clinical reminders available in the EHR so that interdisciplinary teams can document changes to mentation and identify opportunities for continuous improvement.
Closely aligned with mentation is mobility, with evidence suggesting that regular physical activity reduces the risk of falls (preventing associated complications), maintains physical functioning, and lowers the risk of cognitive impairment and depression.5 Ensuring early, frequent, and safe mobility helps patients achieve better health outcomes and prevent injury.5 Mobility programs within the VHA include the STRIDEprogram for the inpatient setting and Gerofit for outpatient settings.11,12
HRO Principles
An HRO is a complex environment of care that experiences fewer than anticipated accidents or adverse events by (1) establishing trust among leaders and staff by balancing individual accountability with systems thinking; (2) empowering staff to lead continuous process improvements; and (3) creating an environment where employees feel safe to report harm or near misses, focusing on the reasons errors occur.13 The work of AFHS incorporates HRO principles with an emphasis on 3 elements. First, it involves interactive systems and processes needed to support 4Ms care across care settings. Second, AFHS acknowledge the complexity of age-friendly work and deference to the expertise of interdisciplinary team members. Finally, AFHS are committed to resilience by overcoming failures and challenges to implementation and long-term sustainment as a standard of practice.
Case study
The names and details in this case have been modified to protect patient privacy. It is representative of many Community Living Centers (CLCs) involved in AFHS that work to create a safe, person-centered environment for veterans.
In a CLC team workroom, 2 nurses were discussing a long-term care resident. The nurses approached the attending physician and explained that they were worried about Sgt Johnson, who seemed depressed and sometimes combative. They had noticed a change in his behavior when they helped him clean up after an episode of incontinence and were concerned that he would try to get out of bed on his own and fall. The attending physician thanked them for sharing their concerns. Sgt Johnson was a retired Army veteran who had a long, decorated military career. His chronic health conditions had led to muscle weakness, and he fell and broke a hip before this admission. He had an uneventful hip replacement but was showing signs of depression due to his limited mobility, loss of independence, and inability to live at home without additional support.
The attending physician knocked on the door of his room, sat down next to the bed, and asked, “How are you feeling today?” Sgt Johnson tersely replied, “About the same.” The physician asked, “Sgt Johnson, what matters most to you related to your recovery? What is important to you?” Sgt Johnson responded, “Feeling like a man!” The doctor replied, “So what makes you feel ‘not like a man’?” The Sgt replied, “Having to be cleaned up by the nurses and not being able to use the toilet on my own.” The physician surmised that his decline in physical functioning had a connection to his worsening depression and combativeness and said to the Sgt, “Let’s get the team together and work out a plan to get you strong enough to use a bedside commode by yourself. Let’s make that the first goal in our plan to get you back to using the toilet independently. Can you work with us on that?” He smiled and said, “Sir, yes Sir!”
At the weekly interdisciplinary team meeting, the team discussed Sgt Johnson’s wishes and the nurses’ safety concerns. The physician reported to the team what mattered to the veteran. The nurses arranged for a bedside commode and supplies to be placed in his room, encouraged and assisted him, and provided a privacy screen. The physical therapist continued to support his mobility needs, concentrating on transfers, small steps like standing and turning with a walker to get in position to use the bedside commode, and later the bathroom toilet. The psychologist addressed what matters to Sgt Johnson and his mentation, health goals, and coping strategies. The social worker provided support and counseling for the veteran and his family. The pharmacist checked his medications to be sure that none were affecting his gastrointestinal tract and his ability to move safely and do what matters to him. Knowing what mattered to Sgt Johnson was the driver of the interdisciplinary care plan to provide 4Ms care.
The team worked collaboratively with the veteran to develop and set attainable goals around toileting and regaining his dignity. This improved his overall recovery. As Sgt Johnson became more independent, his mood gradually improved and he began to participate in other activities and interact with other residents on the unit, and he did not experience any falls. By addressing the 4Ms, the interdisciplinary team coordinated efforts to provide high-quality, person-centered care. They built trust with the veteran, shared accountability, and followed HRO principles to keep the veteran safe.
Becoming an Age-Friendly HRO
Becoming an HRO is a dynamic, ever-changing process to maintain high standards, improve care quality, and cause no harm. There are 3 pillars and 5 principles that guide an HRO. The pillars are critical areas of focus and include leadership commitment, culture of safety, and continuous process improvement.14 The first of 5 HRO principles is sensitivity to operations. This is defined as an awareness of how processes and systems impact the entire organization, the downstream impact.15 Focusing on the 4Ms helps develop the capability of frontline staff to provide high-quality care for older adults while ensuring that processes are in place to support the work. The 4Ms provide an efficient way to organize interdisciplinary team meetings, provide warm handoffs using Situation-Background-Assessment-Recommendation, and standardize documentation. Involvement in the AFHS movement improves communication, care quality, and patient and staff satisfaction to meet this HRO principle.15
The second HRO principle, reluctance to simplify, ensures that direct care staff and leaders delve further into issues to find solutions.15 AFHS use the Plan-Do-Study-Act cycle to put the 4Ms into practice; this cycle helps teams test small increments of change, study their performance, and act to ensure that all 4Ms are being practiced as a set. AFHS teams are encouraged to review at least 3 months of data after implementation of the 4Ms, working to find solutions if there are gaps or issues identified.
The third principle, preoccupation with failure, refers to shared attentiveness—being prepared for the unexpected and learning from mistakes.15 The entire AFHS team shares responsibility for providing 4Ms care, where staff are empowered to report any safety concerns or close calls. The fourth principle of deference to expertise includes listening to staff who have the most knowledge for the task at hand, which aligns with the collaborative interdisciplinary teamwork of age-friendly teams.15
The final HRO principle, commitment to resilience, includes continuous learning, interdisciplinary team training, and sharing of lessons learned.15 Although IHI offers 2 levels of AFHS recognition, teams are continuously learning to improve and sustain care beyond level 2, Committed to Care Excellence recognition.16
The Table shows the VHA’s AFHS implementation strategies and the HRO principles adapted from the Joint Commission’s High Reliability Health Care Maturity Model and the IHI’s Framework for Safe, Reliable, and Effective Care. The VHA is developing a national dashboard to capture age-friendly processes and health outcome measures that address patient safety and care quality.
Conclusions
AFHS empowers VHA teams to honor veterans’ care preferences and values, supporting their independence, dignity, and quality of life across care settings. The adoption of AFHS brings evidence-based practices to the point of care by addressing common pitfalls in the care of older adults, drawing attention to, and calling for action on inappropriate medication use, physical inactivity, and assessment of the vulnerable brain. The 4Ms also serve as a framework to continuously improve care and cause zero harm, reinforcing HRO pillars and principles across the VHA, and ensuring that older adults reliably receive the evidence-based, high-quality care they deserve.
1. Veterans Health Administration. Providing healthcare for veterans. Updated June 20, 2023. Accessed June 26, 2023. https://www.va.gov/health
2. Veazie S, Peterson K, Bourne D. Evidence brief: implementation of high reliability organization principles. Washington, DC: Evidence Synthesis Program, Health Services Research and Development Service, Office of Research and Development, Department of Veterans Affairs. VA ESP Project #09-199; 2019. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/esp/high-reliability-org.cfm
3. Church K, Munro S, Shaughnessy M, Clancy C. Age-Friendly Health Systems: improving care for older adults in the Veterans Health Administration. Health Serv Res. 2023;58(suppl 1):5-8. doi:10.1111/1475-6773.14110
4. Farrell TW, Volden TA, Butler JM, et al. Age-friendly care in the Veterans Health Administration: past, present, and future. J Am Geriatr Soc. 2023;71(1):18-25. doi:10.1111/jgs.18070
5. Mate K, Fulmer T, Pelton L, et al. Evidence for the 4Ms: interactions and outcomes across the care continuum. J Aging Health. 2021;33(7-8):469-481. doi:10.1177/0898264321991658
6. Tinetti ME, Naik AD, Dindo L, et al. Association of patient priorities-aligned decision-making with patient outcomes and ambulatory health care burden among older adults with multiple chronic conditions: A nonrandomized clinical trial. JAMA Intern Med. 2019;179(12):1688-1697. doi:10.1001/jamainternmed.2019.4235
7. US Department of Veterans Affairs. What is whole health? Updated: October 31, 2023. November 30, 2023. https://www.va.gov/wholehealth
8. Patient Priorities Care. Updated 2019. Accessed November 30, 2023. https://patientprioritiescare.org
9. Battar S, Watson Dickerson KR, Sedgwick C, Cmelik T. Understanding principles of high reliability organizations through the eyes of VIONE: a clinical program to improve patient safety by deprescribing potentially inappropriate medications and reducing polypharmacy. Fed Pract. 2019;36(12):564-568.
10. VA Diffusion Marketplace. VIONE- medication optimization and polypharmacy reduction initiative. Accessed November 30, 2023. https://marketplace.va.gov/innovations/vione
11. US Department of Veterans Affairs, Office of Research and Development. STRIDE program to keep hospitalized veterans mobile. Updated November 6, 2018. Accessed November 30, 2023. https://www.research.va.gov/research_in_action/STRIDE-program-to-keep-hospitalized-Veterans-mobile.cfm
12. US Department of Veterans Affairs, VA Geriatrics and Extended Care. Gerofit: a program promoting exercise and health for older veterans. Updated August 2, 2023. Accessed November 30, 2023. https://www.va.gov/GERIATRICS/pages/gerofit_Home.asp
13. US Department of Veterans Affairs, Health Services Research and Development. VHA’s vision for a high reliability organization. Updated August 14, 2020. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/forum/summer20/default.cfm?ForumMenu=summer20-1
14. US Department of Veterans Affairs, Health Services Research and Development. Three HRO evaluation priorities. Updated August 14, 2020. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/forum/summer20/default.cfm?ForumMenu=summer20-2
15. Oster CA, Deakins S. Practical application of high-reliability principles in healthcare to optimize quality and safety outcomes. J Nurs Adm. 2018;48(1):50-55. doi:10.1097/NNA.0000000000000570
16. Institute for Healthcare Improvement. Age-Friendly Health Systems recognitions. Accessed November 30, 2023. https://www.ihi.org/Engage/Initiatives/Age-Friendly-Health-Systems/Pages/Recognition.aspx
1. Veterans Health Administration. Providing healthcare for veterans. Updated June 20, 2023. Accessed June 26, 2023. https://www.va.gov/health
2. Veazie S, Peterson K, Bourne D. Evidence brief: implementation of high reliability organization principles. Washington, DC: Evidence Synthesis Program, Health Services Research and Development Service, Office of Research and Development, Department of Veterans Affairs. VA ESP Project #09-199; 2019. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/esp/high-reliability-org.cfm
3. Church K, Munro S, Shaughnessy M, Clancy C. Age-Friendly Health Systems: improving care for older adults in the Veterans Health Administration. Health Serv Res. 2023;58(suppl 1):5-8. doi:10.1111/1475-6773.14110
4. Farrell TW, Volden TA, Butler JM, et al. Age-friendly care in the Veterans Health Administration: past, present, and future. J Am Geriatr Soc. 2023;71(1):18-25. doi:10.1111/jgs.18070
5. Mate K, Fulmer T, Pelton L, et al. Evidence for the 4Ms: interactions and outcomes across the care continuum. J Aging Health. 2021;33(7-8):469-481. doi:10.1177/0898264321991658
6. Tinetti ME, Naik AD, Dindo L, et al. Association of patient priorities-aligned decision-making with patient outcomes and ambulatory health care burden among older adults with multiple chronic conditions: A nonrandomized clinical trial. JAMA Intern Med. 2019;179(12):1688-1697. doi:10.1001/jamainternmed.2019.4235
7. US Department of Veterans Affairs. What is whole health? Updated: October 31, 2023. November 30, 2023. https://www.va.gov/wholehealth
8. Patient Priorities Care. Updated 2019. Accessed November 30, 2023. https://patientprioritiescare.org
9. Battar S, Watson Dickerson KR, Sedgwick C, Cmelik T. Understanding principles of high reliability organizations through the eyes of VIONE: a clinical program to improve patient safety by deprescribing potentially inappropriate medications and reducing polypharmacy. Fed Pract. 2019;36(12):564-568.
10. VA Diffusion Marketplace. VIONE- medication optimization and polypharmacy reduction initiative. Accessed November 30, 2023. https://marketplace.va.gov/innovations/vione
11. US Department of Veterans Affairs, Office of Research and Development. STRIDE program to keep hospitalized veterans mobile. Updated November 6, 2018. Accessed November 30, 2023. https://www.research.va.gov/research_in_action/STRIDE-program-to-keep-hospitalized-Veterans-mobile.cfm
12. US Department of Veterans Affairs, VA Geriatrics and Extended Care. Gerofit: a program promoting exercise and health for older veterans. Updated August 2, 2023. Accessed November 30, 2023. https://www.va.gov/GERIATRICS/pages/gerofit_Home.asp
13. US Department of Veterans Affairs, Health Services Research and Development. VHA’s vision for a high reliability organization. Updated August 14, 2020. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/forum/summer20/default.cfm?ForumMenu=summer20-1
14. US Department of Veterans Affairs, Health Services Research and Development. Three HRO evaluation priorities. Updated August 14, 2020. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/forum/summer20/default.cfm?ForumMenu=summer20-2
15. Oster CA, Deakins S. Practical application of high-reliability principles in healthcare to optimize quality and safety outcomes. J Nurs Adm. 2018;48(1):50-55. doi:10.1097/NNA.0000000000000570
16. Institute for Healthcare Improvement. Age-Friendly Health Systems recognitions. Accessed November 30, 2023. https://www.ihi.org/Engage/Initiatives/Age-Friendly-Health-Systems/Pages/Recognition.aspx
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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0124 FED AFHS and HROs</fileName> <TBEID>0C02EE46.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02EE46</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20240103T214554</firstPublished> <LastPublished>20240103T214554</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240103T214553</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>Kimberly Church, MSa; Shannon Munro, PhD, APRN, BC, NPb; Laurence M. Solberg, MD, AGSFc; Erica A. Gruber, A-GNP, BCENd; Marianne Shaughnessy, PhD, AGPCNP-BC, GS-Ca</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 the largest integrated health care system in the US, providing care to more than 9 million enrolled veterans at 1298</metaDescription> <articlePDF/> <teaserImage/> <title>Age-Friendly Health Systems and Meeting the Principles of High Reliability Organizations in the VHA</title> <deck/> <eyebrow>Commentary</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>January</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>1</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>2951</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>January 2024</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Feature | 2951<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">52</term> <term>106</term> </sections> <topics> <term canonical="true">27442</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Age-Friendly Health Systems and Meeting the Principles of High Reliability Organizations in the VHA</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background:</b> The Veterans Health Administration (VHA) is the largest integrated health care system in the US, providing care to more than 9 million enrolled veterans. In February 2019, the VHA identified key actionable steps to become a high reliability organization (HRO), transforming how employees think about patient safety and care quality. The VHA is also working toward becoming the largest age-friendly health system in the US to be recognized by the Institute for Healthcare Improvement for its commitment to providing care guided by the 4Ms (what matters, medication, mentation, and mobility), causing no harm, and aligning care with what matters to older veterans.<br/><br/><b>Observations:</b> In this article, we describe how the Age-Friendly Health Systems (AFHS) movement supports the culture shift observed in HROs. AFHS use the 4Ms as a framework to be implemented in every care setting. The 4Ms are used in conjunction with the 3 pillars (leadership commitment, culture of safety, and continuous process improvement) and 5 principles (sensitivity to operations, reluctance to simplify, preoccupation with failure, deference to clinical expertise, and commitment to resilience) that guide an HRO. We also share an HRO case study that is representative of many Community Living Centers involved in AFHS.<br/><br/><b>Conclusions:</b> AFHS empower VHA teams to honor veterans’ care preferences and values, supporting their independence, dignity, and quality of life across care settings. The adoption of AFHS brings evidence-based practices to the point of care by addressing common pitfalls in the care of older adults, drawing attention to, and calling for action on inappropriate medication use, physical inactivity, and assessment of the vulnerable brain. The 4Ms also serve as a framework to continuously improve care and cause zero harm, reinforcing HRO pillars and principles across the VHA and ensuring that older adults reliably receive the evidence-based, high-quality care they deserve.</p> <p><span class="Drop">T</span>he Veterans Health Administration (VHA) is the largest integrated health care system in the US, providing care to more than 9 million enrolled veterans at 1298 facilities.<sup>1</sup> In February 2019, the VHA identified key action steps to become a high reliability organization (HRO), transforming how employees think about patient safety and care quality.<sup>2</sup> The VHA is also working toward becoming the largest age-friendly health system in the US to be recognized by the Institute for Healthcare Improvement (IHI) for its commitment to providing care guided by the 4Ms (what matters, medication, mentation, and mobility), causing no harm, and aligning care with what matters to older veterans.<sup>3</sup> In this article, we describe how the Age-Friendly Health Systems (AFHS) movement supports the culture shift observed in HROs. </p> <h2>Age-Friendly Veteran Care</h2> <p>By 2060, the US population of adults aged ≥ 65 years is projected to increase to about 95 million.<sup>3</sup> In the VHA, nearly half of veteran enrollees are aged ≥ 65 years, necessitating evidence-based models of care, such as the 4Ms, to meet their complex care needs.<sup>3</sup> Historically, the VHA has been a leader in caring for older adults, recognizing the value of age-friendly care for veterans.<sup>4</sup> In 1975, the VHA established the Geriatric Research, Education, and Clinical Centers (GRECCs) to serve as catalysts for developing, implementing, and refining enduring models of geriatric care.<sup>4</sup> For 5 decades, GRECCs have driven innovations related to the 4Ms. </p> <p>The VHA is well positioned to be a leader in the AFHS movement, building on decades of GRECC innovations and geriatric programs that align with the 4Ms and providing specialized geriatric training for health care professionals to expand age-friendly care to new settings and health systems.<sup>4</sup> The AFHS movement organizes the 4Ms into a simple framework for frontline staff, and the VHA has recently begun tracking 4Ms care in the electronic health record (EHR) to facilitate evaluation and continuous improvement.<br/><br/>AFHS use the 4Ms as a framework to be implemented in every care setting, from the emergency department to inpatient units, outpatient settings, and postacute and long-term care. By assessing and acting on each M and practicing the 4Ms collectively, all members of the care team work to improve health outcomes and prevent avoidable harm.<sup>5</sup> </p> <h3>The 4Ms</h3> <p>What matters, is the driver of this person-centered approach. Any member of the care team may initiate a what matters conversation with the older adult to understand their personal values, health goals, and care preferences. When compared with usual care, care aligned with the older adult’s health priorities has been shown to decrease the use of high-risk medications and reduce treatment burden.<sup>6</sup> The VHA has adopted Whole Health principles of care and the Patient Priorities Care approach to identify and support what matters to veterans.<sup>7,8</sup></p> <p>Addressing polypharmacy and identifying and deprescribing potentially inappropriate medications are essential in preventing adverse drug events, drug-drug interactions, and medication nonadherence.<sup>9</sup> In the VHA, VIONE (Vital, Important, Optional, Not indicated, Every medication has an indication) is a rapidly expanding medication deprescribing program that exemplifies HRO principles.<sup>9</sup> VIONE provides medication management that supports shared decision making, reducing risk and improving patient safety and quality of life.<sup>9</sup> As of June 2023, > 600,000 unique veterans have benefited from VIONE, with an average of 2.2 medications deprescribed per patient with an annual cost avoidance of > $100 million.<sup>10<br/><br/></sup>Assessing and acting on mentation includes preventing, identifying, and managing depression and dementia in outpatient settings and delirium in hospital and long-term care settings.<sup>5</sup> There are many tools and clinical reminders available in the EHR so that interdisciplinary teams can document changes to mentation and identify opportunities for continuous improvement. <br/><br/>Closely aligned with mentation is mobility, with evidence suggesting that regular physical activity reduces the risk of falls (preventing associated complications), maintains physical functioning, and lowers the risk of cognitive impairment and depression.<sup>5</sup> Ensuring early, frequent, and safe mobility helps patients achieve better health outcomes and prevent injury.<sup>5</sup> Mobility programs within the VHA include the STRIDE<sup> </sup>program for the inpatient setting and Gerofit for outpatient settings.<sup>11,12</sup> </p> <h3>HRO Principles</h3> <p>An HRO is a complex environment of care that experiences fewer than anticipated accidents or adverse events by (1) establishing trust among leaders and staff by balancing individual accountability with systems thinking; (2) empowering staff to lead continuous process improvements; and (3) creating an environment where employees feel safe to report harm or near misses, focusing on the reasons errors occur.<sup>13</sup> The work of AFHS incorporates HRO principles with an emphasis on 3 elements. First, it involves interactive systems and processes needed to support 4Ms care across care settings. Second, AFHS acknowledge the complexity of age-friendly work and deference to the expertise of interdisciplinary team members. Finally, AFHS are committed to resilience by overcoming failures and challenges to implementation and long-term sustainment as a standard of practice. </p> <h2>Case study</h2> <p>The names and details in this case have been modified to protect patient privacy. It is representative of many Community Living Centers (CLCs) involved in AFHS that work to create a safe, person-centered environment for veterans.</p> <p>In a CLC team workroom, 2 nurses were discussing a long-term care resident. The nurses approached the attending physician and explained that they were worried about Sgt Johnson, who seemed depressed and sometimes combative. They had noticed a change in his behavior when they helped him clean up after an episode of incontinence and were concerned that he would try to get out of bed on his own and fall. The attending physician thanked them for sharing their concerns. Sgt Johnson was a retired Army veteran who had a long, decorated military career. His chronic health conditions had led to muscle weakness, and he fell and broke a hip before this admission. He had an uneventful hip replacement but was showing signs of depression due to his limited mobility, loss of independence, and inability to live at home without additional support. <br/><br/>The attending physician knocked on the door of his room, sat down next to the bed, and asked, “How are you feeling today?” Sgt Johnson tersely replied, “About the same.” The physician asked, “Sgt Johnson, what matters most to you related to your recovery? What is important to you?” Sgt Johnson responded, “Feeling like a man!” The doctor replied, “So what makes you feel ‘not like a man’?” The Sgt replied, “Having to be cleaned up by the nurses and not being able to use the toilet on my own.” The physician surmised that his decline in physical functioning had a connection to his worsening depression and combativeness and said to the Sgt, “Let’s get the team together and work out a plan to get you strong enough to use a bedside commode by yourself. Let’s make that the first goal in our plan to get you back to using the toilet independently. Can you work with us on that?” He smiled and said, “Sir, yes Sir!”<br/><br/>At the weekly interdisciplinary team meeting, the team discussed Sgt Johnson’s wishes and the nurses’ safety concerns. The physician reported to the team what mattered to the veteran. The nurses arranged for a bedside commode and supplies to be placed in his room, encouraged and assisted him, and provided a privacy screen. The physical therapist continued to support his mobility needs, concentrating on transfers, small steps like standing and turning with a walker to get in position to use the bedside commode, and later the bathroom toilet. The psychologist addressed what matters to Sgt Johnson and his mentation, health goals, and coping strategies. The social worker provided support and counseling for the veteran and his family. The pharmacist checked his medications to be sure that none were affecting his gastrointestinal tract and his ability to move safely and do what matters to him. Knowing what mattered to Sgt Johnson was the driver of the interdisciplinary care plan to provide 4Ms care. <br/><br/>The team worked collaboratively with the veteran to develop and set attainable goals around toileting and regaining his dignity. This improved his overall recovery. As Sgt Johnson became more independent, his mood gradually improved and he began to participate in other activities and interact with other residents on the unit, and he did not experience any falls. By addressing the 4Ms, the interdisciplinary team coordinated efforts to provide high-quality, person-centered care. They built trust with the veteran, shared accountability, and followed HRO principles to keep the veteran safe. </p> <h2>becoming an Age-Friendly HRO </h2> <p>Becoming an HRO is a dynamic, ever-changing process to maintain high standards, improve care quality, and cause no harm. There are 3 pillars and 5 principles that guide an HRO. The pillars are critical areas of focus and include leadership commitment, culture of safety, and continuous process improvement.<sup>14</sup> The first of 5 HRO principles is sensitivity to operations. This is defined as an awareness of how processes and systems impact the entire organization, the downstream impact.<sup>15</sup> Focusing on the 4Ms helps develop the capability of frontline staff to provide high-quality care for older adults while ensuring that processes are in place to support the work. The 4Ms provide an efficient way to organize interdisciplinary team meetings, provide warm handoffs using Situation-Background-Assessment-Recommendation, and standardize documentation. Involvement in the AFHS movement improves communication, care quality, and patient and staff satisfaction to meet this HRO principle.<sup>15</sup></p> <p>The second HRO principle, reluctance to simplify, ensures that direct care staff and leaders delve further into issues to find solutions.<sup>15</sup> AFHS use the Plan-Do-Study-Act cycle to put the 4Ms into practice; this cycle helps teams test small increments of change, study their performance, and act to ensure that all 4Ms are being practiced as a set. AFHS teams are encouraged to review at least 3 months of data after implementation of the 4Ms, working to find solutions if there are gaps or issues identified. <br/><br/>The third principle, preoccupation with failure, refers to shared attentiveness—being prepared for the unexpected and learning from mistakes.<sup>15</sup> The entire AFHS team shares responsibility for providing 4Ms care, where staff are empowered to report any safety concerns or close calls. The fourth principle of deference to expertise includes listening to staff who have the most knowledge for the task at hand, which aligns with the collaborative interdisciplinary teamwork of age-friendly teams.<sup>15</sup> The final HRO principle, commitment to resilience, includes continuous learning, interdisciplinary team training, and sharing of lessons learned.<sup>15</sup> Although IHI offers 2 levels of AFHS recognition, teams are continuously learning to improve and sustain care beyond level 2, Committed to Care Excellence recognition.<sup>16</sup>The Table shows the VHA’s AFHS implementation strategies and the HRO principles adapted from the Joint Commission’s High Reliability Health Care Maturity Model and the IHI’s Framework for Safe, Reliable, and Effective Care. The VHA is developing a national dashboard to capture age-friendly processes and health outcome measures that address patient safety and care quality. </p> <h2>Conclusions</h2> <p>AFHS empowers VHA teams to honor veterans’ care preferences and values, supporting their independence, dignity, and quality of life across care settings. The adoption of AFHS brings evidence-based practices to the point of care by addressing common pitfalls in the care of older adults, drawing attention to, and calling for action on inappropriate medication use, physical inactivity, and assessment of the vulnerable brain. The 4Ms also serve as a framework to continuously improve care and cause zero harm, reinforcing HRO pillars and principles across the VHA, and ensuring that older adults reliably receive the evidence-based, high-quality care they deserve. </p> <h3> Author affiliations </h3> <p> <em><sup>a</sup>Veterans Health Administration, Office of Geriatrics and Extended Care, Washington, DC<br/><br/><sup>b</sup>Veterans Health Administration, Innovation Ecosystem, Washington, DC<br/><br/><sup>c</sup>Veterans Health Administration, Geriatrics Research, Education, and Clinical Center, Gainesville, Florida<br/><br/><sup>d</sup>Richard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana</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>The names and details in this case have been modified to protect patient privacy.</em> </p> <h3> References </h3> <p class="reference"> 1. Veterans Health Administration. Providing healthcare for veterans. Updated June 20, 2023. Accessed June 26, 2023. https://www.va.gov/health<br/><br/> 2. Veazie S, Peterson K, Bourne D. Evidence brief: implementation of high reliability organization principles. Washington, DC: Evidence Synthesis Program, Health Services Research and Development Service, Office of Research and Development, Department of Veterans Affairs. VA ESP Project #09-199; 2019. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/esp/high-reliability-org.cfm <br/><br/> 3. Church K, Munro S, Shaughnessy M, Clancy C. Age-Friendly Health Systems: improving care for older adults in the Veterans Health Administration. <i>Health Serv Res</i>. 2023;58(suppl 1):5-8. doi:10.1111/1475-6773.14110<br/><br/> 4. Farrell TW, Volden TA, Butler JM, et al. Age-friendly care in the Veterans Health Administration: past, present, and future. <i>J Am Geriatr Soc</i>. 2023;71(1):18-25. doi:10.1111/jgs.18070<br/><br/> 5. Mate K, Fulmer T, Pelton L, et al. Evidence for the 4Ms: interactions and outcomes across the care continuum. <i>J Aging Health</i>. 2021;33(7-8):469-481. doi:10.1177/0898264321991658<br/><br/> 6. Tinetti ME, Naik AD, Dindo L, et al. Association of patient priorities-aligned decision-making with patient outcomes and ambulatory health care burden among older adults with multiple chronic conditions: A nonrandomized clinical trial. <i>JAMA Intern Med</i>. 2019;179(12):1688-1697. doi:10.1001/jamainternmed.2019.4235<br/><br/> 7. US Department of Veterans Affairs. What is whole health? Updated: October 31, 2023. November 30, 2023. https://www.va.gov/wholehealth <br/><br/> 8. Patient Priorities Care. Updated 2019. Accessed November 30, 2023. https://patientprioritiescare.org<br/><br/> 9. Battar S, Watson Dickerson KR, Sedgwick C, Cmelik T. Understanding principles of high reliability organizations through the eyes of VIONE: a clinical program to improve patient safety by deprescribing potentially inappropriate medications and reducing polypharmacy. <i>Fed Pract</i>. 2019;36(12):564-568. <br/><br/>10. VA Diffusion Marketplace. VIONE- medication optimization and polypharmacy reduction initiative. Accessed November 30, 2023. https://marketplace.va.gov/innovations/vione<br/><br/>11. US Department of Veterans Affairs, Office of Research and Development. STRIDE program to keep hospitalized veterans mobile. Updated November 6, 2018. Accessed November 30, 2023. https://www.research.va.gov/research_in_action/STRIDE-program-to-keep-hospitalized-Veterans-mobile.cfm<br/><br/>12. US Department of Veterans Affairs, VA Geriatrics and Extended Care. Gerofit: a program promoting exercise and health for older veterans. Updated August 2, 2023. Accessed November 30, 2023. https://www.va.gov/GERIATRICS/pages/gerofit_Home.asp<br/><br/>13. <hl name="33665"/>US Department of Veterans Affairs, Health Services Research and Development. VHA’s vision for a high reliability organization. Updated August 14, 2020. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/forum/summer20/default.cfm?ForumMenu=summer20-1 <br/><br/>14. US Department of Veterans Affairs, Health Services Research and Development. Three HRO evaluation priorities. Updated August 14, 2020. Accessed November 30, 2023. https://www.hsrd.research.va.gov/publications/forum/summer20/default.cfm?ForumMenu=summer20-2 <br/><br/>15. Oster CA, Deakins S. Practical application of high-reliability principles in healthcare to optimize quality and safety outcomes. <i>J Nurs Adm</i>. 2018;48(1):50-55. doi:10.1097/NNA.0000000000000570<br/><br/>16. Institute for Healthcare Improvement. Age-Friendly Health Systems recognitions. Accessed November 30, 2023. https://www.ihi.org/Engage/Initiatives/Age-Friendly-Health-Systems/Pages/Recognition.aspx </p> </itemContent> </newsItem> </itemSet></root>
Who Gets to Determine Whether Home Is “Unsafe” at the End of Life?
Sometimes a patient at the end of life (EOL) just wants to go home. We recently treated such a patient, “Joe,” a 66-year-old veteran with end-stage chronic obstructive pulmonary disorder (COPD), severe hearing loss, and heavy alcohol use. A neighbor brought Joe to the hospital when he developed a urinary tract infection. Before hospitalization, Joe spent his days in bed. His neighbor was his designated health care agent (HCA) and caregiver, dropping off meals and bringing Joe to medical appointments. Joe had no other social support. In the hospital, Joe could not participate in physical therapy (PT) evaluations due to severe dyspnea on exertion. He was recommended for home PT, a home health aide, and home nursing, but Joe declined these services out of concern for encroachment on his independence. Given his heavy alcohol use, limited support, and functional limitations, the hospitalist team felt that Joe would be best served in a skilled nursing facility. As the palliative care team, we were consulted and felt that he was eligible for hospice. Joe simply wanted to go home.
Many patients like Joe experience functional decline at EOL, leading to increased care needs and transitions between sites of care.1 Some hospitalized patients at EOL want to transition directly to home, but due to their limited functioning and social support, discharge home may be deemed unsafe by health care professionals (HCPs). Clinicians then face the difficult balancing act of honoring patient wishes and avoiding a bad outcome. For patients at EOL, issues of capacity and risk become particularly salient. Furthermore, the unique structure of the US Department of Veterans Affairs (VA) health system and the psychosocial needs of some veterans add additional considerations for complex EOL discharges.2
End-of-life Decision Making
While patients may express strong preferences regarding their health care, their decision-making ability may worsen as they approach EOL. Contributing factors include older age, effects of hospitalization, treatment adverse effects, and comorbidities, including cognitive impairment. Studies of terminally ill patients show high rates of impaired decisional capacity.3,4 It is critical to assess capacity as part of discharge planning. Even when patients have the capacity, families and caregivers have an important voice, since they are often instrumental in maintaining patients at home.
Defining Risk
Determining whether a discharge is risky or unsafe is highly subjective, with differing opinions among clinicians and between patients and clinicians.5-7 In a qualitative study by Coombs and colleagues, HCPs tended toward a risk-averse approach to discharge decisions, sometimes favoring discharge to care facilities despite patient preferences.6 This approach also reflects pressures from the health care system to decrease the length of stay and reduce readmissions, important metrics for patient care and cost containment. However, keeping patients hospitalized or in nursing facilities does not completely mitigate risks (eg, falls) and carries other hazards (eg, nosocomial infections), as highlighted during the COVID-19 pandemic.7,8 The prospect of malpractice lawsuits and HCP moral distress about perceived risky home situations can also understandably affect decision making.
At the same time, risk calculation changes depending on the patient’s clinical status and priorities. Coombs and colleagues found that in contrast to clinicians, patients nearing EOL are willing to accept increasing risks and suboptimal living conditions to remain at home.6 What may be intolerable for a younger, healthier patient with a long life expectancy may be acceptable for someone who is approaching EOL. In our framework, a risky home discharge at EOL is considered one in which other adverse events, such as falls or inadequate symptom management, are likely.
Ethical Considerations
Unsafe discharges are challenging in part because some of the pillars of medical ethics can conflict. Prior articles have analyzed the ethical concerns of unsafe discharges in detail.9-11 Briefly, when patients wish to return home against initial medical recommendations, treatment teams may focus on the principles of beneficence and nonmaleficence, as exemplified by the desire to minimize harm, and justice, in which clinicians consider resource allocation and risks that a home discharge poses to family members, caregivers, and home health professionals. However, autonomy is important to consider as well. The concept of dignity of risk highlights the imperative to respect others’ decisions even when they increase the chance of harm, particularly given the overall shift in medicine from paternalism to shared decision making.12 Accommodating patient choice in how and where health care is received allows patients to regain some control over their lives, thereby enhancing their quality of life and promoting patient dignity, especially in their remaining days.13
Discharge Risk Framework
Our risk assessment framework helps clinicians more objectively identify factors that increase or decrease risk, inform discharge planning, partner with patients and families, give patients a prominent role in EOL decisions, and mitigate the risk of a bad outcome. This concept has been used in psychiatry, in which formal suicide assessment includes identifying risk factors and protective factors to estimate suicide risk and determine interventions.14 Similar to suicide risk estimation, this framework is based on clinical judgment rather than a specific calculation.
While this framework serves as a guide for determining and mitigating risk, we encourage teams to consider legal or ethical consultations in challenging cases, such as those in which patients lack both capacity and an involved HCA.
Step 1: Determine the patient’s capacity regarding disposition planning. Patients at EOL are at a higher risk of impaired decision-making capabilities; therefore, capacity evaluation is a critical step.
Step 2: Identify risk factors and protective factors for discharge home. Risk factors are intrinsic and extrinsic factors that increase risk such as functional or sensory impairments. Protective factors are intrinsic and extrinsic factors that decrease risk, including a good understanding of illness and consistent connection with the health care system (Table 1).
Step 3: Determine discharge to home risk level based on identified risk factors and protective factors. Patients may be at low, moderate, or high risk of having an adverse event, such as a fall or inadequate symptom control (Table 2).
Step 4: Identify risk mitigation strategies. These should be tailored to the patient based on the factors identified in Step 2. Examples include home nursing and therapy, mental health treatment, a medical alert system, and frequent contact between the patient and health care team.
Step 5: Meet with inpatient and outpatient HCP teams. Meetings should include the primary care professional (PCP) or relevant subspecialist, such as an oncologist for patients with cancer. For veterans receiving care solely at a local VA medical center, this can be easier to facilitate, but for veterans who receive care through both VA and non-VA systems, this step may require additional coordination. We also recommend including interdisciplinary team members, such as social workers, case managers, and the relevant home care or hospice agency. Certain agencies may decline admission if they perceive increased risk, such as no 24-hour care, perceived self-neglect, and limited instrumental support. During this meeting, HCPs discuss risk mitigation strategies identified in Step 4 and create a plan to propose to patients and families.
Step 6: Meet with patient, HCA, and family members. In addition to sharing information about prognosis, assessing caregiver capabilities and burden can guide conversations about discharge. The discharge plan should be determined through shared decision making.11 If the patient lacks capacity regarding disposition planning, this should be shared with the HCA. However, even when patients lack capacity, it is important to continue to engage them to understand their goals and preferences.
Step 7: Maximize risk mitigation strategies. If a moderate- or high-risk discharge is requested, the health care team should maximize risk mitigation strategies. For low-risk discharges, risk mitigation strategies can still promote safety, especially since risk increases as patients progress toward EOL. In some instances, patients, their HCAs, or caregivers may decline all risk mitigation strategies despite best efforts to communicate and negotiate options. In such circumstances, we recommend discussing the case with the outpatient team for a warm handoff. HCPs should also document all efforts (helpful from a legal standpoint as well as for the patient’s future treatment teams) and respect the decision to discharge home.
Applying the Framework
Our patient Joe provides a good illustration of how to implement this EOL framework. He was deemed to have the capacity to make decisions regarding discharge (Step 1). We determined his risk factors and protective factors for discharge (Step 2). His poor functional status, limited instrumental support, heavy alcohol use, rejection of home services, and communication barriers due to severe hearing impairment all increased his risk. Protective factors included an appreciation of functional limitations, intact cognition, and an involved HCA. Based on his limited instrumental support and poor function but good insight into limitations, discharge home was deemed to be of moderate risk (Step 3). Although risk factors such as alcohol use and severe hearing impairment could have raised his level to high risk, we felt that his involved HCA maintained him in the moderate-risk category.
We worked with the hospitalist team, PT, and audiology to identify multiple risk mitigation strategies: frequent phone calls between the HCA and outpatient palliative care team, home PT to improve transfers from bed to bedside commode, home nursing services either through a routine agency or hospice, and hearing aids for better communication (Steps 4 and 5). We then proposed these strategies to Joe and his HCA (Step 6). Due to concerns about infringement on his independence, Joe declined all home services but agreed to twice-daily check-ins by his HCA, frequent communication between his HCA and our team, and new hearing aids.
Joe returned home with the agreed-upon risk mitigation strategies in place (Step 7). Despite clinicians’ original reservations about sending Joe home without formal services, his HCA maintained close contact with our team, noting that Joe remained stable and happy to be at home in the months following discharge.
Conclusions
Fortunately, VA HCPs operate in an integrated health care system with access to psychological, social, and at-home medical support that can help mitigate risks. Still, we have benefitted from having a tool to help us evaluate risk systematically. Even if patients, families, and HCPs disagree on ideal discharge plans, this tool helps clinicians approach discharges methodically while maintaining open communication and partnership with patients. In doing so, our framework reflects the shift in medical culture from a patriarchal approach to shared decision-making practices regarding all aspects of medical care. Furthermore, we hope that this can help reduce clinician moral distress stemming from these challenging cases.
Future research on best practices for discharge risk assessment and optimizing home safety are needed. We also hope to evaluate the impact and effectiveness of our framework through interviews with key stakeholders. For Joe and other veterans like him, where to spend their final days may be the last important decision they make in life, and our framework allows for their voices to be better heard throughout the decision-making process.
Acknowledgments
We thank Brooke Lifland, MD, for her theoretical contributions to the concept behind this paper.
1. Committee on Approaching Death: Addressing Key End of Life Issues; Institute of Medicine. Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life. Washington (DC): National Academies Press (US); March 19, 2015.
2. Casarett D, Pickard A, Amos Bailey F, et al. Important aspects of end-of-life care among veterans: implications for measurement and quality improvement. J Pain Symptom Manage. 2008;35(2):115-125. doi:10.1016/j.jpainsymman.2007.03.008
3. Kolva E, Rosenfeld B, Brescia R, Comfort C. Assessing decision-making capacity at end of life. Gen Hosp Psychiatry. 2014;36(4):392-397. doi:10.1016/j.genhosppsych.2014.02.013
4. Kolva E, Rosenfeld B, Saracino R. Assessing the decision-making capacity of terminally ill patients with cancer. Am J Geriatr Psychiatry. 2018;26(5):523-531. doi:10.1016/j.jagp.2017.11.012
5. Macmillan MS. Hospital staff’s perceptions of risk associated with the discharge of elderly people from acute hospital care. J Adv Nurs. 1994;19(2):249-256. doi:10.1111/j.1365-2648.1994.tb01078.x
6. Coombs MA, Parker R, de Vries K. Managing risk during care transitions when approaching end of life: A qualitative study of patients’ and health care professionals’ decision making. Palliat Med. 2017;31(7):617-624. doi:10.1177/0269216316673476
7. Hyslop B. ‘Not safe for discharge’? Words, values, and person-centred care. Age Ageing. 2020;49(3):334-336. doi:10.1093/ageing/afz170
8. Goodacre S. Safe discharge: an irrational, unhelpful and unachievable concept. Emerg Med J. 2006;23(10):753-755. doi:10.1136/emj.2006.037903
9. Swidler RN, Seastrum T, Shelton W. Difficult hospital inpatient discharge decisions: ethical, legal and clinical practice issues. Am J Bioeth. 2007;7(3):23-28. doi:10.1080/15265160601171739
10. Hill J, Filer W. Safety and ethical considerations in discharging patients to suboptimal living situations. AMA J Ethics. 2015;17(6):506-510. Published 2015 Jun 1. doi:10.1001/journalofethics.2015.17.6.ecas2-1506
11. West JC. What is an ethically informed approach to managing patient safety risk during discharge planning?. AMA J Ethics. 2020;22(11):E919-E923. Published 2020 Nov 1. doi:10.1001/amajethics.2020.919
12. Mukherjee D. Discharge decisions and the dignity of risk. Hastings Cent Rep. 2015;45(3):7-8. doi:10.1002/hast.441
13. Wheatley VJ, Baker JI. “Please, I want to go home”: ethical issues raised when considering choice of place of care in palliative care. Postgrad Med J. 2007;83(984):643-648. doi:10.1136/pgmj.2007.058487
14. Work Group on Suicidal Behaviors. Practice guideline for the assessment and treatment of patients with suicidal behaviors. Am J Psychiatry. 2003;160(suppl 11):1-60.
Sometimes a patient at the end of life (EOL) just wants to go home. We recently treated such a patient, “Joe,” a 66-year-old veteran with end-stage chronic obstructive pulmonary disorder (COPD), severe hearing loss, and heavy alcohol use. A neighbor brought Joe to the hospital when he developed a urinary tract infection. Before hospitalization, Joe spent his days in bed. His neighbor was his designated health care agent (HCA) and caregiver, dropping off meals and bringing Joe to medical appointments. Joe had no other social support. In the hospital, Joe could not participate in physical therapy (PT) evaluations due to severe dyspnea on exertion. He was recommended for home PT, a home health aide, and home nursing, but Joe declined these services out of concern for encroachment on his independence. Given his heavy alcohol use, limited support, and functional limitations, the hospitalist team felt that Joe would be best served in a skilled nursing facility. As the palliative care team, we were consulted and felt that he was eligible for hospice. Joe simply wanted to go home.
Many patients like Joe experience functional decline at EOL, leading to increased care needs and transitions between sites of care.1 Some hospitalized patients at EOL want to transition directly to home, but due to their limited functioning and social support, discharge home may be deemed unsafe by health care professionals (HCPs). Clinicians then face the difficult balancing act of honoring patient wishes and avoiding a bad outcome. For patients at EOL, issues of capacity and risk become particularly salient. Furthermore, the unique structure of the US Department of Veterans Affairs (VA) health system and the psychosocial needs of some veterans add additional considerations for complex EOL discharges.2
End-of-life Decision Making
While patients may express strong preferences regarding their health care, their decision-making ability may worsen as they approach EOL. Contributing factors include older age, effects of hospitalization, treatment adverse effects, and comorbidities, including cognitive impairment. Studies of terminally ill patients show high rates of impaired decisional capacity.3,4 It is critical to assess capacity as part of discharge planning. Even when patients have the capacity, families and caregivers have an important voice, since they are often instrumental in maintaining patients at home.
Defining Risk
Determining whether a discharge is risky or unsafe is highly subjective, with differing opinions among clinicians and between patients and clinicians.5-7 In a qualitative study by Coombs and colleagues, HCPs tended toward a risk-averse approach to discharge decisions, sometimes favoring discharge to care facilities despite patient preferences.6 This approach also reflects pressures from the health care system to decrease the length of stay and reduce readmissions, important metrics for patient care and cost containment. However, keeping patients hospitalized or in nursing facilities does not completely mitigate risks (eg, falls) and carries other hazards (eg, nosocomial infections), as highlighted during the COVID-19 pandemic.7,8 The prospect of malpractice lawsuits and HCP moral distress about perceived risky home situations can also understandably affect decision making.
At the same time, risk calculation changes depending on the patient’s clinical status and priorities. Coombs and colleagues found that in contrast to clinicians, patients nearing EOL are willing to accept increasing risks and suboptimal living conditions to remain at home.6 What may be intolerable for a younger, healthier patient with a long life expectancy may be acceptable for someone who is approaching EOL. In our framework, a risky home discharge at EOL is considered one in which other adverse events, such as falls or inadequate symptom management, are likely.
Ethical Considerations
Unsafe discharges are challenging in part because some of the pillars of medical ethics can conflict. Prior articles have analyzed the ethical concerns of unsafe discharges in detail.9-11 Briefly, when patients wish to return home against initial medical recommendations, treatment teams may focus on the principles of beneficence and nonmaleficence, as exemplified by the desire to minimize harm, and justice, in which clinicians consider resource allocation and risks that a home discharge poses to family members, caregivers, and home health professionals. However, autonomy is important to consider as well. The concept of dignity of risk highlights the imperative to respect others’ decisions even when they increase the chance of harm, particularly given the overall shift in medicine from paternalism to shared decision making.12 Accommodating patient choice in how and where health care is received allows patients to regain some control over their lives, thereby enhancing their quality of life and promoting patient dignity, especially in their remaining days.13
Discharge Risk Framework
Our risk assessment framework helps clinicians more objectively identify factors that increase or decrease risk, inform discharge planning, partner with patients and families, give patients a prominent role in EOL decisions, and mitigate the risk of a bad outcome. This concept has been used in psychiatry, in which formal suicide assessment includes identifying risk factors and protective factors to estimate suicide risk and determine interventions.14 Similar to suicide risk estimation, this framework is based on clinical judgment rather than a specific calculation.
While this framework serves as a guide for determining and mitigating risk, we encourage teams to consider legal or ethical consultations in challenging cases, such as those in which patients lack both capacity and an involved HCA.
Step 1: Determine the patient’s capacity regarding disposition planning. Patients at EOL are at a higher risk of impaired decision-making capabilities; therefore, capacity evaluation is a critical step.
Step 2: Identify risk factors and protective factors for discharge home. Risk factors are intrinsic and extrinsic factors that increase risk such as functional or sensory impairments. Protective factors are intrinsic and extrinsic factors that decrease risk, including a good understanding of illness and consistent connection with the health care system (Table 1).
Step 3: Determine discharge to home risk level based on identified risk factors and protective factors. Patients may be at low, moderate, or high risk of having an adverse event, such as a fall or inadequate symptom control (Table 2).
Step 4: Identify risk mitigation strategies. These should be tailored to the patient based on the factors identified in Step 2. Examples include home nursing and therapy, mental health treatment, a medical alert system, and frequent contact between the patient and health care team.
Step 5: Meet with inpatient and outpatient HCP teams. Meetings should include the primary care professional (PCP) or relevant subspecialist, such as an oncologist for patients with cancer. For veterans receiving care solely at a local VA medical center, this can be easier to facilitate, but for veterans who receive care through both VA and non-VA systems, this step may require additional coordination. We also recommend including interdisciplinary team members, such as social workers, case managers, and the relevant home care or hospice agency. Certain agencies may decline admission if they perceive increased risk, such as no 24-hour care, perceived self-neglect, and limited instrumental support. During this meeting, HCPs discuss risk mitigation strategies identified in Step 4 and create a plan to propose to patients and families.
Step 6: Meet with patient, HCA, and family members. In addition to sharing information about prognosis, assessing caregiver capabilities and burden can guide conversations about discharge. The discharge plan should be determined through shared decision making.11 If the patient lacks capacity regarding disposition planning, this should be shared with the HCA. However, even when patients lack capacity, it is important to continue to engage them to understand their goals and preferences.
Step 7: Maximize risk mitigation strategies. If a moderate- or high-risk discharge is requested, the health care team should maximize risk mitigation strategies. For low-risk discharges, risk mitigation strategies can still promote safety, especially since risk increases as patients progress toward EOL. In some instances, patients, their HCAs, or caregivers may decline all risk mitigation strategies despite best efforts to communicate and negotiate options. In such circumstances, we recommend discussing the case with the outpatient team for a warm handoff. HCPs should also document all efforts (helpful from a legal standpoint as well as for the patient’s future treatment teams) and respect the decision to discharge home.
Applying the Framework
Our patient Joe provides a good illustration of how to implement this EOL framework. He was deemed to have the capacity to make decisions regarding discharge (Step 1). We determined his risk factors and protective factors for discharge (Step 2). His poor functional status, limited instrumental support, heavy alcohol use, rejection of home services, and communication barriers due to severe hearing impairment all increased his risk. Protective factors included an appreciation of functional limitations, intact cognition, and an involved HCA. Based on his limited instrumental support and poor function but good insight into limitations, discharge home was deemed to be of moderate risk (Step 3). Although risk factors such as alcohol use and severe hearing impairment could have raised his level to high risk, we felt that his involved HCA maintained him in the moderate-risk category.
We worked with the hospitalist team, PT, and audiology to identify multiple risk mitigation strategies: frequent phone calls between the HCA and outpatient palliative care team, home PT to improve transfers from bed to bedside commode, home nursing services either through a routine agency or hospice, and hearing aids for better communication (Steps 4 and 5). We then proposed these strategies to Joe and his HCA (Step 6). Due to concerns about infringement on his independence, Joe declined all home services but agreed to twice-daily check-ins by his HCA, frequent communication between his HCA and our team, and new hearing aids.
Joe returned home with the agreed-upon risk mitigation strategies in place (Step 7). Despite clinicians’ original reservations about sending Joe home without formal services, his HCA maintained close contact with our team, noting that Joe remained stable and happy to be at home in the months following discharge.
Conclusions
Fortunately, VA HCPs operate in an integrated health care system with access to psychological, social, and at-home medical support that can help mitigate risks. Still, we have benefitted from having a tool to help us evaluate risk systematically. Even if patients, families, and HCPs disagree on ideal discharge plans, this tool helps clinicians approach discharges methodically while maintaining open communication and partnership with patients. In doing so, our framework reflects the shift in medical culture from a patriarchal approach to shared decision-making practices regarding all aspects of medical care. Furthermore, we hope that this can help reduce clinician moral distress stemming from these challenging cases.
Future research on best practices for discharge risk assessment and optimizing home safety are needed. We also hope to evaluate the impact and effectiveness of our framework through interviews with key stakeholders. For Joe and other veterans like him, where to spend their final days may be the last important decision they make in life, and our framework allows for their voices to be better heard throughout the decision-making process.
Acknowledgments
We thank Brooke Lifland, MD, for her theoretical contributions to the concept behind this paper.
Sometimes a patient at the end of life (EOL) just wants to go home. We recently treated such a patient, “Joe,” a 66-year-old veteran with end-stage chronic obstructive pulmonary disorder (COPD), severe hearing loss, and heavy alcohol use. A neighbor brought Joe to the hospital when he developed a urinary tract infection. Before hospitalization, Joe spent his days in bed. His neighbor was his designated health care agent (HCA) and caregiver, dropping off meals and bringing Joe to medical appointments. Joe had no other social support. In the hospital, Joe could not participate in physical therapy (PT) evaluations due to severe dyspnea on exertion. He was recommended for home PT, a home health aide, and home nursing, but Joe declined these services out of concern for encroachment on his independence. Given his heavy alcohol use, limited support, and functional limitations, the hospitalist team felt that Joe would be best served in a skilled nursing facility. As the palliative care team, we were consulted and felt that he was eligible for hospice. Joe simply wanted to go home.
Many patients like Joe experience functional decline at EOL, leading to increased care needs and transitions between sites of care.1 Some hospitalized patients at EOL want to transition directly to home, but due to their limited functioning and social support, discharge home may be deemed unsafe by health care professionals (HCPs). Clinicians then face the difficult balancing act of honoring patient wishes and avoiding a bad outcome. For patients at EOL, issues of capacity and risk become particularly salient. Furthermore, the unique structure of the US Department of Veterans Affairs (VA) health system and the psychosocial needs of some veterans add additional considerations for complex EOL discharges.2
End-of-life Decision Making
While patients may express strong preferences regarding their health care, their decision-making ability may worsen as they approach EOL. Contributing factors include older age, effects of hospitalization, treatment adverse effects, and comorbidities, including cognitive impairment. Studies of terminally ill patients show high rates of impaired decisional capacity.3,4 It is critical to assess capacity as part of discharge planning. Even when patients have the capacity, families and caregivers have an important voice, since they are often instrumental in maintaining patients at home.
Defining Risk
Determining whether a discharge is risky or unsafe is highly subjective, with differing opinions among clinicians and between patients and clinicians.5-7 In a qualitative study by Coombs and colleagues, HCPs tended toward a risk-averse approach to discharge decisions, sometimes favoring discharge to care facilities despite patient preferences.6 This approach also reflects pressures from the health care system to decrease the length of stay and reduce readmissions, important metrics for patient care and cost containment. However, keeping patients hospitalized or in nursing facilities does not completely mitigate risks (eg, falls) and carries other hazards (eg, nosocomial infections), as highlighted during the COVID-19 pandemic.7,8 The prospect of malpractice lawsuits and HCP moral distress about perceived risky home situations can also understandably affect decision making.
At the same time, risk calculation changes depending on the patient’s clinical status and priorities. Coombs and colleagues found that in contrast to clinicians, patients nearing EOL are willing to accept increasing risks and suboptimal living conditions to remain at home.6 What may be intolerable for a younger, healthier patient with a long life expectancy may be acceptable for someone who is approaching EOL. In our framework, a risky home discharge at EOL is considered one in which other adverse events, such as falls or inadequate symptom management, are likely.
Ethical Considerations
Unsafe discharges are challenging in part because some of the pillars of medical ethics can conflict. Prior articles have analyzed the ethical concerns of unsafe discharges in detail.9-11 Briefly, when patients wish to return home against initial medical recommendations, treatment teams may focus on the principles of beneficence and nonmaleficence, as exemplified by the desire to minimize harm, and justice, in which clinicians consider resource allocation and risks that a home discharge poses to family members, caregivers, and home health professionals. However, autonomy is important to consider as well. The concept of dignity of risk highlights the imperative to respect others’ decisions even when they increase the chance of harm, particularly given the overall shift in medicine from paternalism to shared decision making.12 Accommodating patient choice in how and where health care is received allows patients to regain some control over their lives, thereby enhancing their quality of life and promoting patient dignity, especially in their remaining days.13
Discharge Risk Framework
Our risk assessment framework helps clinicians more objectively identify factors that increase or decrease risk, inform discharge planning, partner with patients and families, give patients a prominent role in EOL decisions, and mitigate the risk of a bad outcome. This concept has been used in psychiatry, in which formal suicide assessment includes identifying risk factors and protective factors to estimate suicide risk and determine interventions.14 Similar to suicide risk estimation, this framework is based on clinical judgment rather than a specific calculation.
While this framework serves as a guide for determining and mitigating risk, we encourage teams to consider legal or ethical consultations in challenging cases, such as those in which patients lack both capacity and an involved HCA.
Step 1: Determine the patient’s capacity regarding disposition planning. Patients at EOL are at a higher risk of impaired decision-making capabilities; therefore, capacity evaluation is a critical step.
Step 2: Identify risk factors and protective factors for discharge home. Risk factors are intrinsic and extrinsic factors that increase risk such as functional or sensory impairments. Protective factors are intrinsic and extrinsic factors that decrease risk, including a good understanding of illness and consistent connection with the health care system (Table 1).
Step 3: Determine discharge to home risk level based on identified risk factors and protective factors. Patients may be at low, moderate, or high risk of having an adverse event, such as a fall or inadequate symptom control (Table 2).
Step 4: Identify risk mitigation strategies. These should be tailored to the patient based on the factors identified in Step 2. Examples include home nursing and therapy, mental health treatment, a medical alert system, and frequent contact between the patient and health care team.
Step 5: Meet with inpatient and outpatient HCP teams. Meetings should include the primary care professional (PCP) or relevant subspecialist, such as an oncologist for patients with cancer. For veterans receiving care solely at a local VA medical center, this can be easier to facilitate, but for veterans who receive care through both VA and non-VA systems, this step may require additional coordination. We also recommend including interdisciplinary team members, such as social workers, case managers, and the relevant home care or hospice agency. Certain agencies may decline admission if they perceive increased risk, such as no 24-hour care, perceived self-neglect, and limited instrumental support. During this meeting, HCPs discuss risk mitigation strategies identified in Step 4 and create a plan to propose to patients and families.
Step 6: Meet with patient, HCA, and family members. In addition to sharing information about prognosis, assessing caregiver capabilities and burden can guide conversations about discharge. The discharge plan should be determined through shared decision making.11 If the patient lacks capacity regarding disposition planning, this should be shared with the HCA. However, even when patients lack capacity, it is important to continue to engage them to understand their goals and preferences.
Step 7: Maximize risk mitigation strategies. If a moderate- or high-risk discharge is requested, the health care team should maximize risk mitigation strategies. For low-risk discharges, risk mitigation strategies can still promote safety, especially since risk increases as patients progress toward EOL. In some instances, patients, their HCAs, or caregivers may decline all risk mitigation strategies despite best efforts to communicate and negotiate options. In such circumstances, we recommend discussing the case with the outpatient team for a warm handoff. HCPs should also document all efforts (helpful from a legal standpoint as well as for the patient’s future treatment teams) and respect the decision to discharge home.
Applying the Framework
Our patient Joe provides a good illustration of how to implement this EOL framework. He was deemed to have the capacity to make decisions regarding discharge (Step 1). We determined his risk factors and protective factors for discharge (Step 2). His poor functional status, limited instrumental support, heavy alcohol use, rejection of home services, and communication barriers due to severe hearing impairment all increased his risk. Protective factors included an appreciation of functional limitations, intact cognition, and an involved HCA. Based on his limited instrumental support and poor function but good insight into limitations, discharge home was deemed to be of moderate risk (Step 3). Although risk factors such as alcohol use and severe hearing impairment could have raised his level to high risk, we felt that his involved HCA maintained him in the moderate-risk category.
We worked with the hospitalist team, PT, and audiology to identify multiple risk mitigation strategies: frequent phone calls between the HCA and outpatient palliative care team, home PT to improve transfers from bed to bedside commode, home nursing services either through a routine agency or hospice, and hearing aids for better communication (Steps 4 and 5). We then proposed these strategies to Joe and his HCA (Step 6). Due to concerns about infringement on his independence, Joe declined all home services but agreed to twice-daily check-ins by his HCA, frequent communication between his HCA and our team, and new hearing aids.
Joe returned home with the agreed-upon risk mitigation strategies in place (Step 7). Despite clinicians’ original reservations about sending Joe home without formal services, his HCA maintained close contact with our team, noting that Joe remained stable and happy to be at home in the months following discharge.
Conclusions
Fortunately, VA HCPs operate in an integrated health care system with access to psychological, social, and at-home medical support that can help mitigate risks. Still, we have benefitted from having a tool to help us evaluate risk systematically. Even if patients, families, and HCPs disagree on ideal discharge plans, this tool helps clinicians approach discharges methodically while maintaining open communication and partnership with patients. In doing so, our framework reflects the shift in medical culture from a patriarchal approach to shared decision-making practices regarding all aspects of medical care. Furthermore, we hope that this can help reduce clinician moral distress stemming from these challenging cases.
Future research on best practices for discharge risk assessment and optimizing home safety are needed. We also hope to evaluate the impact and effectiveness of our framework through interviews with key stakeholders. For Joe and other veterans like him, where to spend their final days may be the last important decision they make in life, and our framework allows for their voices to be better heard throughout the decision-making process.
Acknowledgments
We thank Brooke Lifland, MD, for her theoretical contributions to the concept behind this paper.
1. Committee on Approaching Death: Addressing Key End of Life Issues; Institute of Medicine. Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life. Washington (DC): National Academies Press (US); March 19, 2015.
2. Casarett D, Pickard A, Amos Bailey F, et al. Important aspects of end-of-life care among veterans: implications for measurement and quality improvement. J Pain Symptom Manage. 2008;35(2):115-125. doi:10.1016/j.jpainsymman.2007.03.008
3. Kolva E, Rosenfeld B, Brescia R, Comfort C. Assessing decision-making capacity at end of life. Gen Hosp Psychiatry. 2014;36(4):392-397. doi:10.1016/j.genhosppsych.2014.02.013
4. Kolva E, Rosenfeld B, Saracino R. Assessing the decision-making capacity of terminally ill patients with cancer. Am J Geriatr Psychiatry. 2018;26(5):523-531. doi:10.1016/j.jagp.2017.11.012
5. Macmillan MS. Hospital staff’s perceptions of risk associated with the discharge of elderly people from acute hospital care. J Adv Nurs. 1994;19(2):249-256. doi:10.1111/j.1365-2648.1994.tb01078.x
6. Coombs MA, Parker R, de Vries K. Managing risk during care transitions when approaching end of life: A qualitative study of patients’ and health care professionals’ decision making. Palliat Med. 2017;31(7):617-624. doi:10.1177/0269216316673476
7. Hyslop B. ‘Not safe for discharge’? Words, values, and person-centred care. Age Ageing. 2020;49(3):334-336. doi:10.1093/ageing/afz170
8. Goodacre S. Safe discharge: an irrational, unhelpful and unachievable concept. Emerg Med J. 2006;23(10):753-755. doi:10.1136/emj.2006.037903
9. Swidler RN, Seastrum T, Shelton W. Difficult hospital inpatient discharge decisions: ethical, legal and clinical practice issues. Am J Bioeth. 2007;7(3):23-28. doi:10.1080/15265160601171739
10. Hill J, Filer W. Safety and ethical considerations in discharging patients to suboptimal living situations. AMA J Ethics. 2015;17(6):506-510. Published 2015 Jun 1. doi:10.1001/journalofethics.2015.17.6.ecas2-1506
11. West JC. What is an ethically informed approach to managing patient safety risk during discharge planning?. AMA J Ethics. 2020;22(11):E919-E923. Published 2020 Nov 1. doi:10.1001/amajethics.2020.919
12. Mukherjee D. Discharge decisions and the dignity of risk. Hastings Cent Rep. 2015;45(3):7-8. doi:10.1002/hast.441
13. Wheatley VJ, Baker JI. “Please, I want to go home”: ethical issues raised when considering choice of place of care in palliative care. Postgrad Med J. 2007;83(984):643-648. doi:10.1136/pgmj.2007.058487
14. Work Group on Suicidal Behaviors. Practice guideline for the assessment and treatment of patients with suicidal behaviors. Am J Psychiatry. 2003;160(suppl 11):1-60.
1. Committee on Approaching Death: Addressing Key End of Life Issues; Institute of Medicine. Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life. Washington (DC): National Academies Press (US); March 19, 2015.
2. Casarett D, Pickard A, Amos Bailey F, et al. Important aspects of end-of-life care among veterans: implications for measurement and quality improvement. J Pain Symptom Manage. 2008;35(2):115-125. doi:10.1016/j.jpainsymman.2007.03.008
3. Kolva E, Rosenfeld B, Brescia R, Comfort C. Assessing decision-making capacity at end of life. Gen Hosp Psychiatry. 2014;36(4):392-397. doi:10.1016/j.genhosppsych.2014.02.013
4. Kolva E, Rosenfeld B, Saracino R. Assessing the decision-making capacity of terminally ill patients with cancer. Am J Geriatr Psychiatry. 2018;26(5):523-531. doi:10.1016/j.jagp.2017.11.012
5. Macmillan MS. Hospital staff’s perceptions of risk associated with the discharge of elderly people from acute hospital care. J Adv Nurs. 1994;19(2):249-256. doi:10.1111/j.1365-2648.1994.tb01078.x
6. Coombs MA, Parker R, de Vries K. Managing risk during care transitions when approaching end of life: A qualitative study of patients’ and health care professionals’ decision making. Palliat Med. 2017;31(7):617-624. doi:10.1177/0269216316673476
7. Hyslop B. ‘Not safe for discharge’? Words, values, and person-centred care. Age Ageing. 2020;49(3):334-336. doi:10.1093/ageing/afz170
8. Goodacre S. Safe discharge: an irrational, unhelpful and unachievable concept. Emerg Med J. 2006;23(10):753-755. doi:10.1136/emj.2006.037903
9. Swidler RN, Seastrum T, Shelton W. Difficult hospital inpatient discharge decisions: ethical, legal and clinical practice issues. Am J Bioeth. 2007;7(3):23-28. doi:10.1080/15265160601171739
10. Hill J, Filer W. Safety and ethical considerations in discharging patients to suboptimal living situations. AMA J Ethics. 2015;17(6):506-510. Published 2015 Jun 1. doi:10.1001/journalofethics.2015.17.6.ecas2-1506
11. West JC. What is an ethically informed approach to managing patient safety risk during discharge planning?. AMA J Ethics. 2020;22(11):E919-E923. Published 2020 Nov 1. doi:10.1001/amajethics.2020.919
12. Mukherjee D. Discharge decisions and the dignity of risk. Hastings Cent Rep. 2015;45(3):7-8. doi:10.1002/hast.441
13. Wheatley VJ, Baker JI. “Please, I want to go home”: ethical issues raised when considering choice of place of care in palliative care. Postgrad Med J. 2007;83(984):643-648. doi:10.1136/pgmj.2007.058487
14. Work Group on Suicidal Behaviors. Practice guideline for the assessment and treatment of patients with suicidal behaviors. Am J Psychiatry. 2003;160(suppl 11):1-60.
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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>1123 FED EOL</fileName> <TBEID>0C02E7CC.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02E7CC</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20231103T223641</firstPublished> <LastPublished>20231103T223641</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20231103T223641</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>Jessica X. Zuo, MDa,b; Andrea Ruskin, MDc; Margaret R. Bauer, PhDc</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>Sometimes a patient at the end of life (EOL) just wants to go home. We recently treated such a patient, “Joe,” a 66-year-old veteran with end-stage chronic obst</metaDescription> <articlePDF/> <teaserImage/> <title>Who Gets to Determine Whether Home Is “Unsafe” at the End of Life?</title> <deck/> <eyebrow>Commentary</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2023</pubPubdateYear> <pubPubdateMonth>November</pubPubdateMonth> <pubPubdateDay/> <pubVolume>40</pubVolume> <pubNumber>11</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>2951</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>November 2023</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Feature | 2951<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">52</term> </sections> <topics> <term canonical="true">223</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Who Gets to Determine Whether Home Is “Unsafe” at the End of Life?</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background: </b>At the end of life, some patients wish to be discharged directly home from the hospital, but health care teams may consider this unsafe, raising concerns for capacity and risk. However, defining risk is subjective and impacted by values, preferences, and clinical status. Accommodating patient preferences in discharge destinations can promote autonomy, dignity, and quality of life at the end of life.<br/><br/><b>Observations: </b>We developed a risk assessment framework to help clinicians objectively identify risk factors and protective factors and develop a comprehensive discharge plan. We applied this framework to a veteran nearing the end of life and he was able to successfully return home from the hospital.<b>Conclusions: </b>Approaching end-of-life discharges with a framework can inform discharge planning and lessen the risk of adverse events. Importantly, this framework can help clinicians communicate better and partner with patients and their loved ones in prioritizing patient values and preferences.</p> <p><span class="Drop">S</span>ometimes a patient at the end of life (EOL) just wants to go home. We recently treated such a patient, “Joe,” a 66-year-old veteran with end-stage chronic obstructive pulmonary disorder (COPD), severe hearing loss, and heavy alcohol use. A neighbor brought Joe to the hospital when he developed a urinary tract infection. Before hospitalization, Joe spent his days in bed. His neighbor was his designated health care agent (HCA) and caregiver, dropping off meals and bringing Joe to medical appointments. Joe had no other social support. In the hospital, Joe could not participate in physical therapy (PT) evaluations due to severe dyspnea on exertion. He was recommended for home PT, a home health aide, and home nursing, but Joe declined these services out of concern for encroachment on his independence. Given his heavy alcohol use, limited support, and functional limitations, the hospitalist team felt that Joe would be best served in a skilled nursing facility. As the palliative care team, we were consulted and felt that he was eligible for hospice. Joe simply wanted to go home.</p> <p>Many patients like Joe experience functional decline at EOL, leading to increased care needs and transitions between sites of care.<sup>1</sup> Some hospitalized patients at EOL want to transition directly to home, but due to their limited functioning and social support, discharge home may be deemed unsafe by health care professionals (HCPs). Clinicians then face the difficult balancing act of honoring patient wishes and avoiding a bad outcome. For patients at EOL, issues of capacity and risk become particularly salient. Furthermore, the unique structure of the US Department of Veterans Affairs (VA) health system and the psychosocial needs of some veterans add additional considerations for complex EOL discharges.<sup>2</sup></p> <h2>End-of-life Decision Making</h2> <p>While patients may express strong preferences regarding their health care, their decision-making ability may worsen as they approach EOL. Contributing factors include older age, effects of hospitalization, treatment adverse effects, and comorbidities, including cognitive impairment. Studies of terminally ill patients show high rates of impaired decisional capacity.<sup>3,4</sup> It is critical to assess capacity as part of discharge planning. Even when patients have the capacity, families and caregivers have an important voice, since they are often instrumental in maintaining patients at home.</p> <h3>Defining Risk</h3> <p>Determining whether a discharge is risky or unsafe is highly subjective, with differing opinions among clinicians and between patients and clinicians.<sup>5-7</sup> In a qualitative study by Coombs and colleagues, HCPs tended toward a risk-averse approach to discharge decisions, sometimes favoring discharge to care facilities despite patient preferences.<sup>6</sup> This approach also reflects pressures from the health care system to decrease the length of stay and reduce readmissions, important metrics for patient care and cost containment. However, keeping patients hospitalized or in nursing facilities does not completely mitigate risks (eg, falls) and carries other hazards (eg, nosocomial infections), as highlighted during the COVID-19 pandemic.<sup>7,8</sup> The prospect of malpractice lawsuits and HCP moral distress about perceived risky home situations can also understandably affect decision making. </p> <p>At the same time, risk calculation changes depending on the patient’s clinical status and priorities. Coombs and colleagues found that in contrast to clinicians, patients nearing EOL are willing to accept increasing risks and suboptimal living conditions to remain at home.<sup>6</sup> What may be intolerable for a younger, healthier patient with a long life expectancy may be acceptable for someone who is approaching EOL. In our framework, a risky home discharge at EOL is considered one in which other adverse events, such as falls or inadequate symptom management, are likely.</p> <h3>Ethical Considerations</h3> <p>Unsafe discharges are challenging in part because some of the pillars of medical ethics can conflict. Prior articles have analyzed the ethical concerns of unsafe discharges in detail.<sup>9-11</sup> Briefly, when patients wish to return home against initial medical recommendations, treatment teams may focus on the principles of beneficence and nonmaleficence, as exemplified by the desire to minimize harm, and justice, in which clinicians consider resource allocation and risks that a home discharge poses to family members, caregivers, and home health professionals. However, autonomy is important to consider as well. The concept of dignity of risk highlights the imperative to respect others’ decisions even when they increase the chance of harm, particularly given the overall shift in medicine from paternalism to shared decision making.<sup>12</sup> Accommodating patient choice in how and where health care is received allows patients to regain some control over their lives, thereby enhancing their quality of life and promoting patient dignity, especially in their remaining days.<sup>13</sup> </p> <h2>Discharge Risk Framework </h2> <p>Our risk assessment framework helps clinicians more objectively identify factors that increase or decrease risk, inform discharge planning, partner with patients and families, give patients a prominent role in EOL decisions, and mitigate the risk of a bad outcome. This concept has been used in psychiatry, in which formal suicide assessment includes identifying risk factors and protective factors to estimate suicide risk and determine interventions.<sup>14</sup> Similar to suicide risk estimation, this framework is based on clinical judgment rather than a specific calculation.</p> <p>While this framework serves as a guide for determining and mitigating risk, we encourage teams to consider legal or ethical consultations in challenging cases, such as those in which patients lack both capacity and an involved HCA.</p> <p><b>Step 1: Determine the patient’s capacity regarding disposition planning.</b> Patients at EOL are at a higher risk of impaired decision-making capabilities; therefore, capacity evaluation is a critical step.<b>Step 2: Identify risk factors and protective factors for discharge home.</b> Risk factors are intrinsic and extrinsic factors that increase risk such as functional or sensory impairments. Protective factors are intrinsic and extrinsic factors that decrease risk, including a good understanding of illness and consistent connection with the health care system (Table 1).<b>Step 3: Determine discharge to home risk level based on identified risk factors and protective factors.</b> Patients may be at low, moderate, or high risk of having an adverse event, such as a fall or inadequate symptom control (Table 2).<br/><br/><b>Step 4: Identify risk mitigation strategies.</b> These should be tailored to the patient based on the factors identified in Step 2. Examples include home nursing and therapy, mental health treatment, a medical alert system, and frequent contact between the patient and health care team.<b>Step 5: Meet with inpatient and outpatient HCP teams.</b> Meetings should include the primary care professional (PCP) or relevant subspecialist, such as an oncologist for patients with cancer. For veterans receiving care solely at a local VA medical center, this can be easier to facilitate, but for veterans who receive care through both VA and non-VA systems, this step may require additional coordination. We also recommend including interdisciplinary team members, such as social workers, case managers, and the relevant home care or hospice agency. Certain agencies may decline admission if they perceive increased risk, such as no 24-hour care, perceived self-neglect, and limited instrumental support. During this meeting, HCPs discuss risk mitigation strategies identified in Step 4 and create a plan to propose to patients and families.<br/><br/><b>Step 6: Meet with patient, HCA, and family members.</b> In addition to sharing information about prognosis, assessing caregiver capabilities and burden can guide conversations about discharge. The discharge plan should be determined through shared decision making.<sup>11</sup> If the patient lacks capacity regarding disposition planning, this should be shared with the HCA. However, even when patients lack capacity, it is important to continue to engage them to understand their goals and preferences.<b>Step 7: Maximize risk mitigation strategies.</b> If a moderate- or high-risk discharge is requested, the health care team should maximize risk mitigation strategies. For low-risk discharges, risk mitigation strategies can still promote safety, especially since risk increases as patients progress toward EOL. In some instances, patients, their HCAs, or caregivers may decline all risk mitigation strategies despite best efforts to communicate and negotiate options. In such circumstances, we recommend discussing the case with the outpatient team for a warm handoff. HCPs should also document all efforts (helpful from a legal standpoint as well as for the patient’s future treatment teams) and respect the decision to discharge home.</p> <h3>Applying the Framework</h3> <p>Our patient Joe provides a good illustration of how to implement this EOL framework. He was deemed to have the capacity to make decisions regarding discharge (Step 1). We determined his risk factors and protective factors for discharge (Step 2). His poor functional status, limited instrumental support, heavy alcohol use, rejection of home services, and communication barriers due to severe hearing impairment all increased his risk. Protective factors included an appreciation of functional limitations, intact cognition, and an involved HCA. Based on his limited instrumental support and poor function but good insight into limitations, discharge home was deemed to be of moderate risk (Step 3). Although risk factors such as alcohol use and severe hearing impairment could have raised his level to high risk, we felt that his involved HCA maintained him in the moderate-risk category. </p> <p>We worked with the hospitalist team, PT, and audiology to identify multiple risk mitigation strategies: frequent phone calls between the HCA and outpatient palliative care team, home PT to improve transfers from bed to bedside commode, home nursing services either through a routine agency or hospice, and hearing aids for better communication (Steps 4 and 5). We then proposed these strategies to Joe and his HCA (Step 6). Due to concerns about infringement on his independence, Joe declined all home services but agreed to twice-daily check-ins by his HCA, frequent communication between his HCA and our team, and new hearing aids. <br/><br/>Joe returned home with the agreed-upon risk mitigation strategies in place (Step 7). Despite clinicians’ original reservations about sending Joe home without formal services, his HCA maintained close contact with our team, noting that Joe remained stable and happy to be at home in the months following discharge. </p> <h2>Conclusions</h2> <p>Fortunately, VA HCPs operate in an integrated health care system with access to psychological, social, and at-home medical support that can help mitigate risks. Still, we have benefitted from having a tool to help us evaluate risk systematically. Even if patients, families, and HCPs disagree on ideal discharge plans, this tool helps clinicians approach discharges methodically while maintaining open communication and partnership with patients. In doing so, our framework reflects the shift in medical culture from a patriarchal approach to shared decision-making practices regarding all aspects of medical care. Furthermore, we hope that this can help reduce clinician moral distress stemming from these challenging cases.</p> <p>Future research on best practices for discharge risk assessment and optimizing home safety are needed. We also hope to evaluate the impact and effectiveness of our framework through interviews with key stakeholders. For Joe and other veterans like him, where to spend their final days may be the last important decision they make in life, and our framework allows for their voices to be better heard throughout the decision-making process. </p> <h3> Acknowledgments </h3> <p> <em>We thank Brooke Lifland, MD, for her theoretical contributions to the concept behind this paper.</em> </p> <h3> Author affiliations </h3> <p> <em><sup>a</sup>University of Pennsylvania, Philadelphia<br/><br/><sup>b</sup>Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania<br/><br/><sup>c</sup>Veterans Affairs Connecticut Healthcare System, West Haven</em> </p> <h3> Author disclosures </h3> <p> <em>At the time of this work, Jessica Zuo was funded as a Geriatric Medicine Education Fellow by the Connecticut Older Adult Collaboration for Health 4M (COACH 4M) grant, a Geriatric Workforce Enhancement Program funded by the Health Resources and Services Administration (HRSA). The COACH 4M grant and HRSA had no role in the development of this work or the preparation of this manuscript. The authors report no actual or potential conflicts of interest 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 US Government, or any of its agencies.</em> </p> <h3> Ethics and consent </h3> <p> <em>Verbal consent was obtained from the veteran reported.</em> </p> <h3> References </h3> <p class="reference"> 1. Committee on Approaching Death: Addressing Key End of Life Issues; Institute of Medicine. <i>Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life</i>. Washington (DC): National Academies Press (US); March 19, 2015.<br/><br/> 2. Casarett D, Pickard A, Amos Bailey F, et al. Important aspects of end-of-life care among veterans: implications for measurement and quality improvement. <i>J Pain Symptom Manage</i>. 2008;35(2):115-125. doi:10.1016/j.jpainsymman.2007.03.008<br/><br/> 3. Kolva E, Rosenfeld B, Brescia R, Comfort C. Assessing decision-making capacity at end of life. <i>Gen Hosp Psychiatry</i>. 2014;36(4):392-397. doi:10.1016/j.genhosppsych.2014.02.013<br/><br/> 4. Kolva E, Rosenfeld B, Saracino R. Assessing the decision-making capacity of terminally ill patients with cancer. <i>Am J Geriatr Psychiatry</i>. 2018;26(5):523-531. doi:10.1016/j.jagp.2017.11.012<br/><br/> 5. Macmillan MS. Hospital staff’s perceptions of risk associated with the discharge of elderly people from acute hospital care. <i>J Adv Nurs</i>. 1994;19(2):249-256. doi:10.1111/j.1365-2648.1994.tb01078.x<br/><br/> 6. Coombs MA, Parker R, de Vries K. Managing risk during care transitions when approaching end of life: A qualitative study of patients’ and health care professionals’ decision making. <i>Palliat Med</i>. 2017;31(7):617-624. doi:10.1177/0269216316673476<br/><br/> 7. Hyslop B. ‘Not safe for discharge’? Words, values, and person-centred care. <i>Age Ageing</i>. 2020;49(3):334-336. doi:10.1093/ageing/afz170<br/><br/> 8. Goodacre S. Safe discharge: an irrational, unhelpful and unachievable concept. <i>Emerg Med J</i>. 2006;23(10):753-755. doi:10.1136/emj.2006.037903<br/><br/> 9. Swidler RN, Seastrum T, Shelton W. Difficult hospital inpatient discharge decisions: ethical, legal and clinical practice issues. <i>Am J Bioeth</i>. 2007;7(3):23-28. doi:10.1080/15265160601171739<br/><br/>10. Hill J, Filer W. Safety and ethical considerations in discharging patients to suboptimal living situations. <i>AMA J Ethics</i>. 2015;17(6):506-510. Published 2015 Jun 1. doi:10.1001/journalofethics.2015.17.6.ecas2-1506<br/><br/>11. West JC. What is an ethically informed approach to managing patient safety risk during discharge planning?. <i>AMA J Ethics</i>. 2020;22(11):E919-E923. Published 2020 Nov 1. doi:10.1001/amajethics.2020.919<br/><br/>12. Mukherjee D. Discharge decisions and the dignity of risk. <i>Hastings Cent Rep</i>. 2015;45(3):7-8. doi:10.1002/hast.441<br/><br/>13. Wheatley VJ, Baker JI. “Please, I want to go home”: ethical issues raised when considering choice of place of care in palliative care. <i>Postgrad Med J</i>. 2007;83(984):643-648. doi:10.1136/pgmj.2007.058487<br/><br/>14. Work Group on Suicidal Behaviors. Practice guideline for the assessment and treatment of patients with suicidal behaviors. <i>Am J Psychiatry</i>. 2003;160(suppl 11):1-60.</p> </itemContent> </newsItem> </itemSet></root>
Reducing Financial Toxicity Associated With Cancer Treatment New Mexico VAHCS Fisher House at its Finest!
PURPOSE
Reduce financial toxicity of housing costs associated with cancer treatment for rural Veterans.
BACKGROUND
Veterans diagnosed with cancer experience financial burdens associated with treatments: financial toxicities (FT). New Mexico (NM) an underserved and socioeconomically challenged state has one VA facility. Veterans commonly experience increased FT in the form of financial burdens related to travel distance, housing, and time off from work for caregivers as required to seek specialized care and cancer treatments. Travel pay and the Mission Act does little to alleviate this burden, and many still experience financial hardships.
METHODS
NMVAHCS Fisher House is reserved for families seeking housing accommodations during their loved one’s hospitalization. Surgical Service coordinated an additional plan to provide services for rural Veterans requiring 4-6 weeks of daily radiation therapy. Special accommodations were granted. Each case is reviewed via consult. Veteran requires an accompanying caregiver. Prior available Veteran discounted hotel rates averaged $96 per night. A 6-week course of shelter during radiation therapy could be $4,032.00, before taxes. No discounts or vouchers were available for meals, or other expenses.
RESULTS
Since FY23, 38 families seeking oncology care were welcomed into the Fisher House, reflecting a potential Veteran cost savings of $153,216.00 related to housing alone. Veterans also experienced cost saving related to food, as most meals were provided through community donations. Veteran satisfaction was improved, evidenced by Fisher House journal for families. Entries were heartwarming, with an outpouring of gratitude to the staff and VA for providing care and hospitality in a difficult time. Several Veterans stated they would not have been able to complete treatment without the Fisher House.
IMPLICATIONS
Although most Veterans have manageable associated out of pocket expenses with cancer treatments, many have associated extensive financial burdens related to receiving treatments. Even with the Mission Act, many live 4-6 hours from the closest oncology center providing radiation therapy, making a round trip for daily treatment up to 12 hours. Consideration in the reduction of travel time and housing expenses, can mean the difference of Veterans accepting treatments resulting in improved overall quality of life and survival outcomes.
PURPOSE
Reduce financial toxicity of housing costs associated with cancer treatment for rural Veterans.
BACKGROUND
Veterans diagnosed with cancer experience financial burdens associated with treatments: financial toxicities (FT). New Mexico (NM) an underserved and socioeconomically challenged state has one VA facility. Veterans commonly experience increased FT in the form of financial burdens related to travel distance, housing, and time off from work for caregivers as required to seek specialized care and cancer treatments. Travel pay and the Mission Act does little to alleviate this burden, and many still experience financial hardships.
METHODS
NMVAHCS Fisher House is reserved for families seeking housing accommodations during their loved one’s hospitalization. Surgical Service coordinated an additional plan to provide services for rural Veterans requiring 4-6 weeks of daily radiation therapy. Special accommodations were granted. Each case is reviewed via consult. Veteran requires an accompanying caregiver. Prior available Veteran discounted hotel rates averaged $96 per night. A 6-week course of shelter during radiation therapy could be $4,032.00, before taxes. No discounts or vouchers were available for meals, or other expenses.
RESULTS
Since FY23, 38 families seeking oncology care were welcomed into the Fisher House, reflecting a potential Veteran cost savings of $153,216.00 related to housing alone. Veterans also experienced cost saving related to food, as most meals were provided through community donations. Veteran satisfaction was improved, evidenced by Fisher House journal for families. Entries were heartwarming, with an outpouring of gratitude to the staff and VA for providing care and hospitality in a difficult time. Several Veterans stated they would not have been able to complete treatment without the Fisher House.
IMPLICATIONS
Although most Veterans have manageable associated out of pocket expenses with cancer treatments, many have associated extensive financial burdens related to receiving treatments. Even with the Mission Act, many live 4-6 hours from the closest oncology center providing radiation therapy, making a round trip for daily treatment up to 12 hours. Consideration in the reduction of travel time and housing expenses, can mean the difference of Veterans accepting treatments resulting in improved overall quality of life and survival outcomes.
PURPOSE
Reduce financial toxicity of housing costs associated with cancer treatment for rural Veterans.
BACKGROUND
Veterans diagnosed with cancer experience financial burdens associated with treatments: financial toxicities (FT). New Mexico (NM) an underserved and socioeconomically challenged state has one VA facility. Veterans commonly experience increased FT in the form of financial burdens related to travel distance, housing, and time off from work for caregivers as required to seek specialized care and cancer treatments. Travel pay and the Mission Act does little to alleviate this burden, and many still experience financial hardships.
METHODS
NMVAHCS Fisher House is reserved for families seeking housing accommodations during their loved one’s hospitalization. Surgical Service coordinated an additional plan to provide services for rural Veterans requiring 4-6 weeks of daily radiation therapy. Special accommodations were granted. Each case is reviewed via consult. Veteran requires an accompanying caregiver. Prior available Veteran discounted hotel rates averaged $96 per night. A 6-week course of shelter during radiation therapy could be $4,032.00, before taxes. No discounts or vouchers were available for meals, or other expenses.
RESULTS
Since FY23, 38 families seeking oncology care were welcomed into the Fisher House, reflecting a potential Veteran cost savings of $153,216.00 related to housing alone. Veterans also experienced cost saving related to food, as most meals were provided through community donations. Veteran satisfaction was improved, evidenced by Fisher House journal for families. Entries were heartwarming, with an outpouring of gratitude to the staff and VA for providing care and hospitality in a difficult time. Several Veterans stated they would not have been able to complete treatment without the Fisher House.
IMPLICATIONS
Although most Veterans have manageable associated out of pocket expenses with cancer treatments, many have associated extensive financial burdens related to receiving treatments. Even with the Mission Act, many live 4-6 hours from the closest oncology center providing radiation therapy, making a round trip for daily treatment up to 12 hours. Consideration in the reduction of travel time and housing expenses, can mean the difference of Veterans accepting treatments resulting in improved overall quality of life and survival outcomes.
Optimizing Health Literacy to Improve Veteran Satisfaction and Overall Surgical Outcomes
PURPOSE
To improve veteran surgical literacy, satisfaction, and overall outcomes.
BACKGROUND
For years, discharge education at the New Mexico VAHCS consisted of a fill-in templated non-specific and limited facility wide CPRS note written above an 8th grade reading level. Specific surgical instructions were not provided regarding drain/catheter/ostomy/wound care, activity and bathing instructions, and signs and symptoms to notify the provider. This resulted in post-discharge anxiety, provider calls, and avoidable re-admissions.
METHODS
Nurse Navigator/Patient Educator position was created and filled with intent to create discharge education database specific to diagnosis and procedure, 1:1 patient centered education, and direct access to subject matter expert. The Navigators collaborated with surgeons to develop concise post-operative, evidence- based education, which included easy to read diagrams, 8th grade reading level, and 14 font. Packets were approved through the VHEC/I committee for distribution and stored on the VA Intranet for afterhours ward access to ensure consistency.
RESULTS
28 educational packets were created for the most common surgeries completed to customize education to fit individual needs of the Veteran. Each packet contains basic information regarding the procedure and wound care, but is customizable to include specific drain, catheter, or ostomy teaching. The Navigators meet with the Veteran prior to surgery to develop trusting relationships and begin the education process. After surgery, they visit daily to reinforce education with teach back demonstrations and encourage self-care. Family members are included in education sessions and are provided time for questions. The Navigators ensure veterans do not leave the hospital without necessary equipment and medications. As a result, the NMVAHCS has experienced improvements in the Survey of Healthcare Experiences of Patients (SHEP) scores. Prior to improvements in the educational process, SHEP scores related to discharge education identified areas of concern. After hiring Nurse Navigators, SHEP scores for discharge information increased to 90.3%. General Surgery 14-day readmission rate improved (2.9% in FY 21 to 1.7% FY 22); and 30-day readmission rate improved (12.8% FY21 to 8.7% FY 22), despite increased operative volume.
IMPLICATIONS
Providing Veteran Centered Care with comprehensive education improves selfcare, patient satisfaction, and decreases avoidable readmissions.
PURPOSE
To improve veteran surgical literacy, satisfaction, and overall outcomes.
BACKGROUND
For years, discharge education at the New Mexico VAHCS consisted of a fill-in templated non-specific and limited facility wide CPRS note written above an 8th grade reading level. Specific surgical instructions were not provided regarding drain/catheter/ostomy/wound care, activity and bathing instructions, and signs and symptoms to notify the provider. This resulted in post-discharge anxiety, provider calls, and avoidable re-admissions.
METHODS
Nurse Navigator/Patient Educator position was created and filled with intent to create discharge education database specific to diagnosis and procedure, 1:1 patient centered education, and direct access to subject matter expert. The Navigators collaborated with surgeons to develop concise post-operative, evidence- based education, which included easy to read diagrams, 8th grade reading level, and 14 font. Packets were approved through the VHEC/I committee for distribution and stored on the VA Intranet for afterhours ward access to ensure consistency.
RESULTS
28 educational packets were created for the most common surgeries completed to customize education to fit individual needs of the Veteran. Each packet contains basic information regarding the procedure and wound care, but is customizable to include specific drain, catheter, or ostomy teaching. The Navigators meet with the Veteran prior to surgery to develop trusting relationships and begin the education process. After surgery, they visit daily to reinforce education with teach back demonstrations and encourage self-care. Family members are included in education sessions and are provided time for questions. The Navigators ensure veterans do not leave the hospital without necessary equipment and medications. As a result, the NMVAHCS has experienced improvements in the Survey of Healthcare Experiences of Patients (SHEP) scores. Prior to improvements in the educational process, SHEP scores related to discharge education identified areas of concern. After hiring Nurse Navigators, SHEP scores for discharge information increased to 90.3%. General Surgery 14-day readmission rate improved (2.9% in FY 21 to 1.7% FY 22); and 30-day readmission rate improved (12.8% FY21 to 8.7% FY 22), despite increased operative volume.
IMPLICATIONS
Providing Veteran Centered Care with comprehensive education improves selfcare, patient satisfaction, and decreases avoidable readmissions.
PURPOSE
To improve veteran surgical literacy, satisfaction, and overall outcomes.
BACKGROUND
For years, discharge education at the New Mexico VAHCS consisted of a fill-in templated non-specific and limited facility wide CPRS note written above an 8th grade reading level. Specific surgical instructions were not provided regarding drain/catheter/ostomy/wound care, activity and bathing instructions, and signs and symptoms to notify the provider. This resulted in post-discharge anxiety, provider calls, and avoidable re-admissions.
METHODS
Nurse Navigator/Patient Educator position was created and filled with intent to create discharge education database specific to diagnosis and procedure, 1:1 patient centered education, and direct access to subject matter expert. The Navigators collaborated with surgeons to develop concise post-operative, evidence- based education, which included easy to read diagrams, 8th grade reading level, and 14 font. Packets were approved through the VHEC/I committee for distribution and stored on the VA Intranet for afterhours ward access to ensure consistency.
RESULTS
28 educational packets were created for the most common surgeries completed to customize education to fit individual needs of the Veteran. Each packet contains basic information regarding the procedure and wound care, but is customizable to include specific drain, catheter, or ostomy teaching. The Navigators meet with the Veteran prior to surgery to develop trusting relationships and begin the education process. After surgery, they visit daily to reinforce education with teach back demonstrations and encourage self-care. Family members are included in education sessions and are provided time for questions. The Navigators ensure veterans do not leave the hospital without necessary equipment and medications. As a result, the NMVAHCS has experienced improvements in the Survey of Healthcare Experiences of Patients (SHEP) scores. Prior to improvements in the educational process, SHEP scores related to discharge education identified areas of concern. After hiring Nurse Navigators, SHEP scores for discharge information increased to 90.3%. General Surgery 14-day readmission rate improved (2.9% in FY 21 to 1.7% FY 22); and 30-day readmission rate improved (12.8% FY21 to 8.7% FY 22), despite increased operative volume.
IMPLICATIONS
Providing Veteran Centered Care with comprehensive education improves selfcare, patient satisfaction, and decreases avoidable readmissions.
Delivering Complex Oncologic Care to the Veteran’s “Front Door”: A Case Report of Leveraging Nationwide VA Expertise
INTRODUCTION
Fragmentation of medical services is a significant barrier in modern patient care with contributing factors including patient and system level details. The Veterans Affairs (VA) department is the largest integrated health care organization in the US. Given the complex challenges of such a system, the VA has developed resources to lessen the impact of care fragmentation, potentially widening services and diminishing traditional barriers to care. We present a patient case as an example of how VA programs are impacting current veteran oncologic care.
CASE PRESENTATION
An 86-year-old veteran with shortness of breath and fatigue was found to have macrocytic anemia. Located nearly 200 miles from the closest VA with hematology services he was referred through the National TeleOncology (NTO) service to see hematology using clinical video telehealth (CVT) technology stationed at a VA approximately 100 miles from his home. Consultation led to lab work revealing no viral, nutritional, or rheumatologic explanation. A bone marrow biopsy was completed without clear diagnosis though molecular alterations demonstrated ASXL1, TET2 and CBL mutations. Hematopathology services were sought, and the patient’s case was presented at the NTO virtual hematologic tumor board where expert VA hematopathology, radiology and medical hematology opinions were available. A diagnosis of myelodysplastic syndrome was rendered with care recommendations including the novel agent luspatercept. Given patient age and comorbidities, transportation remained a barrier. The patient was set up to receive services through home based primary care (HBPC) with weekly lab draws and medication administration. Ultimately, the patient was able to receive the first dose of luspatercept through the NTO affiliated VA with subsequent administrations to be given by HBPC. Additional visits planned using at home VA video Connect (VVC) service and CVT visits with NTO hematology at his local community based outpatient center (CBOC) located 30 miles from his home.
DISCUSSION
Located over 3 hours from the closest in-person VA hematologist, this patient was able to receive complex care thanks to a marriage of in-person and virtual services involving specialty nurses, pharmacists, and physicians from across VA. Services such as the NTO hub-spoke model, virtual tumor boards and HBPC, reveal a care framework unique to the VA.
INTRODUCTION
Fragmentation of medical services is a significant barrier in modern patient care with contributing factors including patient and system level details. The Veterans Affairs (VA) department is the largest integrated health care organization in the US. Given the complex challenges of such a system, the VA has developed resources to lessen the impact of care fragmentation, potentially widening services and diminishing traditional barriers to care. We present a patient case as an example of how VA programs are impacting current veteran oncologic care.
CASE PRESENTATION
An 86-year-old veteran with shortness of breath and fatigue was found to have macrocytic anemia. Located nearly 200 miles from the closest VA with hematology services he was referred through the National TeleOncology (NTO) service to see hematology using clinical video telehealth (CVT) technology stationed at a VA approximately 100 miles from his home. Consultation led to lab work revealing no viral, nutritional, or rheumatologic explanation. A bone marrow biopsy was completed without clear diagnosis though molecular alterations demonstrated ASXL1, TET2 and CBL mutations. Hematopathology services were sought, and the patient’s case was presented at the NTO virtual hematologic tumor board where expert VA hematopathology, radiology and medical hematology opinions were available. A diagnosis of myelodysplastic syndrome was rendered with care recommendations including the novel agent luspatercept. Given patient age and comorbidities, transportation remained a barrier. The patient was set up to receive services through home based primary care (HBPC) with weekly lab draws and medication administration. Ultimately, the patient was able to receive the first dose of luspatercept through the NTO affiliated VA with subsequent administrations to be given by HBPC. Additional visits planned using at home VA video Connect (VVC) service and CVT visits with NTO hematology at his local community based outpatient center (CBOC) located 30 miles from his home.
DISCUSSION
Located over 3 hours from the closest in-person VA hematologist, this patient was able to receive complex care thanks to a marriage of in-person and virtual services involving specialty nurses, pharmacists, and physicians from across VA. Services such as the NTO hub-spoke model, virtual tumor boards and HBPC, reveal a care framework unique to the VA.
INTRODUCTION
Fragmentation of medical services is a significant barrier in modern patient care with contributing factors including patient and system level details. The Veterans Affairs (VA) department is the largest integrated health care organization in the US. Given the complex challenges of such a system, the VA has developed resources to lessen the impact of care fragmentation, potentially widening services and diminishing traditional barriers to care. We present a patient case as an example of how VA programs are impacting current veteran oncologic care.
CASE PRESENTATION
An 86-year-old veteran with shortness of breath and fatigue was found to have macrocytic anemia. Located nearly 200 miles from the closest VA with hematology services he was referred through the National TeleOncology (NTO) service to see hematology using clinical video telehealth (CVT) technology stationed at a VA approximately 100 miles from his home. Consultation led to lab work revealing no viral, nutritional, or rheumatologic explanation. A bone marrow biopsy was completed without clear diagnosis though molecular alterations demonstrated ASXL1, TET2 and CBL mutations. Hematopathology services were sought, and the patient’s case was presented at the NTO virtual hematologic tumor board where expert VA hematopathology, radiology and medical hematology opinions were available. A diagnosis of myelodysplastic syndrome was rendered with care recommendations including the novel agent luspatercept. Given patient age and comorbidities, transportation remained a barrier. The patient was set up to receive services through home based primary care (HBPC) with weekly lab draws and medication administration. Ultimately, the patient was able to receive the first dose of luspatercept through the NTO affiliated VA with subsequent administrations to be given by HBPC. Additional visits planned using at home VA video Connect (VVC) service and CVT visits with NTO hematology at his local community based outpatient center (CBOC) located 30 miles from his home.
DISCUSSION
Located over 3 hours from the closest in-person VA hematologist, this patient was able to receive complex care thanks to a marriage of in-person and virtual services involving specialty nurses, pharmacists, and physicians from across VA. Services such as the NTO hub-spoke model, virtual tumor boards and HBPC, reveal a care framework unique to the VA.
Open Clinical Trials for Patients With Lymphoma, Leukemia, and Esophageal Cancer
Providing access to clinical trials for veteran and active-duty military patients can be a challenge, but many trials are now recruiting patients from those populations. Some trials explicitly recruit patients seeking care at the US Department of Veterans Affairs (VA), US Department of Defense (DoD) Military Health System, and Indian Health Service. The VA Office of Research and Development alone supported > 7260 research projects in 2022, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities. The clinical trials listed below are all open as of July 20, 2023; have at least 1 VA or DoD location recruiting patients; and are focused on treatments for lymphoma, leukemia, and esophageal cancer. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.
Lymphoma
Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin’s Lymphomas
Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the efficacy of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkin’s lymphoma.
ID: NCT04305444
Sponsor: Zhejiang DTRM Biopharma
Locations: 8 locations, including Memphis VA Medical Center
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator’s Choice in PTCL (PTCL)
Peripheral T-cell lymphoma (PTCL) is a rare and heterogeneous group of non-Hodgkin lymphoma (NHL) originating from mature (or post-thymic or ‘peripheral’) T-lymphocytes and NK cells. They are considered very aggressive and are often resistant to conventional chemotherapy.
This study employs a stratified randomization with equal allocation within strata of patients to receive oral 5-azacytidine (AZA) plus romidepsin (ROMI) versus prespecified investigator choice (ROMI, belinostat, pralatrexate or gemcitabine), for the treatment of relapsed or refractory (R/R) PTCL. The dose and schedule of AZA/ROMI has been determined from a phase I clinical trial of the combination. The primary objective of this study is to estimate the progression-free survival (PFS) among patients receiving the combination compared to single agent of choice.
ID: NCT04747236
Sponsor: Collaborator: University of Virginia; Celgene
Locations: 4 locations, including VA Long Beach Health Care System
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
This Disease Registry is designed to capture the patient characteristics, practice patterns, and therapeutic strategies evaluated in community and academic centers when treating relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), and R/R follicular lymphoma (FL). The data collected in this Registry will facilitate the evaluation of the current treatment landscape for non-Hodgkin lymphoma (NHL), including the clinical effectiveness, safety. No investigational product or drug will be administered as part of this study. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including any previous lymphoma treatments. Clinical outcomes will be documented as part of an objective clinical assessment. In addition, patient-reported health-related quality of life (HRQoL) outcomes data will be collected from patients using various validated instruments. Social support data will also be collected.
ID: NCT04982471
Sponsor: Celgene
Locations: 60 locations, including VA Central California Health Care System, Harry S. Truman Memorial Veterans’ Hospital, and Brooke Army Medical Center
Obinutuzumab With or Without Umbralisib,Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in the body’s immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Chemotherapy drugs, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.
ID: NCT03269669
Sponsor: National Cancer Institute (NCI)
Locations: 427 locations, including VA Palo Alto Health Care System
Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement (recurrent) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30-positive cancer cells in a targeted way and delivers vedotin to kill them. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.
ID: NCT01896999
Sponsor: National Cancer Institute (NCI)
Locations: 486 locations, including Walter Reed National Military Medical Center
Leukemia
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.
ID: NCT04269902
Sponsor: National Cancer Institute (NCI)
Locations: 545 locations, Tibor Rubin VA Medical Center, Minneapolis VA Medical Center, and Durham VA Medical Center
Testing the Use of Steroids and TyrosineKinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-cell Engager (‘BiTE’) that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
ID: NCT04530565
Sponsor: National Cancer Institute (NCI)
Locations: 180 locations, including Walter Reed National Military Medical Center
Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia (ASC2ESCALATE)
This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP-binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.
ID: NCT05384587
Sponsor: Novartis
Locations: 26 locations, including VA Puget Sound Health Care System
Connect® Myeloid Disease Registry
This Disease Registry will collect data on patient characteristics, treatment patterns and clinical outcomes. The objective is to describe how patients with myeloid diseases are treated; and to build a knowledge base regarding the effectiveness and safety of first-line and subsequent treatment regimens in both community and academic settings. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including initial treatment and any subsequent therapy. Data on treatment outcomes, including response rates as measured by the treating physician, evidence of progression, survival, and patient-reported outcomes will be collected quarterly on the electronic CRF.
ID: NCT01688011
Sponsor: Celgene
Locations: 240 locations, including VA Central California Health Care System, John D. Dingell VA Medical Center, Manchester VA Medical Center, Dallas VA Medical Center, White River Junction VA Medical Center, and VA Caribbean Healthcare System
Esophageal Cancer
Non-endoscopic Esophageal Sampling to Detect Barrett’s Esophagus and Esophageal Cancer in Veterans
This study seeks to incorporate non-endoscopic detection method (Esocheck/Esoguard) in primary care practice and test whether this screening modality increases the positive predictive value of upper endoscopy and increases the detection of Barrett’s esophagus and esophageal cancer.
Currently, BE is diagnosed only when patients undergo endoscopy with esophagogastroduodenoscopy (EGD). However, due to the high cost of EGD and the lack of a randomized controlled trials supporting its efficacy, endoscopy to screen for BE is not routinely recommended. Current guidelines do recommend sedated EGD in patients with multiple BE risk factors, refractory GERD, or alarm symptoms. This strategy fails to detect BE in patients whose symptoms are well controlled with either over the counter medications or physician prescribed therapies. It also fails to detect BE in asymptomatic subjects who comprise 40% of those that develop EAC. Thus, < 10% of EACs are diagnosed as early stage lesions caught by surveillance of patients with previously detected BE. Ablative nonsurgical therapies that have been developed for preventing cancer in patients with BE with high-grade dysplasia over the past decade will have little impact and the 5-year survival for EACs will remain a dismal 18% unless more effective programs for identifying BE and early EAC are developed.
Esocheck/Esoguard is a FDA approved device designed to sample the distal esophagus and analyze the collected material for presence of two methylated DNA markers. The Specific Aims of this study are:
To determine sensitivity, specificity, positive and negative predictive value of Esocheck/Esoguard performed in routine practice for detecting BE in an at risk Veteran population
To compare the yield of detected BE using EGD alone vs. stepwise molecular diagnostics(Esocheck/Esoguard) and endoscopic screening strategy (EGD) in at risk Veteran population.
ID: NCT05210049
Sponsor: Cleveland VA Medical Research and Education Foundation
Location: Louis Stokes Cleveland VA Medical Center
Progression of Gastroesophageal Reflux Disease and Barrett’s Esophagus and the Creation of a Barrett’s Registry
The purpose of this study is to determine or evaluate the risk factors such as smoking, family history etc. that cause esophageal cancer and to determine the genetic changes that lead to esophageal cancer. The investigators hypothesis is that systematic collection of data on the natural history of GERD and BE patients and risk factors for development of BE in patients with chronic GERD and progression of BE to dysplasia and adenocarcinoma will provide useful information to develop a decision model for risk stratification and risk reduction strategies in these patients.
ID: NCT00574327
Sponsor: Midwest Biomedical Research Foundation
Location: Kansas City VA Medical Center
Providing access to clinical trials for veteran and active-duty military patients can be a challenge, but many trials are now recruiting patients from those populations. Some trials explicitly recruit patients seeking care at the US Department of Veterans Affairs (VA), US Department of Defense (DoD) Military Health System, and Indian Health Service. The VA Office of Research and Development alone supported > 7260 research projects in 2022, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities. The clinical trials listed below are all open as of July 20, 2023; have at least 1 VA or DoD location recruiting patients; and are focused on treatments for lymphoma, leukemia, and esophageal cancer. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.
Lymphoma
Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin’s Lymphomas
Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the efficacy of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkin’s lymphoma.
ID: NCT04305444
Sponsor: Zhejiang DTRM Biopharma
Locations: 8 locations, including Memphis VA Medical Center
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator’s Choice in PTCL (PTCL)
Peripheral T-cell lymphoma (PTCL) is a rare and heterogeneous group of non-Hodgkin lymphoma (NHL) originating from mature (or post-thymic or ‘peripheral’) T-lymphocytes and NK cells. They are considered very aggressive and are often resistant to conventional chemotherapy.
This study employs a stratified randomization with equal allocation within strata of patients to receive oral 5-azacytidine (AZA) plus romidepsin (ROMI) versus prespecified investigator choice (ROMI, belinostat, pralatrexate or gemcitabine), for the treatment of relapsed or refractory (R/R) PTCL. The dose and schedule of AZA/ROMI has been determined from a phase I clinical trial of the combination. The primary objective of this study is to estimate the progression-free survival (PFS) among patients receiving the combination compared to single agent of choice.
ID: NCT04747236
Sponsor: Collaborator: University of Virginia; Celgene
Locations: 4 locations, including VA Long Beach Health Care System
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
This Disease Registry is designed to capture the patient characteristics, practice patterns, and therapeutic strategies evaluated in community and academic centers when treating relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), and R/R follicular lymphoma (FL). The data collected in this Registry will facilitate the evaluation of the current treatment landscape for non-Hodgkin lymphoma (NHL), including the clinical effectiveness, safety. No investigational product or drug will be administered as part of this study. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including any previous lymphoma treatments. Clinical outcomes will be documented as part of an objective clinical assessment. In addition, patient-reported health-related quality of life (HRQoL) outcomes data will be collected from patients using various validated instruments. Social support data will also be collected.
ID: NCT04982471
Sponsor: Celgene
Locations: 60 locations, including VA Central California Health Care System, Harry S. Truman Memorial Veterans’ Hospital, and Brooke Army Medical Center
Obinutuzumab With or Without Umbralisib,Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in the body’s immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Chemotherapy drugs, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.
ID: NCT03269669
Sponsor: National Cancer Institute (NCI)
Locations: 427 locations, including VA Palo Alto Health Care System
Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement (recurrent) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30-positive cancer cells in a targeted way and delivers vedotin to kill them. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.
ID: NCT01896999
Sponsor: National Cancer Institute (NCI)
Locations: 486 locations, including Walter Reed National Military Medical Center
Leukemia
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.
ID: NCT04269902
Sponsor: National Cancer Institute (NCI)
Locations: 545 locations, Tibor Rubin VA Medical Center, Minneapolis VA Medical Center, and Durham VA Medical Center
Testing the Use of Steroids and TyrosineKinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-cell Engager (‘BiTE’) that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
ID: NCT04530565
Sponsor: National Cancer Institute (NCI)
Locations: 180 locations, including Walter Reed National Military Medical Center
Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia (ASC2ESCALATE)
This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP-binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.
ID: NCT05384587
Sponsor: Novartis
Locations: 26 locations, including VA Puget Sound Health Care System
Connect® Myeloid Disease Registry
This Disease Registry will collect data on patient characteristics, treatment patterns and clinical outcomes. The objective is to describe how patients with myeloid diseases are treated; and to build a knowledge base regarding the effectiveness and safety of first-line and subsequent treatment regimens in both community and academic settings. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including initial treatment and any subsequent therapy. Data on treatment outcomes, including response rates as measured by the treating physician, evidence of progression, survival, and patient-reported outcomes will be collected quarterly on the electronic CRF.
ID: NCT01688011
Sponsor: Celgene
Locations: 240 locations, including VA Central California Health Care System, John D. Dingell VA Medical Center, Manchester VA Medical Center, Dallas VA Medical Center, White River Junction VA Medical Center, and VA Caribbean Healthcare System
Esophageal Cancer
Non-endoscopic Esophageal Sampling to Detect Barrett’s Esophagus and Esophageal Cancer in Veterans
This study seeks to incorporate non-endoscopic detection method (Esocheck/Esoguard) in primary care practice and test whether this screening modality increases the positive predictive value of upper endoscopy and increases the detection of Barrett’s esophagus and esophageal cancer.
Currently, BE is diagnosed only when patients undergo endoscopy with esophagogastroduodenoscopy (EGD). However, due to the high cost of EGD and the lack of a randomized controlled trials supporting its efficacy, endoscopy to screen for BE is not routinely recommended. Current guidelines do recommend sedated EGD in patients with multiple BE risk factors, refractory GERD, or alarm symptoms. This strategy fails to detect BE in patients whose symptoms are well controlled with either over the counter medications or physician prescribed therapies. It also fails to detect BE in asymptomatic subjects who comprise 40% of those that develop EAC. Thus, < 10% of EACs are diagnosed as early stage lesions caught by surveillance of patients with previously detected BE. Ablative nonsurgical therapies that have been developed for preventing cancer in patients with BE with high-grade dysplasia over the past decade will have little impact and the 5-year survival for EACs will remain a dismal 18% unless more effective programs for identifying BE and early EAC are developed.
Esocheck/Esoguard is a FDA approved device designed to sample the distal esophagus and analyze the collected material for presence of two methylated DNA markers. The Specific Aims of this study are:
To determine sensitivity, specificity, positive and negative predictive value of Esocheck/Esoguard performed in routine practice for detecting BE in an at risk Veteran population
To compare the yield of detected BE using EGD alone vs. stepwise molecular diagnostics(Esocheck/Esoguard) and endoscopic screening strategy (EGD) in at risk Veteran population.
ID: NCT05210049
Sponsor: Cleveland VA Medical Research and Education Foundation
Location: Louis Stokes Cleveland VA Medical Center
Progression of Gastroesophageal Reflux Disease and Barrett’s Esophagus and the Creation of a Barrett’s Registry
The purpose of this study is to determine or evaluate the risk factors such as smoking, family history etc. that cause esophageal cancer and to determine the genetic changes that lead to esophageal cancer. The investigators hypothesis is that systematic collection of data on the natural history of GERD and BE patients and risk factors for development of BE in patients with chronic GERD and progression of BE to dysplasia and adenocarcinoma will provide useful information to develop a decision model for risk stratification and risk reduction strategies in these patients.
ID: NCT00574327
Sponsor: Midwest Biomedical Research Foundation
Location: Kansas City VA Medical Center
Providing access to clinical trials for veteran and active-duty military patients can be a challenge, but many trials are now recruiting patients from those populations. Some trials explicitly recruit patients seeking care at the US Department of Veterans Affairs (VA), US Department of Defense (DoD) Military Health System, and Indian Health Service. The VA Office of Research and Development alone supported > 7260 research projects in 2022, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities. The clinical trials listed below are all open as of July 20, 2023; have at least 1 VA or DoD location recruiting patients; and are focused on treatments for lymphoma, leukemia, and esophageal cancer. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.
Lymphoma
Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin’s Lymphomas
Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the efficacy of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkin’s lymphoma.
ID: NCT04305444
Sponsor: Zhejiang DTRM Biopharma
Locations: 8 locations, including Memphis VA Medical Center
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator’s Choice in PTCL (PTCL)
Peripheral T-cell lymphoma (PTCL) is a rare and heterogeneous group of non-Hodgkin lymphoma (NHL) originating from mature (or post-thymic or ‘peripheral’) T-lymphocytes and NK cells. They are considered very aggressive and are often resistant to conventional chemotherapy.
This study employs a stratified randomization with equal allocation within strata of patients to receive oral 5-azacytidine (AZA) plus romidepsin (ROMI) versus prespecified investigator choice (ROMI, belinostat, pralatrexate or gemcitabine), for the treatment of relapsed or refractory (R/R) PTCL. The dose and schedule of AZA/ROMI has been determined from a phase I clinical trial of the combination. The primary objective of this study is to estimate the progression-free survival (PFS) among patients receiving the combination compared to single agent of choice.
ID: NCT04747236
Sponsor: Collaborator: University of Virginia; Celgene
Locations: 4 locations, including VA Long Beach Health Care System
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
This Disease Registry is designed to capture the patient characteristics, practice patterns, and therapeutic strategies evaluated in community and academic centers when treating relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), and R/R follicular lymphoma (FL). The data collected in this Registry will facilitate the evaluation of the current treatment landscape for non-Hodgkin lymphoma (NHL), including the clinical effectiveness, safety. No investigational product or drug will be administered as part of this study. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including any previous lymphoma treatments. Clinical outcomes will be documented as part of an objective clinical assessment. In addition, patient-reported health-related quality of life (HRQoL) outcomes data will be collected from patients using various validated instruments. Social support data will also be collected.
ID: NCT04982471
Sponsor: Celgene
Locations: 60 locations, including VA Central California Health Care System, Harry S. Truman Memorial Veterans’ Hospital, and Brooke Army Medical Center
Obinutuzumab With or Without Umbralisib,Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in the body’s immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Chemotherapy drugs, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.
ID: NCT03269669
Sponsor: National Cancer Institute (NCI)
Locations: 427 locations, including VA Palo Alto Health Care System
Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement (recurrent) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30-positive cancer cells in a targeted way and delivers vedotin to kill them. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.
ID: NCT01896999
Sponsor: National Cancer Institute (NCI)
Locations: 486 locations, including Walter Reed National Military Medical Center
Leukemia
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.
ID: NCT04269902
Sponsor: National Cancer Institute (NCI)
Locations: 545 locations, Tibor Rubin VA Medical Center, Minneapolis VA Medical Center, and Durham VA Medical Center
Testing the Use of Steroids and TyrosineKinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-cell Engager (‘BiTE’) that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
ID: NCT04530565
Sponsor: National Cancer Institute (NCI)
Locations: 180 locations, including Walter Reed National Military Medical Center
Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia (ASC2ESCALATE)
This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP-binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.
ID: NCT05384587
Sponsor: Novartis
Locations: 26 locations, including VA Puget Sound Health Care System
Connect® Myeloid Disease Registry
This Disease Registry will collect data on patient characteristics, treatment patterns and clinical outcomes. The objective is to describe how patients with myeloid diseases are treated; and to build a knowledge base regarding the effectiveness and safety of first-line and subsequent treatment regimens in both community and academic settings. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including initial treatment and any subsequent therapy. Data on treatment outcomes, including response rates as measured by the treating physician, evidence of progression, survival, and patient-reported outcomes will be collected quarterly on the electronic CRF.
ID: NCT01688011
Sponsor: Celgene
Locations: 240 locations, including VA Central California Health Care System, John D. Dingell VA Medical Center, Manchester VA Medical Center, Dallas VA Medical Center, White River Junction VA Medical Center, and VA Caribbean Healthcare System
Esophageal Cancer
Non-endoscopic Esophageal Sampling to Detect Barrett’s Esophagus and Esophageal Cancer in Veterans
This study seeks to incorporate non-endoscopic detection method (Esocheck/Esoguard) in primary care practice and test whether this screening modality increases the positive predictive value of upper endoscopy and increases the detection of Barrett’s esophagus and esophageal cancer.
Currently, BE is diagnosed only when patients undergo endoscopy with esophagogastroduodenoscopy (EGD). However, due to the high cost of EGD and the lack of a randomized controlled trials supporting its efficacy, endoscopy to screen for BE is not routinely recommended. Current guidelines do recommend sedated EGD in patients with multiple BE risk factors, refractory GERD, or alarm symptoms. This strategy fails to detect BE in patients whose symptoms are well controlled with either over the counter medications or physician prescribed therapies. It also fails to detect BE in asymptomatic subjects who comprise 40% of those that develop EAC. Thus, < 10% of EACs are diagnosed as early stage lesions caught by surveillance of patients with previously detected BE. Ablative nonsurgical therapies that have been developed for preventing cancer in patients with BE with high-grade dysplasia over the past decade will have little impact and the 5-year survival for EACs will remain a dismal 18% unless more effective programs for identifying BE and early EAC are developed.
Esocheck/Esoguard is a FDA approved device designed to sample the distal esophagus and analyze the collected material for presence of two methylated DNA markers. The Specific Aims of this study are:
To determine sensitivity, specificity, positive and negative predictive value of Esocheck/Esoguard performed in routine practice for detecting BE in an at risk Veteran population
To compare the yield of detected BE using EGD alone vs. stepwise molecular diagnostics(Esocheck/Esoguard) and endoscopic screening strategy (EGD) in at risk Veteran population.
ID: NCT05210049
Sponsor: Cleveland VA Medical Research and Education Foundation
Location: Louis Stokes Cleveland VA Medical Center
Progression of Gastroesophageal Reflux Disease and Barrett’s Esophagus and the Creation of a Barrett’s Registry
The purpose of this study is to determine or evaluate the risk factors such as smoking, family history etc. that cause esophageal cancer and to determine the genetic changes that lead to esophageal cancer. The investigators hypothesis is that systematic collection of data on the natural history of GERD and BE patients and risk factors for development of BE in patients with chronic GERD and progression of BE to dysplasia and adenocarcinoma will provide useful information to develop a decision model for risk stratification and risk reduction strategies in these patients.
ID: NCT00574327
Sponsor: Midwest Biomedical Research Foundation
Location: Kansas City VA Medical Center
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All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">106</term> </sections> <topics> <term canonical="true">263</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Open Clinical Trials for Patients With Lymphoma, Leukemia, and Esophageal Cancer</title> <deck/> </itemMeta> <itemContent> <p class="Body">Providing access to clinical trials for veteran and active-duty military patients can be a challenge, but many trials are now recruiting patients from those populations. Some trials explicitly recruit patients seeking care at the US Department of Veterans Affairs (VA), US Department of Defense (DoD) Military Health System, and Indian Health Service. The VA Office of Research and Development alone supported > 7260 research projects in 2022, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities. The clinical trials listed below are all open as of July 20, 2023; have at least 1 VA or DoD location recruiting patients; and are focused on treatments for lymphoma, leukemia, and esophageal cancer. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.</p> <p class="Normal"> <b>Lymphoma</b> </p> <h2>Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin’s Lymphomas</h2> <p>Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the efficacy of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkin’s lymphoma.<br/><br/><b>ID: </b>NCT04305444<br/><br/><b>Sponsor:</b> Zhejiang DTRM Biopharma<br/><br/><b>Locations: </b>8 locations, including Memphis VA Medical Center</p> <h2>Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator’s Choice in PTCL (PTCL)</h2> <p>Peripheral T-cell lymphoma (PTCL) is a rare and heterogeneous group of non-Hodgkin lymphoma (NHL) originating from mature (or post-thymic or ‘peripheral’) T-lymphocytes and NK cells. They are considered very aggressive and are often resistant to conventional chemotherapy.</p> <p>This study employs a stratified randomization with equal allocation within strata of patients to receive oral 5-azacytidine (AZA) plus romidepsin (ROMI) versus prespecified investigator choice (ROMI, belinostat, pralatrexate or gemcitabine), for the treatment of relapsed or refractory (R/R) PTCL. The dose and schedule of AZA/ROMI has been determined from a phase I clinical trial of the combination. The primary objective of this study is to estimate the progression-free survival (PFS) among patients receiving the combination compared to single agent of choice.</p> <p><b>ID:</b> NCT04747236<br/><br/><b>Sponsor: </b>Collaborator: University of Virginia; Celgene<br/><br/><b>Locations:</b> 4 locations, including VA Long Beach Health Care System</p> <h2>Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study</h2> <p>This Disease Registry is designed to capture the patient characteristics, practice patterns, and therapeutic strategies evaluated in community and academic centers when treating relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), and R/R follicular lymphoma (FL). The data collected in this Registry will facilitate the evaluation of the current treatment landscape for non-Hodgkin lymphoma (NHL), including the clinical effectiveness, safety. No investigational product or drug will be administered as part of this study. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including any previous lymphoma treatments. Clinical outcomes will be documented as part of an objective clinical assessment. In addition, patient-reported health-related quality of life (HRQoL) outcomes data will be collected from patients using various validated instruments. Social support data will also be collected.<b>ID: </b>NCT04982471<br/><br/><b>Sponsor: </b>Celgene<br/><br/><b>Locations: </b>60 locations, including VA Central California Health Care System, Harry S. Truman Memorial Veterans’ Hospital, and Brooke Army Medical Center </p> <h2>Obinutuzumab With or Without Umbralisib,Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma</h2> <p>This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in the body’s immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Chemotherapy drugs, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.<b>ID: </b>NCT03269669<br/><br/><b>Sponsor: </b>National Cancer Institute (NCI)<br/><br/><b>Locations:</b> 427 locations, including VA Palo Alto Health Care System</p> <h2>Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma</h2> <p>This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement (recurrent) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30-positive cancer cells in a targeted way and delivers vedotin to kill them. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.<b>ID: </b>NCT01896999<br/><br/><b>Sponsor: </b>National Cancer Institute (NCI)<br/><br/><b>Locations:</b> 486 locations, including Walter Reed National Military Medical Center</p> <p class="Normal"> <b>Leukemia</b> </p> <h2>Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study</h2> <p>This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.<br/><br/><b>ID: </b>NCT04269902<br/><br/><b>Sponsor:</b> National Cancer Institute (NCI)<br/><br/><b>Locations:</b> 545 locations, Tibor Rubin VA Medical Center, Minneapolis VA Medical Center, and Durham VA Medical Center</p> <h2>Testing the Use of Steroids and TyrosineKinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults</h2> <p>This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-cell Engager (‘BiTE’) that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.<br/><br/>I<b>D: </b>NCT04530565<br/><br/><b>Sponsor: </b>National Cancer Institute (NCI)<br/><br/><b>Locations: </b>180 locations, including Walter Reed National Military Medical Center</p> <h2>Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia (ASC2ESCALATE)</h2> <p>This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP-binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.<br/><br/><b>ID:</b> NCT05384587<br/><br/><b>Sponsor: </b>Novartis<br/><br/><b>Locations: </b>26 locations, including VA Puget Sound Health Care System</p> <h2>Connect® Myeloid Disease Registry</h2> <p>This Disease Registry will collect data on patient characteristics, treatment patterns and clinical outcomes. The objective is to describe how patients with myeloid diseases are treated; and to build a knowledge base regarding the effectiveness and safety of first-line and subsequent treatment regimens in both community and academic settings. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including initial treatment and any subsequent therapy. Data on treatment outcomes, including response rates as measured by the treating physician, evidence of progression, survival, and patient-reported outcomes will be collected quarterly on the electronic CRF.<b>ID:</b> NCT01688011<br/><br/><b>Sponsor</b><b>:</b> Celgene<br/><br/><b>Locations:</b> 240 locations, including VA Central California Health Care System, John D. Dingell VA Medical Center, Manchester VA Medical Center, Dallas VA Medical Center, White River Junction VA Medical Center, and VA Caribbean Healthcare System</p> <p class="Normal"> <b>Esophageal Cancer</b> </p> <h2>Non-endoscopic Esophageal Sampling to Detect Barrett’s Esophagus and Esophageal Cancer in Veterans</h2> <p>This study seeks to incorporate non-endoscopic detection method (Esocheck/Esoguard) in primary care practice and test whether this screening modality increases the positive predictive value of upper endoscopy and increases the detection of Barrett’s esophagus and esophageal cancer.</p> <p>Currently, BE is diagnosed only when patients undergo endoscopy with esophagogastroduodenoscopy (EGD). However, due to the high cost of EGD and the lack of a randomized controlled trials supporting its efficacy, endoscopy to screen for BE is not routinely recommended. Current guidelines do recommend sedated EGD in patients with multiple BE risk factors, refractory GERD, or alarm symptoms. This strategy fails to detect BE in patients whose symptoms are well controlled with either over the counter medications or physician prescribed therapies. It also fails to detect BE in asymptomatic subjects who comprise 40% of those that develop EAC. Thus, < 10% of EACs are diagnosed as early stage lesions caught by surveillance of patients with previously detected BE. Ablative nonsurgical therapies that have been developed for preventing cancer in patients with BE with high-grade dysplasia over the past decade will have little impact and the 5-year survival for EACs will remain a dismal 18% unless more effective programs for identifying BE and early EAC are developed. <br/><br/>Esocheck/Esoguard is a FDA approved device designed to sample the distal esophagus and analyze the collected material for presence of two methylated DNA markers. The Specific Aims of this study are: <br/><br/>To determine sensitivity, specificity, positive and negative predictive value of Esocheck/Esoguard performed in routine practice for detecting BE in an at risk Veteran population<br/><br/>To compare the yield of detected BE using EGD alone vs. stepwise molecular diagnostics(Esocheck/Esoguard) and endoscopic screening strategy (EGD) in at risk Veteran population.</p> <p><b>ID: </b>NCT05210049<br/><br/><b>Sponsor: </b>Cleveland VA Medical Research and Education Foundation<br/><br/><b>Location: </b>Louis Stokes Cleveland VA Medical Center</p> <h2>Progression of Gastroesophageal Reflux Disease and Barrett’s Esophagus and the Creation of a Barrett’s Registry</h2> <p>The purpose of this study is to determine or evaluate the risk factors such as smoking, family history etc. that cause esophageal cancer and to determine the genetic changes that lead to esophageal cancer. The investigators hypothesis is that systematic collection of data on the natural history of GERD and BE patients and risk factors for development of BE in patients with chronic GERD and progression of BE to dysplasia and adenocarcinoma will provide useful information to develop a decision model for risk stratification and risk reduction strategies in these patients.<br/><br/><b>ID: </b>NCT00574327<br/><br/><b>Sponsor: </b>Midwest Biomedical Research Foundation<br/><br/><b>Location:</b> Kansas City VA Medical Center </p> </itemContent> </newsItem> </itemSet></root>
Open Clinical Trials for Patients With Cancer
Prostate Cancer
18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer (PROSPYL)
The main purpose of this phase II trial study is to determine whether a positron emission tomography (PET)/computed tomography (CT) scan using 18F-DCFPyL affects the clinical management plan in veterans. In this study, the management plan prior to and after 18F-DCFPyL PET/CT will be recorded by specific questionnaires and corresponding changes in management will be analyzed. The scan will be used to see how the disease has spread. Both the treatment strategies and probable disease outcomes as relevant to clinical endpoints will be assessed. This study is open to veterans only.
ID: NCT04390880
Sponsor: VA Greater Los Angeles Healthcare System
Location: VA Greater Los Angeles Healthcare System
Patient Decision-Making About Precision Oncology in Veterans With Advanced Prostate Cancer
This project proposes to understand and improve veterans’ decision-making in precision oncology (germline testing, somatic tumor testing, and targeted therapy) for advanced prostate cancer. As precision oncology expands, a comprehensive strategy to support patient informed decision-making has not been developed.
ID: NCT05396872
Sponsor; Collaborator: University of California, San Francisco; US Department of Defense
Location: San Francisco VA Medical Center
Intramuscular Mechanisms of Androgen Deprivation-Related Sarcopenia
Prostate cancer is the most common cancer among men and is even more common in the military and veteran population. For patients with advanced prostate cancer, the most common treatment includes lowering the levels of the hormone testosterone as much as possible, which is called androgen deprivation therapy (ADT). Unfortunately, ADT also causes patients to be fatigued, weak, and to lose muscle. This is often referred to as sarcopenia, and it leads to falls, poor quality of life, and higher risk of death. Currently, there is no treatment for sarcopenia because investigators do not understand the mechanisms that cause it. The mitochondria is the part of the cells responsible for providing energy to muscles but to date the investigators do not know if it is affected in prostate cancer patients with sarcopenia due to ADT. The overall goal of this proposal is to establish if the mitochondria is responsible for sarcopenia in patients with prostate cancer receiving ADT. The investigators will measure mitochondrial function, muscle mass and strength, and feelings of fatigue and quality of life in patients with prostate cancer before starting and after 6 months of ADT.
ID: NCT03867357
Sponsor; Collaborator: Seattle Institute for Biomedical and Clinical Research; US Department of Defense
Location: VA Puget Sound Health Care System
VA Seamless Phase II/III Randomized Trial of Standard Systemic Therapy With or Without PET-Directed Local Therapy for OligoRecurrent Prostate Cancer (VA STARPORT)
The primary goal of this study is to determine if adding PET-directed local therapy improves disease control compared to standard systemic therapy alone (SST) in veterans with oligorecurrent prostate cancer on PET/CT. The investigators will conduct a multi-institutional phase II/III randomized trial comparing SST with or without PET-directed local therapy using radiation or surgery to all metastases and if a local recurrence is present.
ID: NCT04787744
Sponsor: VA Office of Research and Development
Locations: VA Long Beach Healthcare System, VA Greater Los Angeles Healthcare System, Bay Pines VA Healthcare System, Edward Hines Jr. VA Hospital, Richard L. Roudebush VA Medical Center, VA Boston Healthcare System Jamaica Plain Campus, VA Ann Arbor Healthcare System, Minneapolis VA Health Care System, Kansas City VA Medical Center, St. Louis VA Medical Center John Cochran Division, East Orange Campus of the VA New Jersey Health Care System, Durham VA Medical Center, Louis Stokes VA Medical Center, Michael E. DeBakey VA Medical Center, Hunter Holmes McGuire VA Medical Center, Clement J. Zablocki VA Medical Center
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. The addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
ID: NCT03678025
Sponsor; Collaborator: Southwest Oncology Group; National Cancer Institute (NCI)
Locations: 328 sites, including Tibor Rubin VA Medical Center, Atlanta VA Medical Center, James J. Peters VA Medical Center, Michael E. DeBakey VA Medical Center, and Audie L. Murphy VA Hospital
A Clinical Study Evaluating the Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant to Testosterone-Deprivation Therapy (CASPAR)
This randomized, placebo-controlled, phase III trial is evaluating the benefit of rucaparib and enzalutamide combination therapy vs enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient.
ID: NCT04455750
Sponsor; Collaborator: Alliance for Clinical Trials in Oncology; National Cancer Institute (NCI)
Locations: 413 sites
Digitally Captured Activity Data and PROs to Monitor Physical Function in Prostate Cancer Patients (DigiPRO)
Physical function is a known predictor of quality of life in advanced prostate cancer patients and key measure of treatment tolerability. While treatment with androgen deprivation therapy (ADT) improves survival, it is associated with significant toxicities that lead to physical function (PF) decline. The average age of incident prostate cancer is 66 years, and in this older group of men, chronic comorbid conditions often co-occur with diagnosis, further adding to the risk for PF decline. With over 2.9 million prostate cancer survivors in the US, there is an increasing demand for adequate symptom monitoring and PF assessment throughout cancer care. However, there are currently no validated methods to systematically evaluate and predict PF decline. Thus, the overarching objective of this proposal is to determine whether the use of wearable technology to monitor objective daily activity combined with routine symptom reporting can predict PF decline. To accomplish this, we propose a mixed-methods approach that will provide quantitative information to help identify PC survivors at higher risk for PF decline as well as a qualitative aim gain a deeper understanding of the perceived relationships that PC survivors have with their physical activity levels and treatment symptoms.
ID: NCT04575402
Sponsor; Collaborator: Cedars-Sinai Medical Center; US Department of Defense
Location: Cedars Sinai Medical Center
The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors
The purpose of this prospective, interventional, single-arm pilot study is to evaluate whether virtually delivered group-based physical activity is feasible for adolescent and young adult (AYA) cancer survivors. AYAs who were diagnosed with cancer and have completed cancer treatment will be recruited for this study. This study will enroll 20 participants in total and will last approximately 3 months.
ID: NCT05131815
Sponsor; Collaborator: Cedars-Sinai Medical Center; Walter Reed National Military Medical Center
Location: Cedars-Sinai Medical Center
Lung Cancer
DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers
The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program for lung cancer early detection. DECAMP 1 PLUS aims to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules (8-25 mm). Molecular biomarkers for lung cancer diagnosis measured in minimally invasive and noninvasive biospecimens may be able to distinguish between malignant or benign indeterminate pulmonary nodules in high-risk smokers. Ultimately, this study aims to validate molecular as well as clinical and imaging biomarkers of lung cancer in individuals with indeterminate lung nodules.
ID: NCT04165564
Sponsor: Boston University
Locations: 3 VA medical centers (VA Greater LA Healthcare System, VA Boston Healthcare System, and VA Tennessee Valley Healthcare System), 3 military treatment facilities (Naval Medical Center San Diego, Walter Reed National Military Medical Center, and Naval Medical Center Portsmouth) and 12 academic hospitals
DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer (DECAMP-2)
The goal of this project is to improve lung cancer screening in high-risk individuals by identifying biomarkers of preclinical disease and disease risk that are measured in minimally invasive and noninvasive biospecimens. Existing biomarkers for lung cancer diagnosis as well as new biomarkers discovered specifically in this clinical setting will be examined. Biomarkers that identify individuals at highest risk for being diagnosed with lung cancer prior to the appearance of concerning symptoms could increase the utility of lung cancer surveillance and the efficiency of lung cancer chemoprevention clinical trials. Achieving these goals would improve the detection and treatment of early-stage and incipient lung cancer, while restricting the risk of these procedures to those individuals who currently exhibit the early molecular warning signs of impending disease.
ID: NCT02504697
Sponsor: Boston University
Locations: VA medical centers (including Los Angeles VA Healthcare System, Boston VA Research Institute, Inc, Philadelphia VA Medical Center, Veterans Research Foundation of Pittsburgh, and VA North Texas Health Care System), 4 military treatment facilities (Naval Medical Center San Diego, Walter Reed National Military Medical Center, San Antonio Military Medical Center, and Naval Medical Center Portsmouth), and 4 academic hospitals
Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool (iDECIDE)
This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.
ID: NCT05407168
Sponsor: Oregon Health & Science University Knight Cancer Institute
Locations: Portland VA Medical Center and Oregon Health & Science University Knight Cancer Institute
VA Lung Cancer Surgery or Stereotactic Radiotherapy (VALOR)
The standard of care for stage I non–small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggest that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of 2 incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that demonstrate the outcomes with surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these 2 treatments in a prospective randomized fashion with a goal to compare the overall survival beyond 5 years. It has been designed to enroll patients who have a long life expectancy and are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node sampling.
This study is designed to open at VA medical centers with expertise in both treatments. The recruitment process includes shared decision making and multidisciplinary evaluations with lung cancer specialists. Mandatory evaluations before randomization include tissue confirmation of NSCLC, staging with FDG-PET/CT, and biopsies of all hilar and/or mediastinal lymph nodes > 10 mm that have a SUV > 2.5. Prerandomization elective lymph node sampling is strongly encouraged, but not required. Following treatment, patients will be followed for a minimum of 5 years.
ID: NCT02984761
Sponsor: VA Office of Research and Development
Locations: 17 VA medical centers, including VA Long Beach Healthcare System, VA Greater Los Angeles Healthcare System, Bay Pines VA Healthcare System, Miami VA Healthcare System, Edward Hines Jr. VA Hospital, Richard L. Roudebush VA Medical Center, Baltimore VA Medical Center, VA Boston Healthcare System Jamaica Plain Campus, VA Ann Arbor Healthcare System, Minneapolis VA Health Care System, Durham VA Medical Center, Louis Stokes VA Medical Center, Corporal Micheal J. Crescenz VA Medical Center, VA Pittsburgh Healthcare System University Drive Division, Michael E. DeBakey VA Medical Center, Hunter Holmes McGuire VA Medical Center, and Clement J. Zablocki VA Medical Center
Utility of CAML as Diagnostic for Early Stage Lung Cancer
The primary objective of this study is to determine the prevalence of cancer associated macrophage-like cells (CAMLS) in patients with pulmonary nodules. Secondary objectives include the following: determine the positive and negative predictive value of CAMLS in patients with pulmonary nodules who undergo biopsy; model combinations of clinical factors with the presence/absence of CAMLS to refine strategies for assessment of patients with pulmonary nodules; and evaluate whether these measures result in enhanced T-cell activity and/or natural killer cell function and number.
ID: NCT03992183
Sponsor; Collaborators: Fox Chase Cancer Center; US Department of Defense
Locations: Corporal Michael J. Crescenz VA Medical Center and Fox Chase Cancer Center
PROSPECT - Profiling of Resistance Patterns & Oncogenic Signaling Pathways in Evaluation of Cancers of the Thorax and Therapeutic Target Identification
This study will use therapeutic target-focused (TTF) profiling, genome-wide mRNA profiling, and assessments of tumor phosphopeptides and DNA that are shed into the bloodstream to define how various molecular factors alone and in combination relate to resistance to therapy, to prognosis, and to metastatic patterns at relapse. This study will examine how the presence of factors that drive cell growth, antagonize apoptosis, or confer resistance in other ways may counter the effect of systemic therapies and/or promote rapid tumor recurrence. In this way, the investigators will identify new, previously unappreciated potential therapeutic targets while also identifying which targets are most likely to increase resistance to therapy and worsen prognosis.
ID: NCT05049837
Sponsor; Collaborators: MD Anderson Cancer Center; US Department of Defense, National Institutes of Health (NIH), and National Cancer Institute (NCI)
Location: MD Anderson Cancer Center
Tribally Engaged Approaches to Lung Screening (TEALS)
Lung cancer is the leading cause of cancer mortality among American Indians and Alaska Natives (AI/AN), and AI/AN have worse lung cancer incidence rates, survival, and death compared to the general population. Because lung cancer screening (LCS) with low-dose computed tomography (LDCT) has been shown to reduce lung cancer mortality by roughly 20%, the US Preventive Services Task Force now recommends LCS for persons aged 55 to 80 years who meet specific eligibility criteria (grade-B evidence), and subsequently the Center for Medicare and Medicaid Services (CMS) opted to cover this test. However, the uptake of LCS implementation has been slow in most health care systems, and LCS implementation among AI/AN has never been studied.
To address this knowledge, the Tribally Engaged Approaches to Lung Screening (TEALS) study, a collaborative effort between the Choctaw Nation of Oklahoma, the Stephenson Cancer Center, and the University of Oklahoma Health Sciences Center, will address the following over the course of 5 years: conduct focus groups and semistructured interviews with Choctaw Nation Health Services Authority (CNHSA) patients, clinicians, and health administrators to elucidate individual- and system-level barriers and facilitators that affect the implementation of LCS; develop an LCS care coordination intervention that will identify eligible persons for LCS, help these patients navigate the screening process, and link them with smoking cessation services, when applicable; measure the impact of the TEALS intervention on the receipt of screening and a set of patient- and practice-level outcomes by conducting a cluster-randomized clinical trial of LCS implementation; and disseminate the TEALS program to other researchers and healthcare systems that serve AI/AN patients. TEALS will bridge the gap between evidence and clinical practice for LCS in a high-need, low-resource setting by intervening at the level of the healthcare system.
System-level interventions for guideline implementation tend to be understudied compared to those evaluating individual-level, behavioral interventions. However, the careful development and evaluation of an LCS screening program at the level of the healthcare system would be critical to ensure that more patients can receive LCS. Our research will create a critically needed platform from which future studies could be launched that will examine how to tailor the application of the LCS guideline to the individual preferences of AI/AN patients. TEALS will establish an effective LCS program in a tribal system and thus provide a direct benefit to the Choctaw Nation by increasing LCS participation. TEALS will serve as a blueprint for establishing a sustainable and accessible infrastructure for LCS in AI/AN and other community health systems. By increasing screening for early stage lung cancer, TEALS could ultimately reduce lung cancer mortality in AI/AN communities.
ID: NCT04948060
Sponsor; Collaborator: University of Oklahoma; Choctaw Nation of Oklahoma
Location: University of Oklahoma Health Sciences Center
Prostate Cancer
18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer (PROSPYL)
The main purpose of this phase II trial study is to determine whether a positron emission tomography (PET)/computed tomography (CT) scan using 18F-DCFPyL affects the clinical management plan in veterans. In this study, the management plan prior to and after 18F-DCFPyL PET/CT will be recorded by specific questionnaires and corresponding changes in management will be analyzed. The scan will be used to see how the disease has spread. Both the treatment strategies and probable disease outcomes as relevant to clinical endpoints will be assessed. This study is open to veterans only.
ID: NCT04390880
Sponsor: VA Greater Los Angeles Healthcare System
Location: VA Greater Los Angeles Healthcare System
Patient Decision-Making About Precision Oncology in Veterans With Advanced Prostate Cancer
This project proposes to understand and improve veterans’ decision-making in precision oncology (germline testing, somatic tumor testing, and targeted therapy) for advanced prostate cancer. As precision oncology expands, a comprehensive strategy to support patient informed decision-making has not been developed.
ID: NCT05396872
Sponsor; Collaborator: University of California, San Francisco; US Department of Defense
Location: San Francisco VA Medical Center
Intramuscular Mechanisms of Androgen Deprivation-Related Sarcopenia
Prostate cancer is the most common cancer among men and is even more common in the military and veteran population. For patients with advanced prostate cancer, the most common treatment includes lowering the levels of the hormone testosterone as much as possible, which is called androgen deprivation therapy (ADT). Unfortunately, ADT also causes patients to be fatigued, weak, and to lose muscle. This is often referred to as sarcopenia, and it leads to falls, poor quality of life, and higher risk of death. Currently, there is no treatment for sarcopenia because investigators do not understand the mechanisms that cause it. The mitochondria is the part of the cells responsible for providing energy to muscles but to date the investigators do not know if it is affected in prostate cancer patients with sarcopenia due to ADT. The overall goal of this proposal is to establish if the mitochondria is responsible for sarcopenia in patients with prostate cancer receiving ADT. The investigators will measure mitochondrial function, muscle mass and strength, and feelings of fatigue and quality of life in patients with prostate cancer before starting and after 6 months of ADT.
ID: NCT03867357
Sponsor; Collaborator: Seattle Institute for Biomedical and Clinical Research; US Department of Defense
Location: VA Puget Sound Health Care System
VA Seamless Phase II/III Randomized Trial of Standard Systemic Therapy With or Without PET-Directed Local Therapy for OligoRecurrent Prostate Cancer (VA STARPORT)
The primary goal of this study is to determine if adding PET-directed local therapy improves disease control compared to standard systemic therapy alone (SST) in veterans with oligorecurrent prostate cancer on PET/CT. The investigators will conduct a multi-institutional phase II/III randomized trial comparing SST with or without PET-directed local therapy using radiation or surgery to all metastases and if a local recurrence is present.
ID: NCT04787744
Sponsor: VA Office of Research and Development
Locations: VA Long Beach Healthcare System, VA Greater Los Angeles Healthcare System, Bay Pines VA Healthcare System, Edward Hines Jr. VA Hospital, Richard L. Roudebush VA Medical Center, VA Boston Healthcare System Jamaica Plain Campus, VA Ann Arbor Healthcare System, Minneapolis VA Health Care System, Kansas City VA Medical Center, St. Louis VA Medical Center John Cochran Division, East Orange Campus of the VA New Jersey Health Care System, Durham VA Medical Center, Louis Stokes VA Medical Center, Michael E. DeBakey VA Medical Center, Hunter Holmes McGuire VA Medical Center, Clement J. Zablocki VA Medical Center
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. The addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
ID: NCT03678025
Sponsor; Collaborator: Southwest Oncology Group; National Cancer Institute (NCI)
Locations: 328 sites, including Tibor Rubin VA Medical Center, Atlanta VA Medical Center, James J. Peters VA Medical Center, Michael E. DeBakey VA Medical Center, and Audie L. Murphy VA Hospital
A Clinical Study Evaluating the Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant to Testosterone-Deprivation Therapy (CASPAR)
This randomized, placebo-controlled, phase III trial is evaluating the benefit of rucaparib and enzalutamide combination therapy vs enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient.
ID: NCT04455750
Sponsor; Collaborator: Alliance for Clinical Trials in Oncology; National Cancer Institute (NCI)
Locations: 413 sites
Digitally Captured Activity Data and PROs to Monitor Physical Function in Prostate Cancer Patients (DigiPRO)
Physical function is a known predictor of quality of life in advanced prostate cancer patients and key measure of treatment tolerability. While treatment with androgen deprivation therapy (ADT) improves survival, it is associated with significant toxicities that lead to physical function (PF) decline. The average age of incident prostate cancer is 66 years, and in this older group of men, chronic comorbid conditions often co-occur with diagnosis, further adding to the risk for PF decline. With over 2.9 million prostate cancer survivors in the US, there is an increasing demand for adequate symptom monitoring and PF assessment throughout cancer care. However, there are currently no validated methods to systematically evaluate and predict PF decline. Thus, the overarching objective of this proposal is to determine whether the use of wearable technology to monitor objective daily activity combined with routine symptom reporting can predict PF decline. To accomplish this, we propose a mixed-methods approach that will provide quantitative information to help identify PC survivors at higher risk for PF decline as well as a qualitative aim gain a deeper understanding of the perceived relationships that PC survivors have with their physical activity levels and treatment symptoms.
ID: NCT04575402
Sponsor; Collaborator: Cedars-Sinai Medical Center; US Department of Defense
Location: Cedars Sinai Medical Center
The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors
The purpose of this prospective, interventional, single-arm pilot study is to evaluate whether virtually delivered group-based physical activity is feasible for adolescent and young adult (AYA) cancer survivors. AYAs who were diagnosed with cancer and have completed cancer treatment will be recruited for this study. This study will enroll 20 participants in total and will last approximately 3 months.
ID: NCT05131815
Sponsor; Collaborator: Cedars-Sinai Medical Center; Walter Reed National Military Medical Center
Location: Cedars-Sinai Medical Center
Lung Cancer
DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers
The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program for lung cancer early detection. DECAMP 1 PLUS aims to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules (8-25 mm). Molecular biomarkers for lung cancer diagnosis measured in minimally invasive and noninvasive biospecimens may be able to distinguish between malignant or benign indeterminate pulmonary nodules in high-risk smokers. Ultimately, this study aims to validate molecular as well as clinical and imaging biomarkers of lung cancer in individuals with indeterminate lung nodules.
ID: NCT04165564
Sponsor: Boston University
Locations: 3 VA medical centers (VA Greater LA Healthcare System, VA Boston Healthcare System, and VA Tennessee Valley Healthcare System), 3 military treatment facilities (Naval Medical Center San Diego, Walter Reed National Military Medical Center, and Naval Medical Center Portsmouth) and 12 academic hospitals
DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer (DECAMP-2)
The goal of this project is to improve lung cancer screening in high-risk individuals by identifying biomarkers of preclinical disease and disease risk that are measured in minimally invasive and noninvasive biospecimens. Existing biomarkers for lung cancer diagnosis as well as new biomarkers discovered specifically in this clinical setting will be examined. Biomarkers that identify individuals at highest risk for being diagnosed with lung cancer prior to the appearance of concerning symptoms could increase the utility of lung cancer surveillance and the efficiency of lung cancer chemoprevention clinical trials. Achieving these goals would improve the detection and treatment of early-stage and incipient lung cancer, while restricting the risk of these procedures to those individuals who currently exhibit the early molecular warning signs of impending disease.
ID: NCT02504697
Sponsor: Boston University
Locations: VA medical centers (including Los Angeles VA Healthcare System, Boston VA Research Institute, Inc, Philadelphia VA Medical Center, Veterans Research Foundation of Pittsburgh, and VA North Texas Health Care System), 4 military treatment facilities (Naval Medical Center San Diego, Walter Reed National Military Medical Center, San Antonio Military Medical Center, and Naval Medical Center Portsmouth), and 4 academic hospitals
Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool (iDECIDE)
This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.
ID: NCT05407168
Sponsor: Oregon Health & Science University Knight Cancer Institute
Locations: Portland VA Medical Center and Oregon Health & Science University Knight Cancer Institute
VA Lung Cancer Surgery or Stereotactic Radiotherapy (VALOR)
The standard of care for stage I non–small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggest that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of 2 incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that demonstrate the outcomes with surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these 2 treatments in a prospective randomized fashion with a goal to compare the overall survival beyond 5 years. It has been designed to enroll patients who have a long life expectancy and are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node sampling.
This study is designed to open at VA medical centers with expertise in both treatments. The recruitment process includes shared decision making and multidisciplinary evaluations with lung cancer specialists. Mandatory evaluations before randomization include tissue confirmation of NSCLC, staging with FDG-PET/CT, and biopsies of all hilar and/or mediastinal lymph nodes > 10 mm that have a SUV > 2.5. Prerandomization elective lymph node sampling is strongly encouraged, but not required. Following treatment, patients will be followed for a minimum of 5 years.
ID: NCT02984761
Sponsor: VA Office of Research and Development
Locations: 17 VA medical centers, including VA Long Beach Healthcare System, VA Greater Los Angeles Healthcare System, Bay Pines VA Healthcare System, Miami VA Healthcare System, Edward Hines Jr. VA Hospital, Richard L. Roudebush VA Medical Center, Baltimore VA Medical Center, VA Boston Healthcare System Jamaica Plain Campus, VA Ann Arbor Healthcare System, Minneapolis VA Health Care System, Durham VA Medical Center, Louis Stokes VA Medical Center, Corporal Micheal J. Crescenz VA Medical Center, VA Pittsburgh Healthcare System University Drive Division, Michael E. DeBakey VA Medical Center, Hunter Holmes McGuire VA Medical Center, and Clement J. Zablocki VA Medical Center
Utility of CAML as Diagnostic for Early Stage Lung Cancer
The primary objective of this study is to determine the prevalence of cancer associated macrophage-like cells (CAMLS) in patients with pulmonary nodules. Secondary objectives include the following: determine the positive and negative predictive value of CAMLS in patients with pulmonary nodules who undergo biopsy; model combinations of clinical factors with the presence/absence of CAMLS to refine strategies for assessment of patients with pulmonary nodules; and evaluate whether these measures result in enhanced T-cell activity and/or natural killer cell function and number.
ID: NCT03992183
Sponsor; Collaborators: Fox Chase Cancer Center; US Department of Defense
Locations: Corporal Michael J. Crescenz VA Medical Center and Fox Chase Cancer Center
PROSPECT - Profiling of Resistance Patterns & Oncogenic Signaling Pathways in Evaluation of Cancers of the Thorax and Therapeutic Target Identification
This study will use therapeutic target-focused (TTF) profiling, genome-wide mRNA profiling, and assessments of tumor phosphopeptides and DNA that are shed into the bloodstream to define how various molecular factors alone and in combination relate to resistance to therapy, to prognosis, and to metastatic patterns at relapse. This study will examine how the presence of factors that drive cell growth, antagonize apoptosis, or confer resistance in other ways may counter the effect of systemic therapies and/or promote rapid tumor recurrence. In this way, the investigators will identify new, previously unappreciated potential therapeutic targets while also identifying which targets are most likely to increase resistance to therapy and worsen prognosis.
ID: NCT05049837
Sponsor; Collaborators: MD Anderson Cancer Center; US Department of Defense, National Institutes of Health (NIH), and National Cancer Institute (NCI)
Location: MD Anderson Cancer Center
Tribally Engaged Approaches to Lung Screening (TEALS)
Lung cancer is the leading cause of cancer mortality among American Indians and Alaska Natives (AI/AN), and AI/AN have worse lung cancer incidence rates, survival, and death compared to the general population. Because lung cancer screening (LCS) with low-dose computed tomography (LDCT) has been shown to reduce lung cancer mortality by roughly 20%, the US Preventive Services Task Force now recommends LCS for persons aged 55 to 80 years who meet specific eligibility criteria (grade-B evidence), and subsequently the Center for Medicare and Medicaid Services (CMS) opted to cover this test. However, the uptake of LCS implementation has been slow in most health care systems, and LCS implementation among AI/AN has never been studied.
To address this knowledge, the Tribally Engaged Approaches to Lung Screening (TEALS) study, a collaborative effort between the Choctaw Nation of Oklahoma, the Stephenson Cancer Center, and the University of Oklahoma Health Sciences Center, will address the following over the course of 5 years: conduct focus groups and semistructured interviews with Choctaw Nation Health Services Authority (CNHSA) patients, clinicians, and health administrators to elucidate individual- and system-level barriers and facilitators that affect the implementation of LCS; develop an LCS care coordination intervention that will identify eligible persons for LCS, help these patients navigate the screening process, and link them with smoking cessation services, when applicable; measure the impact of the TEALS intervention on the receipt of screening and a set of patient- and practice-level outcomes by conducting a cluster-randomized clinical trial of LCS implementation; and disseminate the TEALS program to other researchers and healthcare systems that serve AI/AN patients. TEALS will bridge the gap between evidence and clinical practice for LCS in a high-need, low-resource setting by intervening at the level of the healthcare system.
System-level interventions for guideline implementation tend to be understudied compared to those evaluating individual-level, behavioral interventions. However, the careful development and evaluation of an LCS screening program at the level of the healthcare system would be critical to ensure that more patients can receive LCS. Our research will create a critically needed platform from which future studies could be launched that will examine how to tailor the application of the LCS guideline to the individual preferences of AI/AN patients. TEALS will establish an effective LCS program in a tribal system and thus provide a direct benefit to the Choctaw Nation by increasing LCS participation. TEALS will serve as a blueprint for establishing a sustainable and accessible infrastructure for LCS in AI/AN and other community health systems. By increasing screening for early stage lung cancer, TEALS could ultimately reduce lung cancer mortality in AI/AN communities.
ID: NCT04948060
Sponsor; Collaborator: University of Oklahoma; Choctaw Nation of Oklahoma
Location: University of Oklahoma Health Sciences Center
Prostate Cancer
18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer (PROSPYL)
The main purpose of this phase II trial study is to determine whether a positron emission tomography (PET)/computed tomography (CT) scan using 18F-DCFPyL affects the clinical management plan in veterans. In this study, the management plan prior to and after 18F-DCFPyL PET/CT will be recorded by specific questionnaires and corresponding changes in management will be analyzed. The scan will be used to see how the disease has spread. Both the treatment strategies and probable disease outcomes as relevant to clinical endpoints will be assessed. This study is open to veterans only.
ID: NCT04390880
Sponsor: VA Greater Los Angeles Healthcare System
Location: VA Greater Los Angeles Healthcare System
Patient Decision-Making About Precision Oncology in Veterans With Advanced Prostate Cancer
This project proposes to understand and improve veterans’ decision-making in precision oncology (germline testing, somatic tumor testing, and targeted therapy) for advanced prostate cancer. As precision oncology expands, a comprehensive strategy to support patient informed decision-making has not been developed.
ID: NCT05396872
Sponsor; Collaborator: University of California, San Francisco; US Department of Defense
Location: San Francisco VA Medical Center
Intramuscular Mechanisms of Androgen Deprivation-Related Sarcopenia
Prostate cancer is the most common cancer among men and is even more common in the military and veteran population. For patients with advanced prostate cancer, the most common treatment includes lowering the levels of the hormone testosterone as much as possible, which is called androgen deprivation therapy (ADT). Unfortunately, ADT also causes patients to be fatigued, weak, and to lose muscle. This is often referred to as sarcopenia, and it leads to falls, poor quality of life, and higher risk of death. Currently, there is no treatment for sarcopenia because investigators do not understand the mechanisms that cause it. The mitochondria is the part of the cells responsible for providing energy to muscles but to date the investigators do not know if it is affected in prostate cancer patients with sarcopenia due to ADT. The overall goal of this proposal is to establish if the mitochondria is responsible for sarcopenia in patients with prostate cancer receiving ADT. The investigators will measure mitochondrial function, muscle mass and strength, and feelings of fatigue and quality of life in patients with prostate cancer before starting and after 6 months of ADT.
ID: NCT03867357
Sponsor; Collaborator: Seattle Institute for Biomedical and Clinical Research; US Department of Defense
Location: VA Puget Sound Health Care System
VA Seamless Phase II/III Randomized Trial of Standard Systemic Therapy With or Without PET-Directed Local Therapy for OligoRecurrent Prostate Cancer (VA STARPORT)
The primary goal of this study is to determine if adding PET-directed local therapy improves disease control compared to standard systemic therapy alone (SST) in veterans with oligorecurrent prostate cancer on PET/CT. The investigators will conduct a multi-institutional phase II/III randomized trial comparing SST with or without PET-directed local therapy using radiation or surgery to all metastases and if a local recurrence is present.
ID: NCT04787744
Sponsor: VA Office of Research and Development
Locations: VA Long Beach Healthcare System, VA Greater Los Angeles Healthcare System, Bay Pines VA Healthcare System, Edward Hines Jr. VA Hospital, Richard L. Roudebush VA Medical Center, VA Boston Healthcare System Jamaica Plain Campus, VA Ann Arbor Healthcare System, Minneapolis VA Health Care System, Kansas City VA Medical Center, St. Louis VA Medical Center John Cochran Division, East Orange Campus of the VA New Jersey Health Care System, Durham VA Medical Center, Louis Stokes VA Medical Center, Michael E. DeBakey VA Medical Center, Hunter Holmes McGuire VA Medical Center, Clement J. Zablocki VA Medical Center
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. The addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
ID: NCT03678025
Sponsor; Collaborator: Southwest Oncology Group; National Cancer Institute (NCI)
Locations: 328 sites, including Tibor Rubin VA Medical Center, Atlanta VA Medical Center, James J. Peters VA Medical Center, Michael E. DeBakey VA Medical Center, and Audie L. Murphy VA Hospital
A Clinical Study Evaluating the Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant to Testosterone-Deprivation Therapy (CASPAR)
This randomized, placebo-controlled, phase III trial is evaluating the benefit of rucaparib and enzalutamide combination therapy vs enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient.
ID: NCT04455750
Sponsor; Collaborator: Alliance for Clinical Trials in Oncology; National Cancer Institute (NCI)
Locations: 413 sites
Digitally Captured Activity Data and PROs to Monitor Physical Function in Prostate Cancer Patients (DigiPRO)
Physical function is a known predictor of quality of life in advanced prostate cancer patients and key measure of treatment tolerability. While treatment with androgen deprivation therapy (ADT) improves survival, it is associated with significant toxicities that lead to physical function (PF) decline. The average age of incident prostate cancer is 66 years, and in this older group of men, chronic comorbid conditions often co-occur with diagnosis, further adding to the risk for PF decline. With over 2.9 million prostate cancer survivors in the US, there is an increasing demand for adequate symptom monitoring and PF assessment throughout cancer care. However, there are currently no validated methods to systematically evaluate and predict PF decline. Thus, the overarching objective of this proposal is to determine whether the use of wearable technology to monitor objective daily activity combined with routine symptom reporting can predict PF decline. To accomplish this, we propose a mixed-methods approach that will provide quantitative information to help identify PC survivors at higher risk for PF decline as well as a qualitative aim gain a deeper understanding of the perceived relationships that PC survivors have with their physical activity levels and treatment symptoms.
ID: NCT04575402
Sponsor; Collaborator: Cedars-Sinai Medical Center; US Department of Defense
Location: Cedars Sinai Medical Center
The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors
The purpose of this prospective, interventional, single-arm pilot study is to evaluate whether virtually delivered group-based physical activity is feasible for adolescent and young adult (AYA) cancer survivors. AYAs who were diagnosed with cancer and have completed cancer treatment will be recruited for this study. This study will enroll 20 participants in total and will last approximately 3 months.
ID: NCT05131815
Sponsor; Collaborator: Cedars-Sinai Medical Center; Walter Reed National Military Medical Center
Location: Cedars-Sinai Medical Center
Lung Cancer
DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers
The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program for lung cancer early detection. DECAMP 1 PLUS aims to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules (8-25 mm). Molecular biomarkers for lung cancer diagnosis measured in minimally invasive and noninvasive biospecimens may be able to distinguish between malignant or benign indeterminate pulmonary nodules in high-risk smokers. Ultimately, this study aims to validate molecular as well as clinical and imaging biomarkers of lung cancer in individuals with indeterminate lung nodules.
ID: NCT04165564
Sponsor: Boston University
Locations: 3 VA medical centers (VA Greater LA Healthcare System, VA Boston Healthcare System, and VA Tennessee Valley Healthcare System), 3 military treatment facilities (Naval Medical Center San Diego, Walter Reed National Military Medical Center, and Naval Medical Center Portsmouth) and 12 academic hospitals
DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer (DECAMP-2)
The goal of this project is to improve lung cancer screening in high-risk individuals by identifying biomarkers of preclinical disease and disease risk that are measured in minimally invasive and noninvasive biospecimens. Existing biomarkers for lung cancer diagnosis as well as new biomarkers discovered specifically in this clinical setting will be examined. Biomarkers that identify individuals at highest risk for being diagnosed with lung cancer prior to the appearance of concerning symptoms could increase the utility of lung cancer surveillance and the efficiency of lung cancer chemoprevention clinical trials. Achieving these goals would improve the detection and treatment of early-stage and incipient lung cancer, while restricting the risk of these procedures to those individuals who currently exhibit the early molecular warning signs of impending disease.
ID: NCT02504697
Sponsor: Boston University
Locations: VA medical centers (including Los Angeles VA Healthcare System, Boston VA Research Institute, Inc, Philadelphia VA Medical Center, Veterans Research Foundation of Pittsburgh, and VA North Texas Health Care System), 4 military treatment facilities (Naval Medical Center San Diego, Walter Reed National Military Medical Center, San Antonio Military Medical Center, and Naval Medical Center Portsmouth), and 4 academic hospitals
Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool (iDECIDE)
This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.
ID: NCT05407168
Sponsor: Oregon Health & Science University Knight Cancer Institute
Locations: Portland VA Medical Center and Oregon Health & Science University Knight Cancer Institute
VA Lung Cancer Surgery or Stereotactic Radiotherapy (VALOR)
The standard of care for stage I non–small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggest that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of 2 incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that demonstrate the outcomes with surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these 2 treatments in a prospective randomized fashion with a goal to compare the overall survival beyond 5 years. It has been designed to enroll patients who have a long life expectancy and are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node sampling.
This study is designed to open at VA medical centers with expertise in both treatments. The recruitment process includes shared decision making and multidisciplinary evaluations with lung cancer specialists. Mandatory evaluations before randomization include tissue confirmation of NSCLC, staging with FDG-PET/CT, and biopsies of all hilar and/or mediastinal lymph nodes > 10 mm that have a SUV > 2.5. Prerandomization elective lymph node sampling is strongly encouraged, but not required. Following treatment, patients will be followed for a minimum of 5 years.
ID: NCT02984761
Sponsor: VA Office of Research and Development
Locations: 17 VA medical centers, including VA Long Beach Healthcare System, VA Greater Los Angeles Healthcare System, Bay Pines VA Healthcare System, Miami VA Healthcare System, Edward Hines Jr. VA Hospital, Richard L. Roudebush VA Medical Center, Baltimore VA Medical Center, VA Boston Healthcare System Jamaica Plain Campus, VA Ann Arbor Healthcare System, Minneapolis VA Health Care System, Durham VA Medical Center, Louis Stokes VA Medical Center, Corporal Micheal J. Crescenz VA Medical Center, VA Pittsburgh Healthcare System University Drive Division, Michael E. DeBakey VA Medical Center, Hunter Holmes McGuire VA Medical Center, and Clement J. Zablocki VA Medical Center
Utility of CAML as Diagnostic for Early Stage Lung Cancer
The primary objective of this study is to determine the prevalence of cancer associated macrophage-like cells (CAMLS) in patients with pulmonary nodules. Secondary objectives include the following: determine the positive and negative predictive value of CAMLS in patients with pulmonary nodules who undergo biopsy; model combinations of clinical factors with the presence/absence of CAMLS to refine strategies for assessment of patients with pulmonary nodules; and evaluate whether these measures result in enhanced T-cell activity and/or natural killer cell function and number.
ID: NCT03992183
Sponsor; Collaborators: Fox Chase Cancer Center; US Department of Defense
Locations: Corporal Michael J. Crescenz VA Medical Center and Fox Chase Cancer Center
PROSPECT - Profiling of Resistance Patterns & Oncogenic Signaling Pathways in Evaluation of Cancers of the Thorax and Therapeutic Target Identification
This study will use therapeutic target-focused (TTF) profiling, genome-wide mRNA profiling, and assessments of tumor phosphopeptides and DNA that are shed into the bloodstream to define how various molecular factors alone and in combination relate to resistance to therapy, to prognosis, and to metastatic patterns at relapse. This study will examine how the presence of factors that drive cell growth, antagonize apoptosis, or confer resistance in other ways may counter the effect of systemic therapies and/or promote rapid tumor recurrence. In this way, the investigators will identify new, previously unappreciated potential therapeutic targets while also identifying which targets are most likely to increase resistance to therapy and worsen prognosis.
ID: NCT05049837
Sponsor; Collaborators: MD Anderson Cancer Center; US Department of Defense, National Institutes of Health (NIH), and National Cancer Institute (NCI)
Location: MD Anderson Cancer Center
Tribally Engaged Approaches to Lung Screening (TEALS)
Lung cancer is the leading cause of cancer mortality among American Indians and Alaska Natives (AI/AN), and AI/AN have worse lung cancer incidence rates, survival, and death compared to the general population. Because lung cancer screening (LCS) with low-dose computed tomography (LDCT) has been shown to reduce lung cancer mortality by roughly 20%, the US Preventive Services Task Force now recommends LCS for persons aged 55 to 80 years who meet specific eligibility criteria (grade-B evidence), and subsequently the Center for Medicare and Medicaid Services (CMS) opted to cover this test. However, the uptake of LCS implementation has been slow in most health care systems, and LCS implementation among AI/AN has never been studied.
To address this knowledge, the Tribally Engaged Approaches to Lung Screening (TEALS) study, a collaborative effort between the Choctaw Nation of Oklahoma, the Stephenson Cancer Center, and the University of Oklahoma Health Sciences Center, will address the following over the course of 5 years: conduct focus groups and semistructured interviews with Choctaw Nation Health Services Authority (CNHSA) patients, clinicians, and health administrators to elucidate individual- and system-level barriers and facilitators that affect the implementation of LCS; develop an LCS care coordination intervention that will identify eligible persons for LCS, help these patients navigate the screening process, and link them with smoking cessation services, when applicable; measure the impact of the TEALS intervention on the receipt of screening and a set of patient- and practice-level outcomes by conducting a cluster-randomized clinical trial of LCS implementation; and disseminate the TEALS program to other researchers and healthcare systems that serve AI/AN patients. TEALS will bridge the gap between evidence and clinical practice for LCS in a high-need, low-resource setting by intervening at the level of the healthcare system.
System-level interventions for guideline implementation tend to be understudied compared to those evaluating individual-level, behavioral interventions. However, the careful development and evaluation of an LCS screening program at the level of the healthcare system would be critical to ensure that more patients can receive LCS. Our research will create a critically needed platform from which future studies could be launched that will examine how to tailor the application of the LCS guideline to the individual preferences of AI/AN patients. TEALS will establish an effective LCS program in a tribal system and thus provide a direct benefit to the Choctaw Nation by increasing LCS participation. TEALS will serve as a blueprint for establishing a sustainable and accessible infrastructure for LCS in AI/AN and other community health systems. By increasing screening for early stage lung cancer, TEALS could ultimately reduce lung cancer mortality in AI/AN communities.
ID: NCT04948060
Sponsor; Collaborator: University of Oklahoma; Choctaw Nation of Oklahoma
Location: University of Oklahoma Health Sciences Center
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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0523 FED Clinical Trials</fileName> <TBEID>0C02CC93.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02CC93</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20230509T171238</firstPublished> <LastPublished>20230509T171238</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20230509T171238</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <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 main purpose of this phase II trial study is to determine whether a positron emission tomography (PET)/computed tomography (CT) scan using 18F-DCFPyL affect</metaDescription> <articlePDF/> <teaserImage/> <title>Open Clinical Trials for Patients With Cancer</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2023</pubPubdateYear> <pubPubdateMonth>May</pubPubdateMonth> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>fed</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">106</term> </sections> <topics> <term canonical="true">263</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Open Clinical Trials for Patients With Cancer</title> <deck/> </itemMeta> <itemContent> <p class="abstract"> A significant number of trials are now recruiting patients from veteran and active-duty military patient populations. Many trials explicitly recruit patients from the US Department of Veterans Affairs (VA) and Defense (DoD), as well as the Indian Health Service (IHS). The VA Office of Research and Development alone funded > 7260 research projects in 2022, and many more are sponsored by Walter Reed National Military Medical Center and other federal facilities. The clinical trials listed below are all open as of April 1, 20<hl name="1"/>23; have at least 1 federal location recruiting patients; and are focused on treatments for prostate and lung cancer. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov. </p> <p class="tabletitle"> <caps>Prostate Cancer</caps> </p> <p class="tabletitle">18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer (PROSPYL)</p> <p>The main purpose of this phase II trial study is to determine whether a positron emission tomography (PET)/computed tomography (CT) scan using 18F-DCFPyL affects the clinical management plan in veterans. In this study, the management plan prior to and after 18F-DCFPyL PET/CT will be recorded by specific questionnaires and corresponding changes in management will be analyzed. The scan will be used to see how the disease has spread. Both the treatment strategies and probable disease outcomes as relevant to clinical endpoints will be assessed. This study is open to veterans only.<b>ID:</b> NCT04390880<br/><br/><b>Sponsor:</b> VA Greater Los Angeles Healthcare System<br/><br/><b>Location:</b> VA Greater Los Angeles Healthcare System</p> <p class="tabletitle">Patient Decision-Making About Precision Oncology in Veterans With Advanced Prostate Cancer</p> <p>This project proposes to understand and improve veterans’ decision-making in precision oncology (germline testing, somatic tumor testing, and targeted therapy) for advanced prostate cancer. As precision oncology expands, a comprehensive strategy to support patient informed decision-making has not been developed.<br/><br/><b>ID:</b> NCT05396872<br/><br/><b>Sponsor; Collaborator:</b> University of California, San Francisco; US Department of Defense<br/><br/><b>Location:</b> San Francisco VA Medical Center</p> <p class="tabletitle">Intramuscular Mechanisms of Androgen Deprivation-Related Sarcopenia</p> <p>Prostate cancer is the most common cancer among men and is even more common in the military and veteran population. For patients with advanced prostate cancer, the most common treatment includes lowering the levels of the hormone testosterone as much as possible, which is called androgen deprivation therapy (ADT). Unfortunately, ADT also causes patients to be fatigued, weak, and to lose muscle. This is often referred to as sarcopenia, and it leads to falls, poor quality of life, and higher risk of death. Currently, there is no treatment for sarcopenia because investigators do not understand the mechanisms that cause it. The mitochondria is the part of the cells responsible for providing energy to muscles but to date the investigators do not know if it is affected in prostate cancer patients with sarcopenia due to ADT. The overall goal of this proposal is to establish if the mitochondria is responsible for sarcopenia in patients with prostate cancer receiving ADT. The investigators will measure mitochondrial function, muscle mass and strength, and feelings of fatigue and quality of life in patients with prostate cancer before starting and after 6 months of ADT.<b>ID:</b> NCT03867357<br/><br/><b>Sponsor; Collaborator: </b>Seattle Institute for Biomedical and Clinical Research; US Department of Defense<br/><br/><b>Location:</b> VA Puget Sound Health Care System</p> <p class="tabletitle">VA Seamless Phase II/III Randomized Trial of Standard Systemic Therapy With or Without PET-Directed Local Therapy for OligoRecurrent Prostate Cancer (VA STARPORT)</p> <p>The primary goal of this study is to determine if adding PET-directed local therapy improves disease control compared to standard systemic therapy alone (SST) in veterans with oligorecurrent prostate cancer on PET/CT. The investigators will conduct a multi-institutional phase II/III randomized trial comparing SST with or without PET-directed local therapy using radiation or surgery to all metastases and if a local recurrence is present.<br/><br/><b>ID:</b> NCT04787744<br/><br/><b>Sponsor:</b> VA Office of Research and Development<br/><br/><b>Locations:</b> VA Long Beach Healthcare System, VA Greater Los Angeles Healthcare System, Bay Pines VA Healthcare System, Edward Hines Jr. VA Hospital, Richard L. Roudebush VA Medical Center, VA Boston Healthcare System Jamaica Plain Campus, VA Ann Arbor Healthcare System, Minneapolis VA Health Care System, Kansas City VA Medical Center, St. Louis VA Medical Center John Cochran Division, East Orange Campus of the VA New Jersey Health Care System, Durham VA Medical Center, Louis Stokes VA Medical Center, Michael E. DeBakey VA Medical Center, Hunter Holmes McGuire VA Medical Center, Clement J. Zablocki VA Medical Center</p> <p class="tabletitle">Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer</p> <p>This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. The addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.<b>ID:</b> NCT03678025<br/><br/><b>Sponsor; Collaborator:</b> Southwest Oncology Group; National Cancer Institute (NCI)<br/><br/><b>Locations:</b> 328 sites, including Tibor Rubin VA Medical Center, Atlanta VA Medical Center, James J. Peters VA Medical Center, Michael E. DeBakey VA Medical Center, and Audie L. Murphy VA Hospital</p> <p class="tabletitle">A Clinical Study Evaluating the Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant to Testosterone-Deprivation Therapy (CASPAR)</p> <p>This randomized, placebo-controlled, phase III trial is evaluating the benefit of rucaparib and enzalutamide combination therapy vs enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient.<br/><br/><b>ID:</b> NCT04455750<br/><br/><b>Sponsor; Collaborator:</b> Alliance for Clinical Trials in Oncology; National Cancer Institute (NCI)<br/><br/><b>Locations:</b> 413 sites</p> <p class="tabletitle">Digitally Captured Activity Data and PROs to Monitor Physical Function in Prostate Cancer Patients (DigiPRO)</p> <p>Physical function is a known predictor of quality of life in advanced prostate cancer patients and key measure of treatment tolerability. While treatment with androgen deprivation therapy (ADT) improves survival, it is associated with significant toxicities that lead to physical function (PF) decline. The average age of incident prostate cancer is 66 years, and in this older group of men, chronic comorbid conditions often co-occur with diagnosis, further adding to the risk for PF decline. With over 2.9 million prostate cancer survivors in the US, there is an increasing demand for adequate symptom monitoring and PF assessment throughout cancer care. However, there are currently no validated methods to systematically evaluate and predict PF decline. Thus, the overarching objective of this proposal is to determine whether the use of wearable technology to monitor objective daily activity combined with routine symptom reporting can predict PF decline. To accomplish this, we propose a mixed-methods approach that will provide quantitative information to help identify PC survivors at higher risk for PF decline as well as a qualitative aim gain a deeper understanding of the perceived relationships that PC survivors have with their physical activity levels and treatment symptoms.<b>ID:</b> NCT04575402<br/><br/><b>Sponsor; Collaborator:</b> Cedars-Sinai Medical Center; US Department of Defense<br/><br/><b>Location:</b> Cedars Sinai Medical Center</p> <p class="tabletitle">The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors</p> <p>The purpose of this prospective, interventional, single-arm pilot study is to evaluate whether virtually delivered group-based physical activity is feasible for adolescent and young adult (AYA) cancer survivors. AYAs who were diagnosed with cancer and have completed cancer treatment will be recruited for this study. This study will enroll 20 participants in total and will last approximately 3 months.<br/><br/><b>ID:</b> NCT05131815<br/><br/><b>Sponsor; Collaborator:</b> Cedars-Sinai Medical Center; Walter Reed National Military Medical Center<br/><br/><b>Location:</b> Cedars-Sinai Medical Center<br/><br/><br/><br/></p> <p class="tabletitle"> <caps>Lung Cancer</caps> </p> <p class="tabletitle">DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers</p> <p>The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program for lung cancer early detection. DECAMP 1 PLUS aims to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules (8-25 mm). Molecular biomarkers for lung cancer diagnosis measured in minimally invasive and noninvasive biospecimens may be able to distinguish between malignant or benign indeterminate pulmonary nodules in high-risk smokers. Ultimately, this study aims to validate molecular as well as clinical and imaging biomarkers of lung cancer in individuals with indeterminate lung nodules.<br/><br/><b>ID:</b> NCT04165564<br/><br/><b>Sponsor:</b> Boston University<br/><br/><b>Locations:</b> 3 VA medical centers (VA Greater LA Healthcare System, VA Boston Healthcare System, and VA Tennessee Valley Healthcare System), 3 military treatment facilities (Naval Medical Center San Diego, Walter Reed National Military Medical Center, and Naval Medical Center Portsmouth) and 12 academic hospitals</p> <p class="tabletitle">DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer (DECAMP-2)</p> <p>The goal of this project is to improve lung cancer screening in high-risk individuals by identifying biomarkers of preclinical disease and disease risk that are measured in minimally invasive and noninvasive biospecimens. Existing biomarkers for lung cancer diagnosis as well as new biomarkers discovered specifically in this clinical setting will be examined. Biomarkers that identify individuals at highest risk for being diagnosed with lung cancer prior to the appearance of concerning symptoms could increase the utility of lung cancer surveillance and the efficiency of lung cancer chemoprevention clinical trials. Achieving these goals would improve the detection and treatment of early-stage and incipient lung cancer, while restricting the risk of these procedures to those individuals who currently exhibit the early molecular warning signs of impending disease.<br/><br/><b>ID:</b> NCT02504697<br/><br/><b>Sponsor:</b> Boston University<br/><br/><b>Locations:</b> VA medical centers (including Los Angeles VA Healthcare System, Boston VA Research Institute, Inc, Philadelphia VA Medical Center, Veterans Research Foundation of Pittsburgh, and VA North Texas Health Care System), 4 military treatment facilities (Naval Medical Center San Diego, Walter Reed National Military Medical Center, San Antonio Military Medical Center, and Naval Medical Center Portsmouth), and 4 academic hospitals</p> <p class="tabletitle">Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool (iDECIDE)</p> <p>This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.<b>ID:</b> NCT05407168<br/><br/><b>Sponsor:</b> Oregon Health & Science University Knight Cancer Institute<br/><br/><b>Locations:</b> Portland VA Medical Center and Oregon Health & Science University Knight Cancer Institute</p> <p class="tabletitle">VA Lung Cancer Surgery or Stereotactic Radiotherapy (VALOR)</p> <p>The standard of care for stage I non–small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggest that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of 2 incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that demonstrate the outcomes with surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these 2 treatments in a prospective randomized fashion with a goal to compare the overall survival beyond 5 years. It has been designed to enroll patients who have a long life expectancy and are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node sampling.</p> <p>This study is designed to open at VA medical centers with expertise in both treatments. The recruitment process includes shared decision making and multidisciplinary evaluations with lung cancer specialists. Mandatory evaluations before randomization include tissue confirmation of NSCLC, staging with FDG-PET/CT, and biopsies of all hilar and/or mediastinal lymph nodes > 10 mm that have a SUV > 2.5. Prerandomization elective lymph node sampling is strongly encouraged, but not required. Following treatment, patients will be followed for a minimum of 5 years.</p> <p><b>ID:</b> NCT02984761<br/><br/><b>Sponsor:</b> VA Office of Research and Development<br/><br/><b>Locations: </b>17 VA medical centers, including VA Long Beach Healthcare System, VA Greater Los Angeles Healthcare System, Bay Pines VA Healthcare System, Miami VA Healthcare System, Edward Hines Jr. VA Hospital, Richard L. Roudebush VA Medical Center, Baltimore VA Medical Center, VA Boston Healthcare System Jamaica Plain Campus, VA Ann Arbor Healthcare System, Minneapolis VA Health Care System, Durham VA Medical Center, Louis Stokes VA Medical Center, Corporal Micheal J. Crescenz VA Medical Center, VA Pittsburgh Healthcare System University Drive Division, Michael E. DeBakey VA Medical Center, Hunter Holmes McGuire VA Medical Center, and Clement J. Zablocki VA Medical Center</p> <p class="tabletitle">Utility of CAML as Diagnostic for Early Stage Lung Cancer</p> <p>The primary objective of this study is to determine the prevalence of cancer associated macrophage-like cells (CAMLS) in patients with pulmonary nodules. Secondary objectives include the following: determine the positive and negative predictive value of CAMLS in patients with pulmonary nodules who undergo biopsy; model combinations of clinical factors with the presence/absence of CAMLS to refine strategies for assessment of patients with pulmonary nodules; and evaluate whether these measures result in enhanced T-cell activity and/or natural killer cell function and number.<br/><br/><b>ID:</b> NCT03992183<br/><br/><b>Sponsor; Collaborators:</b> Fox Chase Cancer Center; US Department of Defense<br/><br/><b>Locations:</b> Corporal Michael J. Crescenz VA Medical Center and Fox Chase Cancer Center</p> <p class="tabletitle">PROSPECT - Profiling of Resistance Patterns & Oncogenic Signaling Pathways in Evaluation of Cancers of the Thorax and Therapeutic Target Identification</p> <p>This study will use therapeutic target-focused (TTF) profiling, genome-wide mRNA profiling, and assessments of tumor phosphopeptides and DNA that are shed into the bloodstream to define how various molecular factors alone and in combination relate to resistance to therapy, to prognosis, and to metastatic patterns at relapse. This study will examine how the presence of factors that drive cell growth, antagonize apoptosis, or confer resistance in other ways may counter the effect of systemic therapies and/or promote rapid tumor recurrence. In this way, the investigators will identify new, previously unappreciated potential therapeutic targets while also identifying which targets are most likely to increase resistance to therapy and worsen prognosis.<b>ID:</b> NCT05049837<br/><br/><b>Sponsor; Collaborators:</b> MD Anderson Cancer Center; US Department of Defense, National Institutes of Health (NIH), and National Cancer Institute (NCI)<br/><br/><b>Location:</b> MD Anderson Cancer Center</p> <p class="tabletitle">Tribally Engaged Approaches to Lung Screening (TEALS) </p> <p>Lung cancer is the leading cause of cancer mortality among American Indians and Alaska Natives (AI/AN), and AI/AN have worse lung cancer incidence rates, survival, and death compared to the general population. Because lung cancer screening (LCS) with low-dose computed tomography (LDCT) has been shown to reduce lung cancer mortality by roughly 20%, the US Preventive Services Task Force now recommends LCS for persons aged 55 to 80 years who meet specific eligibility criteria (grade-B evidence), and subsequently the Center for Medicare and Medicaid Services (CMS) opted to cover this test. However, the uptake of LCS implementation has been slow in most health care systems, and LCS implementation among AI/AN has never been studied.</p> <p>To address this knowledge, the Tribally Engaged Approaches to Lung Screening (TEALS) study, a collaborative effort between the Choctaw Nation of Oklahoma, the Stephenson Cancer Center, and the University of Oklahoma Health Sciences Center, will address the following over the course of 5 years: conduct focus groups and semistructured interviews with Choctaw Nation Health Services Authority (CNHSA) patients, clinicians, and health administrators to elucidate individual- and system-level barriers and facilitators that affect the implementation of LCS; develop an LCS care coordination intervention that will identify eligible persons for LCS, help these patients navigate the screening process, and link them with smoking cessation services, when applicable; measure the impact of the TEALS intervention on the receipt of screening and a set of patient- and practice-level outcomes by conducting a cluster-randomized clinical trial of LCS implementation; and disseminate the TEALS program to other researchers and healthcare systems that serve AI/AN patients. TEALS will bridge the gap between evidence and clinical practice for LCS in a high-need, low-resource setting by intervening at the level of the healthcare system.<br/><br/>System-level interventions for guideline implementation tend to be understudied compared to those evaluating individual-level, behavioral interventions. However, the careful development and evaluation of an LCS screening program at the level of the healthcare system would be critical to ensure that more patients can receive LCS. Our research will create a critically needed platform from which future studies could be launched that will examine how to tailor the application of the LCS guideline to the individual preferences of AI/AN patients. TEALS will establish an effective LCS program in a tribal system and thus provide a direct benefit to the Choctaw Nation by increasing LCS participation. TEALS will serve as a blueprint for establishing a sustainable and accessible infrastructure for LCS in AI/AN and other community health systems. By increasing screening for early stage lung cancer, TEALS could ultimately reduce lung cancer mortality in AI/AN communities.</p> <p><b>ID:</b> NCT04948060<br/><br/><b>Sponsor; Collaborator:</b> University of Oklahoma; Choctaw Nation of Oklahoma <br/><br/><b>Location:</b> University of Oklahoma Health Sciences Center</p> </itemContent> </newsItem> </itemSet></root>
A Novel Text Message Protocol to Improve Bowel Preparation for Outpatient Colonoscopies in Veterans
Colorectal cancer is the third leading cause of cancer-related death in both men and women.1 Colonoscopy is the current gold standard for screening due to the ability to remove precancerous lesions but remains highly dependent on the quality of bowel preparation.2 Poor bowel preparation has been associated with impaired adenoma detection as well as increased health care utilization due to the need for a repeat colonoscopy.3
Multiple patient factors are associated with increased risk of poor bowel preparation, including age > 60 years, male sex, diabetes mellitus, and presence of a mental health diagnosis, factors that are prevalent among the veteran population.3-5 Text messages have been shown to improve the quality of bowel preparation by increasing patients' understanding and adherence with the preparation process. Improved adherence with bowel preparation directions is associated with a cleaner colon prior to colonoscopy, leading to a thorough examination. Studies using text messaging instructions prior to colonoscopies have also shown measurable improvement in adenoma detection rate, patient preparation-associated discomfort, and completion of colonoscopy.6-10
In 2016, the Veterans Health Administration (VHA) introduced Annie, one of the first automated text messaging services, named after Army Lieutenant Annie Fox, the first woman to receive the Purple Heart for combat. The Annie platform allows for notifications, instructions, and simple data collection. The development of this platform allows VHA practitioners to engage and educate veterans in a similar way to other health care systems using text messaging protocols. Annie text messages have been piloted for the use of hepatitis C treatment, demonstrating promise of improved medication adherence and patient satisfaction.11 We aimed to develop and pilot the Annie bowel preparation protocol to improve the quality of colonoscopy bowel preparation for outpatients at the Minneapolis Veterans Affairs Medical Center (MVAMC) in Minnesota. A secondary goal included measuring patient satisfaction with the text messaging instructions for outpatient colonoscopy preparation.
Methods
We conducted a single center, prospective, endoscopist-blinded, study with two 3-month long Plan-Do-Study-Act (PDSA) cycles to improve the text messaging bowel preparation protocol at MVAMC between January 2019 and April 2020. The MVAMC Institutional Review Board determined the quality improvement project was exempt. Veterans who had outpatient colonoscopies scheduled were included. Veterans undergoing inpatient colonoscopies or outpatients who could not be reached to obtain informed consent, lacked text message capability, declined participation, or required extended colonoscopy preparation were excluded. Per MVAMC procedures, extended colonoscopy preparation was provided to patients receiving general or monitored anesthesia care, with a history of poor bowel preparation, or with risk factors for poor preparation as determined by the ordering health care professional (HCP). Standard bowel preparation involves ingestion of 4 L of polyethylene glycol 3350 with electrolytes; extended bowel preparation requires ingestion of an additional 2 L to total 6 L and uses a different set of instructions. Additionally, the patient population requiring extended bowel preparation also includes patients with spinal cord injuries, who often are admitted for assistance with extended preparation. Patients who consented to receiving text messages were placed in the Annie intervention group, and all others were placed in the control group.
The control group received standardized patient education, including a mailed copy of bowel preparation instructions and a phone call from a gastroenterology service nurse about 1 to 2 weeks before the procedure. Current MVAMC standard of care involves a phone call from a nurse to confirm that patients have received the polyethylene glycol preparation solution, the mailed instructions, have an escort and transportation, and to answer any questions. Both the usual care and intervention group received the phone call. During this call, the Annie text messaging bowel preparation protocol was introduced; if the veteran chose to participate, consent and enrollment were completed. 
On the day of the colonoscopy, veterans in the intervention group were surveyed in the waiting room about their experience receiving the text messages and soliciting feedback for improvement or surveyed via telephone call within 3 days of their procedure. Patient satisfaction was quantified with a scale from 1 (low) to 10 (high), including questions about how helpful the texts were in relation to total number, timing, and content of messages as well as whether veterans would like to receive the text messages again for future procedures.
We reviewed individual charts and collected Boston Bowel Preparation Scale (BBPS) scores to determine adequate preparation. BBPS assigns a score of 0 to 3 for the right, transverse, and left colon applied upon withdrawal after flushing and suctioning have been completed.12 Adequate preparation is considered a total score of ≥ 6 with no segment scoring < 2. This method of preparation assessment is preferred due to its ability to account for difference in preparation quality among colonic segments, well-defined scoring characteristics, and several studies validating its use showing inter- and intraobserver reliability.12 Follow-up studies have shown validity of the BBPS when compared with relevant outcomes such as polyp detection rate and recommended timing for repeat procedure.13 Variables associated with poor bowel preparation (ie, gender, prior abdominal surgery, impaired mobility, high body mass index, diabetes mellitus, stroke, dementia, any neurologic diagnosis, cirrhosis, smoking, polypharmacy [> 8 active medications], and narcotic or tricyclic antidepressant medication use) were also collected through chart review.3-5 We note that immobility was defined by International Classification of Diseases (ICD)-9 and ICD-10 codes and prescriptions for assistive devices (ie, canes, wheelchairs, 4-wheeled walkers).
Veterans assent to be enrolled in Annie. After enrollment, veterans must text back a specific word response to an initial text message to receive the protocolized messages from the Annie program. A contact phone number to the gastrointestinal nurse line was provided for questions during business hours. The start date for the text message protocol is 6 days prior to the procedure date. If a patient rescheduled their colonoscopy, the Annie database was updated manually.
Statistical Analysis
We used both Pearson χ2 test and 2-sample t test analyses to compare demographic information and patient satisfaction scores between the control and intervention groups. We compared continuous BBPS scores between Annie intervention vs control group using parametric and nonparametric independent t tests using the Mann-Whitney U test. We repeated this analysis controlling for both mental health diagnoses and age using linear regression. We were unable to survey 61 of the 187 veterans who received Annie text messages.
RESULTS
During PDSA cycles 1 and 2, 640 veterans were scheduled for outpatient colonoscopy: 453 veterans were in the control group; 187 veterans were in the intervention group, of which 126 were surveyed. A significant percentage of veterans declined participation because they felt like they did not need reinforced education; others were not eligible for Annie due to requirement for extended bowel preparation, cancelled colonoscopy, inability to physically read text messages, or lack of cell phone.
The mean (SD) age was 65 (8) years; 184 (28.8%) had a diabetes mellitus diagnosis, and the mean (SD) body mass index was 31.6 (6.4). The Annie group was slightly more likely to have mental health diagnoses and lower age compared with the control group (Table 1).
Patient Feedback
We collected feedback from veterans after each PDSA cycle to identify areas for improvement by both in-person and telephone surveys. Based on feedback from PDSA cycle 1, we decreased the total number of text messages to create a more succinct set of instructions. The most frequently requested change involved timing the text messages to align with the exact morning a specific instruction should take place.
Patient satisfaction with the Annie text messaging service was high. 
DISCUSSION
To our knowledge, this is the first report of using Annie at a VAMC for colonoscopy bowel preparation improvement. We found a statistically significant improvement in the average BBPS in those receiving Annie text messages compared with the routine care control group. We also found high levels of patient satisfaction with most patients requesting to receive them again for future procedures.
The clinical significance of a BBPS of 7.8 vs 8.2 is unclear, although any score > 6 is considered to be adequate. However, subjectively speaking, the higher the BBPS the cleaner the colon, and theoretically the easier it is to see small or flat polyps. Future steps could include calculating adenoma detection rates for those enrolled in the Annie program vs the control group.
We have received inquiries regarding potential program implementation at other facilities. Success and sustainability of the program will require long-term commitment and ideally protected time for staff. It is helpful to remember that for each person who chooses to enroll in the intervention, the program currently requires that a brief consent note is placed in the patient’s chart. Thus, depending on the facilities’ resources, it is ideal for one staff member to be the designated lead to help oversee, troubleshoot, and train additional personnel. Surveys can be intermittently used to obtain feedback for improvement but are not required for sustainability. Automated text messaging is a promising addition to medicine for clinical education and communication. Future studies should examine the clinical significance (ie, adenoma detection rates) of text messaging bowel preparation protocols.
Limitations
Our study has several limitations. First, this was a single center study, thus generalizability is limited. MVAMC represents a predominantly White, male, and rural population. Second, data are likely an underestimation of the true impact of intervention, because results do not account for patients who were turned away on day of procedure (typically still reporting brown stools at time of check-in for procedure) due to poor preparation or aborted procedures secondary to poor preparation. Only about one-third of the 640 veterans opted to receive Annie text messages.
Studies have shown veterans are willing to use technology for health care; however, access to technology and lack of training remain barriers to use.14 This has been most robustly studied at the VA in veterans experiencing mental illness and homelessness. Targeted strategies to improve veteran adoption of technology within their health care include supplying veterans with cell phones and paid data plans and providing training on specific technology-based resources.15-17 Future improvement for the Annie platform should include improved integration with CPRS. Integration will facilitate automatic import of key information such as mobile phone number or colonoscopy procedure date. Unfortunately, this is not currently an automated process, and the manual workload of staff limits sustainability. Since our study ended, the Annie database now allows an “event date” to be programmed in to center the text message series around. This will be entered at the time of Annie enrollment and eliminate manual activation of the protocol. The issue of updating information for rescheduled procedures remains.
Conclusions
There is increasing evidence that automated text messaging is a promising addition to medicine for clinical education and communication. It continues to gain traction as a readily available and acceptable option, and many patients are willing to incorporate the technology platform into their care plan. We found high patient satisfaction with our protocol, and Annie patients had cleaner bowel preparations compared with control patients. Our study supports the use of text message reminders as an effective intervention for improving patient adherence with bowel preparation instructions. We suspect that creation of a text messaging protocol designed for patients requiring outpatient extended bowel preparation will yield great benefit. As technology continues to improve, future implementation of Annie text messaging will become increasingly seamless within the field of gastroenterology and beyond.
1. Centers for Disease Control and Prevention. Colorectal cancer statistics. Updated June 6, 2022. Accessed September 8, 2022. https://www.cdc.gov/cancer/colorectal/statistics
2. Lieberman D, Ladabaum U, Cruz-Correa M, et al. Screening for colorectal cancer and evolving issues for physicians and patients: a review. JAMA. 2016;316(20):2135-2145. doi:10.1001/jama.2016.17418
3. Nguyen DL, Wieland M. Risk factors predictive of poor quality preparation during average risk colonoscopy screening: the importance of health literacy. J Gastrointestin Liver Dis. 2010;19(4):369-372.
4. Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2018;30(8):819-826. doi:10.1097/MEG.0000000000001175
5. Harrington KM, Nguyen XT, Song RJ, et al. Gender differences in demographic and health characteristics of the Million Veteran Program cohort. Womens Health Issues. 2019;29(suppl 1):S56-S66. doi:10.1016/j.whi.2019.04.012
6. Zhang QX, Li J, Zhang Q, et al. Effect of education by messaging software on the quality of bowel preparation for colonoscopy. Chin Med J (Engl). 2018;131(14):1750-1752. doi:10.4103/0366-6999.235881
7. Walter B, Klare P, Strehle K, et al. Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II). Gastrointest Endosc. 2019;89(3):506-513.e4. doi:10.1016/j.gie.2018.08.014
8. Nadim MM, Doshi S, Coniglio M, et al. Automated text message navigation to improve preparation quality and show rate for colonoscopy. Am J Gastroenterol. 2018;113:S64-S66.
9. Walter B, Frank R, Ludwig L, et al. Smartphone application to reinforce education increases high-quality preparation for colorectal cancer screening colonoscopies in a randomized trial. Clin Gastroenterol Hepatol. 2021;19(2):331-338.e5. doi:10.1016/j.cgh.2020.03.051
10. Guo B, Zuo X, Li Z, et al. Improving the quality of bowel preparation through an app for inpatients undergoing colonoscopy: a randomized controlled trial. J Adv Nurs. 2020;76(4):1037-1045. doi:10.1111/jan.14295
11. Yakovchenko V, Hogan TP, Houston TK, et al. Automated text messaging with patients in department of veterans affairs specialty clinics: cluster randomized trial. J Med Internet Res. 2019;21(8):e14750. doi:10.2196/14750
12. Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009;69(3 Pt 2):620-625. doi:10.1016/j.gie.2008.05.057
13. Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010;72(4):686-692. doi:10.1016/j.gie.2010.06.068
14. Duan-Porter W, Van Houtven CH, Mahanna EP, et al. Internet use and technology-related attitudes of veterans and informal caregivers of veterans. Telemed J E Health. 2018;24(7):471-480. doi:10.1089/tmj.2017.0015
15. Boston University School of Public Health. how mobile technology can increase veteran healthcare and wellbeing. November 10, 2021. Accessed November 1, 2022. https://www.ideahub.org/research-data/how-mobile-technology-increases-veteran-healthcare-and-wellbeing/
16. Klee A, Stacy M, Rosenheck R, Harkness L, Tsai J. Interest in technology-based therapies hampered by access: A survey of veterans with serious mental illnesses. Psychiatr Rehabil J. 2016;39(2):173-179. doi:10.1037/prj0000180
17. Berrouiguet S, Baca-García E, Brandt S, Walter M, Courtet P. Fundamentals for future mobile-health (mHealth): a systematic review of mobile phone and web-based text messaging in mental health. J Med Internet Res. 2016;18(6):e135. Published 2016 Jun 10. doi:10.2196/jmir.5066
Colorectal cancer is the third leading cause of cancer-related death in both men and women.1 Colonoscopy is the current gold standard for screening due to the ability to remove precancerous lesions but remains highly dependent on the quality of bowel preparation.2 Poor bowel preparation has been associated with impaired adenoma detection as well as increased health care utilization due to the need for a repeat colonoscopy.3
Multiple patient factors are associated with increased risk of poor bowel preparation, including age > 60 years, male sex, diabetes mellitus, and presence of a mental health diagnosis, factors that are prevalent among the veteran population.3-5 Text messages have been shown to improve the quality of bowel preparation by increasing patients' understanding and adherence with the preparation process. Improved adherence with bowel preparation directions is associated with a cleaner colon prior to colonoscopy, leading to a thorough examination. Studies using text messaging instructions prior to colonoscopies have also shown measurable improvement in adenoma detection rate, patient preparation-associated discomfort, and completion of colonoscopy.6-10
In 2016, the Veterans Health Administration (VHA) introduced Annie, one of the first automated text messaging services, named after Army Lieutenant Annie Fox, the first woman to receive the Purple Heart for combat. The Annie platform allows for notifications, instructions, and simple data collection. The development of this platform allows VHA practitioners to engage and educate veterans in a similar way to other health care systems using text messaging protocols. Annie text messages have been piloted for the use of hepatitis C treatment, demonstrating promise of improved medication adherence and patient satisfaction.11 We aimed to develop and pilot the Annie bowel preparation protocol to improve the quality of colonoscopy bowel preparation for outpatients at the Minneapolis Veterans Affairs Medical Center (MVAMC) in Minnesota. A secondary goal included measuring patient satisfaction with the text messaging instructions for outpatient colonoscopy preparation.
Methods
We conducted a single center, prospective, endoscopist-blinded, study with two 3-month long Plan-Do-Study-Act (PDSA) cycles to improve the text messaging bowel preparation protocol at MVAMC between January 2019 and April 2020. The MVAMC Institutional Review Board determined the quality improvement project was exempt. Veterans who had outpatient colonoscopies scheduled were included. Veterans undergoing inpatient colonoscopies or outpatients who could not be reached to obtain informed consent, lacked text message capability, declined participation, or required extended colonoscopy preparation were excluded. Per MVAMC procedures, extended colonoscopy preparation was provided to patients receiving general or monitored anesthesia care, with a history of poor bowel preparation, or with risk factors for poor preparation as determined by the ordering health care professional (HCP). Standard bowel preparation involves ingestion of 4 L of polyethylene glycol 3350 with electrolytes; extended bowel preparation requires ingestion of an additional 2 L to total 6 L and uses a different set of instructions. Additionally, the patient population requiring extended bowel preparation also includes patients with spinal cord injuries, who often are admitted for assistance with extended preparation. Patients who consented to receiving text messages were placed in the Annie intervention group, and all others were placed in the control group.
The control group received standardized patient education, including a mailed copy of bowel preparation instructions and a phone call from a gastroenterology service nurse about 1 to 2 weeks before the procedure. Current MVAMC standard of care involves a phone call from a nurse to confirm that patients have received the polyethylene glycol preparation solution, the mailed instructions, have an escort and transportation, and to answer any questions. Both the usual care and intervention group received the phone call. During this call, the Annie text messaging bowel preparation protocol was introduced; if the veteran chose to participate, consent and enrollment were completed.
On the day of the colonoscopy, veterans in the intervention group were surveyed in the waiting room about their experience receiving the text messages and soliciting feedback for improvement or surveyed via telephone call within 3 days of their procedure. Patient satisfaction was quantified with a scale from 1 (low) to 10 (high), including questions about how helpful the texts were in relation to total number, timing, and content of messages as well as whether veterans would like to receive the text messages again for future procedures.
We reviewed individual charts and collected Boston Bowel Preparation Scale (BBPS) scores to determine adequate preparation. BBPS assigns a score of 0 to 3 for the right, transverse, and left colon applied upon withdrawal after flushing and suctioning have been completed.12 Adequate preparation is considered a total score of ≥ 6 with no segment scoring < 2. This method of preparation assessment is preferred due to its ability to account for difference in preparation quality among colonic segments, well-defined scoring characteristics, and several studies validating its use showing inter- and intraobserver reliability.12 Follow-up studies have shown validity of the BBPS when compared with relevant outcomes such as polyp detection rate and recommended timing for repeat procedure.13 Variables associated with poor bowel preparation (ie, gender, prior abdominal surgery, impaired mobility, high body mass index, diabetes mellitus, stroke, dementia, any neurologic diagnosis, cirrhosis, smoking, polypharmacy [> 8 active medications], and narcotic or tricyclic antidepressant medication use) were also collected through chart review.3-5 We note that immobility was defined by International Classification of Diseases (ICD)-9 and ICD-10 codes and prescriptions for assistive devices (ie, canes, wheelchairs, 4-wheeled walkers).
Veterans assent to be enrolled in Annie. After enrollment, veterans must text back a specific word response to an initial text message to receive the protocolized messages from the Annie program. A contact phone number to the gastrointestinal nurse line was provided for questions during business hours. The start date for the text message protocol is 6 days prior to the procedure date. If a patient rescheduled their colonoscopy, the Annie database was updated manually.
Statistical Analysis
We used both Pearson χ2 test and 2-sample t test analyses to compare demographic information and patient satisfaction scores between the control and intervention groups. We compared continuous BBPS scores between Annie intervention vs control group using parametric and nonparametric independent t tests using the Mann-Whitney U test. We repeated this analysis controlling for both mental health diagnoses and age using linear regression. We were unable to survey 61 of the 187 veterans who received Annie text messages.
RESULTS
During PDSA cycles 1 and 2, 640 veterans were scheduled for outpatient colonoscopy: 453 veterans were in the control group; 187 veterans were in the intervention group, of which 126 were surveyed. A significant percentage of veterans declined participation because they felt like they did not need reinforced education; others were not eligible for Annie due to requirement for extended bowel preparation, cancelled colonoscopy, inability to physically read text messages, or lack of cell phone.
The mean (SD) age was 65 (8) years; 184 (28.8%) had a diabetes mellitus diagnosis, and the mean (SD) body mass index was 31.6 (6.4). The Annie group was slightly more likely to have mental health diagnoses and lower age compared with the control group (Table 1).
Patient Feedback
We collected feedback from veterans after each PDSA cycle to identify areas for improvement by both in-person and telephone surveys. Based on feedback from PDSA cycle 1, we decreased the total number of text messages to create a more succinct set of instructions. The most frequently requested change involved timing the text messages to align with the exact morning a specific instruction should take place.
Patient satisfaction with the Annie text messaging service was high.
DISCUSSION
To our knowledge, this is the first report of using Annie at a VAMC for colonoscopy bowel preparation improvement. We found a statistically significant improvement in the average BBPS in those receiving Annie text messages compared with the routine care control group. We also found high levels of patient satisfaction with most patients requesting to receive them again for future procedures.
The clinical significance of a BBPS of 7.8 vs 8.2 is unclear, although any score > 6 is considered to be adequate. However, subjectively speaking, the higher the BBPS the cleaner the colon, and theoretically the easier it is to see small or flat polyps. Future steps could include calculating adenoma detection rates for those enrolled in the Annie program vs the control group.
We have received inquiries regarding potential program implementation at other facilities. Success and sustainability of the program will require long-term commitment and ideally protected time for staff. It is helpful to remember that for each person who chooses to enroll in the intervention, the program currently requires that a brief consent note is placed in the patient’s chart. Thus, depending on the facilities’ resources, it is ideal for one staff member to be the designated lead to help oversee, troubleshoot, and train additional personnel. Surveys can be intermittently used to obtain feedback for improvement but are not required for sustainability. Automated text messaging is a promising addition to medicine for clinical education and communication. Future studies should examine the clinical significance (ie, adenoma detection rates) of text messaging bowel preparation protocols.
Limitations
Our study has several limitations. First, this was a single center study, thus generalizability is limited. MVAMC represents a predominantly White, male, and rural population. Second, data are likely an underestimation of the true impact of intervention, because results do not account for patients who were turned away on day of procedure (typically still reporting brown stools at time of check-in for procedure) due to poor preparation or aborted procedures secondary to poor preparation. Only about one-third of the 640 veterans opted to receive Annie text messages.
Studies have shown veterans are willing to use technology for health care; however, access to technology and lack of training remain barriers to use.14 This has been most robustly studied at the VA in veterans experiencing mental illness and homelessness. Targeted strategies to improve veteran adoption of technology within their health care include supplying veterans with cell phones and paid data plans and providing training on specific technology-based resources.15-17 Future improvement for the Annie platform should include improved integration with CPRS. Integration will facilitate automatic import of key information such as mobile phone number or colonoscopy procedure date. Unfortunately, this is not currently an automated process, and the manual workload of staff limits sustainability. Since our study ended, the Annie database now allows an “event date” to be programmed in to center the text message series around. This will be entered at the time of Annie enrollment and eliminate manual activation of the protocol. The issue of updating information for rescheduled procedures remains.
Conclusions
There is increasing evidence that automated text messaging is a promising addition to medicine for clinical education and communication. It continues to gain traction as a readily available and acceptable option, and many patients are willing to incorporate the technology platform into their care plan. We found high patient satisfaction with our protocol, and Annie patients had cleaner bowel preparations compared with control patients. Our study supports the use of text message reminders as an effective intervention for improving patient adherence with bowel preparation instructions. We suspect that creation of a text messaging protocol designed for patients requiring outpatient extended bowel preparation will yield great benefit. As technology continues to improve, future implementation of Annie text messaging will become increasingly seamless within the field of gastroenterology and beyond.
Colorectal cancer is the third leading cause of cancer-related death in both men and women.1 Colonoscopy is the current gold standard for screening due to the ability to remove precancerous lesions but remains highly dependent on the quality of bowel preparation.2 Poor bowel preparation has been associated with impaired adenoma detection as well as increased health care utilization due to the need for a repeat colonoscopy.3
Multiple patient factors are associated with increased risk of poor bowel preparation, including age > 60 years, male sex, diabetes mellitus, and presence of a mental health diagnosis, factors that are prevalent among the veteran population.3-5 Text messages have been shown to improve the quality of bowel preparation by increasing patients' understanding and adherence with the preparation process. Improved adherence with bowel preparation directions is associated with a cleaner colon prior to colonoscopy, leading to a thorough examination. Studies using text messaging instructions prior to colonoscopies have also shown measurable improvement in adenoma detection rate, patient preparation-associated discomfort, and completion of colonoscopy.6-10
In 2016, the Veterans Health Administration (VHA) introduced Annie, one of the first automated text messaging services, named after Army Lieutenant Annie Fox, the first woman to receive the Purple Heart for combat. The Annie platform allows for notifications, instructions, and simple data collection. The development of this platform allows VHA practitioners to engage and educate veterans in a similar way to other health care systems using text messaging protocols. Annie text messages have been piloted for the use of hepatitis C treatment, demonstrating promise of improved medication adherence and patient satisfaction.11 We aimed to develop and pilot the Annie bowel preparation protocol to improve the quality of colonoscopy bowel preparation for outpatients at the Minneapolis Veterans Affairs Medical Center (MVAMC) in Minnesota. A secondary goal included measuring patient satisfaction with the text messaging instructions for outpatient colonoscopy preparation.
Methods
We conducted a single center, prospective, endoscopist-blinded, study with two 3-month long Plan-Do-Study-Act (PDSA) cycles to improve the text messaging bowel preparation protocol at MVAMC between January 2019 and April 2020. The MVAMC Institutional Review Board determined the quality improvement project was exempt. Veterans who had outpatient colonoscopies scheduled were included. Veterans undergoing inpatient colonoscopies or outpatients who could not be reached to obtain informed consent, lacked text message capability, declined participation, or required extended colonoscopy preparation were excluded. Per MVAMC procedures, extended colonoscopy preparation was provided to patients receiving general or monitored anesthesia care, with a history of poor bowel preparation, or with risk factors for poor preparation as determined by the ordering health care professional (HCP). Standard bowel preparation involves ingestion of 4 L of polyethylene glycol 3350 with electrolytes; extended bowel preparation requires ingestion of an additional 2 L to total 6 L and uses a different set of instructions. Additionally, the patient population requiring extended bowel preparation also includes patients with spinal cord injuries, who often are admitted for assistance with extended preparation. Patients who consented to receiving text messages were placed in the Annie intervention group, and all others were placed in the control group.
The control group received standardized patient education, including a mailed copy of bowel preparation instructions and a phone call from a gastroenterology service nurse about 1 to 2 weeks before the procedure. Current MVAMC standard of care involves a phone call from a nurse to confirm that patients have received the polyethylene glycol preparation solution, the mailed instructions, have an escort and transportation, and to answer any questions. Both the usual care and intervention group received the phone call. During this call, the Annie text messaging bowel preparation protocol was introduced; if the veteran chose to participate, consent and enrollment were completed.
On the day of the colonoscopy, veterans in the intervention group were surveyed in the waiting room about their experience receiving the text messages and soliciting feedback for improvement or surveyed via telephone call within 3 days of their procedure. Patient satisfaction was quantified with a scale from 1 (low) to 10 (high), including questions about how helpful the texts were in relation to total number, timing, and content of messages as well as whether veterans would like to receive the text messages again for future procedures.
We reviewed individual charts and collected Boston Bowel Preparation Scale (BBPS) scores to determine adequate preparation. BBPS assigns a score of 0 to 3 for the right, transverse, and left colon applied upon withdrawal after flushing and suctioning have been completed.12 Adequate preparation is considered a total score of ≥ 6 with no segment scoring < 2. This method of preparation assessment is preferred due to its ability to account for difference in preparation quality among colonic segments, well-defined scoring characteristics, and several studies validating its use showing inter- and intraobserver reliability.12 Follow-up studies have shown validity of the BBPS when compared with relevant outcomes such as polyp detection rate and recommended timing for repeat procedure.13 Variables associated with poor bowel preparation (ie, gender, prior abdominal surgery, impaired mobility, high body mass index, diabetes mellitus, stroke, dementia, any neurologic diagnosis, cirrhosis, smoking, polypharmacy [> 8 active medications], and narcotic or tricyclic antidepressant medication use) were also collected through chart review.3-5 We note that immobility was defined by International Classification of Diseases (ICD)-9 and ICD-10 codes and prescriptions for assistive devices (ie, canes, wheelchairs, 4-wheeled walkers).
Veterans assent to be enrolled in Annie. After enrollment, veterans must text back a specific word response to an initial text message to receive the protocolized messages from the Annie program. A contact phone number to the gastrointestinal nurse line was provided for questions during business hours. The start date for the text message protocol is 6 days prior to the procedure date. If a patient rescheduled their colonoscopy, the Annie database was updated manually.
Statistical Analysis
We used both Pearson χ2 test and 2-sample t test analyses to compare demographic information and patient satisfaction scores between the control and intervention groups. We compared continuous BBPS scores between Annie intervention vs control group using parametric and nonparametric independent t tests using the Mann-Whitney U test. We repeated this analysis controlling for both mental health diagnoses and age using linear regression. We were unable to survey 61 of the 187 veterans who received Annie text messages.
RESULTS
During PDSA cycles 1 and 2, 640 veterans were scheduled for outpatient colonoscopy: 453 veterans were in the control group; 187 veterans were in the intervention group, of which 126 were surveyed. A significant percentage of veterans declined participation because they felt like they did not need reinforced education; others were not eligible for Annie due to requirement for extended bowel preparation, cancelled colonoscopy, inability to physically read text messages, or lack of cell phone.
The mean (SD) age was 65 (8) years; 184 (28.8%) had a diabetes mellitus diagnosis, and the mean (SD) body mass index was 31.6 (6.4). The Annie group was slightly more likely to have mental health diagnoses and lower age compared with the control group (Table 1).
Patient Feedback
We collected feedback from veterans after each PDSA cycle to identify areas for improvement by both in-person and telephone surveys. Based on feedback from PDSA cycle 1, we decreased the total number of text messages to create a more succinct set of instructions. The most frequently requested change involved timing the text messages to align with the exact morning a specific instruction should take place.
Patient satisfaction with the Annie text messaging service was high.
DISCUSSION
To our knowledge, this is the first report of using Annie at a VAMC for colonoscopy bowel preparation improvement. We found a statistically significant improvement in the average BBPS in those receiving Annie text messages compared with the routine care control group. We also found high levels of patient satisfaction with most patients requesting to receive them again for future procedures.
The clinical significance of a BBPS of 7.8 vs 8.2 is unclear, although any score > 6 is considered to be adequate. However, subjectively speaking, the higher the BBPS the cleaner the colon, and theoretically the easier it is to see small or flat polyps. Future steps could include calculating adenoma detection rates for those enrolled in the Annie program vs the control group.
We have received inquiries regarding potential program implementation at other facilities. Success and sustainability of the program will require long-term commitment and ideally protected time for staff. It is helpful to remember that for each person who chooses to enroll in the intervention, the program currently requires that a brief consent note is placed in the patient’s chart. Thus, depending on the facilities’ resources, it is ideal for one staff member to be the designated lead to help oversee, troubleshoot, and train additional personnel. Surveys can be intermittently used to obtain feedback for improvement but are not required for sustainability. Automated text messaging is a promising addition to medicine for clinical education and communication. Future studies should examine the clinical significance (ie, adenoma detection rates) of text messaging bowel preparation protocols.
Limitations
Our study has several limitations. First, this was a single center study, thus generalizability is limited. MVAMC represents a predominantly White, male, and rural population. Second, data are likely an underestimation of the true impact of intervention, because results do not account for patients who were turned away on day of procedure (typically still reporting brown stools at time of check-in for procedure) due to poor preparation or aborted procedures secondary to poor preparation. Only about one-third of the 640 veterans opted to receive Annie text messages.
Studies have shown veterans are willing to use technology for health care; however, access to technology and lack of training remain barriers to use.14 This has been most robustly studied at the VA in veterans experiencing mental illness and homelessness. Targeted strategies to improve veteran adoption of technology within their health care include supplying veterans with cell phones and paid data plans and providing training on specific technology-based resources.15-17 Future improvement for the Annie platform should include improved integration with CPRS. Integration will facilitate automatic import of key information such as mobile phone number or colonoscopy procedure date. Unfortunately, this is not currently an automated process, and the manual workload of staff limits sustainability. Since our study ended, the Annie database now allows an “event date” to be programmed in to center the text message series around. This will be entered at the time of Annie enrollment and eliminate manual activation of the protocol. The issue of updating information for rescheduled procedures remains.
Conclusions
There is increasing evidence that automated text messaging is a promising addition to medicine for clinical education and communication. It continues to gain traction as a readily available and acceptable option, and many patients are willing to incorporate the technology platform into their care plan. We found high patient satisfaction with our protocol, and Annie patients had cleaner bowel preparations compared with control patients. Our study supports the use of text message reminders as an effective intervention for improving patient adherence with bowel preparation instructions. We suspect that creation of a text messaging protocol designed for patients requiring outpatient extended bowel preparation will yield great benefit. As technology continues to improve, future implementation of Annie text messaging will become increasingly seamless within the field of gastroenterology and beyond.
1. Centers for Disease Control and Prevention. Colorectal cancer statistics. Updated June 6, 2022. Accessed September 8, 2022. https://www.cdc.gov/cancer/colorectal/statistics
2. Lieberman D, Ladabaum U, Cruz-Correa M, et al. Screening for colorectal cancer and evolving issues for physicians and patients: a review. JAMA. 2016;316(20):2135-2145. doi:10.1001/jama.2016.17418
3. Nguyen DL, Wieland M. Risk factors predictive of poor quality preparation during average risk colonoscopy screening: the importance of health literacy. J Gastrointestin Liver Dis. 2010;19(4):369-372.
4. Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2018;30(8):819-826. doi:10.1097/MEG.0000000000001175
5. Harrington KM, Nguyen XT, Song RJ, et al. Gender differences in demographic and health characteristics of the Million Veteran Program cohort. Womens Health Issues. 2019;29(suppl 1):S56-S66. doi:10.1016/j.whi.2019.04.012
6. Zhang QX, Li J, Zhang Q, et al. Effect of education by messaging software on the quality of bowel preparation for colonoscopy. Chin Med J (Engl). 2018;131(14):1750-1752. doi:10.4103/0366-6999.235881
7. Walter B, Klare P, Strehle K, et al. Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II). Gastrointest Endosc. 2019;89(3):506-513.e4. doi:10.1016/j.gie.2018.08.014
8. Nadim MM, Doshi S, Coniglio M, et al. Automated text message navigation to improve preparation quality and show rate for colonoscopy. Am J Gastroenterol. 2018;113:S64-S66.
9. Walter B, Frank R, Ludwig L, et al. Smartphone application to reinforce education increases high-quality preparation for colorectal cancer screening colonoscopies in a randomized trial. Clin Gastroenterol Hepatol. 2021;19(2):331-338.e5. doi:10.1016/j.cgh.2020.03.051
10. Guo B, Zuo X, Li Z, et al. Improving the quality of bowel preparation through an app for inpatients undergoing colonoscopy: a randomized controlled trial. J Adv Nurs. 2020;76(4):1037-1045. doi:10.1111/jan.14295
11. Yakovchenko V, Hogan TP, Houston TK, et al. Automated text messaging with patients in department of veterans affairs specialty clinics: cluster randomized trial. J Med Internet Res. 2019;21(8):e14750. doi:10.2196/14750
12. Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009;69(3 Pt 2):620-625. doi:10.1016/j.gie.2008.05.057
13. Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010;72(4):686-692. doi:10.1016/j.gie.2010.06.068
14. Duan-Porter W, Van Houtven CH, Mahanna EP, et al. Internet use and technology-related attitudes of veterans and informal caregivers of veterans. Telemed J E Health. 2018;24(7):471-480. doi:10.1089/tmj.2017.0015
15. Boston University School of Public Health. how mobile technology can increase veteran healthcare and wellbeing. November 10, 2021. Accessed November 1, 2022. https://www.ideahub.org/research-data/how-mobile-technology-increases-veteran-healthcare-and-wellbeing/
16. Klee A, Stacy M, Rosenheck R, Harkness L, Tsai J. Interest in technology-based therapies hampered by access: A survey of veterans with serious mental illnesses. Psychiatr Rehabil J. 2016;39(2):173-179. doi:10.1037/prj0000180
17. Berrouiguet S, Baca-García E, Brandt S, Walter M, Courtet P. Fundamentals for future mobile-health (mHealth): a systematic review of mobile phone and web-based text messaging in mental health. J Med Internet Res. 2016;18(6):e135. Published 2016 Jun 10. doi:10.2196/jmir.5066
1. Centers for Disease Control and Prevention. Colorectal cancer statistics. Updated June 6, 2022. Accessed September 8, 2022. https://www.cdc.gov/cancer/colorectal/statistics
2. Lieberman D, Ladabaum U, Cruz-Correa M, et al. Screening for colorectal cancer and evolving issues for physicians and patients: a review. JAMA. 2016;316(20):2135-2145. doi:10.1001/jama.2016.17418
3. Nguyen DL, Wieland M. Risk factors predictive of poor quality preparation during average risk colonoscopy screening: the importance of health literacy. J Gastrointestin Liver Dis. 2010;19(4):369-372.
4. Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2018;30(8):819-826. doi:10.1097/MEG.0000000000001175
5. Harrington KM, Nguyen XT, Song RJ, et al. Gender differences in demographic and health characteristics of the Million Veteran Program cohort. Womens Health Issues. 2019;29(suppl 1):S56-S66. doi:10.1016/j.whi.2019.04.012
6. Zhang QX, Li J, Zhang Q, et al. Effect of education by messaging software on the quality of bowel preparation for colonoscopy. Chin Med J (Engl). 2018;131(14):1750-1752. doi:10.4103/0366-6999.235881
7. Walter B, Klare P, Strehle K, et al. Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II). Gastrointest Endosc. 2019;89(3):506-513.e4. doi:10.1016/j.gie.2018.08.014
8. Nadim MM, Doshi S, Coniglio M, et al. Automated text message navigation to improve preparation quality and show rate for colonoscopy. Am J Gastroenterol. 2018;113:S64-S66.
9. Walter B, Frank R, Ludwig L, et al. Smartphone application to reinforce education increases high-quality preparation for colorectal cancer screening colonoscopies in a randomized trial. Clin Gastroenterol Hepatol. 2021;19(2):331-338.e5. doi:10.1016/j.cgh.2020.03.051
10. Guo B, Zuo X, Li Z, et al. Improving the quality of bowel preparation through an app for inpatients undergoing colonoscopy: a randomized controlled trial. J Adv Nurs. 2020;76(4):1037-1045. doi:10.1111/jan.14295
11. Yakovchenko V, Hogan TP, Houston TK, et al. Automated text messaging with patients in department of veterans affairs specialty clinics: cluster randomized trial. J Med Internet Res. 2019;21(8):e14750. doi:10.2196/14750
12. Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009;69(3 Pt 2):620-625. doi:10.1016/j.gie.2008.05.057
13. Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010;72(4):686-692. doi:10.1016/j.gie.2010.06.068
14. Duan-Porter W, Van Houtven CH, Mahanna EP, et al. Internet use and technology-related attitudes of veterans and informal caregivers of veterans. Telemed J E Health. 2018;24(7):471-480. doi:10.1089/tmj.2017.0015
15. Boston University School of Public Health. how mobile technology can increase veteran healthcare and wellbeing. November 10, 2021. Accessed November 1, 2022. https://www.ideahub.org/research-data/how-mobile-technology-increases-veteran-healthcare-and-wellbeing/
16. Klee A, Stacy M, Rosenheck R, Harkness L, Tsai J. Interest in technology-based therapies hampered by access: A survey of veterans with serious mental illnesses. Psychiatr Rehabil J. 2016;39(2):173-179. doi:10.1037/prj0000180
17. Berrouiguet S, Baca-García E, Brandt S, Walter M, Courtet P. Fundamentals for future mobile-health (mHealth): a systematic review of mobile phone and web-based text messaging in mental health. J Med Internet Res. 2016;18(6):e135. Published 2016 Jun 10. doi:10.2196/jmir.5066
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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>1222 FED Colonoscopy Rev</fileName> <TBEID>0C02B70B.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02B70B</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20221214T130509</firstPublished> <LastPublished>20221214T130509</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20221214T130509</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>Susan Lou, MDa,b; Morgan Freeman, MDa,b; Nicha Wongjarupong, MDa,b; Anders Westanmo, PharmD, MBAb; Amy Gravely, MAb; Shahnaz Sultan, MD, MHSca,b; Aasma Shaukat, MD, MPHc,d</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 is the third leading cause of cancer-related death in both men and women.1 Colonoscopy is the current gold standard for screening due to the a</metaDescription> <articlePDF/> <teaserImage/> <title>A Novel Text Message Protocol to Improve Bowel Preparation for Outpatient Colonoscopies in Veterans</title> <deck/> <eyebrow>Original Research</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>2857</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>December 2022</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics> <pubTopic>Cancer | 2857</pubTopic> </pubTopics> <pubCategories/> <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">104</term> </sections> <topics> <term canonical="true">174</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>A Novel Text Message Protocol to Improve Bowel Preparation for Outpatient Colonoscopies in Veterans</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Backgroun</b><b>d: </b>The current gold standard for screening for colorectal cancer is colonoscopy, a procedure that depends on the quality of bowel preparation. In 2016, the Veterans Health Administration introduced Annie, a text message service to improve health care communication with patients. The Minneapolis Veterans Affairs Medical Center conducted a prospective, single center study to measure the impact of Annie text messaging on patient satisfaction and quality of bowel preparation for patients undergoing outpatient colonoscopy.<br/><br/><b>Methods: </b>Patients undergoing colonoscopy were divided into 2 groups. The control group received standardized patient education and a phone call prior to procedure. The intervention group, consisting of all patients who agreed to enroll, received a 6-day Annie text messaging protocol consisting of key bowel preparation steps that started 5 days prior to their scheduled procedure. Bowel preparation quality was measured using the Boston Bowel Preparation Scale (BBPS) score. <br/><br/><b>Results: </b>During the study period, 688 veterans were scheduled for outpatient colonoscopy: 484 veterans were in the control group, 204 veterans were in the intervention group, and 126 were surveyed. Annie text messaging instructions were associated with a higher BBPS score (8.2) compared with usual care (7.8); <i>P</i> = .007 using independent<i> t </i>test, and <i>P</i> = .002 using parametric independent<i> t</i> test. Patients also reported satisfaction with the Annie text messaging service.<b>Conclusions: </b>There was a statistically significant improvement in the average BBPS score in veterans receiving Annie text messages compared with the routine care control group for outpatient colonoscopies.</p> <p><span class="Drop">C</span>olorectal cancer is the third leading cause of cancer-related death in both men and women.<sup>1 </sup>Colonoscopy is the current gold standard for screening due to the ability to remove precancerous lesions but remains highly dependent on the quality of bowel preparation.<sup>2</sup> Poor bowel preparation has been associated with impaired adenoma detection as well as increased health care utilization due to the need for a repeat colonoscopy.<sup>3</sup></p> <p>Multiple patient factors are associated with increased risk of poor bowel preparation, including age > 60 years, male sex, diabetes mellitus, and presence of a mental health diagnosis, factors that are prevalent among the veteran population.<sup>3-5</sup> Text messages have been shown to improve the quality of bowel preparation by increasing patients' understanding and adherence with the preparation process. Improved adherence with bowel preparation directions is associated with a cleaner colon prior to colonoscopy, leading to a thorough examination. Studies using text messaging instructions prior to colonoscopies have also shown measurable improvement in adenoma detection rate, patient preparation-associated discomfort, and completion of colonoscopy.<sup>6-10<br/><br/></sup>In 2016, the Veterans Health Administration (VHA) introduced Annie, one of the first automated text messaging services, named after Army Lieutenant Annie Fox, the first woman to receive the Purple Heart for combat. The Annie platform allows for notifications, instructions, and simple data collection. The development of this platform allows VHA practitioners to engage and educate veterans in a similar way to other health care systems using text messaging protocols. Annie text messages have been piloted for the use of hepatitis C treatment, demonstrating promise of improved medication adherence and patient satisfaction.<sup>11</sup> We aimed to develop and pilot the Annie bowel preparation protocol to improve the quality of colonoscopy bowel preparation for outpatients at the Minneapolis Veterans Affairs Medical Center (MVAMC) in Minnesota. A secondary goal included measuring patient satisfaction with the text messaging instructions for outpatient colonoscopy preparation.</p> <h2>Methods</h2> <p>We conducted a single center, prospective, endoscopist-blinded, study with two 3-month long Plan-Do-Study-Act (PDSA) cycles to improve the text messaging bowel preparation protocol at MVAMC between January 2019 and April 2020. The MVAMC Institutional Review Board determined the quality improvement project was exempt. Veterans who had outpatient colonoscopies scheduled were included. Veterans undergoing inpatient colonoscopies or outpatients who could not be reached to obtain informed consent, lacked text message capability, declined participation, or required extended colonoscopy preparation were excluded. Per MVAMC procedures, extended colonoscopy preparation was provided to patients receiving general or monitored anesthesia care, with a history of poor bowel preparation, or with risk factors for poor preparation as determined by the ordering health care professional (HCP). Standard bowel preparation involves ingestion of 4 L of polyethylene glycol 3350 with electrolytes; extended bowel preparation requires ingestion of an additional 2 L to total 6 L and uses a different set of instructions. Additionally, the patient population requiring extended bowel preparation also includes patients with spinal cord injuries, who often are admitted for assistance with extended preparation. Patients who consented to receiving text messages were placed in the Annie intervention group, and all others were placed in the control group. </p> <p>The control group received standardized patient education, including a mailed copy of bowel preparation instructions and a phone call from a gastroenterology service nurse about 1 to 2 weeks before the procedure. Current MVAMC standard of care involves a phone call from a nurse to confirm that patients have received the polyethylene glycol preparation solution, the mailed instructions, have an escort and transportation, and to answer any questions. Both the usual care and intervention group received the phone call. During this call, the Annie text messaging bowel preparation protocol was introduced; if the veteran chose to participate, consent and enrollment were completed. At enrollment, patient information was manually extracted from the Computerized Patient Record System (CPRS) and entered into Annie. A brief consent note was entered in the patient’s chart acknowledging that text messages are a one-way communication and standard payment rates apply. The intervention group received a 6-day Annie text messaging protocol consisting of key standard bowel preparation steps that started 5 days before the scheduled procedure. Details of the text message script are available in the Appendix.<br/><br/>On the day of the colonoscopy, veterans in the intervention group were surveyed in the waiting room about their experience receiving the text messages and soliciting feedback for improvement or surveyed via telephone call within 3 days of their procedure. Patient satisfaction was quantified with a scale from 1 (low) to 10 (high), including questions about how helpful the texts were in relation to total number, timing, and content of messages as well as whether veterans would like to receive the text messages again for future procedures. <br/><br/>We reviewed individual charts and collected Boston Bowel Preparation Scale (BBPS) scores to determine adequate preparation. BBPS assigns a score of 0 to 3 for the right, transverse, and left colon applied upon withdrawal after flushing and suctioning have been completed.<sup>12</sup> Adequate preparation is considered a total score of ≥ 6 with no segment scoring < 2. This method of preparation assessment is preferred due to its ability to account for difference in preparation quality among colonic segments, well-defined scoring characteristics, and several studies validating its use showing inter- and intraobserver reliability.<sup>12</sup> Follow-up studies have shown validity of the BBPS when compared with relevant outcomes such as polyp detection rate and recommended timing for repeat procedure.<sup>13 </sup>Variables associated with poor bowel preparation (ie, gender, prior abdominal surgery, impaired mobility, high body mass index, diabetes mellitus, stroke, dementia, any neurologic diagnosis, cirrhosis, smoking, polypharmacy [> 8 active medications], and narcotic or tricyclic antidepressant medication use) were also collected through chart review.<sup>3-5</sup> We note that immobility was defined by <i>International Classification of Diseases</i> (<i>ICD</i>)<i>-9 </i>and <i>ICD-10</i> codes and prescriptions for assistive devices (ie, canes, wheelchairs, 4-wheeled walkers).<br/><br/>Veterans assent to be enrolled in Annie. After enrollment, veterans must text back a specific word response to an initial text message to receive the protocolized messages from the Annie program. A contact phone number to the gastrointestinal nurse line was provided for questions during business hours. The start date for the text message protocol is 6 days prior to the procedure date. If a patient rescheduled their colonoscopy, the Annie database was updated manually. </p> <h3>Statistical Analysis </h3> <p>We used both Pearson χ<sup>2</sup> test and 2-sample <i>t</i> test analyses to compare demographic information and patient satisfaction scores between the control and intervention groups. We compared continuous BBPS scores between Annie intervention vs control group using parametric and nonparametric independent <i>t</i> tests using the Mann-Whitney U test. We repeated this analysis controlling for both mental health diagnoses and age using linear regression. We were unable to survey 61 of the 187 veterans who received Annie text messages. </p> <h2>RESULTS </h2> <p>During PDSA cycles 1 and 2, 640 veterans were scheduled for outpatient colonoscopy: 453 veterans were in the control group; 187 veterans were in the intervention group, of which 126 were surveyed. A significant percentage of veterans declined participation because they felt like they did not need reinforced education; others were not eligible for Annie due to requirement for extended bowel preparation, cancelled colonoscopy, inability to physically read text messages, or lack of cell phone.</p> <p>The mean (SD) age was 65 (8) years; 184 (28.8%) had a diabetes mellitus diagnosis, and the mean (SD) body mass index was 31.6 (6.4). The Annie group was slightly more likely to have mental health diagnoses and lower age compared with the control group (Table 1). Annie text messaging instructions were associated with a higher BBPS score (8.2) compared with usual care (7.8); <i>P</i> = .007 using independent <i>t</i> test, and <i>P</i> = .002 using parametric independent <i>t</i> test. Differences between Annie and control groups remained significant after controlling for age and mental health diagnoses (<i>P</i> = .04)</p> <h3>Patient Feedback</h3> <p>We collected feedback from veterans after each PDSA cycle to identify areas for improvement by both in-person and telephone surveys. Based on feedback from PDSA cycle 1, we decreased the total number of text messages to create a more succinct set of instructions. The most frequently requested change involved timing the text messages to align with the exact morning a specific instruction should take place. </p> <p>Patient satisfaction with the Annie text messaging service was high. All veterans from PDSA cycle 2 wanted to receive the text messages again for future procedures, a significant improvement from PDSA cycle 1 (Table 2). Veterans most appreciated the factors of convenience and brevity; they felt much pride that their VA was making technologic advancements. </p> <h2>DISCUSSION </h2> <p>To our knowledge, this is the first report of using Annie at a VAMC for colonoscopy bowel preparation improvement. We found a statistically significant improvement in the average BBPS in those receiving Annie text messages compared with the routine care control group. We also found high levels of patient satisfaction with most patients requesting to receive them again for future procedures. </p> <p>The clinical significance of a BBPS of 7.8 vs 8.2 is unclear, although any score > 6 is considered to be adequate. However, subjectively speaking, the higher the BBPS the cleaner the colon, and theoretically the easier it is to see small or flat polyps. Future steps could include calculating adenoma detection rates for those enrolled in the Annie program vs the control group.<br/><br/>We have received inquiries regarding potential program implementation at other facilities. Success and sustainability of the program will require long-term commitment and ideally protected time for staff. It is helpful to remember that for each person who chooses to enroll in the intervention, the program currently requires that a brief consent note is placed in the patient’s chart. Thus, depending on the facilities’ resources, it is ideal for one staff member to be the designated lead to help oversee, troubleshoot, and train additional personnel. Surveys can be intermittently used to obtain feedback for improvement but are not required for sustainability. Automated text messaging is a promising addition to medicine for clinical education and communication. Future studies should examine the clinical significance (ie, adenoma detection rates) of text messaging bowel preparation protocols.</p> <h3>Limitations</h3> <p>Our study has several limitations. First, this was a single center study, thus generalizability is limited. MVAMC represents a predominantly White, male, and rural population. Second, data are likely an underestimation of the true impact of intervention, because results do not account for patients who were turned away on day of procedure (typically still reporting brown stools at time of check-in for procedure) due to poor preparation or aborted procedures secondary to poor preparation. Only about one-third of the 640 veterans opted to receive Annie text messages. </p> <p>Studies have shown veterans are willing to use technology for health care; however, access to technology and lack of training remain barriers to use.<sup>14</sup> This has been most robustly studied at the VA in veterans experiencing mental illness and homelessness. Targeted strategies to improve veteran adoption of technology within their health care include supplying veterans with cell phones and paid data plans and providing training on specific technology-based resources.<sup>15-17</sup> Future improvement for the Annie platform should include improved integration with CPRS. Integration will facilitate automatic import of key information such as mobile phone number or colonoscopy procedure date. Unfortunately, this is not currently an automated process, and the manual workload of staff limits sustainability. Since our study ended, the Annie database now allows an “event date” to be programmed in to center the text message series around. This will be entered at the time of Annie enrollment and eliminate manual activation of the protocol. The issue of updating information for rescheduled procedures remains. </p> <h2>Conclusions</h2> <p>There is increasing evidence that automated text messaging is a promising addition to medicine for clinical education and communication. It continues to gain traction as a readily available and acceptable option, and many patients are willing to incorporate the technology platform into their care plan. We found high patient satisfaction with our protocol, and Annie patients had cleaner bowel preparations compared with control patients. Our study supports the use of text message reminders as an effective intervention for improving patient adherence with bowel preparation instructions. We suspect that creation of a text messaging protocol designed for patients requiring outpatient extended bowel preparation will yield great benefit. As technology continues to improve, future implementation of Annie text messaging will become increasingly seamless within the field of gastroenterology and beyond. </p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>University of Minnesota, Minneapolis<br/><br/><sup>b</sup>Minneapolis Veterans Affairs Medical Center, Minnesota<br/><br/><sup>c</sup>Veterans Affairs New York Harbor Health Care System, New York City<br/><br/><sup>d</sup>New York University Grossman School of Medicine, New York City</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. This research was supported by the Center for Care Delivery and Outcomes Research (CIN 13-406), Minneapolis, Minnesota. Additional funding was provided by the Steve and Alex Cohen Foundation.</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 study was deemed exempt by the Minneapolis Veterans Affairs Medical Center Institutional Review Board.</em> </p> <p class="isub">References </p> <p class="reference"> 1. Centers for Disease Control and Prevention. Colorectal cancer statistics. Updated June 6, 2022. Accessed September 8, 2022. https://www.cdc.gov/cancer/colorectal/statistics<br/><br/> 2. Lieberman D, Ladabaum U, Cruz-Correa M, et al. Screening for colorectal cancer and evolving issues for physicians and patients: a review. <i>JAMA.</i> 2016;316(20):2135-2145. doi:10.1001/jama.2016.17418<br/><br/> 3. Nguyen DL, Wieland M. Risk factors predictive of poor quality preparation during average risk colonoscopy screening: the importance of health literacy. <i>J Gastrointestin Liver Dis.</i> 2010;19(4):369-372.<br/><br/> 4. Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. <i>Eur J Gastroenterol Hepatol. </i>2018;30(8):819-826. doi:10.1097/MEG.0000000000001175 <br/><br/> 5. Harrington KM, Nguyen XT, Song RJ, et al. Gender differences in demographic and health characteristics of the Million Veteran Program cohort. <i>Womens Health Issues. </i>2019;29(suppl 1):S56-S66. doi:10.1016/j.whi.2019.04.012<br/><br/> 6. Zhang QX, Li J, Zhang Q, et al. Effect of education by messaging software on the quality of bowel preparation for colonoscopy. <i>Chin Med J (Engl).</i> 2018;131(14):1750-1752. doi:10.4103/0366-6999.235881<br/><br/> 7. Walter B, Klare P, Strehle K, et al. Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II). <i>Gastrointest Endosc.</i> 2019;89(3):506-513.e4. doi:10.1016/j.gie.2018.08.014<br/><br/> 8. Nadim MM, Doshi S, Coniglio M, et al. Automated text message navigation to improve preparation quality and show rate for colonoscopy. <i>Am J Gastroenterol. </i>2018;113:S64-S66. <br/><br/> 9. Walter B, Frank R, Ludwig L, et al. Smartphone application to reinforce education increases high-quality preparation for colorectal cancer screening colonoscopies in a randomized trial. <i>Clin Gastroenterol Hepatol.</i> 2021;19(2):331-338.e5. doi:10.1016/j.cgh.2020.03.051<br/><br/>10. Guo B, Zuo X, Li Z, et al. Improving the quality of bowel preparation through an app for inpatients undergoing colonoscopy: a randomized controlled trial<i>. J Adv Nurs. </i>2020;76(4):1037-1045. doi:10.1111/jan.14295<br/><br/>11. Yakovchenko V, Hogan TP, Houston TK, et al. Automated text messaging with patients in department of veterans affairs specialty clinics: cluster randomized trial. <i>J Med Internet Res.</i> 2019;21(8):e14750. doi:10.2196/14750<br/><br/>12. Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. <i>Gastrointest Endosc. </i>2009;69(3 Pt 2):620-625. doi:10.1016/j.gie.2008.05.057<br/><br/>13. Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. <i>Gastrointest Endosc.</i> 2010;72(4):686-692. doi:10.1016/j.gie.2010.06.068<br/><br/>14. Duan-Porter W, Van Houtven CH, Mahanna EP, et al. Internet use and technology-related attitudes of veterans and informal caregivers of veterans. <i>Telemed J E Health. </i>2018;24(7):471-480. doi:10.1089/tmj.2017.0015<br/><br/>15. Boston University School of Public Health. how mobile technology can increase veteran healthcare and wellbeing. November 10, 2021. Accessed November 1, 2022. https://www.ideahub.org/research-data/how-mobile-technology-increases-veteran-healthcare-and-wellbeing/<br/><br/>16. Klee A, Stacy M, Rosenheck R, Harkness L, Tsai J. Interest in technology-based therapies hampered by access: A survey of veterans with serious mental illnesses. <i>Psychiatr Rehabil J.</i> 2016;39(2):173-179. doi:10.1037/prj0000180<br/><br/>17. Berrouiguet S, Baca-García E, Brandt S, Walter M, Courtet P. Fundamentals for future mobile-health (mHealth): a systematic review of mobile phone and web-based text messaging in mental health. <i>J Med Internet Res. </i>2016;18(6):e135. Published 2016 Jun 10. doi:10.2196/jmir.5066</p> </itemContent> </newsItem> </itemSet></root>