Bryn Nelson is a former PhD microbiologist who decided he’d much rather write about microbes than mutate them. After seven years at the science desk of Newsday in New York, Nelson relocated to Seattle as a freelancer, where he has consumed far too much coffee and written features and stories for The Hospitalist, The New York Times, Nature, Scientific American, Science News for Students, Mosaic and many other print and online publications. In addition, he contributed a chapter to The Science Writers’ Handbook and edited two chapters for the six-volume Modernist Cuisine: The Art and Science of Cooking.

Paring the risk of antibiotic resistance

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One unintended consequence of the increased attention to early sepsis identification and intervention can be unnecessary or excessive antibiotic use. Overuse of broad-spectrum antibiotics, in turn, can fuel the emergence of life-threatening infections such as antibiotic-resistant Clostridium difficile, a scourge in many hospitals.

For a sepsis quality improvement (QI) initiative at the University of Utah, Salt Lake City, the hospitalist coleaders took several precautions to lessen the risk of antibiotic overuse. Kencee K. Graves, MD, said she and her colleague Devin J. Horton, MD, designed the hospital’s order sets in collaboration with an infectious disease specialist and pharmacist so they could avoid overly broad antibiotics whenever possible. The project also included an educational effort to get pharmacists in the habit of prompting medical providers to initiate antibiotic de-escalation at 48 hours. The hospital had an antibiotic stewardship program that likely helped as well, she said. As a result of their precautions, the team found no significant difference in the amount of broad-spectrum antibiotics doled out before and after their QI pilot project.

Infection control and antimicrobial specialists also can help; they can monitor an area’s resistance profile, create a antibiogram and reevaluate sepsis pathways and order sets to adjust the recommended antibiotics as the resistance profile changes. “I think we still have a long ways to go,” said Andy Odden, MD, SFHM, patient safety officer in the department of medicine at Washington University in St. Louis. “The initial risk of mortality is so much more dramatic than the long-term risks of developing antimicrobial resistors that unless you have the antimicrobial stewardship people with a seat at the table, that voice can get drowned out very easily.”

The antimicrobial stewardship program at University of Pennsylvania, Philadelphia, has received a boost from technology. The program offers initial guidance on which broad-spectrum antibiotics to consider depending on the suspected source of the sepsis-linked infection. Software by Jackson, Wyo.–based biotech company Teqqa also synthesizes the university hospital’s resistance data based on blood, urine, and sputum cultures. “It can predict the antibiotic sensitivity of a given bug growing out of a given culture on a given unit,” said Craig A. Umscheid, MD, MSCE, of the department of epidemiology and vice chair for quality and safety in the department of medicine at the university.

The bigger issue, Dr. Umscheid said, is when and how to de-escalate antibiotic treatment. “If somebody is feeling better in 48 hours or 72 hours and no cultures have grown back, they have no more fever, and their white counts have normalized, do you start pulling off the antibiotics slowly and, if so, how do you do that?” Several trials are examining such questions, including a multicenter collaboration called DETOURS (De-Escalating Empiric Treatment: Opting-Out of Rx for Selected Patients With Suspected Sepsis). One of the trial’s chief aims is to set up a new opt-out protocol for acute care patients in the wards.

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One unintended consequence of the increased attention to early sepsis identification and intervention can be unnecessary or excessive antibiotic use. Overuse of broad-spectrum antibiotics, in turn, can fuel the emergence of life-threatening infections such as antibiotic-resistant Clostridium difficile, a scourge in many hospitals.

For a sepsis quality improvement (QI) initiative at the University of Utah, Salt Lake City, the hospitalist coleaders took several precautions to lessen the risk of antibiotic overuse. Kencee K. Graves, MD, said she and her colleague Devin J. Horton, MD, designed the hospital’s order sets in collaboration with an infectious disease specialist and pharmacist so they could avoid overly broad antibiotics whenever possible. The project also included an educational effort to get pharmacists in the habit of prompting medical providers to initiate antibiotic de-escalation at 48 hours. The hospital had an antibiotic stewardship program that likely helped as well, she said. As a result of their precautions, the team found no significant difference in the amount of broad-spectrum antibiotics doled out before and after their QI pilot project.

Infection control and antimicrobial specialists also can help; they can monitor an area’s resistance profile, create a antibiogram and reevaluate sepsis pathways and order sets to adjust the recommended antibiotics as the resistance profile changes. “I think we still have a long ways to go,” said Andy Odden, MD, SFHM, patient safety officer in the department of medicine at Washington University in St. Louis. “The initial risk of mortality is so much more dramatic than the long-term risks of developing antimicrobial resistors that unless you have the antimicrobial stewardship people with a seat at the table, that voice can get drowned out very easily.”

The antimicrobial stewardship program at University of Pennsylvania, Philadelphia, has received a boost from technology. The program offers initial guidance on which broad-spectrum antibiotics to consider depending on the suspected source of the sepsis-linked infection. Software by Jackson, Wyo.–based biotech company Teqqa also synthesizes the university hospital’s resistance data based on blood, urine, and sputum cultures. “It can predict the antibiotic sensitivity of a given bug growing out of a given culture on a given unit,” said Craig A. Umscheid, MD, MSCE, of the department of epidemiology and vice chair for quality and safety in the department of medicine at the university.

The bigger issue, Dr. Umscheid said, is when and how to de-escalate antibiotic treatment. “If somebody is feeling better in 48 hours or 72 hours and no cultures have grown back, they have no more fever, and their white counts have normalized, do you start pulling off the antibiotics slowly and, if so, how do you do that?” Several trials are examining such questions, including a multicenter collaboration called DETOURS (De-Escalating Empiric Treatment: Opting-Out of Rx for Selected Patients With Suspected Sepsis). One of the trial’s chief aims is to set up a new opt-out protocol for acute care patients in the wards.

 

One unintended consequence of the increased attention to early sepsis identification and intervention can be unnecessary or excessive antibiotic use. Overuse of broad-spectrum antibiotics, in turn, can fuel the emergence of life-threatening infections such as antibiotic-resistant Clostridium difficile, a scourge in many hospitals.

For a sepsis quality improvement (QI) initiative at the University of Utah, Salt Lake City, the hospitalist coleaders took several precautions to lessen the risk of antibiotic overuse. Kencee K. Graves, MD, said she and her colleague Devin J. Horton, MD, designed the hospital’s order sets in collaboration with an infectious disease specialist and pharmacist so they could avoid overly broad antibiotics whenever possible. The project also included an educational effort to get pharmacists in the habit of prompting medical providers to initiate antibiotic de-escalation at 48 hours. The hospital had an antibiotic stewardship program that likely helped as well, she said. As a result of their precautions, the team found no significant difference in the amount of broad-spectrum antibiotics doled out before and after their QI pilot project.

Infection control and antimicrobial specialists also can help; they can monitor an area’s resistance profile, create a antibiogram and reevaluate sepsis pathways and order sets to adjust the recommended antibiotics as the resistance profile changes. “I think we still have a long ways to go,” said Andy Odden, MD, SFHM, patient safety officer in the department of medicine at Washington University in St. Louis. “The initial risk of mortality is so much more dramatic than the long-term risks of developing antimicrobial resistors that unless you have the antimicrobial stewardship people with a seat at the table, that voice can get drowned out very easily.”

The antimicrobial stewardship program at University of Pennsylvania, Philadelphia, has received a boost from technology. The program offers initial guidance on which broad-spectrum antibiotics to consider depending on the suspected source of the sepsis-linked infection. Software by Jackson, Wyo.–based biotech company Teqqa also synthesizes the university hospital’s resistance data based on blood, urine, and sputum cultures. “It can predict the antibiotic sensitivity of a given bug growing out of a given culture on a given unit,” said Craig A. Umscheid, MD, MSCE, of the department of epidemiology and vice chair for quality and safety in the department of medicine at the university.

The bigger issue, Dr. Umscheid said, is when and how to de-escalate antibiotic treatment. “If somebody is feeling better in 48 hours or 72 hours and no cultures have grown back, they have no more fever, and their white counts have normalized, do you start pulling off the antibiotics slowly and, if so, how do you do that?” Several trials are examining such questions, including a multicenter collaboration called DETOURS (De-Escalating Empiric Treatment: Opting-Out of Rx for Selected Patients With Suspected Sepsis). One of the trial’s chief aims is to set up a new opt-out protocol for acute care patients in the wards.

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Preventing sepsis alert fatigue

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If they’re too infrequent, alerts can delay sepsis identification and treatment. If they’re too abundant, the alerts can overwhelm providers. Finding the sweet spot for sepsis alerts, QI leaders say, can require time, technology, patience – and sometimes trial and error.

University Hospital in Salt Lake City wanted to broaden its sepsis recognition system to ensure that decompensating patients were seen and resuscitated quickly, regardless of the cause. Another hospital offered a lesson in what not to do when a staff member cautioned that a sepsis alert system based on SIRS alone had been a “total disaster” and left providers fuming. One report suggested that nearly half of all ward patients meet SIRS criteria at some point during their hospitalization, and that using the criteria for sepsis screening in hospital wards is both “time consuming and impractical.”1

Dr. Devin J. Horton, University of Utah, Salt Lake City

Instead, University Hospital tweaked its MEWS or Modified Early Warning System, based on consultations with hospitalists, ICU physicians, and other providers about the appropriate thresholds for vital signs. “It’s kind of like asking someone, ‘Well, when are you really scared of the heart rate and when are you sort of scared and when are you not scared at all?’ ” said project coleader Devin J. Horton, MD, an academic hospitalist.

The team also analyzed the number of alerts per week per unit and their sensitivity and specificity in detecting sepsis. As junior faculty members, Dr. Horton and his collaborator, academic hospitalist Kencee K. Graves, MD, were mindful to avoid angering other doctors over being alerted too often. For their MEWS scoring system, they sacrificed a bit of sensitivity to ensure that the number of alerts remained manageable.

Before going live with its own new alert system, Middlesex Hospital in Middletown, Conn., had a subgroup spend several weeks testing the system in silent mode and tweaking different parameters such as respiratory rate and heart rate to reduce the potential for too many alerts. “If you look at each and every alert, then you can identify how to make your adjustment so that it’s not overly sensitive,” said Terri Savino, MSN, RN, CPHQ, the hospital’s manager of patient experience and service excellence.

A sepsis task force also shared data showing the hospital’s significant reductions in sepsis mortality, total hospital mortality, and sepsis length of stay. “Medical staff were willing to accept the frequency and high sensitivity of the alert because the data demonstrated that it was making a difference in the lives of our patients,” said David M. Cosentino, MD, the hospital’s chief medical information officer.

Other alert systems’ mixed performances have yielded important lessons. At the University of Pennsylvania, Philadelphia, one prototype detected clinically deteriorating patients and sent an alert to the nurse, physician, and a rapid response team. Alerted providers converged on the patient’s bedside within 30 minutes and decided whether to elevate the level of care. Craig Umscheid, MD, MSCE, of the department of epidemiology and vice chair for quality and safety in the department of medicine, said the system was associated with a suggestion of reduced mortality.2 But it was noisy and less helpful than it could have been, he said, because it didn’t separate out declining patients already known to the team from those who were still unrecognized.

Tools to predict which patients may develop severe sepsis or septic shock have worked even less well, he said. One triggered an alarm before patients showed signs of clinical deterioration. “The team didn’t know what to do with that prediction,” Dr. Umscheid said. As a result, the alert didn’t improve mortality or discharges to home. “If you’re making this prediction too early and providers don’t know what to do with the information, it’s not going to change care or affect patient outcomes,” he said. “It’s just going to frustrate providers.”
 

References

1. Churpek MM et al. Incidence and prognostic value of the systemic inflammatory response syndrome and organ dysfunctions in ward patients. Am J Respir Crit Care Med. 2015 Oct 15;192(8):958-64.

2. Umscheid CA et al. Development, implementation, and impact of an automated early warning and response system for sepsis. J Hosp Med. 2015 Jan;10: 26-31.

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If they’re too infrequent, alerts can delay sepsis identification and treatment. If they’re too abundant, the alerts can overwhelm providers. Finding the sweet spot for sepsis alerts, QI leaders say, can require time, technology, patience – and sometimes trial and error.

University Hospital in Salt Lake City wanted to broaden its sepsis recognition system to ensure that decompensating patients were seen and resuscitated quickly, regardless of the cause. Another hospital offered a lesson in what not to do when a staff member cautioned that a sepsis alert system based on SIRS alone had been a “total disaster” and left providers fuming. One report suggested that nearly half of all ward patients meet SIRS criteria at some point during their hospitalization, and that using the criteria for sepsis screening in hospital wards is both “time consuming and impractical.”1

Dr. Devin J. Horton, University of Utah, Salt Lake City

Instead, University Hospital tweaked its MEWS or Modified Early Warning System, based on consultations with hospitalists, ICU physicians, and other providers about the appropriate thresholds for vital signs. “It’s kind of like asking someone, ‘Well, when are you really scared of the heart rate and when are you sort of scared and when are you not scared at all?’ ” said project coleader Devin J. Horton, MD, an academic hospitalist.

The team also analyzed the number of alerts per week per unit and their sensitivity and specificity in detecting sepsis. As junior faculty members, Dr. Horton and his collaborator, academic hospitalist Kencee K. Graves, MD, were mindful to avoid angering other doctors over being alerted too often. For their MEWS scoring system, they sacrificed a bit of sensitivity to ensure that the number of alerts remained manageable.

Before going live with its own new alert system, Middlesex Hospital in Middletown, Conn., had a subgroup spend several weeks testing the system in silent mode and tweaking different parameters such as respiratory rate and heart rate to reduce the potential for too many alerts. “If you look at each and every alert, then you can identify how to make your adjustment so that it’s not overly sensitive,” said Terri Savino, MSN, RN, CPHQ, the hospital’s manager of patient experience and service excellence.

A sepsis task force also shared data showing the hospital’s significant reductions in sepsis mortality, total hospital mortality, and sepsis length of stay. “Medical staff were willing to accept the frequency and high sensitivity of the alert because the data demonstrated that it was making a difference in the lives of our patients,” said David M. Cosentino, MD, the hospital’s chief medical information officer.

Other alert systems’ mixed performances have yielded important lessons. At the University of Pennsylvania, Philadelphia, one prototype detected clinically deteriorating patients and sent an alert to the nurse, physician, and a rapid response team. Alerted providers converged on the patient’s bedside within 30 minutes and decided whether to elevate the level of care. Craig Umscheid, MD, MSCE, of the department of epidemiology and vice chair for quality and safety in the department of medicine, said the system was associated with a suggestion of reduced mortality.2 But it was noisy and less helpful than it could have been, he said, because it didn’t separate out declining patients already known to the team from those who were still unrecognized.

Tools to predict which patients may develop severe sepsis or septic shock have worked even less well, he said. One triggered an alarm before patients showed signs of clinical deterioration. “The team didn’t know what to do with that prediction,” Dr. Umscheid said. As a result, the alert didn’t improve mortality or discharges to home. “If you’re making this prediction too early and providers don’t know what to do with the information, it’s not going to change care or affect patient outcomes,” he said. “It’s just going to frustrate providers.”
 

References

1. Churpek MM et al. Incidence and prognostic value of the systemic inflammatory response syndrome and organ dysfunctions in ward patients. Am J Respir Crit Care Med. 2015 Oct 15;192(8):958-64.

2. Umscheid CA et al. Development, implementation, and impact of an automated early warning and response system for sepsis. J Hosp Med. 2015 Jan;10: 26-31.

 

If they’re too infrequent, alerts can delay sepsis identification and treatment. If they’re too abundant, the alerts can overwhelm providers. Finding the sweet spot for sepsis alerts, QI leaders say, can require time, technology, patience – and sometimes trial and error.

University Hospital in Salt Lake City wanted to broaden its sepsis recognition system to ensure that decompensating patients were seen and resuscitated quickly, regardless of the cause. Another hospital offered a lesson in what not to do when a staff member cautioned that a sepsis alert system based on SIRS alone had been a “total disaster” and left providers fuming. One report suggested that nearly half of all ward patients meet SIRS criteria at some point during their hospitalization, and that using the criteria for sepsis screening in hospital wards is both “time consuming and impractical.”1

Dr. Devin J. Horton, University of Utah, Salt Lake City

Instead, University Hospital tweaked its MEWS or Modified Early Warning System, based on consultations with hospitalists, ICU physicians, and other providers about the appropriate thresholds for vital signs. “It’s kind of like asking someone, ‘Well, when are you really scared of the heart rate and when are you sort of scared and when are you not scared at all?’ ” said project coleader Devin J. Horton, MD, an academic hospitalist.

The team also analyzed the number of alerts per week per unit and their sensitivity and specificity in detecting sepsis. As junior faculty members, Dr. Horton and his collaborator, academic hospitalist Kencee K. Graves, MD, were mindful to avoid angering other doctors over being alerted too often. For their MEWS scoring system, they sacrificed a bit of sensitivity to ensure that the number of alerts remained manageable.

Before going live with its own new alert system, Middlesex Hospital in Middletown, Conn., had a subgroup spend several weeks testing the system in silent mode and tweaking different parameters such as respiratory rate and heart rate to reduce the potential for too many alerts. “If you look at each and every alert, then you can identify how to make your adjustment so that it’s not overly sensitive,” said Terri Savino, MSN, RN, CPHQ, the hospital’s manager of patient experience and service excellence.

A sepsis task force also shared data showing the hospital’s significant reductions in sepsis mortality, total hospital mortality, and sepsis length of stay. “Medical staff were willing to accept the frequency and high sensitivity of the alert because the data demonstrated that it was making a difference in the lives of our patients,” said David M. Cosentino, MD, the hospital’s chief medical information officer.

Other alert systems’ mixed performances have yielded important lessons. At the University of Pennsylvania, Philadelphia, one prototype detected clinically deteriorating patients and sent an alert to the nurse, physician, and a rapid response team. Alerted providers converged on the patient’s bedside within 30 minutes and decided whether to elevate the level of care. Craig Umscheid, MD, MSCE, of the department of epidemiology and vice chair for quality and safety in the department of medicine, said the system was associated with a suggestion of reduced mortality.2 But it was noisy and less helpful than it could have been, he said, because it didn’t separate out declining patients already known to the team from those who were still unrecognized.

Tools to predict which patients may develop severe sepsis or septic shock have worked even less well, he said. One triggered an alarm before patients showed signs of clinical deterioration. “The team didn’t know what to do with that prediction,” Dr. Umscheid said. As a result, the alert didn’t improve mortality or discharges to home. “If you’re making this prediction too early and providers don’t know what to do with the information, it’s not going to change care or affect patient outcomes,” he said. “It’s just going to frustrate providers.”
 

References

1. Churpek MM et al. Incidence and prognostic value of the systemic inflammatory response syndrome and organ dysfunctions in ward patients. Am J Respir Crit Care Med. 2015 Oct 15;192(8):958-64.

2. Umscheid CA et al. Development, implementation, and impact of an automated early warning and response system for sepsis. J Hosp Med. 2015 Jan;10: 26-31.

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Charting a new course in sepsis management

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‘Motivated and multidisciplinary’ team critical to improving sepsis care

 

A drug overdose victim is admitted to a hospital. Providers focus on treating the overdose and blame it for some of the patient’s troubling vital signs, including low blood pressure and increased heart rate. Prior to admission, however, the patient had vomited and aspirated, leading to an infection. In fact, the patient is developing sepsis.

This real-world incident is but one of many ways that sepsis can fool hospitalists and other providers, often with rapidly deteriorating and deadly consequences. A range of quality improvement (QI) projects, however, are demonstrating how earlier identification and treatment may help to set a new course for addressing a condition that has remained stubbornly difficult to manage.

Dr. Devin J. Horton, University of Utah, Salt Lake City
Dr. Devin J. Horton
Every year, more than 1.5 million Americans develop sepsis – arising from the body’s overwhelming and self-destructive response to infection – and roughly 250,000 die from it. According to the Centers for Disease Control and Prevention, about one in three hospital deaths can be at least partially linked to sepsis.

Devin J. Horton, MD, an academic hospitalist at University Hospital in Salt Lake City, sometimes compares sepsis to acute MI to illustrate the difficulty of early detection. A patient complaining of chest pain immediately sets in motion a well-rehearsed chain of events. “But the patient doesn’t look at you and say, ‘You know, I think I’m having SIRS [systemic inflammatory response syndrome] criteria in the setting of infection,’ ” he said. “And yet, the mortality of severe septic shock is at least as bad as acute myocardial infarction.” The trick is generating the same sense of urgency without a clear warning.

The location in a hospital also can present a major obstacle for early identification. Hospitalist Andy Odden, MD, SFHM, patient safety officer in the department of medicine at Washington University in St. Louis, calls hospital wards the “third space” of sepsis care, after the ICU and ED. “A lot of the historical improvement efforts and research has really focused on streamlining care in the ICU and streamlining care in the emergency department,” he said. Often, however, sepsis or septic shock isn’t recognized until a patient is admitted to a medical or surgical ward.

Dr. Andy Odden, patient safety officer in the department of medicine at Washington University in St. Louis
Dr. Andy Odden
Patients on the wards, though, usually begin with a nonsepsis diagnosis, which can produce an anchoring bias. Furthermore, Dr. Odden said, the data needed to identify sepsis may arrive asynchronously, increasingly the difficulty of pulling it all together for a timely diagnosis. As Dr. Horton points out, the trigger for transferring a decompensating sepsis patient from the wards to the ICU is murkier as well. “We don’t know what is too sick for the floor,” he said. “A lot of it is kind of a gestalt.”

Observational studies by the Surviving Sepsis Campaign suggested that patients diagnosed on the floor had mortality rates comparable to and substantially higher than theoretically sicker patients diagnosed in the ICU and ED, respectively.1 “That was kind of a sea change for a lot of people and really articulated what a lot of us on the wards had been feeling,” Dr. Odden said. “We can’t simply apply the lessons that we’ve learned from the emergency department and the ICU to the wards if we’re going to provide the right care for these patients,” he said.
 

Dueling definitions

Better sepsis care in hospital wards will require a better understanding of shifting management guidelines. Confusing and contradictory definitions haven’t helped. In October 2015, the Centers for Medicare & Medicaid Services instituted its Sepsis Core Measure (SEP-1) for Medicare, requiring every hospital to audit a percentage of patients treated with best-practice 3- and 6-hour bundles for severe sepsis and septic shock. The SEP-1 measure uses the traditional definition of severe sepsis as two or more SIRS criteria, a suspected or proven infection, and organ dysfunction.

A separate set of guidelines issued by the international Sepsis-3 task force in February 2016, by contrast, concluded that the term “severe sepsis” is redundant.2 The update defines sepsis as “life-threatening organ dysfunction caused by a dysregulated host response to infection” and asserts that the condition can be represented by an increase in the SOFA (Sequential Organ Failure Assessment) score of 2 or more points.

For hospital wards, the task force recommended a bedside scoring system called qSOFA (quickSOFA) for adult patients with a suspected infection. The risk stratification tool may help rapidly identify those who are likely to have poorer outcomes typical of sepsis if they meet two of the following three clinical criteria: a “respiratory rate of 22 [breaths]/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less.”

CMS doesn’t recognize the Sepsis-3 definition at all and multiple providers have described widespread skepticism and uncertainty over how to reconcile it with the prior definition. Dr. Odden says the dueling definitions have “caused a tremendous amount of confusion” over diagnoses, the necessary sense of urgency, and whether severe sepsis is still a recognized entity. “When people aren’t speaking the same language with the same terminology, there is enormous opportunity for miscommunication to occur,” he said.

Dr. Lisa Shieh, medical director of quality in the department of medicine at Stanford (Calif.) University Medical Center
Dr. Lisa Shieh
Hospitalist Lisa Shieh, MD, PhD, medical director of quality in the department of medicine at Stanford (Calif.) University Medical Center, said Sepsis-3 was never meant to be a screening tool. It can, however, help doctors identify patients at higher risk. Craig A. Umscheid, MD, MSCE, of the department of epidemiology and vice chair for quality and safety in the department of medicine at the University of Pennsylvania, Philadelphia, said many providers agree that, at least theoretically, changes in a patient’s qSOFA score can predict bad outcomes better than SIRS criteria.

Obtaining reliable scores is another matter. The qSOFA blood pressure score generally is measured accurately, he said. On noncritical care units, though, nurses aren’t always trained to consistently and accurately document a patient’s mental status. Likewise, he said, documentation of respiratory rate often is subjective, and an abnormal rate can be easily missed. Changing that dynamic, he stressed, will require coordination with nursing leadership to ensure more consistent and accurate measurements.

Dr. Craig Umscheid, of the department of epidemiology and vice chair for quality and safety in the department of medicine at the University of Pennsylvania, Philadelphia
Dr. Craig Umscheid
Another big issue is that sepsis screening still is based on early recognition, Dr. Shieh said. “The problem with Sepsis-3 is that it is later in the continuum of sepsis.” As such, she recommends sticking with the CMS definition for now. “It catches sepsis earlier, which is the whole strategy for improving sepsis mortality,” she said.
 

 

 

Reshaping sepsis pathways

So how can hospitals identify sepsis sooner? Some hospitals have relied more on EMR-based screening methods; others have relied more on nurses to lead the charge. Either way, Dr. Shieh said, the field is trying to encourage the use of set pathways. Almost every medical center that performs well on sepsis measures, she says, has a good screening program, a pathway implemented through an order set or nursing staff, and a highly trained sepsis team that ensures patients get the treatment they need.

At Middlesex Hospital in Middletown, Conn., a major QI project led to significant improvements in sepsis mortality, total mortality, sepsis-related serious safety events and sepsis length of stay. Terri Savino, MSN, RN, CPHQ, the hospital’s manager of patient experience and service excellence, said the project sprang from concerns by the hospital’s Rapid Response Review Committee about some serious safety events involving a delay in sepsis diagnosis and treatment.

Terri Savino, manager of patient experience and service excellence, Middlesex Hospital in Middletown, Conn
Terri Savino
As part of a QI effort led by an interdepartmental task force, the hospital first updated its inpatient and ED sepsis pathways to incorporate the Surviving Sepsis Campaign’s 2012 guidelines. “We continued to tweak our pathways, so they’ve now embedded other infection pathways into the sepsis pathway to make sure that we’re not missing anybody,” Ms. Savino said. The hospital also launched an early recognition and treatment educational effort targeting all health care staff and rolled out a new electronic early-warning system in February 2014.

In 2013, the hospital documented three serious safety events related to a delay in diagnosis and treatment of sepsis. In 2014, it recorded only one event and has had none since then. From 2014 to 2015, sepsis-related mortality fell by more than 20%, saving an estimated 25 lives. Sepsis length of stay also declined. “We’re identifying them sooner and treating them sooner so they’re not getting as sick or requiring critical care and longer length of stays,” Ms. Savino said.

Dr. Odden has participated in two multicenter QI initiatives on sepsis. One, a partnership led by the Institute for Healthcare Improvement in Cambridge, Mass., and New York’s North Shore-LIJ Health System, focused on how to diagnose sepsis in hospital ward patients as quickly as possible and how to successfully deliver the 3-hour sepsis bundle.3 Beyond getting everyone on the same page regarding definitions, he said, the collaborators discussed and shared strategies for identifying patients. “One hospital would often have a solution for a problem that other hospitals could either take directly or modify based on their own understanding of their own processes,” he said.

Dr. Odden also participated in a national project sponsored by the Surviving Sepsis Campaign that focused on developing protocols for nurse-led screening processes in hospital wards. Within a pilot unit of each participating hospital, bedside nurses screened every patient for sepsis during every shift. For positive screens, the hospitals then developed protocols for order sets, like blood work and fluids.

The initiative suggested that a nurse-based, every-shift screening method might be one feasible way to identify sick patients as early as possible. “Going through the screening process really seemed to empower the nurses to take a much more active role in partnering with the physicians and in recognizing some of the early warning signs,” Dr. Odden said. The project led to other benefits as well, including improved identification of strokes, delirium, and even a gastrointestinal bleed because the “barriers in communication had been broken down,” he said.

To help medical providers recognize sepsis earlier, Dr. Shieh and her colleagues created a free game called Septris as an adjunctive teaching tool. Based on a player’s diagnosis and treatment decisions, patient outcomes either rise or fall – often rapidly. “I’m an educator and what I know is that the best way you learn is by doing,” she said. The interactive and repetitive nature of Septris, she said, helps its take-home messages stick in a player’s mind without the expense of patient simulations. Dr. Shieh said the game has been adapted for German and British medical institutions as well, and that she collects data from players around the world about their experiences and scores.
 

Winning interdisciplinary buy-in

To maximize the chances for success, several doctors emphasize the importance of forming an interdisciplinary task force that includes every department affected by a QI project. Ms. Savino said executive sponsorship of her hospital’s QI project was key as well. So was meeting frequently with the carefully chosen team members representing key stakeholders throughout the hospital. “It was a lot of work,” she said. “But I really think that was one reason why it was so successful. We had everybody’s buy-in, and we kept our short-term goals on track.”

 

 

Dr. Kencee K. Graves, an academic hospitalist at the University of Utah, Salt Lake City
Dr. Kencee K. Graves
Dr. Horton and collaborator Kencee K. Graves, MD, an academic hospitalist at the University of Utah, Salt Lake City, agreed that “face time” was the best way to get buy-in throughout their hospital during their own QI initiative. “We spent a lot of time sitting and listening to concerns and feedback from providers,” Dr. Graves said. “We would then integrate some of their feedback into the process, so people they knew they were heard.” Securing the buy-in of nursing staff was another huge key to their success in improving the quality of sepsis care and reducing costs.4 “Honestly, they were the secret sauce of the whole project,” Dr. Horton said. Changing the culture in the hospital helped immensely but required considerable time and patience to build both trust and acceptance within different units.

Based on their success, the QI initiative has spread to two other hospitals in the University of Utah’s network. “Once the culture changes have been made and the project’s up and going, it’s kind of self-sufficient,” Dr. Horton said. “But it was so much work.” He and Dr. Graves are careful to emphasize that there are other options for sepsis-related QI efforts. “I think it is better to start something small than to believe you can’t do anything at all,” Dr. Graves said.

No matter what the size, assembling a motivated and multidisciplinary team is critical, she said. So is empowering nurses to talk to physicians about decompensating patients and other aspects of sepsis care. Being available and willing to listen to other providers also can pay big dividends. “Knowing that we cared about the project’s success was important to people working on it,” Dr. Graves said.

Despite the remaining challenges, Dr. Shieh points out that sepsis mortality rates have improved significantly, thanks in large part to more awareness and ambitious QI projects. “I do want to say that we have come a long way,” she said.
 

References

1. Levy MM et al. Surviving Sepsis Campaign: Association between performance metrics and outcomes in a 7.5-year study. Intensive Care Med. 2014 Nov;40(11):1623-33.

2. Singer M et al. The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA. 2016;315(8):801-10.

3. Schorr C et al. Implementation of a multicenter performance improvement program for early detection and treatment of severe sepsis in general medical-surgical wards. J Hosp Med. 2016 Nov;11:S32-9.

4. Lee VS et al. Implementation of a value-driven outcomes program to identify high variability in clinical costs and outcomes and association with reduced cost and improved quality. JAMA. 2016 Sep 13;316(10):1061-72.

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‘Motivated and multidisciplinary’ team critical to improving sepsis care
‘Motivated and multidisciplinary’ team critical to improving sepsis care

 

A drug overdose victim is admitted to a hospital. Providers focus on treating the overdose and blame it for some of the patient’s troubling vital signs, including low blood pressure and increased heart rate. Prior to admission, however, the patient had vomited and aspirated, leading to an infection. In fact, the patient is developing sepsis.

This real-world incident is but one of many ways that sepsis can fool hospitalists and other providers, often with rapidly deteriorating and deadly consequences. A range of quality improvement (QI) projects, however, are demonstrating how earlier identification and treatment may help to set a new course for addressing a condition that has remained stubbornly difficult to manage.

Dr. Devin J. Horton, University of Utah, Salt Lake City
Dr. Devin J. Horton
Every year, more than 1.5 million Americans develop sepsis – arising from the body’s overwhelming and self-destructive response to infection – and roughly 250,000 die from it. According to the Centers for Disease Control and Prevention, about one in three hospital deaths can be at least partially linked to sepsis.

Devin J. Horton, MD, an academic hospitalist at University Hospital in Salt Lake City, sometimes compares sepsis to acute MI to illustrate the difficulty of early detection. A patient complaining of chest pain immediately sets in motion a well-rehearsed chain of events. “But the patient doesn’t look at you and say, ‘You know, I think I’m having SIRS [systemic inflammatory response syndrome] criteria in the setting of infection,’ ” he said. “And yet, the mortality of severe septic shock is at least as bad as acute myocardial infarction.” The trick is generating the same sense of urgency without a clear warning.

The location in a hospital also can present a major obstacle for early identification. Hospitalist Andy Odden, MD, SFHM, patient safety officer in the department of medicine at Washington University in St. Louis, calls hospital wards the “third space” of sepsis care, after the ICU and ED. “A lot of the historical improvement efforts and research has really focused on streamlining care in the ICU and streamlining care in the emergency department,” he said. Often, however, sepsis or septic shock isn’t recognized until a patient is admitted to a medical or surgical ward.

Dr. Andy Odden, patient safety officer in the department of medicine at Washington University in St. Louis
Dr. Andy Odden
Patients on the wards, though, usually begin with a nonsepsis diagnosis, which can produce an anchoring bias. Furthermore, Dr. Odden said, the data needed to identify sepsis may arrive asynchronously, increasingly the difficulty of pulling it all together for a timely diagnosis. As Dr. Horton points out, the trigger for transferring a decompensating sepsis patient from the wards to the ICU is murkier as well. “We don’t know what is too sick for the floor,” he said. “A lot of it is kind of a gestalt.”

Observational studies by the Surviving Sepsis Campaign suggested that patients diagnosed on the floor had mortality rates comparable to and substantially higher than theoretically sicker patients diagnosed in the ICU and ED, respectively.1 “That was kind of a sea change for a lot of people and really articulated what a lot of us on the wards had been feeling,” Dr. Odden said. “We can’t simply apply the lessons that we’ve learned from the emergency department and the ICU to the wards if we’re going to provide the right care for these patients,” he said.
 

Dueling definitions

Better sepsis care in hospital wards will require a better understanding of shifting management guidelines. Confusing and contradictory definitions haven’t helped. In October 2015, the Centers for Medicare & Medicaid Services instituted its Sepsis Core Measure (SEP-1) for Medicare, requiring every hospital to audit a percentage of patients treated with best-practice 3- and 6-hour bundles for severe sepsis and septic shock. The SEP-1 measure uses the traditional definition of severe sepsis as two or more SIRS criteria, a suspected or proven infection, and organ dysfunction.

A separate set of guidelines issued by the international Sepsis-3 task force in February 2016, by contrast, concluded that the term “severe sepsis” is redundant.2 The update defines sepsis as “life-threatening organ dysfunction caused by a dysregulated host response to infection” and asserts that the condition can be represented by an increase in the SOFA (Sequential Organ Failure Assessment) score of 2 or more points.

For hospital wards, the task force recommended a bedside scoring system called qSOFA (quickSOFA) for adult patients with a suspected infection. The risk stratification tool may help rapidly identify those who are likely to have poorer outcomes typical of sepsis if they meet two of the following three clinical criteria: a “respiratory rate of 22 [breaths]/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less.”

CMS doesn’t recognize the Sepsis-3 definition at all and multiple providers have described widespread skepticism and uncertainty over how to reconcile it with the prior definition. Dr. Odden says the dueling definitions have “caused a tremendous amount of confusion” over diagnoses, the necessary sense of urgency, and whether severe sepsis is still a recognized entity. “When people aren’t speaking the same language with the same terminology, there is enormous opportunity for miscommunication to occur,” he said.

Dr. Lisa Shieh, medical director of quality in the department of medicine at Stanford (Calif.) University Medical Center
Dr. Lisa Shieh
Hospitalist Lisa Shieh, MD, PhD, medical director of quality in the department of medicine at Stanford (Calif.) University Medical Center, said Sepsis-3 was never meant to be a screening tool. It can, however, help doctors identify patients at higher risk. Craig A. Umscheid, MD, MSCE, of the department of epidemiology and vice chair for quality and safety in the department of medicine at the University of Pennsylvania, Philadelphia, said many providers agree that, at least theoretically, changes in a patient’s qSOFA score can predict bad outcomes better than SIRS criteria.

Obtaining reliable scores is another matter. The qSOFA blood pressure score generally is measured accurately, he said. On noncritical care units, though, nurses aren’t always trained to consistently and accurately document a patient’s mental status. Likewise, he said, documentation of respiratory rate often is subjective, and an abnormal rate can be easily missed. Changing that dynamic, he stressed, will require coordination with nursing leadership to ensure more consistent and accurate measurements.

Dr. Craig Umscheid, of the department of epidemiology and vice chair for quality and safety in the department of medicine at the University of Pennsylvania, Philadelphia
Dr. Craig Umscheid
Another big issue is that sepsis screening still is based on early recognition, Dr. Shieh said. “The problem with Sepsis-3 is that it is later in the continuum of sepsis.” As such, she recommends sticking with the CMS definition for now. “It catches sepsis earlier, which is the whole strategy for improving sepsis mortality,” she said.
 

 

 

Reshaping sepsis pathways

So how can hospitals identify sepsis sooner? Some hospitals have relied more on EMR-based screening methods; others have relied more on nurses to lead the charge. Either way, Dr. Shieh said, the field is trying to encourage the use of set pathways. Almost every medical center that performs well on sepsis measures, she says, has a good screening program, a pathway implemented through an order set or nursing staff, and a highly trained sepsis team that ensures patients get the treatment they need.

At Middlesex Hospital in Middletown, Conn., a major QI project led to significant improvements in sepsis mortality, total mortality, sepsis-related serious safety events and sepsis length of stay. Terri Savino, MSN, RN, CPHQ, the hospital’s manager of patient experience and service excellence, said the project sprang from concerns by the hospital’s Rapid Response Review Committee about some serious safety events involving a delay in sepsis diagnosis and treatment.

Terri Savino, manager of patient experience and service excellence, Middlesex Hospital in Middletown, Conn
Terri Savino
As part of a QI effort led by an interdepartmental task force, the hospital first updated its inpatient and ED sepsis pathways to incorporate the Surviving Sepsis Campaign’s 2012 guidelines. “We continued to tweak our pathways, so they’ve now embedded other infection pathways into the sepsis pathway to make sure that we’re not missing anybody,” Ms. Savino said. The hospital also launched an early recognition and treatment educational effort targeting all health care staff and rolled out a new electronic early-warning system in February 2014.

In 2013, the hospital documented three serious safety events related to a delay in diagnosis and treatment of sepsis. In 2014, it recorded only one event and has had none since then. From 2014 to 2015, sepsis-related mortality fell by more than 20%, saving an estimated 25 lives. Sepsis length of stay also declined. “We’re identifying them sooner and treating them sooner so they’re not getting as sick or requiring critical care and longer length of stays,” Ms. Savino said.

Dr. Odden has participated in two multicenter QI initiatives on sepsis. One, a partnership led by the Institute for Healthcare Improvement in Cambridge, Mass., and New York’s North Shore-LIJ Health System, focused on how to diagnose sepsis in hospital ward patients as quickly as possible and how to successfully deliver the 3-hour sepsis bundle.3 Beyond getting everyone on the same page regarding definitions, he said, the collaborators discussed and shared strategies for identifying patients. “One hospital would often have a solution for a problem that other hospitals could either take directly or modify based on their own understanding of their own processes,” he said.

Dr. Odden also participated in a national project sponsored by the Surviving Sepsis Campaign that focused on developing protocols for nurse-led screening processes in hospital wards. Within a pilot unit of each participating hospital, bedside nurses screened every patient for sepsis during every shift. For positive screens, the hospitals then developed protocols for order sets, like blood work and fluids.

The initiative suggested that a nurse-based, every-shift screening method might be one feasible way to identify sick patients as early as possible. “Going through the screening process really seemed to empower the nurses to take a much more active role in partnering with the physicians and in recognizing some of the early warning signs,” Dr. Odden said. The project led to other benefits as well, including improved identification of strokes, delirium, and even a gastrointestinal bleed because the “barriers in communication had been broken down,” he said.

To help medical providers recognize sepsis earlier, Dr. Shieh and her colleagues created a free game called Septris as an adjunctive teaching tool. Based on a player’s diagnosis and treatment decisions, patient outcomes either rise or fall – often rapidly. “I’m an educator and what I know is that the best way you learn is by doing,” she said. The interactive and repetitive nature of Septris, she said, helps its take-home messages stick in a player’s mind without the expense of patient simulations. Dr. Shieh said the game has been adapted for German and British medical institutions as well, and that she collects data from players around the world about their experiences and scores.
 

Winning interdisciplinary buy-in

To maximize the chances for success, several doctors emphasize the importance of forming an interdisciplinary task force that includes every department affected by a QI project. Ms. Savino said executive sponsorship of her hospital’s QI project was key as well. So was meeting frequently with the carefully chosen team members representing key stakeholders throughout the hospital. “It was a lot of work,” she said. “But I really think that was one reason why it was so successful. We had everybody’s buy-in, and we kept our short-term goals on track.”

 

 

Dr. Kencee K. Graves, an academic hospitalist at the University of Utah, Salt Lake City
Dr. Kencee K. Graves
Dr. Horton and collaborator Kencee K. Graves, MD, an academic hospitalist at the University of Utah, Salt Lake City, agreed that “face time” was the best way to get buy-in throughout their hospital during their own QI initiative. “We spent a lot of time sitting and listening to concerns and feedback from providers,” Dr. Graves said. “We would then integrate some of their feedback into the process, so people they knew they were heard.” Securing the buy-in of nursing staff was another huge key to their success in improving the quality of sepsis care and reducing costs.4 “Honestly, they were the secret sauce of the whole project,” Dr. Horton said. Changing the culture in the hospital helped immensely but required considerable time and patience to build both trust and acceptance within different units.

Based on their success, the QI initiative has spread to two other hospitals in the University of Utah’s network. “Once the culture changes have been made and the project’s up and going, it’s kind of self-sufficient,” Dr. Horton said. “But it was so much work.” He and Dr. Graves are careful to emphasize that there are other options for sepsis-related QI efforts. “I think it is better to start something small than to believe you can’t do anything at all,” Dr. Graves said.

No matter what the size, assembling a motivated and multidisciplinary team is critical, she said. So is empowering nurses to talk to physicians about decompensating patients and other aspects of sepsis care. Being available and willing to listen to other providers also can pay big dividends. “Knowing that we cared about the project’s success was important to people working on it,” Dr. Graves said.

Despite the remaining challenges, Dr. Shieh points out that sepsis mortality rates have improved significantly, thanks in large part to more awareness and ambitious QI projects. “I do want to say that we have come a long way,” she said.
 

References

1. Levy MM et al. Surviving Sepsis Campaign: Association between performance metrics and outcomes in a 7.5-year study. Intensive Care Med. 2014 Nov;40(11):1623-33.

2. Singer M et al. The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA. 2016;315(8):801-10.

3. Schorr C et al. Implementation of a multicenter performance improvement program for early detection and treatment of severe sepsis in general medical-surgical wards. J Hosp Med. 2016 Nov;11:S32-9.

4. Lee VS et al. Implementation of a value-driven outcomes program to identify high variability in clinical costs and outcomes and association with reduced cost and improved quality. JAMA. 2016 Sep 13;316(10):1061-72.

 

A drug overdose victim is admitted to a hospital. Providers focus on treating the overdose and blame it for some of the patient’s troubling vital signs, including low blood pressure and increased heart rate. Prior to admission, however, the patient had vomited and aspirated, leading to an infection. In fact, the patient is developing sepsis.

This real-world incident is but one of many ways that sepsis can fool hospitalists and other providers, often with rapidly deteriorating and deadly consequences. A range of quality improvement (QI) projects, however, are demonstrating how earlier identification and treatment may help to set a new course for addressing a condition that has remained stubbornly difficult to manage.

Dr. Devin J. Horton, University of Utah, Salt Lake City
Dr. Devin J. Horton
Every year, more than 1.5 million Americans develop sepsis – arising from the body’s overwhelming and self-destructive response to infection – and roughly 250,000 die from it. According to the Centers for Disease Control and Prevention, about one in three hospital deaths can be at least partially linked to sepsis.

Devin J. Horton, MD, an academic hospitalist at University Hospital in Salt Lake City, sometimes compares sepsis to acute MI to illustrate the difficulty of early detection. A patient complaining of chest pain immediately sets in motion a well-rehearsed chain of events. “But the patient doesn’t look at you and say, ‘You know, I think I’m having SIRS [systemic inflammatory response syndrome] criteria in the setting of infection,’ ” he said. “And yet, the mortality of severe septic shock is at least as bad as acute myocardial infarction.” The trick is generating the same sense of urgency without a clear warning.

The location in a hospital also can present a major obstacle for early identification. Hospitalist Andy Odden, MD, SFHM, patient safety officer in the department of medicine at Washington University in St. Louis, calls hospital wards the “third space” of sepsis care, after the ICU and ED. “A lot of the historical improvement efforts and research has really focused on streamlining care in the ICU and streamlining care in the emergency department,” he said. Often, however, sepsis or septic shock isn’t recognized until a patient is admitted to a medical or surgical ward.

Dr. Andy Odden, patient safety officer in the department of medicine at Washington University in St. Louis
Dr. Andy Odden
Patients on the wards, though, usually begin with a nonsepsis diagnosis, which can produce an anchoring bias. Furthermore, Dr. Odden said, the data needed to identify sepsis may arrive asynchronously, increasingly the difficulty of pulling it all together for a timely diagnosis. As Dr. Horton points out, the trigger for transferring a decompensating sepsis patient from the wards to the ICU is murkier as well. “We don’t know what is too sick for the floor,” he said. “A lot of it is kind of a gestalt.”

Observational studies by the Surviving Sepsis Campaign suggested that patients diagnosed on the floor had mortality rates comparable to and substantially higher than theoretically sicker patients diagnosed in the ICU and ED, respectively.1 “That was kind of a sea change for a lot of people and really articulated what a lot of us on the wards had been feeling,” Dr. Odden said. “We can’t simply apply the lessons that we’ve learned from the emergency department and the ICU to the wards if we’re going to provide the right care for these patients,” he said.
 

Dueling definitions

Better sepsis care in hospital wards will require a better understanding of shifting management guidelines. Confusing and contradictory definitions haven’t helped. In October 2015, the Centers for Medicare & Medicaid Services instituted its Sepsis Core Measure (SEP-1) for Medicare, requiring every hospital to audit a percentage of patients treated with best-practice 3- and 6-hour bundles for severe sepsis and septic shock. The SEP-1 measure uses the traditional definition of severe sepsis as two or more SIRS criteria, a suspected or proven infection, and organ dysfunction.

A separate set of guidelines issued by the international Sepsis-3 task force in February 2016, by contrast, concluded that the term “severe sepsis” is redundant.2 The update defines sepsis as “life-threatening organ dysfunction caused by a dysregulated host response to infection” and asserts that the condition can be represented by an increase in the SOFA (Sequential Organ Failure Assessment) score of 2 or more points.

For hospital wards, the task force recommended a bedside scoring system called qSOFA (quickSOFA) for adult patients with a suspected infection. The risk stratification tool may help rapidly identify those who are likely to have poorer outcomes typical of sepsis if they meet two of the following three clinical criteria: a “respiratory rate of 22 [breaths]/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less.”

CMS doesn’t recognize the Sepsis-3 definition at all and multiple providers have described widespread skepticism and uncertainty over how to reconcile it with the prior definition. Dr. Odden says the dueling definitions have “caused a tremendous amount of confusion” over diagnoses, the necessary sense of urgency, and whether severe sepsis is still a recognized entity. “When people aren’t speaking the same language with the same terminology, there is enormous opportunity for miscommunication to occur,” he said.

Dr. Lisa Shieh, medical director of quality in the department of medicine at Stanford (Calif.) University Medical Center
Dr. Lisa Shieh
Hospitalist Lisa Shieh, MD, PhD, medical director of quality in the department of medicine at Stanford (Calif.) University Medical Center, said Sepsis-3 was never meant to be a screening tool. It can, however, help doctors identify patients at higher risk. Craig A. Umscheid, MD, MSCE, of the department of epidemiology and vice chair for quality and safety in the department of medicine at the University of Pennsylvania, Philadelphia, said many providers agree that, at least theoretically, changes in a patient’s qSOFA score can predict bad outcomes better than SIRS criteria.

Obtaining reliable scores is another matter. The qSOFA blood pressure score generally is measured accurately, he said. On noncritical care units, though, nurses aren’t always trained to consistently and accurately document a patient’s mental status. Likewise, he said, documentation of respiratory rate often is subjective, and an abnormal rate can be easily missed. Changing that dynamic, he stressed, will require coordination with nursing leadership to ensure more consistent and accurate measurements.

Dr. Craig Umscheid, of the department of epidemiology and vice chair for quality and safety in the department of medicine at the University of Pennsylvania, Philadelphia
Dr. Craig Umscheid
Another big issue is that sepsis screening still is based on early recognition, Dr. Shieh said. “The problem with Sepsis-3 is that it is later in the continuum of sepsis.” As such, she recommends sticking with the CMS definition for now. “It catches sepsis earlier, which is the whole strategy for improving sepsis mortality,” she said.
 

 

 

Reshaping sepsis pathways

So how can hospitals identify sepsis sooner? Some hospitals have relied more on EMR-based screening methods; others have relied more on nurses to lead the charge. Either way, Dr. Shieh said, the field is trying to encourage the use of set pathways. Almost every medical center that performs well on sepsis measures, she says, has a good screening program, a pathway implemented through an order set or nursing staff, and a highly trained sepsis team that ensures patients get the treatment they need.

At Middlesex Hospital in Middletown, Conn., a major QI project led to significant improvements in sepsis mortality, total mortality, sepsis-related serious safety events and sepsis length of stay. Terri Savino, MSN, RN, CPHQ, the hospital’s manager of patient experience and service excellence, said the project sprang from concerns by the hospital’s Rapid Response Review Committee about some serious safety events involving a delay in sepsis diagnosis and treatment.

Terri Savino, manager of patient experience and service excellence, Middlesex Hospital in Middletown, Conn
Terri Savino
As part of a QI effort led by an interdepartmental task force, the hospital first updated its inpatient and ED sepsis pathways to incorporate the Surviving Sepsis Campaign’s 2012 guidelines. “We continued to tweak our pathways, so they’ve now embedded other infection pathways into the sepsis pathway to make sure that we’re not missing anybody,” Ms. Savino said. The hospital also launched an early recognition and treatment educational effort targeting all health care staff and rolled out a new electronic early-warning system in February 2014.

In 2013, the hospital documented three serious safety events related to a delay in diagnosis and treatment of sepsis. In 2014, it recorded only one event and has had none since then. From 2014 to 2015, sepsis-related mortality fell by more than 20%, saving an estimated 25 lives. Sepsis length of stay also declined. “We’re identifying them sooner and treating them sooner so they’re not getting as sick or requiring critical care and longer length of stays,” Ms. Savino said.

Dr. Odden has participated in two multicenter QI initiatives on sepsis. One, a partnership led by the Institute for Healthcare Improvement in Cambridge, Mass., and New York’s North Shore-LIJ Health System, focused on how to diagnose sepsis in hospital ward patients as quickly as possible and how to successfully deliver the 3-hour sepsis bundle.3 Beyond getting everyone on the same page regarding definitions, he said, the collaborators discussed and shared strategies for identifying patients. “One hospital would often have a solution for a problem that other hospitals could either take directly or modify based on their own understanding of their own processes,” he said.

Dr. Odden also participated in a national project sponsored by the Surviving Sepsis Campaign that focused on developing protocols for nurse-led screening processes in hospital wards. Within a pilot unit of each participating hospital, bedside nurses screened every patient for sepsis during every shift. For positive screens, the hospitals then developed protocols for order sets, like blood work and fluids.

The initiative suggested that a nurse-based, every-shift screening method might be one feasible way to identify sick patients as early as possible. “Going through the screening process really seemed to empower the nurses to take a much more active role in partnering with the physicians and in recognizing some of the early warning signs,” Dr. Odden said. The project led to other benefits as well, including improved identification of strokes, delirium, and even a gastrointestinal bleed because the “barriers in communication had been broken down,” he said.

To help medical providers recognize sepsis earlier, Dr. Shieh and her colleagues created a free game called Septris as an adjunctive teaching tool. Based on a player’s diagnosis and treatment decisions, patient outcomes either rise or fall – often rapidly. “I’m an educator and what I know is that the best way you learn is by doing,” she said. The interactive and repetitive nature of Septris, she said, helps its take-home messages stick in a player’s mind without the expense of patient simulations. Dr. Shieh said the game has been adapted for German and British medical institutions as well, and that she collects data from players around the world about their experiences and scores.
 

Winning interdisciplinary buy-in

To maximize the chances for success, several doctors emphasize the importance of forming an interdisciplinary task force that includes every department affected by a QI project. Ms. Savino said executive sponsorship of her hospital’s QI project was key as well. So was meeting frequently with the carefully chosen team members representing key stakeholders throughout the hospital. “It was a lot of work,” she said. “But I really think that was one reason why it was so successful. We had everybody’s buy-in, and we kept our short-term goals on track.”

 

 

Dr. Kencee K. Graves, an academic hospitalist at the University of Utah, Salt Lake City
Dr. Kencee K. Graves
Dr. Horton and collaborator Kencee K. Graves, MD, an academic hospitalist at the University of Utah, Salt Lake City, agreed that “face time” was the best way to get buy-in throughout their hospital during their own QI initiative. “We spent a lot of time sitting and listening to concerns and feedback from providers,” Dr. Graves said. “We would then integrate some of their feedback into the process, so people they knew they were heard.” Securing the buy-in of nursing staff was another huge key to their success in improving the quality of sepsis care and reducing costs.4 “Honestly, they were the secret sauce of the whole project,” Dr. Horton said. Changing the culture in the hospital helped immensely but required considerable time and patience to build both trust and acceptance within different units.

Based on their success, the QI initiative has spread to two other hospitals in the University of Utah’s network. “Once the culture changes have been made and the project’s up and going, it’s kind of self-sufficient,” Dr. Horton said. “But it was so much work.” He and Dr. Graves are careful to emphasize that there are other options for sepsis-related QI efforts. “I think it is better to start something small than to believe you can’t do anything at all,” Dr. Graves said.

No matter what the size, assembling a motivated and multidisciplinary team is critical, she said. So is empowering nurses to talk to physicians about decompensating patients and other aspects of sepsis care. Being available and willing to listen to other providers also can pay big dividends. “Knowing that we cared about the project’s success was important to people working on it,” Dr. Graves said.

Despite the remaining challenges, Dr. Shieh points out that sepsis mortality rates have improved significantly, thanks in large part to more awareness and ambitious QI projects. “I do want to say that we have come a long way,” she said.
 

References

1. Levy MM et al. Surviving Sepsis Campaign: Association between performance metrics and outcomes in a 7.5-year study. Intensive Care Med. 2014 Nov;40(11):1623-33.

2. Singer M et al. The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA. 2016;315(8):801-10.

3. Schorr C et al. Implementation of a multicenter performance improvement program for early detection and treatment of severe sepsis in general medical-surgical wards. J Hosp Med. 2016 Nov;11:S32-9.

4. Lee VS et al. Implementation of a value-driven outcomes program to identify high variability in clinical costs and outcomes and association with reduced cost and improved quality. JAMA. 2016 Sep 13;316(10):1061-72.

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Naloxone: Difficult conversations about a potential lifesaver

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Assessing an opioid-safety intervention

 

New tools to help minimize the risk of opioid-related adverse events are becoming more widely available, although providers are still struggling over how best to implement them.

A recent study by Shane Mueller, MSW, and Ingrid Binswanger, MD, at Kaiser Permanente Colorado Institute for Health Research, Denver, for instance, found that doctors are frequently uncomfortable prescribing the opioid antagonist naloxone to counteract a potential overdose.1

Shane Mueller is a project manager at the Kaiser Permanente Colorado Institute for Health Research.
Shane Mueller
The discomfort may prevent doctors from having difficult but necessary conversations about the medication’s risks and benefits, says Mr. Mueller, a project manager at the institute. For their part, patients recognized the utility of naloxone but were afraid that accepting a prescription for it would suggest that they were misusing their opioid medication.

Although much of the research was conducted in outpatient settings, the researchers say several lessons may be translated to the hospital readily. “Patients were really willing to embrace the idea of naloxone when it was framed to be used in a worst-case scenario,” Mr. Mueller said; some providers, for example, compared it to having a fire extinguisher in the house. “I think one patient said, ‘You know, I don’t plan on starting a fire in my kitchen, but it’s good to have there just in case something goes wrong.’ ”

Another important lesson, Mr. Mueller said, is to consider multiple factors that might heighten the overdose risk, such as a change in the prescription or a medical condition like renal failure. Including those considerations in a conversation might help destigmatize the topic and help patients who are concerned that they might be perceived as misusing the medication.

Dr. Ingrid Binswanger is a hospitalist in Denver.
Dr. Ingrid Binswanger
The study suggested that, when providers adopted a nonjudgmental and better-safe-than-sorry tone, patients were much more willing to accept the message and the naloxone prescription. “It seemed like patients were also more amenable to receiving naloxone when they thought about other people in their home who could potentially experience an overdose just by having medication in the home,” said Dr. Binswanger, a senior investigator at Kaiser Permanente. Framing the prescription as protection for loved ones, then, also can be effective.

Ideally, opioid-safety interventions should be more patient centered, emphasizing safer home storage to prevent secondary exposures and educating patients fully about the medication’s downsides, she said. “They may have been on them a long time but never been fully informed of the risks,” she said. Among her group’s future research goals, Dr. Binswanger hopes to investigate how best to communicate such risks to patients.
 

References

1. Mueller SR, Koester S, Glanz JM, et al. Attitudes toward naloxone prescribing in clinical settings: A qualitative study of patients prescribed high dose opioids for chronic non-cancer pain. J Gen Intern Med. 2017 March;32(3):277-83.
 

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Assessing an opioid-safety intervention
Assessing an opioid-safety intervention

 

New tools to help minimize the risk of opioid-related adverse events are becoming more widely available, although providers are still struggling over how best to implement them.

A recent study by Shane Mueller, MSW, and Ingrid Binswanger, MD, at Kaiser Permanente Colorado Institute for Health Research, Denver, for instance, found that doctors are frequently uncomfortable prescribing the opioid antagonist naloxone to counteract a potential overdose.1

Shane Mueller is a project manager at the Kaiser Permanente Colorado Institute for Health Research.
Shane Mueller
The discomfort may prevent doctors from having difficult but necessary conversations about the medication’s risks and benefits, says Mr. Mueller, a project manager at the institute. For their part, patients recognized the utility of naloxone but were afraid that accepting a prescription for it would suggest that they were misusing their opioid medication.

Although much of the research was conducted in outpatient settings, the researchers say several lessons may be translated to the hospital readily. “Patients were really willing to embrace the idea of naloxone when it was framed to be used in a worst-case scenario,” Mr. Mueller said; some providers, for example, compared it to having a fire extinguisher in the house. “I think one patient said, ‘You know, I don’t plan on starting a fire in my kitchen, but it’s good to have there just in case something goes wrong.’ ”

Another important lesson, Mr. Mueller said, is to consider multiple factors that might heighten the overdose risk, such as a change in the prescription or a medical condition like renal failure. Including those considerations in a conversation might help destigmatize the topic and help patients who are concerned that they might be perceived as misusing the medication.

Dr. Ingrid Binswanger is a hospitalist in Denver.
Dr. Ingrid Binswanger
The study suggested that, when providers adopted a nonjudgmental and better-safe-than-sorry tone, patients were much more willing to accept the message and the naloxone prescription. “It seemed like patients were also more amenable to receiving naloxone when they thought about other people in their home who could potentially experience an overdose just by having medication in the home,” said Dr. Binswanger, a senior investigator at Kaiser Permanente. Framing the prescription as protection for loved ones, then, also can be effective.

Ideally, opioid-safety interventions should be more patient centered, emphasizing safer home storage to prevent secondary exposures and educating patients fully about the medication’s downsides, she said. “They may have been on them a long time but never been fully informed of the risks,” she said. Among her group’s future research goals, Dr. Binswanger hopes to investigate how best to communicate such risks to patients.
 

References

1. Mueller SR, Koester S, Glanz JM, et al. Attitudes toward naloxone prescribing in clinical settings: A qualitative study of patients prescribed high dose opioids for chronic non-cancer pain. J Gen Intern Med. 2017 March;32(3):277-83.
 

 

New tools to help minimize the risk of opioid-related adverse events are becoming more widely available, although providers are still struggling over how best to implement them.

A recent study by Shane Mueller, MSW, and Ingrid Binswanger, MD, at Kaiser Permanente Colorado Institute for Health Research, Denver, for instance, found that doctors are frequently uncomfortable prescribing the opioid antagonist naloxone to counteract a potential overdose.1

Shane Mueller is a project manager at the Kaiser Permanente Colorado Institute for Health Research.
Shane Mueller
The discomfort may prevent doctors from having difficult but necessary conversations about the medication’s risks and benefits, says Mr. Mueller, a project manager at the institute. For their part, patients recognized the utility of naloxone but were afraid that accepting a prescription for it would suggest that they were misusing their opioid medication.

Although much of the research was conducted in outpatient settings, the researchers say several lessons may be translated to the hospital readily. “Patients were really willing to embrace the idea of naloxone when it was framed to be used in a worst-case scenario,” Mr. Mueller said; some providers, for example, compared it to having a fire extinguisher in the house. “I think one patient said, ‘You know, I don’t plan on starting a fire in my kitchen, but it’s good to have there just in case something goes wrong.’ ”

Another important lesson, Mr. Mueller said, is to consider multiple factors that might heighten the overdose risk, such as a change in the prescription or a medical condition like renal failure. Including those considerations in a conversation might help destigmatize the topic and help patients who are concerned that they might be perceived as misusing the medication.

Dr. Ingrid Binswanger is a hospitalist in Denver.
Dr. Ingrid Binswanger
The study suggested that, when providers adopted a nonjudgmental and better-safe-than-sorry tone, patients were much more willing to accept the message and the naloxone prescription. “It seemed like patients were also more amenable to receiving naloxone when they thought about other people in their home who could potentially experience an overdose just by having medication in the home,” said Dr. Binswanger, a senior investigator at Kaiser Permanente. Framing the prescription as protection for loved ones, then, also can be effective.

Ideally, opioid-safety interventions should be more patient centered, emphasizing safer home storage to prevent secondary exposures and educating patients fully about the medication’s downsides, she said. “They may have been on them a long time but never been fully informed of the risks,” she said. Among her group’s future research goals, Dr. Binswanger hopes to investigate how best to communicate such risks to patients.
 

References

1. Mueller SR, Koester S, Glanz JM, et al. Attitudes toward naloxone prescribing in clinical settings: A qualitative study of patients prescribed high dose opioids for chronic non-cancer pain. J Gen Intern Med. 2017 March;32(3):277-83.
 

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SHM’s RADEO Program aids safer opioid prescribing

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In January 2017, the U.S. Centers for Medicare & Medicaid Services honored SHM for its hospital patient safety and quality improvement efforts. A big reason for the plaudits was the society’s successful program and implementation toolkit called Reducing Adverse Drug Events related to Opioids (RADEO), now in its second phase.

Kevin Vuernick, senior project manager of SHM’s Center for Hospital Innovation and Improvement, says that the freely available RADEO guide explains how to develop and carry out quality improvement projects related to inpatient opioid prescribing. One of the first steps was devising interventions that hospitalists could implement to reduce opioid-related adverse events. An independent evaluator will help analyze the program’s data, best practices, and outcomes.

Dr. Thomas W. Frederickson is the medical director for hospital medicine and palliative care at CHI Health in Omaha, Neb.
Dr. Thomas Frederickson
Five hospitals participated in the program’s first phase, with another 10 joining the second phase, which began in November 2016. Thomas Frederickson, MD, FACP, SFHM, medical director for hospital medicine and palliative care at CHI Health in Omaha, Neb., was lead author of the implementation guide and has been a mentor in both phases of the program. The guide has been well received so far, he says, because it presents existing evidence and practical advice on launching opioid-related quality improvement efforts. “It’s just a start, but I do think it’s a start in the right direction,” Dr. Frederickson said. Subsequent versions of the guide, he added, will be updated to reflect new evidence on transitions of care, prescribing guidelines, and monitoring.

Keri Holmes-Maybank, MD, MSCR, FHM, an academic hospitalist at the Medical University of South Carolina, Charleston, said that the RADEO guide has a been a “phenomenal” resource. Dr. Holmes-Maybank, who led her medical center’s involvement in RADEO’s first round, says the guide helped her identify areas that her institution could work on. For one project, the medical university implemented the Pasero Opioid-Induced Sedation Scale to help prevent adverse opioid-related events, such as life-threatening respiratory depression. For a second project, the center combined existing discharge information into a more complete document that could be given to patients to educate them and their caregivers better.

Dr. Keri Holmes-Maybank of Charleston, SC, is a hospitalist with Medical University of South Carolina
Dr. Kari Holmes-Maybank
Dr. Holmes-Maybank is now a mentor for a Texas hospital in RADEO’s second round. Her mentee institution is hoping to change its approach to prescribing opioids with a revised order set, drop its reliance on the visual analog scale for pain in favor of functional assessments, and produce an explanatory video for patients to help reset their expectations. She “cannot wait” to learn from that hospital’s experience and see if their lessons might apply to her own institution as well, she said.

St. Anthony Hospital in Oklahoma City first used RADEO to revisit how it was evaluating patients’ pain and then widened the scope to reassess how it was managing its opioid treatment and narcotic use. “We just kept swinging at the tree, trying to hit the low-hanging fruit and seeing what we could improve upon,” said Matthew Jared, MD, a hospitalist at St. Anthony and its program lead during its involvement in phase one of RADEO.

Dr. Matthew Jared is a hospitalist at St. Anthony Hospital in Oklahoma City.
Dr. Matthew Jared
RADEO has also helped the hospital provide patients with a beefed-up informational handout either at the beginning of their stay or when they’re first prescribed opioids. Initiating the educational process earlier in the course of care, Dr. Jared said, has reshaped expectations and eased previously difficult conversations. In fact, early results suggest a trend toward improved patient satisfaction scores – a result that could be an “exciting breakthrough” for the hospital if it holds, he said.

Dr. Jared is hoping to build on the momentum with a plan to develop better in-house protocols for monitoring pain, employing alternative treatments, and establishing clear lines of communication. “That’s our next step forward: really taking what we’ve learned and beginning to implement it into a holistic type of pain management within the hospital that each physician can tailor to the individual patient but still have the framework to support them,” he said. This ambitious plan is precisely the goal of RADEO, Mr. Vuernick said: providing the catalyst for change not just for hospital medicine but also for entire institutions.

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In January 2017, the U.S. Centers for Medicare & Medicaid Services honored SHM for its hospital patient safety and quality improvement efforts. A big reason for the plaudits was the society’s successful program and implementation toolkit called Reducing Adverse Drug Events related to Opioids (RADEO), now in its second phase.

Kevin Vuernick, senior project manager of SHM’s Center for Hospital Innovation and Improvement, says that the freely available RADEO guide explains how to develop and carry out quality improvement projects related to inpatient opioid prescribing. One of the first steps was devising interventions that hospitalists could implement to reduce opioid-related adverse events. An independent evaluator will help analyze the program’s data, best practices, and outcomes.

Dr. Thomas W. Frederickson is the medical director for hospital medicine and palliative care at CHI Health in Omaha, Neb.
Dr. Thomas Frederickson
Five hospitals participated in the program’s first phase, with another 10 joining the second phase, which began in November 2016. Thomas Frederickson, MD, FACP, SFHM, medical director for hospital medicine and palliative care at CHI Health in Omaha, Neb., was lead author of the implementation guide and has been a mentor in both phases of the program. The guide has been well received so far, he says, because it presents existing evidence and practical advice on launching opioid-related quality improvement efforts. “It’s just a start, but I do think it’s a start in the right direction,” Dr. Frederickson said. Subsequent versions of the guide, he added, will be updated to reflect new evidence on transitions of care, prescribing guidelines, and monitoring.

Keri Holmes-Maybank, MD, MSCR, FHM, an academic hospitalist at the Medical University of South Carolina, Charleston, said that the RADEO guide has a been a “phenomenal” resource. Dr. Holmes-Maybank, who led her medical center’s involvement in RADEO’s first round, says the guide helped her identify areas that her institution could work on. For one project, the medical university implemented the Pasero Opioid-Induced Sedation Scale to help prevent adverse opioid-related events, such as life-threatening respiratory depression. For a second project, the center combined existing discharge information into a more complete document that could be given to patients to educate them and their caregivers better.

Dr. Keri Holmes-Maybank of Charleston, SC, is a hospitalist with Medical University of South Carolina
Dr. Kari Holmes-Maybank
Dr. Holmes-Maybank is now a mentor for a Texas hospital in RADEO’s second round. Her mentee institution is hoping to change its approach to prescribing opioids with a revised order set, drop its reliance on the visual analog scale for pain in favor of functional assessments, and produce an explanatory video for patients to help reset their expectations. She “cannot wait” to learn from that hospital’s experience and see if their lessons might apply to her own institution as well, she said.

St. Anthony Hospital in Oklahoma City first used RADEO to revisit how it was evaluating patients’ pain and then widened the scope to reassess how it was managing its opioid treatment and narcotic use. “We just kept swinging at the tree, trying to hit the low-hanging fruit and seeing what we could improve upon,” said Matthew Jared, MD, a hospitalist at St. Anthony and its program lead during its involvement in phase one of RADEO.

Dr. Matthew Jared is a hospitalist at St. Anthony Hospital in Oklahoma City.
Dr. Matthew Jared
RADEO has also helped the hospital provide patients with a beefed-up informational handout either at the beginning of their stay or when they’re first prescribed opioids. Initiating the educational process earlier in the course of care, Dr. Jared said, has reshaped expectations and eased previously difficult conversations. In fact, early results suggest a trend toward improved patient satisfaction scores – a result that could be an “exciting breakthrough” for the hospital if it holds, he said.

Dr. Jared is hoping to build on the momentum with a plan to develop better in-house protocols for monitoring pain, employing alternative treatments, and establishing clear lines of communication. “That’s our next step forward: really taking what we’ve learned and beginning to implement it into a holistic type of pain management within the hospital that each physician can tailor to the individual patient but still have the framework to support them,” he said. This ambitious plan is precisely the goal of RADEO, Mr. Vuernick said: providing the catalyst for change not just for hospital medicine but also for entire institutions.

 

In January 2017, the U.S. Centers for Medicare & Medicaid Services honored SHM for its hospital patient safety and quality improvement efforts. A big reason for the plaudits was the society’s successful program and implementation toolkit called Reducing Adverse Drug Events related to Opioids (RADEO), now in its second phase.

Kevin Vuernick, senior project manager of SHM’s Center for Hospital Innovation and Improvement, says that the freely available RADEO guide explains how to develop and carry out quality improvement projects related to inpatient opioid prescribing. One of the first steps was devising interventions that hospitalists could implement to reduce opioid-related adverse events. An independent evaluator will help analyze the program’s data, best practices, and outcomes.

Dr. Thomas W. Frederickson is the medical director for hospital medicine and palliative care at CHI Health in Omaha, Neb.
Dr. Thomas Frederickson
Five hospitals participated in the program’s first phase, with another 10 joining the second phase, which began in November 2016. Thomas Frederickson, MD, FACP, SFHM, medical director for hospital medicine and palliative care at CHI Health in Omaha, Neb., was lead author of the implementation guide and has been a mentor in both phases of the program. The guide has been well received so far, he says, because it presents existing evidence and practical advice on launching opioid-related quality improvement efforts. “It’s just a start, but I do think it’s a start in the right direction,” Dr. Frederickson said. Subsequent versions of the guide, he added, will be updated to reflect new evidence on transitions of care, prescribing guidelines, and monitoring.

Keri Holmes-Maybank, MD, MSCR, FHM, an academic hospitalist at the Medical University of South Carolina, Charleston, said that the RADEO guide has a been a “phenomenal” resource. Dr. Holmes-Maybank, who led her medical center’s involvement in RADEO’s first round, says the guide helped her identify areas that her institution could work on. For one project, the medical university implemented the Pasero Opioid-Induced Sedation Scale to help prevent adverse opioid-related events, such as life-threatening respiratory depression. For a second project, the center combined existing discharge information into a more complete document that could be given to patients to educate them and their caregivers better.

Dr. Keri Holmes-Maybank of Charleston, SC, is a hospitalist with Medical University of South Carolina
Dr. Kari Holmes-Maybank
Dr. Holmes-Maybank is now a mentor for a Texas hospital in RADEO’s second round. Her mentee institution is hoping to change its approach to prescribing opioids with a revised order set, drop its reliance on the visual analog scale for pain in favor of functional assessments, and produce an explanatory video for patients to help reset their expectations. She “cannot wait” to learn from that hospital’s experience and see if their lessons might apply to her own institution as well, she said.

St. Anthony Hospital in Oklahoma City first used RADEO to revisit how it was evaluating patients’ pain and then widened the scope to reassess how it was managing its opioid treatment and narcotic use. “We just kept swinging at the tree, trying to hit the low-hanging fruit and seeing what we could improve upon,” said Matthew Jared, MD, a hospitalist at St. Anthony and its program lead during its involvement in phase one of RADEO.

Dr. Matthew Jared is a hospitalist at St. Anthony Hospital in Oklahoma City.
Dr. Matthew Jared
RADEO has also helped the hospital provide patients with a beefed-up informational handout either at the beginning of their stay or when they’re first prescribed opioids. Initiating the educational process earlier in the course of care, Dr. Jared said, has reshaped expectations and eased previously difficult conversations. In fact, early results suggest a trend toward improved patient satisfaction scores – a result that could be an “exciting breakthrough” for the hospital if it holds, he said.

Dr. Jared is hoping to build on the momentum with a plan to develop better in-house protocols for monitoring pain, employing alternative treatments, and establishing clear lines of communication. “That’s our next step forward: really taking what we’ve learned and beginning to implement it into a holistic type of pain management within the hospital that each physician can tailor to the individual patient but still have the framework to support them,” he said. This ambitious plan is precisely the goal of RADEO, Mr. Vuernick said: providing the catalyst for change not just for hospital medicine but also for entire institutions.

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Hospitalists struggle with opioid epidemic’s rising toll

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Confronting a prescribing “black box”

 

It’s the stuff of doctors’ nightmares. In a recent analysis of attitudes, beliefs, and practices regarding opioid prescribing, one hospitalist described how a patient had overdosed: “She crushed up the oxycodone we were giving her in the hospital and shot it up through her central line and died.”1

Generic oxycodone tablets in hands of doctor
BackyardProduction/Thinkstock
Another hospitalist recounted how a patient, after having her gallbladder removed, asked for a prescription to tide her over until she could see her primary care physician. “I later found out she had forged my script and had changed it from 18 pills to 180 pills. She took it all over the state to try to fill.”

Susan Calcaterra, MD, MPH, of the department of family medicine at the University of Colorado at Denver, Aurora; a hospitalist at Denver Health Hospital; and lead author of the recent study, says that the dramatic anecdotes don’t surprise her. “These are not uncommon events,” she said. “Across the country, you hear about overdose, you hear about people abusing fentanyl, and I think, when you have an addiction, your judgment of the dangers associated with your personal opioid use may be limited.”

Some critics have blamed the ubiquity of opioid prescriptions on the controversial movement to establish pain as a vital sign. Multiple investigations also have accused the pharmaceutical industry of aggressively promoting these prescription drugs while downplaying their risks. The CDC found that, in fact, so many opioid prescriptions were being written by 2012 that the 259 million scripts could have supplied every U.S. adult with his and her own bottle. In August 2017, President Trump declared the opioid crisis a national emergency, although opinions differ regarding the best ways forward.

Until recently, however, few studies had looked at how inpatient prescribing may be fueling a surging epidemic that already has exacted a staggering toll. So far, the early data paint a disturbing picture that suggests hospitals are both a part of the problem and a key to its solution.

Dr. Hilary Mosher, assistant head of internatl medicine, University of Iowa
Dr. Hilary Mosher
“This has been a very, very rapidly evolving change from very little opioid use to widespread opioid use with the belief that there weren’t consequences,” said Hilary Mosher, MD, FHM, of the department of internal medicine at the University of Iowa in Iowa City. Hospitalists have to own their role in contributing to the current reality, she said, while also recognizing their power and responsibility to be agents of change. “We’re learning as we’re going,” said Dr. Mosher, who is also a hospitalist with the Iowa City Veterans Affairs Health Care System. “I think rather than looking back and saying, ‘Oh, my gosh, what have we done? Look at everything we did wrong,’ we’ve got to assess where we are and say, ‘How do we do right?’ ”
 

Illuminating a ‘black box’

Changing the trajectory will be difficult. From 2002 to 2015, the nation’s overdose death rate from opioid analgesics, heroin, and synthetic opioids, such as fentanyl, nearly tripled, and studies suggest that prescription painkillers have become major gateway drugs for heroin.2 In the last 3 years alone, fentanyl-related deaths soared by more than 500%, and annual mortality from all drug overdoses has blown by the peak of the HIV/AIDS epidemic in 1995, when nearly 51,000 died from the disease.3

Amid the ringing alarm bells, hospitals have remained a largely neglected “regulatory dead zone” for opioids, said Shoshana Herzig, MD, MPH, of the department of medicine at Harvard Medical School, Boston, and director of hospital medicine research at Beth Israel Deaconess Medical Center, also in Boston. In an editorial accompanying the recent study of hospitalist perspectives, Dr. Herzig called the inpatient setting an opioid prescribing “black box.”4

In a previous analysis of 1.1 million nonsurgical hospital admissions, however, she and colleagues found that opioids were prescribed to 51% of all patients.5 More than half of those with inpatient exposure were still taking opioids on their discharge day. With other studies suggesting that such practices may be contributing to chronic opioid use long after hospitalization, Dr. Herzig wrote, “reigning in inpatient prescribing may be a crucial step in curbing the opioid epidemic as a whole.”

A recent study led by Anupam Jena, MD, PhD, a health care policy expert at Harvard Medical School, echoes the refrain. “It’s kind of remarkable that the hospital setting hasn’t really been studied, and it’s an important setting,” he said. When he and colleagues did their own analysis of hospitalized Medicare beneficiaries, they found that 15% of previously opioid-naive patients were discharged with a prescription.6 Of those patients, more than 40% remained on opioids three months after discharge. The research also revealed a nearly two-fold variation in prescription rates across hospitals.

Pinar Karaca-Mandic, PhD, is a health economist at the University of Minnesota School of Public Health, Minneapolis.
Dr. Pinar Karaca-Mandic
Study coauthor Pinar Karaca-Mandic, PhD, a health economist at the University of Minnesota School of Public Health in Minneapolis, said the group’s research was motivated by a prior study in which they found that more than 30% of Medicare beneficiaries with opioid prescriptions were getting them from multiple providers.7 Nearly two-thirds of those prescriptions were concurrent. Although the study couldn’t assess appropriateness, Dr. Karaca-Mandic said that concurrent prescriptions from multiple providers correlated with higher rates of opioid-related hospitalization.

Some hospitalists have asserted that the increase in opioid prescriptions may partially be tied to pressure to reduce 30-day readmission rates; Dr. Jena and Dr. Karaca-Mandic’s work leaves open the possibility that such prescriptions may increase readmissions instead. The researchers, however, say a bigger driving force may be financial pressure tied to discharging patients earlier or scoring higher on quality measures that gauge factors, such as pain management. Hospitals that scored better on HCAHPS measures of inpatient pain control, their study found, were slightly more likely to discharge patients on opioids.

Keri Holmes-Maybank, MD, MSCR, FHM, an academic hospitalist at the Medical University of South Carolina, Charleston, says a lack of clear evidence and guidelines, unrealistic expectations, and variable patient responses to opioids are compounding a “very frustrating and very scary” situation for hospital medicine. Hospitalists who conclude that a patient-requested antibiotic will do more harm than good, for example, usually feel comfortable saying no. “But a patient can talk you into an opioid,” she said. “It’s much harder to stand your ground with that, even though we need to be viewing it the same way.”
 

 

 

The pain paradox

The desire to alleviate pain, as doctors are discovering, often has replaced one harm with another inadvertently. Perhaps the single largest contributing factor, Dr. Herzig said, is the subjectivity of pain and the difficulty in discerning whether a patient’s self-reporting can be trusted. “We want to relieve suffering,” she said, “but we also don’t want to give a patient a drug to which they may develop an addiction or to which they may already be addicted, and so therein lies the conundrum.”

Susan Calcaterra, MD, MPH, is an assistant professor of medicine at the University of Colorado at Denver, Aurora, and a hospitalist at Denver Health Hospital, Denver.
Dr. Susan Calcaterra
Dr. Calcaterra said she and many other hospitalists struggle with the issue regularly. Most physicians are comfortable addressing a “very obvious source of pain,” such as trauma, heart attack, or surgery, she said. But treating more nebulous pain from chronic conditions or syndromes that lack clear supporting data can be tricky. Bridging the potential divide between patients’ understanding of how their pain might be managed and what options are realistically available, she noted, may depend upon establishing clear up-front expectations and effectively communicating the treatment plan and goals.

Some medical providers are also beginning to focus less on visual pain assessments and more on clinically meaningful functional improvements. “For example, instead of asking, ‘What level is your pain today?’ we might say, ‘Were you able to get up and work with physical therapy today?’ and ‘Were you able to get out of the bed to the chair while maintaining your pain at a tolerable level?’ ” Dr. Herzig said.

In addition, providers are recognizing that they should be clearer in telling patients that a complete absence of pain is not only unrealistic but also potentially harmful. “It takes time to have those discussions with patients, where you’re trying to explain to them, ‘Pain is the body’s way of telling you don’t do that, and you need to have some pain in order to know what your limitations are,’ ” Dr. Herzig said.

Shoshana Herzig, MD, MPH, is an assistant professor of medicine at Harvard Medical School, Boston, and director of Hospital Medicine Research at Beth Israel Deaconess Medical Center in Boston.
Dr. Shoshana Herzig
She strongly emphasized the importance of trying nonopioid analgesics first, especially given their superior effectiveness for certain types of pain. “And then, if you do go on to prescribe opioids, you should always pair them with nonopioid analgesics,” she said.

From talking with hospitalized patients, Dr. Mosher and her colleagues found that pain-related suffering can be manifested in or exacerbated by poor sleep or diet, boredom, physical discomfort, immobility, or inability to maintain comforting activities. In other words, how can the hospital improve sleeping conditions or address the understandable anxiety around health issues or being in a strange new environment and losing control? “One of the upsides of all this is that it may drive us to really think about, and make thoughtful investments in, changing the hospital to be a more therapeutic environment,” Dr. Mosher said.
 

Chronic use and discharge dilemmas

What about patients who already used opioids regularly before their hospital admission? In a 2014 study, Dr. Mosher and her colleagues found that among patients admitted to Veterans Affairs hospitals between 2009 and 2011, more than one in four were on chronic opioid therapy in the 6 months prior to their hospitalization.8 That subset of patients, the study suggested, was at greater risk for both 30-day readmission and death.

Determining whether an opioid prescription is appropriate or not, though, takes time. “Hospitalists are often terribly busy,” Dr. Mosher said. “There’s a lot of pressure to move people through the hospital. It’s a big ask to say, ‘How will hospitalists do what might be ideal?’ versus ‘What can we do?’ ” A workable solution, she said, may depend upon a cultural shift in recognizing that “pain is not something you measure by numbers,” but rather a part of a patient’s complex medical condition that may require consultations and coordination with specialists both within and beyond the hospital.

Sometimes, relatively simple questions can go a long way. When Dr. Mosher asks patients on opioids whether they help, she said, “I’ve had very few patients who will say it makes the pain go away.” Likewise, she contends that very few patients have been informed of potential side effects such as decreased muscle mass, osteoporosis, and endocrinopathy. Men on opioids can have a significant reduction in testosterone levels that negatively affects their sex life. When Dr. Mosher has talked to them about the downsides of long-term use, more than a few have requested her help in weaning them off the drugs.

If given the time to educate such patients and consider how their chronic pain and opioid use might be connected to the hospitalization, she said, “We can find opportunities to use that as a change moment.”

Discharging a patient with a well-considered opioid prescription can still present multiple challenges. The best-case scenario, Dr. Calcaterra said, is to coordinate a plan with the patient’s primary care provider. “A lot of patients that we take care of, though, don’t have a follow-up provider. They don’t have a primary care physician,” she said.

The opioid epidemic also has walloped many communities that lack sufficient resources for at-risk patients, whether it’s alternative pain therapy or a buprenorphine clinic. “If you look at access to medication-assisted therapies, the lights are out for a lot of America. There just isn’t access,” Dr. Mosher said. The limited options can set up a frustrating quandary: Hospitalists may be reluctant to wean patients off opioids and get them on buprenorphine if there’s no reliable resource to continue the therapy after a postdischarge handoff.

Until better safety nets and evidence-based protocols are woven together, hospitalists may need to make judgment calls based on their experience and available data and be creative in using existing resources to help their patients. Although electronic prescribing may help reduce the potential for tampering with a doctor’s script, Dr. Calcaterra said, diversion of opioid pills remains a “huge issue across the United States.” Several states now limit the amount of opioids that can be prescribed upon discharge, and hospitalists in many states can access prescription drug monitoring programs to determine whether patients are receiving opioids from other providers.
 

 

 

Pushing for proactive solutions

Anupam Jena, MD, PhD, is a health care policy expert at Harvard Medical School, Boston.
Dr. Anupam Jena
One of the biggest unmet needs, according to multiple hospitalists, is a clear and uniform set of inpatient prescribing guidelines. A consensus document might address some of the high variability in opioid prescribing practices seen by experts, such as Dr. Jena. “That’s a big issue because it’s that variability that leads to adverse consequences for patients when the opioids are inappropriately prescribed either in terms of the frequency or terms of their dose,” he said.

Kevin Vuernick, senior project manager of SHM’s Center for Hospital Innovation and Improvement, said the society’s Hospital Quality and Patient Safety Committee is actively exploring plans to develop pain prescribing guidelines for hospitalized patients based on the input of hospitalists and other medical specialists. The society also hopes to set up a website that compiles available resources, such as its own well-received Reducing Adverse Drug Events related to Opioids Mentored Implementation Program.

Dr. Mosher said SHM and other professional organizations also could assume leadership roles in setting a research agenda, establishing priorities for quality improvement efforts, and evaluating the utility of intervention programs. She and others have said additional help is sorely needed in educating providers, most of whom have never received formal training in pain management.

Talented and skilled physicians with the right language and approach could serve as role models in teaching providers how to appropriately bring up sensitive topics, such as concerns that a patient may be misusing opioids or that the pain may be more psychological than physical in nature. “We need a common language,” Dr. Herzig said.

More broadly, hospital medicine practitioners could serve as institutional role models. Many already sit on safety and quality improvement committees, meaning that they can help develop standardized protocols and help inform decisions regarding both prescribing and oversight to improve the appropriateness and safety of opioid prescriptions.

Matthew Jared, MD, a hospitalist at St. Anthony Hospital in Oklahoma City, said he and his colleagues have long worried about striking the right balance on opioids and about “trying to find an objective way to treat a subjective problem.” Because he and his hospitalist counterparts see 95% of St. Anthony’s inpatients, however, he said hospital medicine is uniquely positioned to help initiate a more holistic and consistent opioid management plan. “We’re key in the equation of trying to get this under control in a way that’s healthy and respectful to the patient and to the staff,” he said.

Bryn Nelson is a freelance writer in Seattle.

References

1. Calcaterra SL, Drabkin AD, Leslie SE, Doyle R, et al. The hospitalist perspective on opioid prescribing: A qualitative analysis. J Hosp Med. 2016 Aug;11(8):536-42.

2. Rudd RA, Seth P, David F, Scholl L. Increases in drug and opioid-involved overdose deaths – United States, 2010–2015. MMWR Morb Mortal Wkly Rep. 2016 Dec;65(50-51):1445-52; and https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates.

3. Katz, J. The First Count of Fentanyl Deaths in 2016: Up 540% in Three Years. New York Times, Sept. 2, 2017. https://www.nytimes.com/interactive/2017/09/02/upshot/fentanyl-drug-overdose-deaths.html?mcubz=1&_r=0

4. Herzig SJ. Opening the black box of inpatient opioid prescribing. J Hosp Med. 2016 Aug;11(8):595-6.

5. Herzig SJ, Rothberg MB, Cheung M, et al. Opioid utilization and opioid-related adverse events in nonsurgical patients in U.S. hospitals. J Hosp Med. 2014;9(2):73-81.

6. Jena AB, Goldman D, Karaca-Mandic P. Hospital prescribing of opioids to Medicare beneficiaries. JAMA Intern Med. 2016 July;176(7):990-7.

7. Jena AB, Goldman D, Weaver L, Karaca-Mandic P. Opioid prescribing by multiple providers in Medicare: Retrospective observational study of insurance claims. BMJ. 2014;348:g1393.

8. Mosher HJ, Jiang L, Vaughan Sarrazin MS, et al. Prevalence and characteristics of hospitalized adults on chronic opioid therapy. J Hosp Med. 2014 Feb;9(2):82-7.

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Confronting a prescribing “black box”
Confronting a prescribing “black box”

 

It’s the stuff of doctors’ nightmares. In a recent analysis of attitudes, beliefs, and practices regarding opioid prescribing, one hospitalist described how a patient had overdosed: “She crushed up the oxycodone we were giving her in the hospital and shot it up through her central line and died.”1

Generic oxycodone tablets in hands of doctor
BackyardProduction/Thinkstock
Another hospitalist recounted how a patient, after having her gallbladder removed, asked for a prescription to tide her over until she could see her primary care physician. “I later found out she had forged my script and had changed it from 18 pills to 180 pills. She took it all over the state to try to fill.”

Susan Calcaterra, MD, MPH, of the department of family medicine at the University of Colorado at Denver, Aurora; a hospitalist at Denver Health Hospital; and lead author of the recent study, says that the dramatic anecdotes don’t surprise her. “These are not uncommon events,” she said. “Across the country, you hear about overdose, you hear about people abusing fentanyl, and I think, when you have an addiction, your judgment of the dangers associated with your personal opioid use may be limited.”

Some critics have blamed the ubiquity of opioid prescriptions on the controversial movement to establish pain as a vital sign. Multiple investigations also have accused the pharmaceutical industry of aggressively promoting these prescription drugs while downplaying their risks. The CDC found that, in fact, so many opioid prescriptions were being written by 2012 that the 259 million scripts could have supplied every U.S. adult with his and her own bottle. In August 2017, President Trump declared the opioid crisis a national emergency, although opinions differ regarding the best ways forward.

Until recently, however, few studies had looked at how inpatient prescribing may be fueling a surging epidemic that already has exacted a staggering toll. So far, the early data paint a disturbing picture that suggests hospitals are both a part of the problem and a key to its solution.

Dr. Hilary Mosher, assistant head of internatl medicine, University of Iowa
Dr. Hilary Mosher
“This has been a very, very rapidly evolving change from very little opioid use to widespread opioid use with the belief that there weren’t consequences,” said Hilary Mosher, MD, FHM, of the department of internal medicine at the University of Iowa in Iowa City. Hospitalists have to own their role in contributing to the current reality, she said, while also recognizing their power and responsibility to be agents of change. “We’re learning as we’re going,” said Dr. Mosher, who is also a hospitalist with the Iowa City Veterans Affairs Health Care System. “I think rather than looking back and saying, ‘Oh, my gosh, what have we done? Look at everything we did wrong,’ we’ve got to assess where we are and say, ‘How do we do right?’ ”
 

Illuminating a ‘black box’

Changing the trajectory will be difficult. From 2002 to 2015, the nation’s overdose death rate from opioid analgesics, heroin, and synthetic opioids, such as fentanyl, nearly tripled, and studies suggest that prescription painkillers have become major gateway drugs for heroin.2 In the last 3 years alone, fentanyl-related deaths soared by more than 500%, and annual mortality from all drug overdoses has blown by the peak of the HIV/AIDS epidemic in 1995, when nearly 51,000 died from the disease.3

Amid the ringing alarm bells, hospitals have remained a largely neglected “regulatory dead zone” for opioids, said Shoshana Herzig, MD, MPH, of the department of medicine at Harvard Medical School, Boston, and director of hospital medicine research at Beth Israel Deaconess Medical Center, also in Boston. In an editorial accompanying the recent study of hospitalist perspectives, Dr. Herzig called the inpatient setting an opioid prescribing “black box.”4

In a previous analysis of 1.1 million nonsurgical hospital admissions, however, she and colleagues found that opioids were prescribed to 51% of all patients.5 More than half of those with inpatient exposure were still taking opioids on their discharge day. With other studies suggesting that such practices may be contributing to chronic opioid use long after hospitalization, Dr. Herzig wrote, “reigning in inpatient prescribing may be a crucial step in curbing the opioid epidemic as a whole.”

A recent study led by Anupam Jena, MD, PhD, a health care policy expert at Harvard Medical School, echoes the refrain. “It’s kind of remarkable that the hospital setting hasn’t really been studied, and it’s an important setting,” he said. When he and colleagues did their own analysis of hospitalized Medicare beneficiaries, they found that 15% of previously opioid-naive patients were discharged with a prescription.6 Of those patients, more than 40% remained on opioids three months after discharge. The research also revealed a nearly two-fold variation in prescription rates across hospitals.

Pinar Karaca-Mandic, PhD, is a health economist at the University of Minnesota School of Public Health, Minneapolis.
Dr. Pinar Karaca-Mandic
Study coauthor Pinar Karaca-Mandic, PhD, a health economist at the University of Minnesota School of Public Health in Minneapolis, said the group’s research was motivated by a prior study in which they found that more than 30% of Medicare beneficiaries with opioid prescriptions were getting them from multiple providers.7 Nearly two-thirds of those prescriptions were concurrent. Although the study couldn’t assess appropriateness, Dr. Karaca-Mandic said that concurrent prescriptions from multiple providers correlated with higher rates of opioid-related hospitalization.

Some hospitalists have asserted that the increase in opioid prescriptions may partially be tied to pressure to reduce 30-day readmission rates; Dr. Jena and Dr. Karaca-Mandic’s work leaves open the possibility that such prescriptions may increase readmissions instead. The researchers, however, say a bigger driving force may be financial pressure tied to discharging patients earlier or scoring higher on quality measures that gauge factors, such as pain management. Hospitals that scored better on HCAHPS measures of inpatient pain control, their study found, were slightly more likely to discharge patients on opioids.

Keri Holmes-Maybank, MD, MSCR, FHM, an academic hospitalist at the Medical University of South Carolina, Charleston, says a lack of clear evidence and guidelines, unrealistic expectations, and variable patient responses to opioids are compounding a “very frustrating and very scary” situation for hospital medicine. Hospitalists who conclude that a patient-requested antibiotic will do more harm than good, for example, usually feel comfortable saying no. “But a patient can talk you into an opioid,” she said. “It’s much harder to stand your ground with that, even though we need to be viewing it the same way.”
 

 

 

The pain paradox

The desire to alleviate pain, as doctors are discovering, often has replaced one harm with another inadvertently. Perhaps the single largest contributing factor, Dr. Herzig said, is the subjectivity of pain and the difficulty in discerning whether a patient’s self-reporting can be trusted. “We want to relieve suffering,” she said, “but we also don’t want to give a patient a drug to which they may develop an addiction or to which they may already be addicted, and so therein lies the conundrum.”

Susan Calcaterra, MD, MPH, is an assistant professor of medicine at the University of Colorado at Denver, Aurora, and a hospitalist at Denver Health Hospital, Denver.
Dr. Susan Calcaterra
Dr. Calcaterra said she and many other hospitalists struggle with the issue regularly. Most physicians are comfortable addressing a “very obvious source of pain,” such as trauma, heart attack, or surgery, she said. But treating more nebulous pain from chronic conditions or syndromes that lack clear supporting data can be tricky. Bridging the potential divide between patients’ understanding of how their pain might be managed and what options are realistically available, she noted, may depend upon establishing clear up-front expectations and effectively communicating the treatment plan and goals.

Some medical providers are also beginning to focus less on visual pain assessments and more on clinically meaningful functional improvements. “For example, instead of asking, ‘What level is your pain today?’ we might say, ‘Were you able to get up and work with physical therapy today?’ and ‘Were you able to get out of the bed to the chair while maintaining your pain at a tolerable level?’ ” Dr. Herzig said.

In addition, providers are recognizing that they should be clearer in telling patients that a complete absence of pain is not only unrealistic but also potentially harmful. “It takes time to have those discussions with patients, where you’re trying to explain to them, ‘Pain is the body’s way of telling you don’t do that, and you need to have some pain in order to know what your limitations are,’ ” Dr. Herzig said.

Shoshana Herzig, MD, MPH, is an assistant professor of medicine at Harvard Medical School, Boston, and director of Hospital Medicine Research at Beth Israel Deaconess Medical Center in Boston.
Dr. Shoshana Herzig
She strongly emphasized the importance of trying nonopioid analgesics first, especially given their superior effectiveness for certain types of pain. “And then, if you do go on to prescribe opioids, you should always pair them with nonopioid analgesics,” she said.

From talking with hospitalized patients, Dr. Mosher and her colleagues found that pain-related suffering can be manifested in or exacerbated by poor sleep or diet, boredom, physical discomfort, immobility, or inability to maintain comforting activities. In other words, how can the hospital improve sleeping conditions or address the understandable anxiety around health issues or being in a strange new environment and losing control? “One of the upsides of all this is that it may drive us to really think about, and make thoughtful investments in, changing the hospital to be a more therapeutic environment,” Dr. Mosher said.
 

Chronic use and discharge dilemmas

What about patients who already used opioids regularly before their hospital admission? In a 2014 study, Dr. Mosher and her colleagues found that among patients admitted to Veterans Affairs hospitals between 2009 and 2011, more than one in four were on chronic opioid therapy in the 6 months prior to their hospitalization.8 That subset of patients, the study suggested, was at greater risk for both 30-day readmission and death.

Determining whether an opioid prescription is appropriate or not, though, takes time. “Hospitalists are often terribly busy,” Dr. Mosher said. “There’s a lot of pressure to move people through the hospital. It’s a big ask to say, ‘How will hospitalists do what might be ideal?’ versus ‘What can we do?’ ” A workable solution, she said, may depend upon a cultural shift in recognizing that “pain is not something you measure by numbers,” but rather a part of a patient’s complex medical condition that may require consultations and coordination with specialists both within and beyond the hospital.

Sometimes, relatively simple questions can go a long way. When Dr. Mosher asks patients on opioids whether they help, she said, “I’ve had very few patients who will say it makes the pain go away.” Likewise, she contends that very few patients have been informed of potential side effects such as decreased muscle mass, osteoporosis, and endocrinopathy. Men on opioids can have a significant reduction in testosterone levels that negatively affects their sex life. When Dr. Mosher has talked to them about the downsides of long-term use, more than a few have requested her help in weaning them off the drugs.

If given the time to educate such patients and consider how their chronic pain and opioid use might be connected to the hospitalization, she said, “We can find opportunities to use that as a change moment.”

Discharging a patient with a well-considered opioid prescription can still present multiple challenges. The best-case scenario, Dr. Calcaterra said, is to coordinate a plan with the patient’s primary care provider. “A lot of patients that we take care of, though, don’t have a follow-up provider. They don’t have a primary care physician,” she said.

The opioid epidemic also has walloped many communities that lack sufficient resources for at-risk patients, whether it’s alternative pain therapy or a buprenorphine clinic. “If you look at access to medication-assisted therapies, the lights are out for a lot of America. There just isn’t access,” Dr. Mosher said. The limited options can set up a frustrating quandary: Hospitalists may be reluctant to wean patients off opioids and get them on buprenorphine if there’s no reliable resource to continue the therapy after a postdischarge handoff.

Until better safety nets and evidence-based protocols are woven together, hospitalists may need to make judgment calls based on their experience and available data and be creative in using existing resources to help their patients. Although electronic prescribing may help reduce the potential for tampering with a doctor’s script, Dr. Calcaterra said, diversion of opioid pills remains a “huge issue across the United States.” Several states now limit the amount of opioids that can be prescribed upon discharge, and hospitalists in many states can access prescription drug monitoring programs to determine whether patients are receiving opioids from other providers.
 

 

 

Pushing for proactive solutions

Anupam Jena, MD, PhD, is a health care policy expert at Harvard Medical School, Boston.
Dr. Anupam Jena
One of the biggest unmet needs, according to multiple hospitalists, is a clear and uniform set of inpatient prescribing guidelines. A consensus document might address some of the high variability in opioid prescribing practices seen by experts, such as Dr. Jena. “That’s a big issue because it’s that variability that leads to adverse consequences for patients when the opioids are inappropriately prescribed either in terms of the frequency or terms of their dose,” he said.

Kevin Vuernick, senior project manager of SHM’s Center for Hospital Innovation and Improvement, said the society’s Hospital Quality and Patient Safety Committee is actively exploring plans to develop pain prescribing guidelines for hospitalized patients based on the input of hospitalists and other medical specialists. The society also hopes to set up a website that compiles available resources, such as its own well-received Reducing Adverse Drug Events related to Opioids Mentored Implementation Program.

Dr. Mosher said SHM and other professional organizations also could assume leadership roles in setting a research agenda, establishing priorities for quality improvement efforts, and evaluating the utility of intervention programs. She and others have said additional help is sorely needed in educating providers, most of whom have never received formal training in pain management.

Talented and skilled physicians with the right language and approach could serve as role models in teaching providers how to appropriately bring up sensitive topics, such as concerns that a patient may be misusing opioids or that the pain may be more psychological than physical in nature. “We need a common language,” Dr. Herzig said.

More broadly, hospital medicine practitioners could serve as institutional role models. Many already sit on safety and quality improvement committees, meaning that they can help develop standardized protocols and help inform decisions regarding both prescribing and oversight to improve the appropriateness and safety of opioid prescriptions.

Matthew Jared, MD, a hospitalist at St. Anthony Hospital in Oklahoma City, said he and his colleagues have long worried about striking the right balance on opioids and about “trying to find an objective way to treat a subjective problem.” Because he and his hospitalist counterparts see 95% of St. Anthony’s inpatients, however, he said hospital medicine is uniquely positioned to help initiate a more holistic and consistent opioid management plan. “We’re key in the equation of trying to get this under control in a way that’s healthy and respectful to the patient and to the staff,” he said.

Bryn Nelson is a freelance writer in Seattle.

References

1. Calcaterra SL, Drabkin AD, Leslie SE, Doyle R, et al. The hospitalist perspective on opioid prescribing: A qualitative analysis. J Hosp Med. 2016 Aug;11(8):536-42.

2. Rudd RA, Seth P, David F, Scholl L. Increases in drug and opioid-involved overdose deaths – United States, 2010–2015. MMWR Morb Mortal Wkly Rep. 2016 Dec;65(50-51):1445-52; and https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates.

3. Katz, J. The First Count of Fentanyl Deaths in 2016: Up 540% in Three Years. New York Times, Sept. 2, 2017. https://www.nytimes.com/interactive/2017/09/02/upshot/fentanyl-drug-overdose-deaths.html?mcubz=1&_r=0

4. Herzig SJ. Opening the black box of inpatient opioid prescribing. J Hosp Med. 2016 Aug;11(8):595-6.

5. Herzig SJ, Rothberg MB, Cheung M, et al. Opioid utilization and opioid-related adverse events in nonsurgical patients in U.S. hospitals. J Hosp Med. 2014;9(2):73-81.

6. Jena AB, Goldman D, Karaca-Mandic P. Hospital prescribing of opioids to Medicare beneficiaries. JAMA Intern Med. 2016 July;176(7):990-7.

7. Jena AB, Goldman D, Weaver L, Karaca-Mandic P. Opioid prescribing by multiple providers in Medicare: Retrospective observational study of insurance claims. BMJ. 2014;348:g1393.

8. Mosher HJ, Jiang L, Vaughan Sarrazin MS, et al. Prevalence and characteristics of hospitalized adults on chronic opioid therapy. J Hosp Med. 2014 Feb;9(2):82-7.

 

It’s the stuff of doctors’ nightmares. In a recent analysis of attitudes, beliefs, and practices regarding opioid prescribing, one hospitalist described how a patient had overdosed: “She crushed up the oxycodone we were giving her in the hospital and shot it up through her central line and died.”1

Generic oxycodone tablets in hands of doctor
BackyardProduction/Thinkstock
Another hospitalist recounted how a patient, after having her gallbladder removed, asked for a prescription to tide her over until she could see her primary care physician. “I later found out she had forged my script and had changed it from 18 pills to 180 pills. She took it all over the state to try to fill.”

Susan Calcaterra, MD, MPH, of the department of family medicine at the University of Colorado at Denver, Aurora; a hospitalist at Denver Health Hospital; and lead author of the recent study, says that the dramatic anecdotes don’t surprise her. “These are not uncommon events,” she said. “Across the country, you hear about overdose, you hear about people abusing fentanyl, and I think, when you have an addiction, your judgment of the dangers associated with your personal opioid use may be limited.”

Some critics have blamed the ubiquity of opioid prescriptions on the controversial movement to establish pain as a vital sign. Multiple investigations also have accused the pharmaceutical industry of aggressively promoting these prescription drugs while downplaying their risks. The CDC found that, in fact, so many opioid prescriptions were being written by 2012 that the 259 million scripts could have supplied every U.S. adult with his and her own bottle. In August 2017, President Trump declared the opioid crisis a national emergency, although opinions differ regarding the best ways forward.

Until recently, however, few studies had looked at how inpatient prescribing may be fueling a surging epidemic that already has exacted a staggering toll. So far, the early data paint a disturbing picture that suggests hospitals are both a part of the problem and a key to its solution.

Dr. Hilary Mosher, assistant head of internatl medicine, University of Iowa
Dr. Hilary Mosher
“This has been a very, very rapidly evolving change from very little opioid use to widespread opioid use with the belief that there weren’t consequences,” said Hilary Mosher, MD, FHM, of the department of internal medicine at the University of Iowa in Iowa City. Hospitalists have to own their role in contributing to the current reality, she said, while also recognizing their power and responsibility to be agents of change. “We’re learning as we’re going,” said Dr. Mosher, who is also a hospitalist with the Iowa City Veterans Affairs Health Care System. “I think rather than looking back and saying, ‘Oh, my gosh, what have we done? Look at everything we did wrong,’ we’ve got to assess where we are and say, ‘How do we do right?’ ”
 

Illuminating a ‘black box’

Changing the trajectory will be difficult. From 2002 to 2015, the nation’s overdose death rate from opioid analgesics, heroin, and synthetic opioids, such as fentanyl, nearly tripled, and studies suggest that prescription painkillers have become major gateway drugs for heroin.2 In the last 3 years alone, fentanyl-related deaths soared by more than 500%, and annual mortality from all drug overdoses has blown by the peak of the HIV/AIDS epidemic in 1995, when nearly 51,000 died from the disease.3

Amid the ringing alarm bells, hospitals have remained a largely neglected “regulatory dead zone” for opioids, said Shoshana Herzig, MD, MPH, of the department of medicine at Harvard Medical School, Boston, and director of hospital medicine research at Beth Israel Deaconess Medical Center, also in Boston. In an editorial accompanying the recent study of hospitalist perspectives, Dr. Herzig called the inpatient setting an opioid prescribing “black box.”4

In a previous analysis of 1.1 million nonsurgical hospital admissions, however, she and colleagues found that opioids were prescribed to 51% of all patients.5 More than half of those with inpatient exposure were still taking opioids on their discharge day. With other studies suggesting that such practices may be contributing to chronic opioid use long after hospitalization, Dr. Herzig wrote, “reigning in inpatient prescribing may be a crucial step in curbing the opioid epidemic as a whole.”

A recent study led by Anupam Jena, MD, PhD, a health care policy expert at Harvard Medical School, echoes the refrain. “It’s kind of remarkable that the hospital setting hasn’t really been studied, and it’s an important setting,” he said. When he and colleagues did their own analysis of hospitalized Medicare beneficiaries, they found that 15% of previously opioid-naive patients were discharged with a prescription.6 Of those patients, more than 40% remained on opioids three months after discharge. The research also revealed a nearly two-fold variation in prescription rates across hospitals.

Pinar Karaca-Mandic, PhD, is a health economist at the University of Minnesota School of Public Health, Minneapolis.
Dr. Pinar Karaca-Mandic
Study coauthor Pinar Karaca-Mandic, PhD, a health economist at the University of Minnesota School of Public Health in Minneapolis, said the group’s research was motivated by a prior study in which they found that more than 30% of Medicare beneficiaries with opioid prescriptions were getting them from multiple providers.7 Nearly two-thirds of those prescriptions were concurrent. Although the study couldn’t assess appropriateness, Dr. Karaca-Mandic said that concurrent prescriptions from multiple providers correlated with higher rates of opioid-related hospitalization.

Some hospitalists have asserted that the increase in opioid prescriptions may partially be tied to pressure to reduce 30-day readmission rates; Dr. Jena and Dr. Karaca-Mandic’s work leaves open the possibility that such prescriptions may increase readmissions instead. The researchers, however, say a bigger driving force may be financial pressure tied to discharging patients earlier or scoring higher on quality measures that gauge factors, such as pain management. Hospitals that scored better on HCAHPS measures of inpatient pain control, their study found, were slightly more likely to discharge patients on opioids.

Keri Holmes-Maybank, MD, MSCR, FHM, an academic hospitalist at the Medical University of South Carolina, Charleston, says a lack of clear evidence and guidelines, unrealistic expectations, and variable patient responses to opioids are compounding a “very frustrating and very scary” situation for hospital medicine. Hospitalists who conclude that a patient-requested antibiotic will do more harm than good, for example, usually feel comfortable saying no. “But a patient can talk you into an opioid,” she said. “It’s much harder to stand your ground with that, even though we need to be viewing it the same way.”
 

 

 

The pain paradox

The desire to alleviate pain, as doctors are discovering, often has replaced one harm with another inadvertently. Perhaps the single largest contributing factor, Dr. Herzig said, is the subjectivity of pain and the difficulty in discerning whether a patient’s self-reporting can be trusted. “We want to relieve suffering,” she said, “but we also don’t want to give a patient a drug to which they may develop an addiction or to which they may already be addicted, and so therein lies the conundrum.”

Susan Calcaterra, MD, MPH, is an assistant professor of medicine at the University of Colorado at Denver, Aurora, and a hospitalist at Denver Health Hospital, Denver.
Dr. Susan Calcaterra
Dr. Calcaterra said she and many other hospitalists struggle with the issue regularly. Most physicians are comfortable addressing a “very obvious source of pain,” such as trauma, heart attack, or surgery, she said. But treating more nebulous pain from chronic conditions or syndromes that lack clear supporting data can be tricky. Bridging the potential divide between patients’ understanding of how their pain might be managed and what options are realistically available, she noted, may depend upon establishing clear up-front expectations and effectively communicating the treatment plan and goals.

Some medical providers are also beginning to focus less on visual pain assessments and more on clinically meaningful functional improvements. “For example, instead of asking, ‘What level is your pain today?’ we might say, ‘Were you able to get up and work with physical therapy today?’ and ‘Were you able to get out of the bed to the chair while maintaining your pain at a tolerable level?’ ” Dr. Herzig said.

In addition, providers are recognizing that they should be clearer in telling patients that a complete absence of pain is not only unrealistic but also potentially harmful. “It takes time to have those discussions with patients, where you’re trying to explain to them, ‘Pain is the body’s way of telling you don’t do that, and you need to have some pain in order to know what your limitations are,’ ” Dr. Herzig said.

Shoshana Herzig, MD, MPH, is an assistant professor of medicine at Harvard Medical School, Boston, and director of Hospital Medicine Research at Beth Israel Deaconess Medical Center in Boston.
Dr. Shoshana Herzig
She strongly emphasized the importance of trying nonopioid analgesics first, especially given their superior effectiveness for certain types of pain. “And then, if you do go on to prescribe opioids, you should always pair them with nonopioid analgesics,” she said.

From talking with hospitalized patients, Dr. Mosher and her colleagues found that pain-related suffering can be manifested in or exacerbated by poor sleep or diet, boredom, physical discomfort, immobility, or inability to maintain comforting activities. In other words, how can the hospital improve sleeping conditions or address the understandable anxiety around health issues or being in a strange new environment and losing control? “One of the upsides of all this is that it may drive us to really think about, and make thoughtful investments in, changing the hospital to be a more therapeutic environment,” Dr. Mosher said.
 

Chronic use and discharge dilemmas

What about patients who already used opioids regularly before their hospital admission? In a 2014 study, Dr. Mosher and her colleagues found that among patients admitted to Veterans Affairs hospitals between 2009 and 2011, more than one in four were on chronic opioid therapy in the 6 months prior to their hospitalization.8 That subset of patients, the study suggested, was at greater risk for both 30-day readmission and death.

Determining whether an opioid prescription is appropriate or not, though, takes time. “Hospitalists are often terribly busy,” Dr. Mosher said. “There’s a lot of pressure to move people through the hospital. It’s a big ask to say, ‘How will hospitalists do what might be ideal?’ versus ‘What can we do?’ ” A workable solution, she said, may depend upon a cultural shift in recognizing that “pain is not something you measure by numbers,” but rather a part of a patient’s complex medical condition that may require consultations and coordination with specialists both within and beyond the hospital.

Sometimes, relatively simple questions can go a long way. When Dr. Mosher asks patients on opioids whether they help, she said, “I’ve had very few patients who will say it makes the pain go away.” Likewise, she contends that very few patients have been informed of potential side effects such as decreased muscle mass, osteoporosis, and endocrinopathy. Men on opioids can have a significant reduction in testosterone levels that negatively affects their sex life. When Dr. Mosher has talked to them about the downsides of long-term use, more than a few have requested her help in weaning them off the drugs.

If given the time to educate such patients and consider how their chronic pain and opioid use might be connected to the hospitalization, she said, “We can find opportunities to use that as a change moment.”

Discharging a patient with a well-considered opioid prescription can still present multiple challenges. The best-case scenario, Dr. Calcaterra said, is to coordinate a plan with the patient’s primary care provider. “A lot of patients that we take care of, though, don’t have a follow-up provider. They don’t have a primary care physician,” she said.

The opioid epidemic also has walloped many communities that lack sufficient resources for at-risk patients, whether it’s alternative pain therapy or a buprenorphine clinic. “If you look at access to medication-assisted therapies, the lights are out for a lot of America. There just isn’t access,” Dr. Mosher said. The limited options can set up a frustrating quandary: Hospitalists may be reluctant to wean patients off opioids and get them on buprenorphine if there’s no reliable resource to continue the therapy after a postdischarge handoff.

Until better safety nets and evidence-based protocols are woven together, hospitalists may need to make judgment calls based on their experience and available data and be creative in using existing resources to help their patients. Although electronic prescribing may help reduce the potential for tampering with a doctor’s script, Dr. Calcaterra said, diversion of opioid pills remains a “huge issue across the United States.” Several states now limit the amount of opioids that can be prescribed upon discharge, and hospitalists in many states can access prescription drug monitoring programs to determine whether patients are receiving opioids from other providers.
 

 

 

Pushing for proactive solutions

Anupam Jena, MD, PhD, is a health care policy expert at Harvard Medical School, Boston.
Dr. Anupam Jena
One of the biggest unmet needs, according to multiple hospitalists, is a clear and uniform set of inpatient prescribing guidelines. A consensus document might address some of the high variability in opioid prescribing practices seen by experts, such as Dr. Jena. “That’s a big issue because it’s that variability that leads to adverse consequences for patients when the opioids are inappropriately prescribed either in terms of the frequency or terms of their dose,” he said.

Kevin Vuernick, senior project manager of SHM’s Center for Hospital Innovation and Improvement, said the society’s Hospital Quality and Patient Safety Committee is actively exploring plans to develop pain prescribing guidelines for hospitalized patients based on the input of hospitalists and other medical specialists. The society also hopes to set up a website that compiles available resources, such as its own well-received Reducing Adverse Drug Events related to Opioids Mentored Implementation Program.

Dr. Mosher said SHM and other professional organizations also could assume leadership roles in setting a research agenda, establishing priorities for quality improvement efforts, and evaluating the utility of intervention programs. She and others have said additional help is sorely needed in educating providers, most of whom have never received formal training in pain management.

Talented and skilled physicians with the right language and approach could serve as role models in teaching providers how to appropriately bring up sensitive topics, such as concerns that a patient may be misusing opioids or that the pain may be more psychological than physical in nature. “We need a common language,” Dr. Herzig said.

More broadly, hospital medicine practitioners could serve as institutional role models. Many already sit on safety and quality improvement committees, meaning that they can help develop standardized protocols and help inform decisions regarding both prescribing and oversight to improve the appropriateness and safety of opioid prescriptions.

Matthew Jared, MD, a hospitalist at St. Anthony Hospital in Oklahoma City, said he and his colleagues have long worried about striking the right balance on opioids and about “trying to find an objective way to treat a subjective problem.” Because he and his hospitalist counterparts see 95% of St. Anthony’s inpatients, however, he said hospital medicine is uniquely positioned to help initiate a more holistic and consistent opioid management plan. “We’re key in the equation of trying to get this under control in a way that’s healthy and respectful to the patient and to the staff,” he said.

Bryn Nelson is a freelance writer in Seattle.

References

1. Calcaterra SL, Drabkin AD, Leslie SE, Doyle R, et al. The hospitalist perspective on opioid prescribing: A qualitative analysis. J Hosp Med. 2016 Aug;11(8):536-42.

2. Rudd RA, Seth P, David F, Scholl L. Increases in drug and opioid-involved overdose deaths – United States, 2010–2015. MMWR Morb Mortal Wkly Rep. 2016 Dec;65(50-51):1445-52; and https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates.

3. Katz, J. The First Count of Fentanyl Deaths in 2016: Up 540% in Three Years. New York Times, Sept. 2, 2017. https://www.nytimes.com/interactive/2017/09/02/upshot/fentanyl-drug-overdose-deaths.html?mcubz=1&_r=0

4. Herzig SJ. Opening the black box of inpatient opioid prescribing. J Hosp Med. 2016 Aug;11(8):595-6.

5. Herzig SJ, Rothberg MB, Cheung M, et al. Opioid utilization and opioid-related adverse events in nonsurgical patients in U.S. hospitals. J Hosp Med. 2014;9(2):73-81.

6. Jena AB, Goldman D, Karaca-Mandic P. Hospital prescribing of opioids to Medicare beneficiaries. JAMA Intern Med. 2016 July;176(7):990-7.

7. Jena AB, Goldman D, Weaver L, Karaca-Mandic P. Opioid prescribing by multiple providers in Medicare: Retrospective observational study of insurance claims. BMJ. 2014;348:g1393.

8. Mosher HJ, Jiang L, Vaughan Sarrazin MS, et al. Prevalence and characteristics of hospitalized adults on chronic opioid therapy. J Hosp Med. 2014 Feb;9(2):82-7.

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Why Aren’t Doctors Following Guidelines?

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Why Aren’t Doctors Following Guidelines?

Take a quick glance through the medical literature, and chances are good that you’ll find a study citing low or variable adherence to clinical guidelines.

One recent paper in Clinical Pediatrics, for example, chronicled low adherence to the 2011 National Heart, Lung, and Blood Institute lipid screening guidelines in primary-care settings.1 Another cautioned providers to “mind the (implementation) gap” in venous thromboembolism prevention guidelines for medical inpatients.2 A third found that lower adherence to guidelines issued by the American College of Cardiology/American Heart Association for acute coronary syndrome patients was significantly associated with higher bleeding and mortality rates.3

William Lewis, MD
William Lewis, MD

Both clinical trials and real-world studies have demonstrated that when guidelines are applied, patients do better, says William Lewis, MD, professor of medicine at Case Western Reserve University and director of the Heart & Vascular Center at MetroHealth in Cleveland. So why aren’t they followed more consistently?

Experts in both HM and other disciplines cite multiple obstacles. Lack of evidence, conflicting evidence, or lack of awareness about evidence can all conspire against the main goal of helping providers deliver consistent high-value care, says Christopher Moriates, MD, assistant clinical professor in the Division of Hospital Medicine at the University of California, San Francisco.

Christopher Moriates, MD
Christopher Moriates, MD

“In our day-to-day lives as hospitalists, for the vast majority probably of what we do there’s no clear guideline or there’s a guideline that doesn’t necessarily apply to the patient standing in front of me,” he says.

Even when a guideline is clear and relevant, other doctors say inadequate dissemination and implementation can still derail quality improvement efforts.

“A lot of what we do as physicians is what we learned in residency, and to incorporate the new data is difficult,” says Leonard Feldman, MD, SFHM, a hospitalist and associate professor of internal medicine and pediatrics at Johns Hopkins School of Medicine in Baltimore.

Leonard Feldman, MD, SFHM
Leonard Feldman, MD, SFHM

Dr. Feldman believes many doctors have yet to integrate recently revised hypertension and cholesterol guidelines into their practice, for example. Some guidelines have proven more complex or controversial, limiting their adoption.

“I know I struggle to keep up with all of the guidelines, and I’m in a big academic center where people are talking about them all the time, and I’m working with residents who are talking about them all the time,” Dr. Feldman says.

Despite the remaining gaps, however, many researchers agree that momentum has built steadily over the past two decades toward a more systematic approach to creating solid evidence-based guidelines and integrating them into real-world decision making.

Emphasis on Evidence and Transparency

Gordon Guyatt, MD, MSc, FRCPC
Gordon Guyatt, MD, MSc, FRCPC

The term “evidence-based medicine” was coined in 1990 by Gordon Guyatt, MD, MSc, FRCPC, distinguished professor of medicine and clinical epidemiology at McMaster University in Hamilton, Ontario. It’s played an active role in formulating guidelines for multiple organizations. The guideline-writing process, Dr. Guyatt says, once consisted of little more than self-selected clinicians sitting around a table.

“It used to be that a bunch of experts got together and decided and made the recommendations with very little in the way of a systematic process and certainly not evidence based,” he says.

Cincinnati Children’s Hospital Medical Center was among the pioneers pushing for a more systematic approach; the hospital began working on its own guidelines in 1995 and published the first of many the following year.

Wendy Gerhardt, MSN
Wendy Gerhardt, MSN

“We started evidence-based guidelines when the docs were still saying, ‘This is cookbook medicine. I don’t know if I want to do this or not,’” says Wendy Gerhardt, MSN, director of evidence-based decision making in the James M. Anderson Center for Health Systems Excellence at Cincinnati Children’s.

 

 

Some doctors also argued that clinical guidelines would stifle innovation, cramp their individual style, or intrude on their relationships with patients. Despite some lingering misgivings among clinicians, however, the process has gained considerable support. In 2000, an organization called the GRADE Working Group (Grading of Recommendations, Assessment, Development and Evaluation) began developing a new approach to raise the quality of evidence and strength of recommendations.

The group’s work led to a 2004 article in BMJ, and the journal subsequently published a six-part series about GRADE for clinicians.4 More recently, the Journal of Clinical Epidemiology also delved into the issue with a 15-part series detailing the GRADE methodology.5 Together, Dr. Guyatt says, the articles have become a go-to guide for guidelines and have helped solidify the focus on evidence.

Cincinnati Children’s and other institutions also have developed tools, and the Institute of Medicine has published guideline-writing standards.

“So it’s easier than it’s ever been to know whether or not you have a decent guideline in your hand,” Gerhardt says.

Likewise, medical organizations are more clearly explaining how they came up with different kinds of guidelines. Evidence-based and consensus guidelines aren’t necessarily mutually exclusive, though consensus building is often used in the absence of high-quality evidence. Some organizations have limited the pool of evidence for guidelines to randomized controlled trial data.

“Unfortunately, for us in the real world, we actually have to make decisions even when there’s not enough data,” Dr. Feldman says.

Sometimes, the best available evidence may be observational studies, and some committees still try to reach a consensus based on that evidence and on the panelists’ professional opinions.

Dr. Guyatt agrees that it’s “absolutely not” true that evidence-based guidelines require randomized controlled trials. “What you need for any recommendation is a thorough review and summary of the best available evidence,” he says.

As part of each final document, Cincinnati Children’s details how it created the guideline, when the literature searches occurred, how the committee reached a consensus, and which panelists participated in the deliberations. The information, Gerhardt says, allows anyone else to “make some sensible decisions about whether or not it’s a guideline you want to use.”

Guideline-crafting institutions are also focusing more on the proper makeup of their panels. In general, Dr. Guyatt says, a panel with more than 10 people can be unwieldy. Guidelines that include many specific recommendations, however, may require multiple subsections, each with its own committee.

Dr. Guyatt is careful to note that, like many other experts, he has multiple potential conflicts of interest, such as working on the anti-thrombotic guidelines issued by the American College of Chest Physicians. Committees, he says, have become increasingly aware of how properly handling conflicts (financial or otherwise) can be critical in building and maintaining trust among clinicians and patients. One technique is to ensure that a diversity of opinions is reflected among a committee whose experts have various conflicts. If one expert’s company makes drug A, for example, then the committee also includes experts involved with drugs B or C. As an alternative, some committees have explicitly barred anyone with a conflict of interest from participating at all.

But experts often provide crucial input, Dr. Guyatt says, and several committees have adopted variations of a middle-ground approach. In an approach that he favors, all guideline-formulating panelists are conflict-free but begin their work by meeting with a separate group of experts who may have some conflicts but can help point out the main issues. The panelists then deliberate and write a draft of the recommendations, after which they meet again with the experts to receive feedback before finalizing the draft.

 

 

In a related approach, experts sit on the panel and discuss the evidence, but those with conflicts recuse themselves before the group votes on any recommendations. Delineating between discussions of the evidence and discussions of recommendations can be tricky, though, increasing the risk that a conflict of interest may influence the outcome. Even so, Dr. Guyatt says the model is still preferable to other alternatives.

Getting the Word Out

Once guidelines have been crafted and vetted, how can hospitalists get up to speed on them? Dr. Feldman’s favorite go-to source is Guideline.gov, a national guideline clearinghouse that he calls one of the best compendiums of available information. Especially helpful, he adds, are details such as how the guidelines were created.

To help maximize his time, he also uses tools like NEJM Journal Watch, which sends daily emails on noteworthy articles and weekend roundups of the most important studies.

“It is a way of at least trying to keep up with what’s going on,” he says. Similarly, he adds, ACP Journal Club provides summaries of important new articles, The Hospitalist can help highlight important guidelines that affect HM, and CME meetings or online modules like SHMconsults.com can help doctors keep pace.

For the past decade, Dr. Guyatt has worked with another popular tool, a guideline-disseminating service called UpToDate. Many alternatives exist, such as DynaMed Plus.

“I think you just need to pick away,” Dr. Feldman says. “You need to decide that as a physician, as a lifelong learner, that you are going to do something that is going to keep you up-to-date. There are many ways of doing it. You just have to decide what you’re going to do and commit to it.”

Lisa Shieh, MD, PhD, FHM
Lisa Shieh, MD, PhD, FHM

Researchers are helping out by studying how to present new guidelines in ways that engage doctors and improve patient outcomes. Another trend is to make guidelines routinely accessible not only in electronic medical records but also on tablets and smartphones. Lisa Shieh, MD, PhD, FHM, a hospitalist and clinical professor of medicine at Stanford University Medical Center, has studied how best-practice alerts, or BPAs, impact adherence to guidelines covering the appropriate use of blood products. Dr. Shieh, who splits her time between quality improvement and hospital medicine, says getting new information and guidelines into clinicians’ hands can be a logistical challenge.

“At Stanford, we had a huge official campaign around the guidelines, and that did make some impact, but it wasn’t huge in improving appropriate blood use,” she says. When the medial center set up a BPA through the electronic medical record system, however, both overall and inappropriate blood use declined significantly. In fact, the percentage of providers ordering blood products for patients with a hemoglobin count above 8 g/dL dropped from 60% to 25%.6

One difference maker, Dr. Shieh says, was providing education at the moment a doctor actually ordered blood. To avoid alert fatigue, the “smart BPA” fires only if a doctor tries to order blood and the patient’s hemoglobin is greater than 7 or 8 g/dL, depending on the diagnosis. If the doctor still wants to transfuse, the system requests a clinical indication for the exception.

Despite the clear improvement in appropriate use, the team wanted to understand why 25% of providers were still ordering blood products for patients with a hemoglobin count greater than 8 despite the triggered BPA and whether additional interventions could yield further improvements. Through their study, the researchers documented several reasons for the continued ordering. In some cases, the system failed to properly document actual or potential bleeding as an indicator. In other cases, the ordering reflected a lack of consensus on the guidelines in fields like hematology and oncology.

 

 

One of the most intriguing reasons, though, was that residents often did the ordering at the behest of an attending who might have never seen the BPA.

“It’s not actually reaching the audience making the decision; it might be reaching the audience that’s just carrying out the order,” Dr. Shieh says.

The insight, she says, may provide an opportunity to talk with attending physicians who may not have completely bought into the guidelines and to involve the entire team in the decision-making process.

Hospitalists, she says, can play a vital role in guideline development and implementation, especially for strategies that include BPAs.

“I think they’re the perfect group to help use this technology wisely because they are at the front lines taking care of patients so they’ll know the best workflow of when these alerts fire and maybe which ones happen the most often,” Dr. Shieh says. “I think this is a fantastic opportunity to get more hospitalists involved in designing these alerts and collaborating with the IT folks.”

Even with widespread buy-in from providers, guidelines may not reach their full potential without a careful consideration of patients’ values and concerns. Experts say joint deliberations and discussions are especially important for guidelines that are complicated, controversial, or carrying potential risks that must be weighed against the benefits.

Some of the conversations are easy, with well-defined risks and benefits and clear patient preferences, but others must traverse vast tracts of gray area. Fortunately, Dr. Feldman says, more tools also are becoming available for this kind of shared decision making. Some use pictorial representations to help patients understand the potential outcomes of alternative courses of action or inaction.

“Sometimes, that pictorial representation is worth the 1,000 words that we wouldn’t be able to adequately describe otherwise,” he says.

Similarly, Cincinnati Children’s has developed tools to help to ease the shared decision-making process.

“We look where there’s equivocal evidence or no evidence and have developed tools that help the clinician have that conversation with the family and then have them informed enough that they can actually weigh in on what they want,” Gerhardt says. One end product is a card or trifold pamphlet that might help parents understand the benefits and side effects of alternate strategies.

“Typically, in medicine, we’re used to telling people what needs to be done,” she says. “So shared decision making is kind of a different thing for clinicians to engage in.” TH


Bryn Nelson, PhD, is a freelance writer in Seattle.

References

  1. Valle CW, Binns HJ, Quadri-Sheriff M, Benuck I, Patel A. Physicians’ lack of adherence to National Heart, Lung, and Blood Institute guidelines for pediatric lipid screening. Clin Pediatr. 2015;54(12):1200-1205.
  2. Maynard G, Jenkins IH, Merli GJ. Venous thromboembolism prevention guidelines for medical inpatients: mind the (implementation) gap. J Hosp Med. 2013;8(10):582-588.
  3. Mehta RH, Chen AY, Alexander KP, Ohman EM, Roe MT, Peterson ED. Doing the right things and doing them the right way: association between hospital guideline adherence, dosing safety, and outcomes among patients with acute coronary syndrome. Circulation. 2015;131(11):980-987.
  4. GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490
  5. Andrews JC, Schünemann HJ, Oxman AD, et al. GRADE guidelines: 15. Going from evidence to recommendation—determinants of a recommendation’s direction and strength. J Clin Epidemiol. 2013;66(7):726-735.
  6. 6. Chen JH, Fang DZ, Tim Goodnough L, Evans KH, Lee Porter M, Shieh L. Why providers transfuse blood products outside recommended guidelines in spite of integrated electronic best practice alerts. J Hosp Med. 2015;10(1):1-7.

How to Gauge Guidelines

For clinical guidelines to be truly trustworthy, Gordon Guyatt, MD, MSc, FRCPC, distinguished professor of medicine and clinical epidemiology at McMaster University in Hamilton, Ontario, says that they should meet several criteria:

  • They should adhere to an evidence-based process of gathering and summarizing the evidence and summarize that evidence in ways doctors can understand.
  • They should rate the overall evidence used in their deliberations and distinguish between strong and weak recommendations.
  • They should recognize that recommendations are value- and preference-sensitive, make their own judgments explicit, and seek out available evidence about patients’ own values and preferences.
  • They should be clear about how they’re dealing with conflicts of interest.

—Bryn Nelson, PhD

 

 

New Tools of the Trade for Crafting Clinical Guidelines

The well-known GRADE system and similar tools such as Levels of Evidence and Grades of Recommendation have helped guideline writers for years, particularly in evaluating bodies of medical literature and the strength of the studies’ conclusions. Cincinnati Children’s Hospital Medical Center uses a similar strength-of-evidence pyramid to gauge the relative reliability of data: physician expertise and practice at the base, a retrospective or cohort study at a higher level, and a systematic review composed of numerous randomized controlled trials at the pinnacle.

Not every clinician has been taught how to appraise articles, however. Accordingly, Cincinnati Children’s James M. Anderson Center for Health Systems Excellence has developed another system called LEGEND (Let Evidence Guide Every New Decision) to help guideline developers know what to look for when reading a study. The system’s analysis boils down to three main questions: Is it valid? What are the results? And are they applicable to my population?

“If you want to know whether the study that you’re reading is something that should prompt you to change practice, you want to know if the study is a good one,” says Wendy Gerhardt, MSN, the hospital center’s director of evidence-based decision making.

In fact, the hospital has developed tools to assist in nearly every step of the guideline-crafting process. The tools help clinicians learn how to read studies, develop an evidence-based guideline, understand whether a guideline is solid, know where separate recommendations agree and differ, and implement new guidelines into regular practice.

One tool called REACH (Rapid Evidence Adoption to improve Child Health) uses quality improvement consultants and multidisciplinary groups to “translate evidence into point-of-care decision making by clinicians, families and patients,” according to its website. The process takes about 120 days and can result in decision aids such as prepopulated electronic order sets that default to evidence-based suggestions for, say, bronchiolitis inhalation therapies.

“It’s really helpful when you’re working in an academic center and the residents are the ones writing the orders,” says Gerhardt. “So it defaults to the right thing, and they have to actually think about not doing it that way.”

Often, it’s not enough merely to give doctors the link to a new guideline.

“If you can pull up an order set that already has the evidence embedded in it, that’s a little more compelling,” she says. “You kind of have to put the evidence at their point of care instead of in a document. And that’s what, in my mind, makes it real.”

At Cincinnati Children’s, she and her colleagues also have taught doctors how to use PubMed to seek out systematic reviews if they have a question. They have rolling computers, too: Medical librarians sometimes go on rounds with clinicians to help with on-the-spot literature searches.

“It’s however you can make it easier for them to use,” Gerhardt says. “By and large, most people just want to practice, so you have to put that evidence in their way.”

Bryn Nelson, PhD

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Take a quick glance through the medical literature, and chances are good that you’ll find a study citing low or variable adherence to clinical guidelines.

One recent paper in Clinical Pediatrics, for example, chronicled low adherence to the 2011 National Heart, Lung, and Blood Institute lipid screening guidelines in primary-care settings.1 Another cautioned providers to “mind the (implementation) gap” in venous thromboembolism prevention guidelines for medical inpatients.2 A third found that lower adherence to guidelines issued by the American College of Cardiology/American Heart Association for acute coronary syndrome patients was significantly associated with higher bleeding and mortality rates.3

William Lewis, MD
William Lewis, MD

Both clinical trials and real-world studies have demonstrated that when guidelines are applied, patients do better, says William Lewis, MD, professor of medicine at Case Western Reserve University and director of the Heart & Vascular Center at MetroHealth in Cleveland. So why aren’t they followed more consistently?

Experts in both HM and other disciplines cite multiple obstacles. Lack of evidence, conflicting evidence, or lack of awareness about evidence can all conspire against the main goal of helping providers deliver consistent high-value care, says Christopher Moriates, MD, assistant clinical professor in the Division of Hospital Medicine at the University of California, San Francisco.

Christopher Moriates, MD
Christopher Moriates, MD

“In our day-to-day lives as hospitalists, for the vast majority probably of what we do there’s no clear guideline or there’s a guideline that doesn’t necessarily apply to the patient standing in front of me,” he says.

Even when a guideline is clear and relevant, other doctors say inadequate dissemination and implementation can still derail quality improvement efforts.

“A lot of what we do as physicians is what we learned in residency, and to incorporate the new data is difficult,” says Leonard Feldman, MD, SFHM, a hospitalist and associate professor of internal medicine and pediatrics at Johns Hopkins School of Medicine in Baltimore.

Leonard Feldman, MD, SFHM
Leonard Feldman, MD, SFHM

Dr. Feldman believes many doctors have yet to integrate recently revised hypertension and cholesterol guidelines into their practice, for example. Some guidelines have proven more complex or controversial, limiting their adoption.

“I know I struggle to keep up with all of the guidelines, and I’m in a big academic center where people are talking about them all the time, and I’m working with residents who are talking about them all the time,” Dr. Feldman says.

Despite the remaining gaps, however, many researchers agree that momentum has built steadily over the past two decades toward a more systematic approach to creating solid evidence-based guidelines and integrating them into real-world decision making.

Emphasis on Evidence and Transparency

Gordon Guyatt, MD, MSc, FRCPC
Gordon Guyatt, MD, MSc, FRCPC

The term “evidence-based medicine” was coined in 1990 by Gordon Guyatt, MD, MSc, FRCPC, distinguished professor of medicine and clinical epidemiology at McMaster University in Hamilton, Ontario. It’s played an active role in formulating guidelines for multiple organizations. The guideline-writing process, Dr. Guyatt says, once consisted of little more than self-selected clinicians sitting around a table.

“It used to be that a bunch of experts got together and decided and made the recommendations with very little in the way of a systematic process and certainly not evidence based,” he says.

Cincinnati Children’s Hospital Medical Center was among the pioneers pushing for a more systematic approach; the hospital began working on its own guidelines in 1995 and published the first of many the following year.

Wendy Gerhardt, MSN
Wendy Gerhardt, MSN

“We started evidence-based guidelines when the docs were still saying, ‘This is cookbook medicine. I don’t know if I want to do this or not,’” says Wendy Gerhardt, MSN, director of evidence-based decision making in the James M. Anderson Center for Health Systems Excellence at Cincinnati Children’s.

 

 

Some doctors also argued that clinical guidelines would stifle innovation, cramp their individual style, or intrude on their relationships with patients. Despite some lingering misgivings among clinicians, however, the process has gained considerable support. In 2000, an organization called the GRADE Working Group (Grading of Recommendations, Assessment, Development and Evaluation) began developing a new approach to raise the quality of evidence and strength of recommendations.

The group’s work led to a 2004 article in BMJ, and the journal subsequently published a six-part series about GRADE for clinicians.4 More recently, the Journal of Clinical Epidemiology also delved into the issue with a 15-part series detailing the GRADE methodology.5 Together, Dr. Guyatt says, the articles have become a go-to guide for guidelines and have helped solidify the focus on evidence.

Cincinnati Children’s and other institutions also have developed tools, and the Institute of Medicine has published guideline-writing standards.

“So it’s easier than it’s ever been to know whether or not you have a decent guideline in your hand,” Gerhardt says.

Likewise, medical organizations are more clearly explaining how they came up with different kinds of guidelines. Evidence-based and consensus guidelines aren’t necessarily mutually exclusive, though consensus building is often used in the absence of high-quality evidence. Some organizations have limited the pool of evidence for guidelines to randomized controlled trial data.

“Unfortunately, for us in the real world, we actually have to make decisions even when there’s not enough data,” Dr. Feldman says.

Sometimes, the best available evidence may be observational studies, and some committees still try to reach a consensus based on that evidence and on the panelists’ professional opinions.

Dr. Guyatt agrees that it’s “absolutely not” true that evidence-based guidelines require randomized controlled trials. “What you need for any recommendation is a thorough review and summary of the best available evidence,” he says.

As part of each final document, Cincinnati Children’s details how it created the guideline, when the literature searches occurred, how the committee reached a consensus, and which panelists participated in the deliberations. The information, Gerhardt says, allows anyone else to “make some sensible decisions about whether or not it’s a guideline you want to use.”

Guideline-crafting institutions are also focusing more on the proper makeup of their panels. In general, Dr. Guyatt says, a panel with more than 10 people can be unwieldy. Guidelines that include many specific recommendations, however, may require multiple subsections, each with its own committee.

Dr. Guyatt is careful to note that, like many other experts, he has multiple potential conflicts of interest, such as working on the anti-thrombotic guidelines issued by the American College of Chest Physicians. Committees, he says, have become increasingly aware of how properly handling conflicts (financial or otherwise) can be critical in building and maintaining trust among clinicians and patients. One technique is to ensure that a diversity of opinions is reflected among a committee whose experts have various conflicts. If one expert’s company makes drug A, for example, then the committee also includes experts involved with drugs B or C. As an alternative, some committees have explicitly barred anyone with a conflict of interest from participating at all.

But experts often provide crucial input, Dr. Guyatt says, and several committees have adopted variations of a middle-ground approach. In an approach that he favors, all guideline-formulating panelists are conflict-free but begin their work by meeting with a separate group of experts who may have some conflicts but can help point out the main issues. The panelists then deliberate and write a draft of the recommendations, after which they meet again with the experts to receive feedback before finalizing the draft.

 

 

In a related approach, experts sit on the panel and discuss the evidence, but those with conflicts recuse themselves before the group votes on any recommendations. Delineating between discussions of the evidence and discussions of recommendations can be tricky, though, increasing the risk that a conflict of interest may influence the outcome. Even so, Dr. Guyatt says the model is still preferable to other alternatives.

Getting the Word Out

Once guidelines have been crafted and vetted, how can hospitalists get up to speed on them? Dr. Feldman’s favorite go-to source is Guideline.gov, a national guideline clearinghouse that he calls one of the best compendiums of available information. Especially helpful, he adds, are details such as how the guidelines were created.

To help maximize his time, he also uses tools like NEJM Journal Watch, which sends daily emails on noteworthy articles and weekend roundups of the most important studies.

“It is a way of at least trying to keep up with what’s going on,” he says. Similarly, he adds, ACP Journal Club provides summaries of important new articles, The Hospitalist can help highlight important guidelines that affect HM, and CME meetings or online modules like SHMconsults.com can help doctors keep pace.

For the past decade, Dr. Guyatt has worked with another popular tool, a guideline-disseminating service called UpToDate. Many alternatives exist, such as DynaMed Plus.

“I think you just need to pick away,” Dr. Feldman says. “You need to decide that as a physician, as a lifelong learner, that you are going to do something that is going to keep you up-to-date. There are many ways of doing it. You just have to decide what you’re going to do and commit to it.”

Lisa Shieh, MD, PhD, FHM
Lisa Shieh, MD, PhD, FHM

Researchers are helping out by studying how to present new guidelines in ways that engage doctors and improve patient outcomes. Another trend is to make guidelines routinely accessible not only in electronic medical records but also on tablets and smartphones. Lisa Shieh, MD, PhD, FHM, a hospitalist and clinical professor of medicine at Stanford University Medical Center, has studied how best-practice alerts, or BPAs, impact adherence to guidelines covering the appropriate use of blood products. Dr. Shieh, who splits her time between quality improvement and hospital medicine, says getting new information and guidelines into clinicians’ hands can be a logistical challenge.

“At Stanford, we had a huge official campaign around the guidelines, and that did make some impact, but it wasn’t huge in improving appropriate blood use,” she says. When the medial center set up a BPA through the electronic medical record system, however, both overall and inappropriate blood use declined significantly. In fact, the percentage of providers ordering blood products for patients with a hemoglobin count above 8 g/dL dropped from 60% to 25%.6

One difference maker, Dr. Shieh says, was providing education at the moment a doctor actually ordered blood. To avoid alert fatigue, the “smart BPA” fires only if a doctor tries to order blood and the patient’s hemoglobin is greater than 7 or 8 g/dL, depending on the diagnosis. If the doctor still wants to transfuse, the system requests a clinical indication for the exception.

Despite the clear improvement in appropriate use, the team wanted to understand why 25% of providers were still ordering blood products for patients with a hemoglobin count greater than 8 despite the triggered BPA and whether additional interventions could yield further improvements. Through their study, the researchers documented several reasons for the continued ordering. In some cases, the system failed to properly document actual or potential bleeding as an indicator. In other cases, the ordering reflected a lack of consensus on the guidelines in fields like hematology and oncology.

 

 

One of the most intriguing reasons, though, was that residents often did the ordering at the behest of an attending who might have never seen the BPA.

“It’s not actually reaching the audience making the decision; it might be reaching the audience that’s just carrying out the order,” Dr. Shieh says.

The insight, she says, may provide an opportunity to talk with attending physicians who may not have completely bought into the guidelines and to involve the entire team in the decision-making process.

Hospitalists, she says, can play a vital role in guideline development and implementation, especially for strategies that include BPAs.

“I think they’re the perfect group to help use this technology wisely because they are at the front lines taking care of patients so they’ll know the best workflow of when these alerts fire and maybe which ones happen the most often,” Dr. Shieh says. “I think this is a fantastic opportunity to get more hospitalists involved in designing these alerts and collaborating with the IT folks.”

Even with widespread buy-in from providers, guidelines may not reach their full potential without a careful consideration of patients’ values and concerns. Experts say joint deliberations and discussions are especially important for guidelines that are complicated, controversial, or carrying potential risks that must be weighed against the benefits.

Some of the conversations are easy, with well-defined risks and benefits and clear patient preferences, but others must traverse vast tracts of gray area. Fortunately, Dr. Feldman says, more tools also are becoming available for this kind of shared decision making. Some use pictorial representations to help patients understand the potential outcomes of alternative courses of action or inaction.

“Sometimes, that pictorial representation is worth the 1,000 words that we wouldn’t be able to adequately describe otherwise,” he says.

Similarly, Cincinnati Children’s has developed tools to help to ease the shared decision-making process.

“We look where there’s equivocal evidence or no evidence and have developed tools that help the clinician have that conversation with the family and then have them informed enough that they can actually weigh in on what they want,” Gerhardt says. One end product is a card or trifold pamphlet that might help parents understand the benefits and side effects of alternate strategies.

“Typically, in medicine, we’re used to telling people what needs to be done,” she says. “So shared decision making is kind of a different thing for clinicians to engage in.” TH


Bryn Nelson, PhD, is a freelance writer in Seattle.

References

  1. Valle CW, Binns HJ, Quadri-Sheriff M, Benuck I, Patel A. Physicians’ lack of adherence to National Heart, Lung, and Blood Institute guidelines for pediatric lipid screening. Clin Pediatr. 2015;54(12):1200-1205.
  2. Maynard G, Jenkins IH, Merli GJ. Venous thromboembolism prevention guidelines for medical inpatients: mind the (implementation) gap. J Hosp Med. 2013;8(10):582-588.
  3. Mehta RH, Chen AY, Alexander KP, Ohman EM, Roe MT, Peterson ED. Doing the right things and doing them the right way: association between hospital guideline adherence, dosing safety, and outcomes among patients with acute coronary syndrome. Circulation. 2015;131(11):980-987.
  4. GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490
  5. Andrews JC, Schünemann HJ, Oxman AD, et al. GRADE guidelines: 15. Going from evidence to recommendation—determinants of a recommendation’s direction and strength. J Clin Epidemiol. 2013;66(7):726-735.
  6. 6. Chen JH, Fang DZ, Tim Goodnough L, Evans KH, Lee Porter M, Shieh L. Why providers transfuse blood products outside recommended guidelines in spite of integrated electronic best practice alerts. J Hosp Med. 2015;10(1):1-7.

How to Gauge Guidelines

For clinical guidelines to be truly trustworthy, Gordon Guyatt, MD, MSc, FRCPC, distinguished professor of medicine and clinical epidemiology at McMaster University in Hamilton, Ontario, says that they should meet several criteria:

  • They should adhere to an evidence-based process of gathering and summarizing the evidence and summarize that evidence in ways doctors can understand.
  • They should rate the overall evidence used in their deliberations and distinguish between strong and weak recommendations.
  • They should recognize that recommendations are value- and preference-sensitive, make their own judgments explicit, and seek out available evidence about patients’ own values and preferences.
  • They should be clear about how they’re dealing with conflicts of interest.

—Bryn Nelson, PhD

 

 

New Tools of the Trade for Crafting Clinical Guidelines

The well-known GRADE system and similar tools such as Levels of Evidence and Grades of Recommendation have helped guideline writers for years, particularly in evaluating bodies of medical literature and the strength of the studies’ conclusions. Cincinnati Children’s Hospital Medical Center uses a similar strength-of-evidence pyramid to gauge the relative reliability of data: physician expertise and practice at the base, a retrospective or cohort study at a higher level, and a systematic review composed of numerous randomized controlled trials at the pinnacle.

Not every clinician has been taught how to appraise articles, however. Accordingly, Cincinnati Children’s James M. Anderson Center for Health Systems Excellence has developed another system called LEGEND (Let Evidence Guide Every New Decision) to help guideline developers know what to look for when reading a study. The system’s analysis boils down to three main questions: Is it valid? What are the results? And are they applicable to my population?

“If you want to know whether the study that you’re reading is something that should prompt you to change practice, you want to know if the study is a good one,” says Wendy Gerhardt, MSN, the hospital center’s director of evidence-based decision making.

In fact, the hospital has developed tools to assist in nearly every step of the guideline-crafting process. The tools help clinicians learn how to read studies, develop an evidence-based guideline, understand whether a guideline is solid, know where separate recommendations agree and differ, and implement new guidelines into regular practice.

One tool called REACH (Rapid Evidence Adoption to improve Child Health) uses quality improvement consultants and multidisciplinary groups to “translate evidence into point-of-care decision making by clinicians, families and patients,” according to its website. The process takes about 120 days and can result in decision aids such as prepopulated electronic order sets that default to evidence-based suggestions for, say, bronchiolitis inhalation therapies.

“It’s really helpful when you’re working in an academic center and the residents are the ones writing the orders,” says Gerhardt. “So it defaults to the right thing, and they have to actually think about not doing it that way.”

Often, it’s not enough merely to give doctors the link to a new guideline.

“If you can pull up an order set that already has the evidence embedded in it, that’s a little more compelling,” she says. “You kind of have to put the evidence at their point of care instead of in a document. And that’s what, in my mind, makes it real.”

At Cincinnati Children’s, she and her colleagues also have taught doctors how to use PubMed to seek out systematic reviews if they have a question. They have rolling computers, too: Medical librarians sometimes go on rounds with clinicians to help with on-the-spot literature searches.

“It’s however you can make it easier for them to use,” Gerhardt says. “By and large, most people just want to practice, so you have to put that evidence in their way.”

Bryn Nelson, PhD

Take a quick glance through the medical literature, and chances are good that you’ll find a study citing low or variable adherence to clinical guidelines.

One recent paper in Clinical Pediatrics, for example, chronicled low adherence to the 2011 National Heart, Lung, and Blood Institute lipid screening guidelines in primary-care settings.1 Another cautioned providers to “mind the (implementation) gap” in venous thromboembolism prevention guidelines for medical inpatients.2 A third found that lower adherence to guidelines issued by the American College of Cardiology/American Heart Association for acute coronary syndrome patients was significantly associated with higher bleeding and mortality rates.3

William Lewis, MD
William Lewis, MD

Both clinical trials and real-world studies have demonstrated that when guidelines are applied, patients do better, says William Lewis, MD, professor of medicine at Case Western Reserve University and director of the Heart & Vascular Center at MetroHealth in Cleveland. So why aren’t they followed more consistently?

Experts in both HM and other disciplines cite multiple obstacles. Lack of evidence, conflicting evidence, or lack of awareness about evidence can all conspire against the main goal of helping providers deliver consistent high-value care, says Christopher Moriates, MD, assistant clinical professor in the Division of Hospital Medicine at the University of California, San Francisco.

Christopher Moriates, MD
Christopher Moriates, MD

“In our day-to-day lives as hospitalists, for the vast majority probably of what we do there’s no clear guideline or there’s a guideline that doesn’t necessarily apply to the patient standing in front of me,” he says.

Even when a guideline is clear and relevant, other doctors say inadequate dissemination and implementation can still derail quality improvement efforts.

“A lot of what we do as physicians is what we learned in residency, and to incorporate the new data is difficult,” says Leonard Feldman, MD, SFHM, a hospitalist and associate professor of internal medicine and pediatrics at Johns Hopkins School of Medicine in Baltimore.

Leonard Feldman, MD, SFHM
Leonard Feldman, MD, SFHM

Dr. Feldman believes many doctors have yet to integrate recently revised hypertension and cholesterol guidelines into their practice, for example. Some guidelines have proven more complex or controversial, limiting their adoption.

“I know I struggle to keep up with all of the guidelines, and I’m in a big academic center where people are talking about them all the time, and I’m working with residents who are talking about them all the time,” Dr. Feldman says.

Despite the remaining gaps, however, many researchers agree that momentum has built steadily over the past two decades toward a more systematic approach to creating solid evidence-based guidelines and integrating them into real-world decision making.

Emphasis on Evidence and Transparency

Gordon Guyatt, MD, MSc, FRCPC
Gordon Guyatt, MD, MSc, FRCPC

The term “evidence-based medicine” was coined in 1990 by Gordon Guyatt, MD, MSc, FRCPC, distinguished professor of medicine and clinical epidemiology at McMaster University in Hamilton, Ontario. It’s played an active role in formulating guidelines for multiple organizations. The guideline-writing process, Dr. Guyatt says, once consisted of little more than self-selected clinicians sitting around a table.

“It used to be that a bunch of experts got together and decided and made the recommendations with very little in the way of a systematic process and certainly not evidence based,” he says.

Cincinnati Children’s Hospital Medical Center was among the pioneers pushing for a more systematic approach; the hospital began working on its own guidelines in 1995 and published the first of many the following year.

Wendy Gerhardt, MSN
Wendy Gerhardt, MSN

“We started evidence-based guidelines when the docs were still saying, ‘This is cookbook medicine. I don’t know if I want to do this or not,’” says Wendy Gerhardt, MSN, director of evidence-based decision making in the James M. Anderson Center for Health Systems Excellence at Cincinnati Children’s.

 

 

Some doctors also argued that clinical guidelines would stifle innovation, cramp their individual style, or intrude on their relationships with patients. Despite some lingering misgivings among clinicians, however, the process has gained considerable support. In 2000, an organization called the GRADE Working Group (Grading of Recommendations, Assessment, Development and Evaluation) began developing a new approach to raise the quality of evidence and strength of recommendations.

The group’s work led to a 2004 article in BMJ, and the journal subsequently published a six-part series about GRADE for clinicians.4 More recently, the Journal of Clinical Epidemiology also delved into the issue with a 15-part series detailing the GRADE methodology.5 Together, Dr. Guyatt says, the articles have become a go-to guide for guidelines and have helped solidify the focus on evidence.

Cincinnati Children’s and other institutions also have developed tools, and the Institute of Medicine has published guideline-writing standards.

“So it’s easier than it’s ever been to know whether or not you have a decent guideline in your hand,” Gerhardt says.

Likewise, medical organizations are more clearly explaining how they came up with different kinds of guidelines. Evidence-based and consensus guidelines aren’t necessarily mutually exclusive, though consensus building is often used in the absence of high-quality evidence. Some organizations have limited the pool of evidence for guidelines to randomized controlled trial data.

“Unfortunately, for us in the real world, we actually have to make decisions even when there’s not enough data,” Dr. Feldman says.

Sometimes, the best available evidence may be observational studies, and some committees still try to reach a consensus based on that evidence and on the panelists’ professional opinions.

Dr. Guyatt agrees that it’s “absolutely not” true that evidence-based guidelines require randomized controlled trials. “What you need for any recommendation is a thorough review and summary of the best available evidence,” he says.

As part of each final document, Cincinnati Children’s details how it created the guideline, when the literature searches occurred, how the committee reached a consensus, and which panelists participated in the deliberations. The information, Gerhardt says, allows anyone else to “make some sensible decisions about whether or not it’s a guideline you want to use.”

Guideline-crafting institutions are also focusing more on the proper makeup of their panels. In general, Dr. Guyatt says, a panel with more than 10 people can be unwieldy. Guidelines that include many specific recommendations, however, may require multiple subsections, each with its own committee.

Dr. Guyatt is careful to note that, like many other experts, he has multiple potential conflicts of interest, such as working on the anti-thrombotic guidelines issued by the American College of Chest Physicians. Committees, he says, have become increasingly aware of how properly handling conflicts (financial or otherwise) can be critical in building and maintaining trust among clinicians and patients. One technique is to ensure that a diversity of opinions is reflected among a committee whose experts have various conflicts. If one expert’s company makes drug A, for example, then the committee also includes experts involved with drugs B or C. As an alternative, some committees have explicitly barred anyone with a conflict of interest from participating at all.

But experts often provide crucial input, Dr. Guyatt says, and several committees have adopted variations of a middle-ground approach. In an approach that he favors, all guideline-formulating panelists are conflict-free but begin their work by meeting with a separate group of experts who may have some conflicts but can help point out the main issues. The panelists then deliberate and write a draft of the recommendations, after which they meet again with the experts to receive feedback before finalizing the draft.

 

 

In a related approach, experts sit on the panel and discuss the evidence, but those with conflicts recuse themselves before the group votes on any recommendations. Delineating between discussions of the evidence and discussions of recommendations can be tricky, though, increasing the risk that a conflict of interest may influence the outcome. Even so, Dr. Guyatt says the model is still preferable to other alternatives.

Getting the Word Out

Once guidelines have been crafted and vetted, how can hospitalists get up to speed on them? Dr. Feldman’s favorite go-to source is Guideline.gov, a national guideline clearinghouse that he calls one of the best compendiums of available information. Especially helpful, he adds, are details such as how the guidelines were created.

To help maximize his time, he also uses tools like NEJM Journal Watch, which sends daily emails on noteworthy articles and weekend roundups of the most important studies.

“It is a way of at least trying to keep up with what’s going on,” he says. Similarly, he adds, ACP Journal Club provides summaries of important new articles, The Hospitalist can help highlight important guidelines that affect HM, and CME meetings or online modules like SHMconsults.com can help doctors keep pace.

For the past decade, Dr. Guyatt has worked with another popular tool, a guideline-disseminating service called UpToDate. Many alternatives exist, such as DynaMed Plus.

“I think you just need to pick away,” Dr. Feldman says. “You need to decide that as a physician, as a lifelong learner, that you are going to do something that is going to keep you up-to-date. There are many ways of doing it. You just have to decide what you’re going to do and commit to it.”

Lisa Shieh, MD, PhD, FHM
Lisa Shieh, MD, PhD, FHM

Researchers are helping out by studying how to present new guidelines in ways that engage doctors and improve patient outcomes. Another trend is to make guidelines routinely accessible not only in electronic medical records but also on tablets and smartphones. Lisa Shieh, MD, PhD, FHM, a hospitalist and clinical professor of medicine at Stanford University Medical Center, has studied how best-practice alerts, or BPAs, impact adherence to guidelines covering the appropriate use of blood products. Dr. Shieh, who splits her time between quality improvement and hospital medicine, says getting new information and guidelines into clinicians’ hands can be a logistical challenge.

“At Stanford, we had a huge official campaign around the guidelines, and that did make some impact, but it wasn’t huge in improving appropriate blood use,” she says. When the medial center set up a BPA through the electronic medical record system, however, both overall and inappropriate blood use declined significantly. In fact, the percentage of providers ordering blood products for patients with a hemoglobin count above 8 g/dL dropped from 60% to 25%.6

One difference maker, Dr. Shieh says, was providing education at the moment a doctor actually ordered blood. To avoid alert fatigue, the “smart BPA” fires only if a doctor tries to order blood and the patient’s hemoglobin is greater than 7 or 8 g/dL, depending on the diagnosis. If the doctor still wants to transfuse, the system requests a clinical indication for the exception.

Despite the clear improvement in appropriate use, the team wanted to understand why 25% of providers were still ordering blood products for patients with a hemoglobin count greater than 8 despite the triggered BPA and whether additional interventions could yield further improvements. Through their study, the researchers documented several reasons for the continued ordering. In some cases, the system failed to properly document actual or potential bleeding as an indicator. In other cases, the ordering reflected a lack of consensus on the guidelines in fields like hematology and oncology.

 

 

One of the most intriguing reasons, though, was that residents often did the ordering at the behest of an attending who might have never seen the BPA.

“It’s not actually reaching the audience making the decision; it might be reaching the audience that’s just carrying out the order,” Dr. Shieh says.

The insight, she says, may provide an opportunity to talk with attending physicians who may not have completely bought into the guidelines and to involve the entire team in the decision-making process.

Hospitalists, she says, can play a vital role in guideline development and implementation, especially for strategies that include BPAs.

“I think they’re the perfect group to help use this technology wisely because they are at the front lines taking care of patients so they’ll know the best workflow of when these alerts fire and maybe which ones happen the most often,” Dr. Shieh says. “I think this is a fantastic opportunity to get more hospitalists involved in designing these alerts and collaborating with the IT folks.”

Even with widespread buy-in from providers, guidelines may not reach their full potential without a careful consideration of patients’ values and concerns. Experts say joint deliberations and discussions are especially important for guidelines that are complicated, controversial, or carrying potential risks that must be weighed against the benefits.

Some of the conversations are easy, with well-defined risks and benefits and clear patient preferences, but others must traverse vast tracts of gray area. Fortunately, Dr. Feldman says, more tools also are becoming available for this kind of shared decision making. Some use pictorial representations to help patients understand the potential outcomes of alternative courses of action or inaction.

“Sometimes, that pictorial representation is worth the 1,000 words that we wouldn’t be able to adequately describe otherwise,” he says.

Similarly, Cincinnati Children’s has developed tools to help to ease the shared decision-making process.

“We look where there’s equivocal evidence or no evidence and have developed tools that help the clinician have that conversation with the family and then have them informed enough that they can actually weigh in on what they want,” Gerhardt says. One end product is a card or trifold pamphlet that might help parents understand the benefits and side effects of alternate strategies.

“Typically, in medicine, we’re used to telling people what needs to be done,” she says. “So shared decision making is kind of a different thing for clinicians to engage in.” TH


Bryn Nelson, PhD, is a freelance writer in Seattle.

References

  1. Valle CW, Binns HJ, Quadri-Sheriff M, Benuck I, Patel A. Physicians’ lack of adherence to National Heart, Lung, and Blood Institute guidelines for pediatric lipid screening. Clin Pediatr. 2015;54(12):1200-1205.
  2. Maynard G, Jenkins IH, Merli GJ. Venous thromboembolism prevention guidelines for medical inpatients: mind the (implementation) gap. J Hosp Med. 2013;8(10):582-588.
  3. Mehta RH, Chen AY, Alexander KP, Ohman EM, Roe MT, Peterson ED. Doing the right things and doing them the right way: association between hospital guideline adherence, dosing safety, and outcomes among patients with acute coronary syndrome. Circulation. 2015;131(11):980-987.
  4. GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490
  5. Andrews JC, Schünemann HJ, Oxman AD, et al. GRADE guidelines: 15. Going from evidence to recommendation—determinants of a recommendation’s direction and strength. J Clin Epidemiol. 2013;66(7):726-735.
  6. 6. Chen JH, Fang DZ, Tim Goodnough L, Evans KH, Lee Porter M, Shieh L. Why providers transfuse blood products outside recommended guidelines in spite of integrated electronic best practice alerts. J Hosp Med. 2015;10(1):1-7.

How to Gauge Guidelines

For clinical guidelines to be truly trustworthy, Gordon Guyatt, MD, MSc, FRCPC, distinguished professor of medicine and clinical epidemiology at McMaster University in Hamilton, Ontario, says that they should meet several criteria:

  • They should adhere to an evidence-based process of gathering and summarizing the evidence and summarize that evidence in ways doctors can understand.
  • They should rate the overall evidence used in their deliberations and distinguish between strong and weak recommendations.
  • They should recognize that recommendations are value- and preference-sensitive, make their own judgments explicit, and seek out available evidence about patients’ own values and preferences.
  • They should be clear about how they’re dealing with conflicts of interest.

—Bryn Nelson, PhD

 

 

New Tools of the Trade for Crafting Clinical Guidelines

The well-known GRADE system and similar tools such as Levels of Evidence and Grades of Recommendation have helped guideline writers for years, particularly in evaluating bodies of medical literature and the strength of the studies’ conclusions. Cincinnati Children’s Hospital Medical Center uses a similar strength-of-evidence pyramid to gauge the relative reliability of data: physician expertise and practice at the base, a retrospective or cohort study at a higher level, and a systematic review composed of numerous randomized controlled trials at the pinnacle.

Not every clinician has been taught how to appraise articles, however. Accordingly, Cincinnati Children’s James M. Anderson Center for Health Systems Excellence has developed another system called LEGEND (Let Evidence Guide Every New Decision) to help guideline developers know what to look for when reading a study. The system’s analysis boils down to three main questions: Is it valid? What are the results? And are they applicable to my population?

“If you want to know whether the study that you’re reading is something that should prompt you to change practice, you want to know if the study is a good one,” says Wendy Gerhardt, MSN, the hospital center’s director of evidence-based decision making.

In fact, the hospital has developed tools to assist in nearly every step of the guideline-crafting process. The tools help clinicians learn how to read studies, develop an evidence-based guideline, understand whether a guideline is solid, know where separate recommendations agree and differ, and implement new guidelines into regular practice.

One tool called REACH (Rapid Evidence Adoption to improve Child Health) uses quality improvement consultants and multidisciplinary groups to “translate evidence into point-of-care decision making by clinicians, families and patients,” according to its website. The process takes about 120 days and can result in decision aids such as prepopulated electronic order sets that default to evidence-based suggestions for, say, bronchiolitis inhalation therapies.

“It’s really helpful when you’re working in an academic center and the residents are the ones writing the orders,” says Gerhardt. “So it defaults to the right thing, and they have to actually think about not doing it that way.”

Often, it’s not enough merely to give doctors the link to a new guideline.

“If you can pull up an order set that already has the evidence embedded in it, that’s a little more compelling,” she says. “You kind of have to put the evidence at their point of care instead of in a document. And that’s what, in my mind, makes it real.”

At Cincinnati Children’s, she and her colleagues also have taught doctors how to use PubMed to seek out systematic reviews if they have a question. They have rolling computers, too: Medical librarians sometimes go on rounds with clinicians to help with on-the-spot literature searches.

“It’s however you can make it easier for them to use,” Gerhardt says. “By and large, most people just want to practice, so you have to put that evidence in their way.”

Bryn Nelson, PhD

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LISTEN NOW: Scott Sears, MD, MBA, Explains How GME Programs Could Be Better Aligned

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New Bill Hopes to Increase Residency Medicare Slots after Two Previous Bills Failed

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The new version again seeks to increase Medicare residency slots by 15,000 over five years, while attempting to identify physician shortage specialties and increase the workforce diversity.

Two federal bills introduced in 2013, the Resident Physician Shortage Reduction Act and the Training Tomorrow’s Doctors Today Act, would have increased the number of Medicare-funded residency slots by 15,000 over five years. The latter bill also would have required each teaching hospital to release annual reports on the costs of training residents and of running specialized services, and it would have tied 2% to 3% of IME funding to quality measures, such as how well an institution trains providers to work in teams and in different settings. (In 2010, the Medicare Payment Advisory Commission, also known as MedPAC, instead recommended redirecting more than half of Medicare’s IME funding to performance-based incentives.)

After both bills died in the House of Representatives, supporters resurrected some key features and incorporated them into the Resident Physician Shortage Reduction Act of 2015 (H.R. 2124), reintroduced this spring in both the House and the Senate. The new version again seeks to increase Medicare residency slots by 15,000 over five years, while attempting to identify physician shortage specialties and increase the workforce diversity.

Deborah Powell, MD, dean emerita of the University of Minnesota Medical School and a member of the IOM committee that recommended a significant GME overhaul, says requirements to increase the transparency of actual training costs would be a step in the right direction if implemented appropriately. She is less enthusiastic about tying a small percentage of funding to quality measures without moving to a robust system that ties funding to residency education in a meaningful way. The IOM report concluded that overall reform of the system is needed, she says, “not tweaking at the edges.”

A bold overhaul may be a tough sell, however, and she acknowledges that the committee’s own recommendations have gained little traction so far.

Vikas Parekh, MD, FACP, SFHM, chair of the SHM Academic Hospitalist Committee, says putting 2% or 3% of a hospital’s total Medicare money at risk is more in line with what the agency is doing in other quality improvement programs.

“So far,” he says, “the indications are that that’s enough money for most big academic medical centers to pay attention to it.”

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The new version again seeks to increase Medicare residency slots by 15,000 over five years, while attempting to identify physician shortage specialties and increase the workforce diversity.

Two federal bills introduced in 2013, the Resident Physician Shortage Reduction Act and the Training Tomorrow’s Doctors Today Act, would have increased the number of Medicare-funded residency slots by 15,000 over five years. The latter bill also would have required each teaching hospital to release annual reports on the costs of training residents and of running specialized services, and it would have tied 2% to 3% of IME funding to quality measures, such as how well an institution trains providers to work in teams and in different settings. (In 2010, the Medicare Payment Advisory Commission, also known as MedPAC, instead recommended redirecting more than half of Medicare’s IME funding to performance-based incentives.)

After both bills died in the House of Representatives, supporters resurrected some key features and incorporated them into the Resident Physician Shortage Reduction Act of 2015 (H.R. 2124), reintroduced this spring in both the House and the Senate. The new version again seeks to increase Medicare residency slots by 15,000 over five years, while attempting to identify physician shortage specialties and increase the workforce diversity.

Deborah Powell, MD, dean emerita of the University of Minnesota Medical School and a member of the IOM committee that recommended a significant GME overhaul, says requirements to increase the transparency of actual training costs would be a step in the right direction if implemented appropriately. She is less enthusiastic about tying a small percentage of funding to quality measures without moving to a robust system that ties funding to residency education in a meaningful way. The IOM report concluded that overall reform of the system is needed, she says, “not tweaking at the edges.”

A bold overhaul may be a tough sell, however, and she acknowledges that the committee’s own recommendations have gained little traction so far.

Vikas Parekh, MD, FACP, SFHM, chair of the SHM Academic Hospitalist Committee, says putting 2% or 3% of a hospital’s total Medicare money at risk is more in line with what the agency is doing in other quality improvement programs.

“So far,” he says, “the indications are that that’s enough money for most big academic medical centers to pay attention to it.”

The new version again seeks to increase Medicare residency slots by 15,000 over five years, while attempting to identify physician shortage specialties and increase the workforce diversity.

Two federal bills introduced in 2013, the Resident Physician Shortage Reduction Act and the Training Tomorrow’s Doctors Today Act, would have increased the number of Medicare-funded residency slots by 15,000 over five years. The latter bill also would have required each teaching hospital to release annual reports on the costs of training residents and of running specialized services, and it would have tied 2% to 3% of IME funding to quality measures, such as how well an institution trains providers to work in teams and in different settings. (In 2010, the Medicare Payment Advisory Commission, also known as MedPAC, instead recommended redirecting more than half of Medicare’s IME funding to performance-based incentives.)

After both bills died in the House of Representatives, supporters resurrected some key features and incorporated them into the Resident Physician Shortage Reduction Act of 2015 (H.R. 2124), reintroduced this spring in both the House and the Senate. The new version again seeks to increase Medicare residency slots by 15,000 over five years, while attempting to identify physician shortage specialties and increase the workforce diversity.

Deborah Powell, MD, dean emerita of the University of Minnesota Medical School and a member of the IOM committee that recommended a significant GME overhaul, says requirements to increase the transparency of actual training costs would be a step in the right direction if implemented appropriately. She is less enthusiastic about tying a small percentage of funding to quality measures without moving to a robust system that ties funding to residency education in a meaningful way. The IOM report concluded that overall reform of the system is needed, she says, “not tweaking at the edges.”

A bold overhaul may be a tough sell, however, and she acknowledges that the committee’s own recommendations have gained little traction so far.

Vikas Parekh, MD, FACP, SFHM, chair of the SHM Academic Hospitalist Committee, says putting 2% or 3% of a hospital’s total Medicare money at risk is more in line with what the agency is doing in other quality improvement programs.

“So far,” he says, “the indications are that that’s enough money for most big academic medical centers to pay attention to it.”

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Institute of Medicine Report Prompts Debate Over Graduate Medical Education Funding, Oversight

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Ever since 1997, when the federal Balanced Budget Act froze Medicare’s overall funding for graduate medical education, debates have flared regularly over whether and how the U.S. government should support medical resident training.

Discussions about the possible redistribution of billions of dollars are bound to make people nervous, but the controversy reached a fever pitch in 2014 when the Institute of Medicine released a report penned by a 21-member committee that recommended significant—and contentious—changes to the existing graduate medical education (GME) financing and governance structure to “address current deficiencies and better shape the physician workforce for the future.”

Should Medicare shake up the system to redistribute existing training slots to where they’re needed most, as the report recommends? Should it instead lift its funding cap to avert a potential bottleneck in the physician pipeline, as several medical associations have requested? One year later, the report has gained little traction amid a largely unchanged status quo that few experts believe is ultimately sustainable. The continuing debate, however, has prompted fresh questions about whether the current GME structure is adequately supporting the nation’s healthcare needs and has spurred widespread agreement on the need for greater transparency, accountability, and innovation.

Deborah Powell, MD, dean emerita of the University of Minnesota Medical School and one of the report’s co-authors, says she has seen firsthand the challenges arising from a lack of physicians in multiple specialties, especially in rural areas. “We believed that simply adding new money to a system that is outdated would not solve the issues in physician education and physician workforce,” she says.

Some HM leaders and other physicians’ groups have cautiously welcomed the report’s focus on better equipping doctors for a rapidly changing reality.

“It wasn’t wrong for them to look at this,” says Darlene B. Tad-y, MD, FHM, chair of the SHM Physicians in Training Committee and assistant professor of medicine at the University of Colorado in Denver. “And it’s probably not wrong for them to propose new ways to think about how we fund GME.”

In fact, she says, efforts to align such funding with healthcare funding in general could be timely in the face of added pressures like ensuring that new insurance beneficiaries have access to primary care.

Scott Sears, MD, FACP, MBA, chief clinical officer of Tacoma, Wash.-based hospitalist management firm Sound Physicians, says healthcare is also moving rapidly toward managing populations as part of team-based care that increases quality while lowering costs. So why not better align GME with innovative Medicare initiatives like bundled payments, he asks, and then use the savings to reward those training programs that accept the risk and achieve results?

“Shifting some of our education to match what Medicare is trying to drive out in the real world, I think, is long overdue,” Dr. Sears says.

Other groups, such as the Association of American Medical Colleges, however, contend that the report’s prescriptions are far less helpful than its diagnoses. “Politically, there’s just stuff in there for everybody to hate,” says Atul Grover, MD, PhD, FACP, FCCP, the AAMC’s chief public policy officer. “I think [the IOM report] did a decent job of pointing out some of the things that we want to improve moving forward, but I’m not sure that the answers are quite right.”

An Uneven Funding Landscape

The strong opinions engendered by the topic underscore the high stakes involved in GME. Every year, the federal government doles out about $15 billion for residency training, including about $10 billion from Medicare coffers. Medicare’s share is divided into two main funding streams that flow primarily to academic medical centers: direct graduate medical education (DGME) and indirect medical education (IME) payments. The first covers training expenses, while the second reimburses teaching hospitals that care for Medicare patients while training residents.

 

 

Some skeptics have questioned whether the government should be funding medical education at all, noting that the arrangement is utterly unique to the field. Advocates have countered that the funding concept was embedded in the original Medicare legislation and that it correctly recognized the added cost of offering GME training while providing more complex Medicare beneficiaries with specialty services.

Nearly everyone acknowledges that there are still enough residency slots for all U.S. graduates, but Dr. Grover says residency programs aren’t growing nearly fast enough to keep pace with medical school enrollment, creating a growing mismatch and a looming bottleneck in the supply chain. Compared to medical school numbers in 2002, for example, the AAMC says enrollment is on track to expand 29% by 2019, while osteopathic schools are set to expand by 162% over the same timeframe.

It wasn’t wrong for the [Institute of Medicine] to look at this. And it’s probably not wrong for them to propose new ways to think about how we fund GME.

—Darlene B. Tad-y, MD, FHM, assistant professor of medicine, University of Colorado, Denver, chair, SHM Physicians in Training Committee


Fundamentally, the idea is not a bad one, to say that programs that were more aligned with national needs and priorities in terms of how they train physicians would get more funding, and those that did not wouldn’t. I think the challenge is that the devil’s in the details of how you do that.

—Vikas Parekh, MD, FACP, SFHM, associate director, hospitalist program, University of Michigan, Ann Arbor, chair, SHM Academic Hospitalist Committee

Despite the continued freeze in Medicare funding, many large medical institutions continue to add residency spots.

“We’ve been hundreds of residency positions over our cap for a very long time,” says Vikas Parekh, MD, FACP, SFHM, associate director of the hospitalist program at the University of Michigan in Ann Arbor. “The hospital funds them through hospital operating margin because in the net, they still view the investment as worthwhile.”

Alternatively, some non-university-based training programs have secured money from other sources to fund their residency positions, potentially creating new funding models for the future if the programs can demonstrate both quality and stability.

One key rationale for the IOM report’s proposed overhaul, however, is the longstanding and sizeable geographical disparity in Medicare’s per capita GME spending, which has skewed heavily toward the Northeast. A 2013 study, in fact, found that one-fifth of all DGME funding in 2010—an estimated $2 billion—went to New York State alone.1 Florida, which recently overtook New York as the third most populous state, received only one-eighth as much money. And Mississippi—the state with the lowest doctor-to-patient ratio—received only $22 million, or about one-ninetieth as much.

The IOM report also suggests that the long-standing GME payment plan has yielded little data on whether it actually accomplishes what it was designed to do: help establish a well-prepared medical workforce in a cost-effective way. In response, one major IOM recommendation is to maintain the overall level of Medicare support but tie some of the payments to performance to ensure oversight and accountability, and provide new incentives for innovation in the content and financing of training programs.

As with other CMS initiatives, however, getting everyone to agree on which quality metrics to use in evaluating GME training could take awhile. For example, should Medicare judge the performance of the trainees, the GME programs, or even the sponsoring institutions? Despite the proliferation of performance-based carrots and sticks elsewhere in healthcare, Dr. Tad-y says, such incentives may work less well for GME.

 

 

“One thing that’s inherent with trainees is that they’re trainees,” she says. “They’re not as efficient or as effective as someone who’s an expert, right? That’s why it’s training.”

Dr. Parekh, who also serves as chair of the SHM Academic Hospitalist Committee, agrees that finding the right outcome measures could be tough. “It gets very dicey, because how do you define who’s a good doctor?” he says. Currently, residents often are assessed via the reputation and history of the training program. “People say, ‘I know that the people coming out of that program are good because they’ve always been good, and it’s a reputable program and has a big name.’ But it’s not objective data,” he says.

Dr. Sears, of Sound Physicians, notes that it’s also often difficult to attribute patients to specific providers.

“Many times in graduate medical education, patients are going in and out of the program or in and out of the hospital, and how do you attribute?” he says. “I think it becomes very complex.”

A New Take on Transformation

Another IOM recommendation would create a single GME fund with two subsidiaries: an operational fund for ongoing support and a transformation fund. The latter fund would finance four new initiatives to:

  • Develop and evaluate innovative GME programs;
  • Determine and validate appropriate performance measures;
  • Establish pilot projects to test out alternative payment methods; and
  • Award new training positions based on priority disciplines—such as primary care—and underserved geographic areas.

A related recommendation seeks to modernize the GME payment methodology. For example, the committee urged Medicare to combine the indirect and direct funding streams into one payment based on a national per-resident amount and adjusted according to each location. In addition, the report endorsed performance-based payments based on the results of pilots launched under the transformation fund.

Dr. Sears says he appreciates the report’s effort to address shortfalls in primary care providers relative to specialists. “That’s not to say that specialty medicine isn’t incredibly important, because it is,” he says. “But I think incentivizing or reallocating spots to ensure that we have adequate primary care physician coverage throughout the country will have tremendous impact on the ability to care for an aging population in the United States, at least.”

I have had physicians tell me that they do not understand why our report said that there was not a physician shortage, and I try to point out that we did NOT say that. Rather, the report [and the committee] said that we could not find compelling evidence of an impending physician shortage and that physician workforce projections had been and are quite unreliable. —Deborah Powell, MD, dean emerita, University of Minnesota Medical School, IOM committee member


Shifting some of our [medical] education to match what Medicare is trying to drive out in the real world, I think, is long overdue. —Scott Sears, MD, FACP, MBA, chief clinical officer, Sound Physicians, Tacoma, Wash.

Dr. Parekh agrees, at least in part.

“Fundamentally, the idea is not a bad one, to say that programs that were more aligned with national needs and priorities in terms of how they train physicians would get more funding, and those that did not wouldn’t,” he says. “I think the challenge is that the devil’s in the details of how you do that.”

A priority-based GME system, he continues, could potentially influence what type of physicians are trained.

“In my mind, it’s not irrational to think that if GME funding was more targeted around expanding slots in certain specialties and not expanding slots in other specialties, that there would be some ability to influence the workforce,” Dr. Parekh says. Influencing where residents go may be more difficult, though a growing mismatch between medical graduates and available residency slots might add a new wrinkle to that debate, as well.

 

 

Currently, U.S. medical graduates fill only about 60% of residency slots for specialties like internal medicine—a main conduit for hospital medicine—while foreign graduates make up the remainder.

“So who’s the first that’s going to be squeezed out? It will be foreign medical graduates,” Dr. Parekh says. Many of those graduates come to the U.S. on J-1 visas, which carry a payback requirement: practicing in underserved areas. “One worry is, will rural and underserved areas suffer from a physician shortage because U.S. grads won’t want to work there after you start squeezing out all of the foreign medical grads?” he asks.

Clear Line of Sight?

Dr. Parekh also supports efforts to establish a clearer connection between the funding’s intent and where the money actually goes. The IOM report’s proposal to do so, however, raises yet another controversy around the true purpose of IME funding. Teaching hospitals argue that the money should continue to be used to reimburse them for the added costs of providing comprehensive and specialized care like level I trauma centers to their more complex Medicare patient populations.

Number one, [the IOM] came out and said, ‘We don’t know that there’s a shortage of physicians and we’re, if anything, going to remove money from the training system rather than putting in additional resources. We found that problematic, given all the evidence we have of the growing, aging population. —Atul Grover, MD, PhD, FACP, FCCP, chief public policy officer, Association of American Medical Colleges


A big part of the problem here is that people are free agents. If you make more residency spots, but the economics are such that people decide to become cardiologists because cardiologists make twice or more what hospitalists make, then you may have increased residency spots but [added only] a very small increment in the number of hospitalists. —Daniel Brotman, MD, FACP, SFHM, chair, SHM Education Committee, director, hospitalist program, Johns Hopkins Hospital, Baltimore

Accordingly, the AAMC panned the report’s recommendation to replace separate IME funding with a single fund directed toward the GME sponsoring institution and subdivided instead into the operational and transformation funds. Dr. Grover says setting up a transformation fund with new money would make sense, but not as a carve-out from existing support.

“You’re removing those resources from the system and not replacing them, which is a challenge,” he says.

Medical schools are more inclined to want the money directed toward training goals, especially if they are to be held accountable for GME outcomes. “Right now, the hospital gets it, and it’s basically somewhere in the bottom line,” Dr. Parekh says. “No one really knows where that money goes. There’s very little accountability or clarity of purpose for that dollar.”

Amid the ongoing debate, the call for more transparency and accountability in GME seems to be gaining the most ground. “I don’t see tons of downside from it,” Dr. Parekh says. “I think it sheds light on the current funding environment and makes people have to justify a little bit more what they’re doing with that money.”

Dr. Tad-y puts it this way: “If you made your own budget at home, the first thing you’d do is try to figure out where all your money goes and what you’re spending your money on.” If Medicare is concerned that its GME money isn’t being spent wisely, then, the first step would be to do some accounting. “And that means a little bit of transparency,” she says. “I don’t think that’s a bad thing, to know exactly what we’re paying for; that makes sense. I mean, we do that for everything else.”

 

 

SHM and most other medical associations also agree on the necessary goal of increasing the nation’s primary care capacity, even if they differ on the details of how best to do so. In the long run, however, some observers say growing the workforce—whether that of primary care providers or of hospitalists—may depend less on the total number of residency spots and more on the enthusiasm of program leadership and the attractiveness of job conditions such as salary and workload.

“A big part of the problem here is that people are free agents,” says Daniel Brotman, MD, FACP, SFHM, chair of the SHM Education Committee and director of the hospitalist program at the Johns Hopkins Hospital in Baltimore. “If you make more residency spots, but the economics are such that people decide to become cardiologists because cardiologists make twice or more what hospitalists make, then you may have increased residency spots but [added only] a very small increment in the number of hospitalists.”

Whatever happens, Dr. Parekh says hospitalists are well positioned to be integral parts of improving quality, accountability, and innovation in residency training programs.

“I think if more GME money is targeted toward the outcomes of the GME programs, hospitalists are going to be tapped to help with that work, in terms of training and broadening their skill sets,” he says. “So I think it’s a great opportunity.”


Bryn Nelson is a freelance medical writer in Seattle.

References

  1. Mullan F, Chen C, Steinmetz E. The geography of graduate medical education: imbalances signal need for new distribution policies. Health Aff. 2013;32(11):1914-1921.
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Ever since 1997, when the federal Balanced Budget Act froze Medicare’s overall funding for graduate medical education, debates have flared regularly over whether and how the U.S. government should support medical resident training.

Discussions about the possible redistribution of billions of dollars are bound to make people nervous, but the controversy reached a fever pitch in 2014 when the Institute of Medicine released a report penned by a 21-member committee that recommended significant—and contentious—changes to the existing graduate medical education (GME) financing and governance structure to “address current deficiencies and better shape the physician workforce for the future.”

Should Medicare shake up the system to redistribute existing training slots to where they’re needed most, as the report recommends? Should it instead lift its funding cap to avert a potential bottleneck in the physician pipeline, as several medical associations have requested? One year later, the report has gained little traction amid a largely unchanged status quo that few experts believe is ultimately sustainable. The continuing debate, however, has prompted fresh questions about whether the current GME structure is adequately supporting the nation’s healthcare needs and has spurred widespread agreement on the need for greater transparency, accountability, and innovation.

Deborah Powell, MD, dean emerita of the University of Minnesota Medical School and one of the report’s co-authors, says she has seen firsthand the challenges arising from a lack of physicians in multiple specialties, especially in rural areas. “We believed that simply adding new money to a system that is outdated would not solve the issues in physician education and physician workforce,” she says.

Some HM leaders and other physicians’ groups have cautiously welcomed the report’s focus on better equipping doctors for a rapidly changing reality.

“It wasn’t wrong for them to look at this,” says Darlene B. Tad-y, MD, FHM, chair of the SHM Physicians in Training Committee and assistant professor of medicine at the University of Colorado in Denver. “And it’s probably not wrong for them to propose new ways to think about how we fund GME.”

In fact, she says, efforts to align such funding with healthcare funding in general could be timely in the face of added pressures like ensuring that new insurance beneficiaries have access to primary care.

Scott Sears, MD, FACP, MBA, chief clinical officer of Tacoma, Wash.-based hospitalist management firm Sound Physicians, says healthcare is also moving rapidly toward managing populations as part of team-based care that increases quality while lowering costs. So why not better align GME with innovative Medicare initiatives like bundled payments, he asks, and then use the savings to reward those training programs that accept the risk and achieve results?

“Shifting some of our education to match what Medicare is trying to drive out in the real world, I think, is long overdue,” Dr. Sears says.

Other groups, such as the Association of American Medical Colleges, however, contend that the report’s prescriptions are far less helpful than its diagnoses. “Politically, there’s just stuff in there for everybody to hate,” says Atul Grover, MD, PhD, FACP, FCCP, the AAMC’s chief public policy officer. “I think [the IOM report] did a decent job of pointing out some of the things that we want to improve moving forward, but I’m not sure that the answers are quite right.”

An Uneven Funding Landscape

The strong opinions engendered by the topic underscore the high stakes involved in GME. Every year, the federal government doles out about $15 billion for residency training, including about $10 billion from Medicare coffers. Medicare’s share is divided into two main funding streams that flow primarily to academic medical centers: direct graduate medical education (DGME) and indirect medical education (IME) payments. The first covers training expenses, while the second reimburses teaching hospitals that care for Medicare patients while training residents.

 

 

Some skeptics have questioned whether the government should be funding medical education at all, noting that the arrangement is utterly unique to the field. Advocates have countered that the funding concept was embedded in the original Medicare legislation and that it correctly recognized the added cost of offering GME training while providing more complex Medicare beneficiaries with specialty services.

Nearly everyone acknowledges that there are still enough residency slots for all U.S. graduates, but Dr. Grover says residency programs aren’t growing nearly fast enough to keep pace with medical school enrollment, creating a growing mismatch and a looming bottleneck in the supply chain. Compared to medical school numbers in 2002, for example, the AAMC says enrollment is on track to expand 29% by 2019, while osteopathic schools are set to expand by 162% over the same timeframe.

It wasn’t wrong for the [Institute of Medicine] to look at this. And it’s probably not wrong for them to propose new ways to think about how we fund GME.

—Darlene B. Tad-y, MD, FHM, assistant professor of medicine, University of Colorado, Denver, chair, SHM Physicians in Training Committee


Fundamentally, the idea is not a bad one, to say that programs that were more aligned with national needs and priorities in terms of how they train physicians would get more funding, and those that did not wouldn’t. I think the challenge is that the devil’s in the details of how you do that.

—Vikas Parekh, MD, FACP, SFHM, associate director, hospitalist program, University of Michigan, Ann Arbor, chair, SHM Academic Hospitalist Committee

Despite the continued freeze in Medicare funding, many large medical institutions continue to add residency spots.

“We’ve been hundreds of residency positions over our cap for a very long time,” says Vikas Parekh, MD, FACP, SFHM, associate director of the hospitalist program at the University of Michigan in Ann Arbor. “The hospital funds them through hospital operating margin because in the net, they still view the investment as worthwhile.”

Alternatively, some non-university-based training programs have secured money from other sources to fund their residency positions, potentially creating new funding models for the future if the programs can demonstrate both quality and stability.

One key rationale for the IOM report’s proposed overhaul, however, is the longstanding and sizeable geographical disparity in Medicare’s per capita GME spending, which has skewed heavily toward the Northeast. A 2013 study, in fact, found that one-fifth of all DGME funding in 2010—an estimated $2 billion—went to New York State alone.1 Florida, which recently overtook New York as the third most populous state, received only one-eighth as much money. And Mississippi—the state with the lowest doctor-to-patient ratio—received only $22 million, or about one-ninetieth as much.

The IOM report also suggests that the long-standing GME payment plan has yielded little data on whether it actually accomplishes what it was designed to do: help establish a well-prepared medical workforce in a cost-effective way. In response, one major IOM recommendation is to maintain the overall level of Medicare support but tie some of the payments to performance to ensure oversight and accountability, and provide new incentives for innovation in the content and financing of training programs.

As with other CMS initiatives, however, getting everyone to agree on which quality metrics to use in evaluating GME training could take awhile. For example, should Medicare judge the performance of the trainees, the GME programs, or even the sponsoring institutions? Despite the proliferation of performance-based carrots and sticks elsewhere in healthcare, Dr. Tad-y says, such incentives may work less well for GME.

 

 

“One thing that’s inherent with trainees is that they’re trainees,” she says. “They’re not as efficient or as effective as someone who’s an expert, right? That’s why it’s training.”

Dr. Parekh, who also serves as chair of the SHM Academic Hospitalist Committee, agrees that finding the right outcome measures could be tough. “It gets very dicey, because how do you define who’s a good doctor?” he says. Currently, residents often are assessed via the reputation and history of the training program. “People say, ‘I know that the people coming out of that program are good because they’ve always been good, and it’s a reputable program and has a big name.’ But it’s not objective data,” he says.

Dr. Sears, of Sound Physicians, notes that it’s also often difficult to attribute patients to specific providers.

“Many times in graduate medical education, patients are going in and out of the program or in and out of the hospital, and how do you attribute?” he says. “I think it becomes very complex.”

A New Take on Transformation

Another IOM recommendation would create a single GME fund with two subsidiaries: an operational fund for ongoing support and a transformation fund. The latter fund would finance four new initiatives to:

  • Develop and evaluate innovative GME programs;
  • Determine and validate appropriate performance measures;
  • Establish pilot projects to test out alternative payment methods; and
  • Award new training positions based on priority disciplines—such as primary care—and underserved geographic areas.

A related recommendation seeks to modernize the GME payment methodology. For example, the committee urged Medicare to combine the indirect and direct funding streams into one payment based on a national per-resident amount and adjusted according to each location. In addition, the report endorsed performance-based payments based on the results of pilots launched under the transformation fund.

Dr. Sears says he appreciates the report’s effort to address shortfalls in primary care providers relative to specialists. “That’s not to say that specialty medicine isn’t incredibly important, because it is,” he says. “But I think incentivizing or reallocating spots to ensure that we have adequate primary care physician coverage throughout the country will have tremendous impact on the ability to care for an aging population in the United States, at least.”

I have had physicians tell me that they do not understand why our report said that there was not a physician shortage, and I try to point out that we did NOT say that. Rather, the report [and the committee] said that we could not find compelling evidence of an impending physician shortage and that physician workforce projections had been and are quite unreliable. —Deborah Powell, MD, dean emerita, University of Minnesota Medical School, IOM committee member


Shifting some of our [medical] education to match what Medicare is trying to drive out in the real world, I think, is long overdue. —Scott Sears, MD, FACP, MBA, chief clinical officer, Sound Physicians, Tacoma, Wash.

Dr. Parekh agrees, at least in part.

“Fundamentally, the idea is not a bad one, to say that programs that were more aligned with national needs and priorities in terms of how they train physicians would get more funding, and those that did not wouldn’t,” he says. “I think the challenge is that the devil’s in the details of how you do that.”

A priority-based GME system, he continues, could potentially influence what type of physicians are trained.

“In my mind, it’s not irrational to think that if GME funding was more targeted around expanding slots in certain specialties and not expanding slots in other specialties, that there would be some ability to influence the workforce,” Dr. Parekh says. Influencing where residents go may be more difficult, though a growing mismatch between medical graduates and available residency slots might add a new wrinkle to that debate, as well.

 

 

Currently, U.S. medical graduates fill only about 60% of residency slots for specialties like internal medicine—a main conduit for hospital medicine—while foreign graduates make up the remainder.

“So who’s the first that’s going to be squeezed out? It will be foreign medical graduates,” Dr. Parekh says. Many of those graduates come to the U.S. on J-1 visas, which carry a payback requirement: practicing in underserved areas. “One worry is, will rural and underserved areas suffer from a physician shortage because U.S. grads won’t want to work there after you start squeezing out all of the foreign medical grads?” he asks.

Clear Line of Sight?

Dr. Parekh also supports efforts to establish a clearer connection between the funding’s intent and where the money actually goes. The IOM report’s proposal to do so, however, raises yet another controversy around the true purpose of IME funding. Teaching hospitals argue that the money should continue to be used to reimburse them for the added costs of providing comprehensive and specialized care like level I trauma centers to their more complex Medicare patient populations.

Number one, [the IOM] came out and said, ‘We don’t know that there’s a shortage of physicians and we’re, if anything, going to remove money from the training system rather than putting in additional resources. We found that problematic, given all the evidence we have of the growing, aging population. —Atul Grover, MD, PhD, FACP, FCCP, chief public policy officer, Association of American Medical Colleges


A big part of the problem here is that people are free agents. If you make more residency spots, but the economics are such that people decide to become cardiologists because cardiologists make twice or more what hospitalists make, then you may have increased residency spots but [added only] a very small increment in the number of hospitalists. —Daniel Brotman, MD, FACP, SFHM, chair, SHM Education Committee, director, hospitalist program, Johns Hopkins Hospital, Baltimore

Accordingly, the AAMC panned the report’s recommendation to replace separate IME funding with a single fund directed toward the GME sponsoring institution and subdivided instead into the operational and transformation funds. Dr. Grover says setting up a transformation fund with new money would make sense, but not as a carve-out from existing support.

“You’re removing those resources from the system and not replacing them, which is a challenge,” he says.

Medical schools are more inclined to want the money directed toward training goals, especially if they are to be held accountable for GME outcomes. “Right now, the hospital gets it, and it’s basically somewhere in the bottom line,” Dr. Parekh says. “No one really knows where that money goes. There’s very little accountability or clarity of purpose for that dollar.”

Amid the ongoing debate, the call for more transparency and accountability in GME seems to be gaining the most ground. “I don’t see tons of downside from it,” Dr. Parekh says. “I think it sheds light on the current funding environment and makes people have to justify a little bit more what they’re doing with that money.”

Dr. Tad-y puts it this way: “If you made your own budget at home, the first thing you’d do is try to figure out where all your money goes and what you’re spending your money on.” If Medicare is concerned that its GME money isn’t being spent wisely, then, the first step would be to do some accounting. “And that means a little bit of transparency,” she says. “I don’t think that’s a bad thing, to know exactly what we’re paying for; that makes sense. I mean, we do that for everything else.”

 

 

SHM and most other medical associations also agree on the necessary goal of increasing the nation’s primary care capacity, even if they differ on the details of how best to do so. In the long run, however, some observers say growing the workforce—whether that of primary care providers or of hospitalists—may depend less on the total number of residency spots and more on the enthusiasm of program leadership and the attractiveness of job conditions such as salary and workload.

“A big part of the problem here is that people are free agents,” says Daniel Brotman, MD, FACP, SFHM, chair of the SHM Education Committee and director of the hospitalist program at the Johns Hopkins Hospital in Baltimore. “If you make more residency spots, but the economics are such that people decide to become cardiologists because cardiologists make twice or more what hospitalists make, then you may have increased residency spots but [added only] a very small increment in the number of hospitalists.”

Whatever happens, Dr. Parekh says hospitalists are well positioned to be integral parts of improving quality, accountability, and innovation in residency training programs.

“I think if more GME money is targeted toward the outcomes of the GME programs, hospitalists are going to be tapped to help with that work, in terms of training and broadening their skill sets,” he says. “So I think it’s a great opportunity.”


Bryn Nelson is a freelance medical writer in Seattle.

References

  1. Mullan F, Chen C, Steinmetz E. The geography of graduate medical education: imbalances signal need for new distribution policies. Health Aff. 2013;32(11):1914-1921.

Ever since 1997, when the federal Balanced Budget Act froze Medicare’s overall funding for graduate medical education, debates have flared regularly over whether and how the U.S. government should support medical resident training.

Discussions about the possible redistribution of billions of dollars are bound to make people nervous, but the controversy reached a fever pitch in 2014 when the Institute of Medicine released a report penned by a 21-member committee that recommended significant—and contentious—changes to the existing graduate medical education (GME) financing and governance structure to “address current deficiencies and better shape the physician workforce for the future.”

Should Medicare shake up the system to redistribute existing training slots to where they’re needed most, as the report recommends? Should it instead lift its funding cap to avert a potential bottleneck in the physician pipeline, as several medical associations have requested? One year later, the report has gained little traction amid a largely unchanged status quo that few experts believe is ultimately sustainable. The continuing debate, however, has prompted fresh questions about whether the current GME structure is adequately supporting the nation’s healthcare needs and has spurred widespread agreement on the need for greater transparency, accountability, and innovation.

Deborah Powell, MD, dean emerita of the University of Minnesota Medical School and one of the report’s co-authors, says she has seen firsthand the challenges arising from a lack of physicians in multiple specialties, especially in rural areas. “We believed that simply adding new money to a system that is outdated would not solve the issues in physician education and physician workforce,” she says.

Some HM leaders and other physicians’ groups have cautiously welcomed the report’s focus on better equipping doctors for a rapidly changing reality.

“It wasn’t wrong for them to look at this,” says Darlene B. Tad-y, MD, FHM, chair of the SHM Physicians in Training Committee and assistant professor of medicine at the University of Colorado in Denver. “And it’s probably not wrong for them to propose new ways to think about how we fund GME.”

In fact, she says, efforts to align such funding with healthcare funding in general could be timely in the face of added pressures like ensuring that new insurance beneficiaries have access to primary care.

Scott Sears, MD, FACP, MBA, chief clinical officer of Tacoma, Wash.-based hospitalist management firm Sound Physicians, says healthcare is also moving rapidly toward managing populations as part of team-based care that increases quality while lowering costs. So why not better align GME with innovative Medicare initiatives like bundled payments, he asks, and then use the savings to reward those training programs that accept the risk and achieve results?

“Shifting some of our education to match what Medicare is trying to drive out in the real world, I think, is long overdue,” Dr. Sears says.

Other groups, such as the Association of American Medical Colleges, however, contend that the report’s prescriptions are far less helpful than its diagnoses. “Politically, there’s just stuff in there for everybody to hate,” says Atul Grover, MD, PhD, FACP, FCCP, the AAMC’s chief public policy officer. “I think [the IOM report] did a decent job of pointing out some of the things that we want to improve moving forward, but I’m not sure that the answers are quite right.”

An Uneven Funding Landscape

The strong opinions engendered by the topic underscore the high stakes involved in GME. Every year, the federal government doles out about $15 billion for residency training, including about $10 billion from Medicare coffers. Medicare’s share is divided into two main funding streams that flow primarily to academic medical centers: direct graduate medical education (DGME) and indirect medical education (IME) payments. The first covers training expenses, while the second reimburses teaching hospitals that care for Medicare patients while training residents.

 

 

Some skeptics have questioned whether the government should be funding medical education at all, noting that the arrangement is utterly unique to the field. Advocates have countered that the funding concept was embedded in the original Medicare legislation and that it correctly recognized the added cost of offering GME training while providing more complex Medicare beneficiaries with specialty services.

Nearly everyone acknowledges that there are still enough residency slots for all U.S. graduates, but Dr. Grover says residency programs aren’t growing nearly fast enough to keep pace with medical school enrollment, creating a growing mismatch and a looming bottleneck in the supply chain. Compared to medical school numbers in 2002, for example, the AAMC says enrollment is on track to expand 29% by 2019, while osteopathic schools are set to expand by 162% over the same timeframe.

It wasn’t wrong for the [Institute of Medicine] to look at this. And it’s probably not wrong for them to propose new ways to think about how we fund GME.

—Darlene B. Tad-y, MD, FHM, assistant professor of medicine, University of Colorado, Denver, chair, SHM Physicians in Training Committee


Fundamentally, the idea is not a bad one, to say that programs that were more aligned with national needs and priorities in terms of how they train physicians would get more funding, and those that did not wouldn’t. I think the challenge is that the devil’s in the details of how you do that.

—Vikas Parekh, MD, FACP, SFHM, associate director, hospitalist program, University of Michigan, Ann Arbor, chair, SHM Academic Hospitalist Committee

Despite the continued freeze in Medicare funding, many large medical institutions continue to add residency spots.

“We’ve been hundreds of residency positions over our cap for a very long time,” says Vikas Parekh, MD, FACP, SFHM, associate director of the hospitalist program at the University of Michigan in Ann Arbor. “The hospital funds them through hospital operating margin because in the net, they still view the investment as worthwhile.”

Alternatively, some non-university-based training programs have secured money from other sources to fund their residency positions, potentially creating new funding models for the future if the programs can demonstrate both quality and stability.

One key rationale for the IOM report’s proposed overhaul, however, is the longstanding and sizeable geographical disparity in Medicare’s per capita GME spending, which has skewed heavily toward the Northeast. A 2013 study, in fact, found that one-fifth of all DGME funding in 2010—an estimated $2 billion—went to New York State alone.1 Florida, which recently overtook New York as the third most populous state, received only one-eighth as much money. And Mississippi—the state with the lowest doctor-to-patient ratio—received only $22 million, or about one-ninetieth as much.

The IOM report also suggests that the long-standing GME payment plan has yielded little data on whether it actually accomplishes what it was designed to do: help establish a well-prepared medical workforce in a cost-effective way. In response, one major IOM recommendation is to maintain the overall level of Medicare support but tie some of the payments to performance to ensure oversight and accountability, and provide new incentives for innovation in the content and financing of training programs.

As with other CMS initiatives, however, getting everyone to agree on which quality metrics to use in evaluating GME training could take awhile. For example, should Medicare judge the performance of the trainees, the GME programs, or even the sponsoring institutions? Despite the proliferation of performance-based carrots and sticks elsewhere in healthcare, Dr. Tad-y says, such incentives may work less well for GME.

 

 

“One thing that’s inherent with trainees is that they’re trainees,” she says. “They’re not as efficient or as effective as someone who’s an expert, right? That’s why it’s training.”

Dr. Parekh, who also serves as chair of the SHM Academic Hospitalist Committee, agrees that finding the right outcome measures could be tough. “It gets very dicey, because how do you define who’s a good doctor?” he says. Currently, residents often are assessed via the reputation and history of the training program. “People say, ‘I know that the people coming out of that program are good because they’ve always been good, and it’s a reputable program and has a big name.’ But it’s not objective data,” he says.

Dr. Sears, of Sound Physicians, notes that it’s also often difficult to attribute patients to specific providers.

“Many times in graduate medical education, patients are going in and out of the program or in and out of the hospital, and how do you attribute?” he says. “I think it becomes very complex.”

A New Take on Transformation

Another IOM recommendation would create a single GME fund with two subsidiaries: an operational fund for ongoing support and a transformation fund. The latter fund would finance four new initiatives to:

  • Develop and evaluate innovative GME programs;
  • Determine and validate appropriate performance measures;
  • Establish pilot projects to test out alternative payment methods; and
  • Award new training positions based on priority disciplines—such as primary care—and underserved geographic areas.

A related recommendation seeks to modernize the GME payment methodology. For example, the committee urged Medicare to combine the indirect and direct funding streams into one payment based on a national per-resident amount and adjusted according to each location. In addition, the report endorsed performance-based payments based on the results of pilots launched under the transformation fund.

Dr. Sears says he appreciates the report’s effort to address shortfalls in primary care providers relative to specialists. “That’s not to say that specialty medicine isn’t incredibly important, because it is,” he says. “But I think incentivizing or reallocating spots to ensure that we have adequate primary care physician coverage throughout the country will have tremendous impact on the ability to care for an aging population in the United States, at least.”

I have had physicians tell me that they do not understand why our report said that there was not a physician shortage, and I try to point out that we did NOT say that. Rather, the report [and the committee] said that we could not find compelling evidence of an impending physician shortage and that physician workforce projections had been and are quite unreliable. —Deborah Powell, MD, dean emerita, University of Minnesota Medical School, IOM committee member


Shifting some of our [medical] education to match what Medicare is trying to drive out in the real world, I think, is long overdue. —Scott Sears, MD, FACP, MBA, chief clinical officer, Sound Physicians, Tacoma, Wash.

Dr. Parekh agrees, at least in part.

“Fundamentally, the idea is not a bad one, to say that programs that were more aligned with national needs and priorities in terms of how they train physicians would get more funding, and those that did not wouldn’t,” he says. “I think the challenge is that the devil’s in the details of how you do that.”

A priority-based GME system, he continues, could potentially influence what type of physicians are trained.

“In my mind, it’s not irrational to think that if GME funding was more targeted around expanding slots in certain specialties and not expanding slots in other specialties, that there would be some ability to influence the workforce,” Dr. Parekh says. Influencing where residents go may be more difficult, though a growing mismatch between medical graduates and available residency slots might add a new wrinkle to that debate, as well.

 

 

Currently, U.S. medical graduates fill only about 60% of residency slots for specialties like internal medicine—a main conduit for hospital medicine—while foreign graduates make up the remainder.

“So who’s the first that’s going to be squeezed out? It will be foreign medical graduates,” Dr. Parekh says. Many of those graduates come to the U.S. on J-1 visas, which carry a payback requirement: practicing in underserved areas. “One worry is, will rural and underserved areas suffer from a physician shortage because U.S. grads won’t want to work there after you start squeezing out all of the foreign medical grads?” he asks.

Clear Line of Sight?

Dr. Parekh also supports efforts to establish a clearer connection between the funding’s intent and where the money actually goes. The IOM report’s proposal to do so, however, raises yet another controversy around the true purpose of IME funding. Teaching hospitals argue that the money should continue to be used to reimburse them for the added costs of providing comprehensive and specialized care like level I trauma centers to their more complex Medicare patient populations.

Number one, [the IOM] came out and said, ‘We don’t know that there’s a shortage of physicians and we’re, if anything, going to remove money from the training system rather than putting in additional resources. We found that problematic, given all the evidence we have of the growing, aging population. —Atul Grover, MD, PhD, FACP, FCCP, chief public policy officer, Association of American Medical Colleges


A big part of the problem here is that people are free agents. If you make more residency spots, but the economics are such that people decide to become cardiologists because cardiologists make twice or more what hospitalists make, then you may have increased residency spots but [added only] a very small increment in the number of hospitalists. —Daniel Brotman, MD, FACP, SFHM, chair, SHM Education Committee, director, hospitalist program, Johns Hopkins Hospital, Baltimore

Accordingly, the AAMC panned the report’s recommendation to replace separate IME funding with a single fund directed toward the GME sponsoring institution and subdivided instead into the operational and transformation funds. Dr. Grover says setting up a transformation fund with new money would make sense, but not as a carve-out from existing support.

“You’re removing those resources from the system and not replacing them, which is a challenge,” he says.

Medical schools are more inclined to want the money directed toward training goals, especially if they are to be held accountable for GME outcomes. “Right now, the hospital gets it, and it’s basically somewhere in the bottom line,” Dr. Parekh says. “No one really knows where that money goes. There’s very little accountability or clarity of purpose for that dollar.”

Amid the ongoing debate, the call for more transparency and accountability in GME seems to be gaining the most ground. “I don’t see tons of downside from it,” Dr. Parekh says. “I think it sheds light on the current funding environment and makes people have to justify a little bit more what they’re doing with that money.”

Dr. Tad-y puts it this way: “If you made your own budget at home, the first thing you’d do is try to figure out where all your money goes and what you’re spending your money on.” If Medicare is concerned that its GME money isn’t being spent wisely, then, the first step would be to do some accounting. “And that means a little bit of transparency,” she says. “I don’t think that’s a bad thing, to know exactly what we’re paying for; that makes sense. I mean, we do that for everything else.”

 

 

SHM and most other medical associations also agree on the necessary goal of increasing the nation’s primary care capacity, even if they differ on the details of how best to do so. In the long run, however, some observers say growing the workforce—whether that of primary care providers or of hospitalists—may depend less on the total number of residency spots and more on the enthusiasm of program leadership and the attractiveness of job conditions such as salary and workload.

“A big part of the problem here is that people are free agents,” says Daniel Brotman, MD, FACP, SFHM, chair of the SHM Education Committee and director of the hospitalist program at the Johns Hopkins Hospital in Baltimore. “If you make more residency spots, but the economics are such that people decide to become cardiologists because cardiologists make twice or more what hospitalists make, then you may have increased residency spots but [added only] a very small increment in the number of hospitalists.”

Whatever happens, Dr. Parekh says hospitalists are well positioned to be integral parts of improving quality, accountability, and innovation in residency training programs.

“I think if more GME money is targeted toward the outcomes of the GME programs, hospitalists are going to be tapped to help with that work, in terms of training and broadening their skill sets,” he says. “So I think it’s a great opportunity.”


Bryn Nelson is a freelance medical writer in Seattle.

References

  1. Mullan F, Chen C, Steinmetz E. The geography of graduate medical education: imbalances signal need for new distribution policies. Health Aff. 2013;32(11):1914-1921.
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