A New Study Suggests More Flexibility in Resident Duty Hours Does Not Mean More Patient Risk
Education Feature — June 2016
Tex Med. 2016;112(6):51-56.
By Amy Lynn Sorrel
Laura Faye Gephart, MD, expected a trial by fire during her residency training, and despite restrictions on how long she could work, that's exactly what she got.
Looking back, the second-year obstetrics-gynecology fellow at Baylor Scott & White in Temple recalls taking calls from the emergency department, formulating a plan with her team, and going on to operate. But there were times when she did not always follow the patient post-surgery if her shift ended. Other times, she was the one to pick up a case — and the postoperative training experience — when a colleague's day was done.
Many training programs worried 2003 rules preventing residents from working long shifts would increase such handoffs and, as a result, undermine care continuity and resident education. Now, the Accreditation Council for Graduate Medical Education (ACGME) is reassessing those duty-hour rules in light of results from the first large-scale study to examine the effects of the reforms, designed to reduce fatigue-related medical errors, improve patient care, and enhance residents' quality of life.
The report, published in the Feb. 2, 2016, online issue of The New England Journal of Medicine, showed that among general surgery residents, more flexible duty hours did not translate to greater patient risk, and trainees reported better learning experiences because they could follow their patients through critical aspects of their care.
While residents and program directors generally approve of some form of duty hour limits, debate over the specifics of those standards persists. Some educators say the new study shows flexible duty hours offer a more positive educational experience for residents and less pressure on GME programs to fill in gaps created by the limits. Others say the evidence is not so clear-cut, especially for nonsurgical specialties, and more changes could challenge GME programs to adapt all over again.
Overall, however, residents and educators seem to agree with study authors that a one-size-fits-all approach may not be the best course.
For obstetrics-gynecology, for example, "handoffs are a reality in practice once you get out of residency," Dr. Gephart said. "We know handoffs can increase the risk of errors in medical care. But handoffs are not in and of themselves a bad thing. You just have to create a system, and programs have those systems in place."
Just as important is residents' well-being, adds the Texas Medical Association board trustee from the Resident and Fellow Section. "The younger generation is interested in quality of life and ensuring they have time outside of the hospital, so overall, restrictions are important personally and professionally," she said.
ACGME began regulating residents' work hours when it established the 80-hour duty cap in 2003. The move came in response to public concern that resident fatigue contributed to medical errors and patient deaths, and to congressional demands for federal oversight. A subsequent 2008 Institute of Medicine (IOM) report found the initial reforms did not go far enough and called for additional revisions that included:
- Maximum shift lengths and defined off-duty periods;
- Greater supervision of residents by experienced physicians;
- Adjusted workloads based on residents' level of training;
- Structured handoff processes; and
- Restricted moonlighting.
ACGME instituted broader reforms in 2011, along with a significant change that restricted first-year residents to 16 hours of continuous duty, down from 30 hours. The thinking was interns were more susceptible to fatigue-related errors because they had less experience.
Amid pushback from programs that increased handoffs could create new risks if residents have to abruptly leave in the middle of a shift, ACGME commissioned the highly anticipated Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial to track how increased flexibility in work hours would affect patient care and resident perceptions of their training. A parallel study of internal medicine residency programs, iCompare, is still under way.
A total of 117 general surgery residency programs and 151 affiliated hospitals participated in the FIRST trial during the 2014–15 academic year. About half, 59 programs, followed standard ACGME policies; for the other 58, ACGME waived certain restrictions. Both groups kept the ACGME core standards of 80-hour workweeks, one day off for every seven worked, and call no more than every third night. The flexible group got permission to implement one or more of these policy changes:
- First-year interns' work shifts could extend beyond the current maximum of 16 hours;
- More senior residents' duty hour periods could exceed 24 hours;
- Residents were not required to have at least eight hours off between shifts; and
- Residents were not required to have at least 14 hours off after 24 hours of continuous duty.
Data from more than 138,000 patients show the less-restrictive policies did not adversely affect patient safety, defined by the rate of deaths or serious complications. Investigators found no difference between the two study groups. "Another important finding in our study was that residents in the flexible-policy group were about half as likely to leave or miss an operation or hand off an active patient care issue," suggesting "less restrictive duty hours had their intended effect of improving continuity of care," study authors wrote. (See "Effects of Duty Hours.")
Residents in both study groups reported similar satisfaction rates with their overall quality of education and well-being. In a subsequent survey released in April, a majority of residency program directors in the flexible group also reported a positive effect on patient care and safety.
In a statement, ACGME said the organization is reviewing certain program requirements, including duty hours, as part of a scheduled five-year review that began in September 2015. In addition to published research, expert testimony, and stakeholder comments, "ACGME will carefully consider the results of the FIRST trial as part of the review of available evidence."
In a March 13, 2014, letter announcing the study, ACGME Chief Executive Officer Thomas J. Nasca, MD, wrote: "The question of duty hour standards appropriately provokes great emotion in our community. We continue to have concerns that the specifics of our standards are not achieving the goals for which they were intended. I believe them to be valid concerns."
Handoffs at Center of Debate
Some patient advocacy groups, like Public Citizen, protested the trial for putting patients at risk with more lenient policies.
But lead investigator Karl Bilimoria, MD, a faculty scholar at the American College of Surgeons (ACS) and director of the Surgical Outcomes and Quality Improvement Center at Northwestern University Feinberg School of Medicine in Chicago, says the results show "making duty hour policies more flexible for surgeons-in-training appears to be safe for patients and acceptable to the trainees." He added the goal of the study "was to revise only the policies that would interfere with continuity of care or would result in increased handoffs, particularly at unsafe times. Residents in the flexible duty hour group did not work more hours; rather, they worked more effectively by rearranging their hours."
The conclusions follow those drawn in previous surveys, although most were anecdotal.
FIRST is the first national, randomized controlled trial of resident duty hour policies and the first to compare clinical outcomes as well as resident perceptions, says Houston thoracic surgeon Kenneth L. Mattox, MD, a distinguished professor in Baylor College of Medicine's Division of Cardiothoracic Surgery. He is a member of TMA's Council on Health Service Organizations and an alternate delegate to the American Medical Association.
"This is the first time we've had hard data, and this is long overdue. There was no real good data in the first place that says we are doing better by restricting work hours. Three years ago, no one would have thought a study like this would be done or allowed. The fact this was completed means the door is open, and we can study this more," Dr. Mattox said, speaking on his own behalf.
He clarifies any rule change will have to come from ACGME, and until then, all residency programs continue to follow current duty-hour standards. But after witnessing a resultant decline in continuity of care and resident preparedness, he says FIRST "could help make them more practical."
Especially in surgical specialties, training depends more heavily on continuous exposure to cases, and under imposed limits "sometimes [residents] don't get their dance card punched out, so their progressive experience in developing [medical] judgment is delayed," Dr. Mattox said. The educational gaps, he adds, were part of the reason ACS launched its Transition to Practice Program, an apprenticeship to help general surgery residents gain additional, independent experience before entering full-time practice.
The restrictions also take a toll on the patient-physician relationship.
Some surgical residents, for example, have adopted what Dr. Mattox describes as a shift-mentality. "But when you are dealing with complex cancer or vascular conditions, or if you are dealing with a trauma after a car wreck, you need continuity of care, and you've got to work until the patient is neatly tucked in ICU. You really need that doctor-patient relationship. Those making the rules don't know what that's about, and you can't make one rule fit all."
Some programs come up short to fill in the holes when resident shifts end, and more handoffs mean more communications meetings and more lost time away from patient care, he adds. "I require more faculty to make up for [residents'] sleeping, whereas they might have slept all night long because it was a light night. We don't have the money for that, so this actually contributes to lower quality and higher cost."
Program Pros and Cons
Without further study, however, more changes still could mean more headaches for GME programs.
Like all GME sponsoring institutions, The University of Texas School of Medicine in San Antonio over the last decade made across-the-board adjustments in how it assigned call and clinical rotations and implemented transition-of-care processes, says Vice Dean for GME Lois L. Bready, MD. The anesthesiologist agrees, "We can pretty effectively conclude one size does not fit all by specialty and individual, and that's part of what makes this so difficult. There is a significant chance that we will soon see changes in the duty-hours structure. But as the person responsible for overseeing measurement and enforcement, I can't imagine how we will monitor all of this if we have different standards for different specialties."
Dr. Bready participated in the ACGME panel that approved the broader 2011 reforms, but — unlike IOM — only after what she described as a lengthy multistakeholder process that included input from across the medical profession, as well as patient safety groups.
But what was missing then is still missing from FIRST, she says.
"The biggest lack — and I said this repeatedly when I was active on the panel — is a reliable, valid instrument to determine residents' functional ability. A good fitness-for-duty assessment tool could get rid of much of the structural regulations we are laboring under now, but lacking that, rules have to be very broadly structured, which may be too tight for some and too loose for others," Dr. Bready said. "We don't want to disrupt the education system we have, but we do want to ensure safe and effective care for our patients, and we want residents to complete training with a strong skill set. Those continue to be our goals."
The UT School of Medicine in San Antonio participated in FIRST and was randomly assigned to the standard-policy group. Current ACGME rules permit some exceptions for residents to continuously care for a patient if circumstances warrant and a duty-hours violation is imminent.
The process is complicated, and more flexibility would be a good thing, says pediatrician and Associate Dean for GME Robert J. Nolan Jr., MD. "But that still has to be balanced with an objective view of how your fatigue is affecting your skills. And surgery, having a procedural nature, is like learning the piano: You get better the more you practice. But that may not hold across the broad spectrum of medical training programs. You want your psychiatrists to be extremely alert to the nuances of your statements and behaviors during interview sessions. You want pathologists to be extremely alert when they are looking at microscopic sections."
Medicine has always been a team sport, he adds, even when physicians were allowed to train 120 hours per week. And at the same time duty hours have changed, "so many other things have changed in our care environment that it's difficult to tease out duty hours."
Recent studies, for example, show internal medicine residents spend five hours a day entering notes and data into electronic health records.
"That didn't exist 10 years ago, and that's five hours a day that used to be available for continuity of care, for study, or classwork, or time with your family," Dr. Nolan said. "Duty hours are a proxy for so many other things; this [study] is the tip of the iceberg in terms of looking at how we optimize patient safety and resident training and well-being when there are so many changes going on at the same time."
FIRST also suggests some trade-offs for residents.
Residents found the flexible policies improved certain aspects of care. When it came to their personal lives, though, they were more likely to perceive a negative impact on time away from the hospital for things like case preparation after work, research participation, time with family and friends, and rest and overall health. In terms of job satisfaction, education quality, and overall well-being, however, there were no significant differences between the standard and flexible groups.
Dr. Gephart says duty hours did not impede her education. "If your program does 100 surgeries in a month, residents still do 100 surgeries in a month. You may not follow the patient through every step every time. But in terms of quantity or quality of cases, that has nothing to do with whether or not there are handoffs in care."
But she did notice a difference in the interns who followed her. Dr. Gephart finished her first year of residency the year before ACGME instituted the 16-hour restriction on interns.
"Most people say the best way to learn about medicine is to do it in clinic or hospital and then go home and read about it. The interns behind me would show up the next day and actually have read something," she said. "I don't lament it [not having intern duty hours]. But I wonder if I would have been better. And given the rates of burnout and suicide among medical providers and overall [career] dissatisfaction, residents' emotional health and well-being are something we have to address to attract the best and brightest to our field."
Amy Lynn Sorrel can be reached by phone at (800) 880-1300, ext. 1392, or (512) 370-1392; by fax at (512) 370-1629; or by email.
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