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Beat the Clock, Round III: Resident Work Hours
Date: June 13, 2014
A study of a change to intern work hours
Osler residency director Sanjay Desai plans to embark on one of the most audacious studies of modern graduate medical education, the results of which have the power to transform intern duty schedules for the third time this century.
The Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCompare) study, a multi-institutional randomized controlled trial of intern work hours at academic and community hospitals, will compare the current policy limiting continuous intern duty to 16 hours with a new strategy: scheduling interns to 28-hour shifts with an embedded four-hour period of protected sleep to manage fatigue.
In 2003, the Accreditation Council for Graduate Medical Education (ACGME) devised new standards limiting trainees to a maximum 30 consecutive-hour shifts, attempting to improve patient outcomes, “but the preponderance of evidence indicates that implementation of these standards did not improve patient safety,” Desai says.
Duty hour standards were further revised in 2011, when interns were limited to 16 hours of continuous duty. But, Desai notes, this has created other issues, such as increased patient handoffs between physicians that can lead to errors. Two years into the revised schedules—the impact of which has yet to be analyzed—he has been thinking about how to achieve the “right” balance in duty hours, patient handoffs and resident education. The 28-hour concept could reduce patient handoffs while still allowing residents to work longer shifts feeling less tired.
Interns from 40 to 50 residency programs serving some 70 to 80 hospitals will be recruited for the two-year trial, scheduled to begin in July 2015. They will be randomized to follow one schedule for one year and the other schedule during the following year. The primary outcomes will include patients’ 30-day mortality and intern sleep duration.
Investigators will measure 30-day mortality using Medicare claims data and sleep duration via wristwatch actigraphy. They also will measure patients’ length of stay and 30-day readmissions, and intern education (including standardized test scores), well-being and safety, continuity of care, other metrics of sleep and alertness, and costs. Colleagues at Harvard and the University of Pennsylvania have signed on to help implement the study and analyze the data collected.
“Our hope is this will inform medical education policy,” Desai says. “If we determine that patients are safe during a longer work shift, sleep is better for interns and education is improved, then the current policy could be made more flexible.”
The project already has garnered interest from more than 100 residency program directors, who have signed up for updates through the study’s website, www.icomparestudy.com. Enrollment begins this spring, and the ACGME has pledged up to $1 million to cover study preparation, while Desai waits to hear back from the National Institutes of Health for funds to run the trial.
The study “is hugely important,” says Redonda Miller, vice president for medical affairs at The Johns Hopkins Hospital, as the data on the benefits of sleep and residency hours have been mixed. Some studies have shown that trainees don’t spend their time outside the hospital sleeping, she says, and other smaller studies have tried to link duty hours to patient outcomes and safety, “but that’s very hard to do.” Miller says she’s hoping Desai’s work will lead to stronger conclusions: “Many in the education and clinical communities are supportive of this. We need data.”
Julia McMillan, associate dean for graduate medical education and executive vice chair of pediatrics, says there is “potential for interesting results” from both this study and a similar but shorter study that ACGME, the American Board of Surgery and the American College of Surgeons are undertaking to evaluate surgery trainees’ schedules.
For now, she says, “I think the limit of 16 hours is a good thing….It’s allowed the most junior trainees who are under the most stress to have a schedule that doesn’t fatigue them to the point where they may make mistakes but also allows them to remain fresh and able to learn.”
“It’s possible to construct a schedule that avoids the handoffs,” she adds, noting that some residency programs have demonstrated a decrease in patient transitions even within the 16-hour confines.