March 27, 2013
Patient Care Risks On The Rise Due To Regulations To Reduce Intern Work Hours
Lawrence LeBlond for redOrbit.com - Your Universe Online
National regulations put in place in 2011 to reduce the number of continuous-duty hours that first-year resident physicians were required to maintain has been more troublesome than beneficial. The norm for 30-hour shifts was reduced to 16 hours in order to protect patients from overworked and sleep-deprived doctors-in-training.However, new joint findings from Johns Hopkins University (JHU) and the University of Michigan reveal that limiting the number of continuous hours trainees work has failed to increase the amount of sleep each intern received each week, and more negatively, dramatically increased the number of potentially dangerous hand-offs of patients from one trainee to another.
In a study of more than 2,300 doctors in their first year of residency at hospitals systems all around the country, questions are now being raised about how well the new regulations are working at protecting both patients and new doctors.
While work hours went down after the new rules went into effect, sleep hours didn´t go up and depressions symptoms stayed roughly the same, according to the study, published online in JAMA Internal Medicine. The most significant finding was that the percentage of residents reporting that they had committed medical errors potentially harming patients jumped up after the rules went into effect.
The results of the study were surprising, according to Srijan Sen, MD, PhD, psychiatrist and first author of the report from the University of Michigan.
"In the year before the new duty hour rules took effect, 19.9 percent of the interns reported committing an error that harmed a patient, but this percentage went up to 23.3 percent after the new rules went into effect," said Sen in a statement. "That's a 15 to 20 percent increase in errors -- a pretty dramatic uptick, especially when you consider that part of the reason these work-hour rules were put into place was to reduce errors."
Sanjay V. Desai, MD, an assistant professor at JHU School of Medicine and director of the internal medicine residency program at The Johns Hopkins Hospital, said data from his research suggests that the unintended consequences from the new regulations could be making patients less safe and compromising resident training.
"The consequences of these sweeping regulations are potentially very serious," said Desai in a statement. "Despite the best of intentions, the reduced work hours are handcuffing training programs, and benefits to patient safety and trainee well-being have not been systematically demonstrated."
Desai said the 16-hour limit was put in place before enough evidence was garnered on the efficacy of such a move on both patients and trainees. “We need a rigorous study“¦ We need data to inform this critical issue," he said, adding that now is the time to collect it.
For his part in the study, Desai and his JHU colleagues compared three different work schedules in the months leading up to the new regulations in 2011. For three months, groups of interns were randomly assigned to either a 2003-compliant model of being on call every fourth night, with a 30-hour duty limit, or to one of two 2011-compliant models — either being on call every fifth night for 16 hours, or a night float schedule, which had interns working a regular week on the night shift not exceeding 16 hours.
While the interns on the 16-hour shift cycle slept an average of three hours longer within the 48 hours encompassing their on-call period than those working 30-hour shifts, the data showed no difference in the amount of sleep between both groups across an entire week.
"During each call period, the interns had 14 extra hours out of the hospital, but they only used three of those hours for sleeping," Desai noted. "We don't know if that's enough of a physiologically meaningful increase in sleep to improve patient safety."
When it came to patient hand-offs, the team found the average was three for those working 30 hours. But with the 2011 regulations, hand-offs increased to as high as nine for those on 16-hour shifts. With more hand-offs, the level of patient care decreases and the risk of medical errors rise. And the minimal number of different interns caring for a given patient during a three-day stay increased from three to as high as five.
Desai and colleagues learned that most trainees and nurses believed that higher quality of care comes with a 30-hour model. Once the new regulations went into effect, most of these same trainees and nurses had much lower perceptions of quality of care for their patients.
Desai also noted that the study shows that educational opportunities suffer greatly from the rule change. He said a main component of an intern´s education at Johns Hopkins is rounds, which used to occur for three to four hours each morning as senior physicians led trainees from bedside to bedside, offering them instructions on how to care for each patient. Because of the regulations, rounds have been cut by half to accommodate shrinking schedules, even though rounds are a core part of patient care and trainee education.
In the U-M end of the study, Sen said all interns surveyed were working under the duty hour restrictions that had gone into effect in 2003 — limiting patients to no more than 80 hours per week, along with other restrictions. The rule changes, put in place by the Accreditation Council for Graduate Medical Education (ACGME), did result in better safety for patients cared for by residents. But in an effort to achieve even greater safety, the ACGME 2011 regulations went a step too far.
Sen and his colleagues send out surveys each year to students entering residency programs around the US. The team then surveys these same interns every three months throughout the first year of their residency, asking questions that gauge mental health, well-being, sleeping habits, work hours and job performance.
By comparing the interns who served before the 2011 rule changes with those serving afterwards, the researchers were able to assess the effects of the new rules. In addition to an increase in self-reported medical errors, one-fifth of residents screened positive for depression.
Sen, who interned in 2006, studies depression among medical students and residents and is in favor of adjusting hours to better suit interns and patients.
"It was obvious that after working for 24 hours, we were not functioning at our best, and this was not optimal for us or the patients we were treating," he explains. But in practice, these new rules have left unintended consequences that ran counter to the goals of new guidelines, he added.
"The 2011 changes were a pretty radical shift," he noted. "Doctors have worked 30-hour shifts for decades, and it may just take time for all parts of the health care system to get used to the new rules and adjust."
However, he cautioned that the new data does not definitively portray reduced hours as the culprit for the increase in patient error rates or the lack of progress in sleep hours and well-being among young doctors. Sen said further research is needed to assess what´s really happening, and determine how to better support young doctors during their stressful training, all while keeping patients as safe as possible.
Desai noted that the ACGMA rules can be relaxed if evidence definitively shows that they are not working the way they were meant to.
"Dramatic policy changes, such as the move to 16 hours, without a better understanding of their implications are concerning," he said. "Training for the next generation of physicians is at risk."