A new study suggests new national regulations to further restrict the duty hours of first year resident medical trainees (interns) in the US may be harming patient safety and physicians’ training.

On 1 July 2011, the Accreditation Council for Graduate Medical Education (ACGME) brought in further restrictions of its 2003 regulations on duty hours and supervision.

The ACGME is the body responsible for accrediting the majority of graduate medical training programs for physicians in the United States.

The 2011 restrictions reduced the continuous-duty working hours of first year interns from 30 to 16.

ACGME focused on first year interns because they are the residents with the least experience and may therefore be at higher risk for making preventable errors.

The idea was that limiting their work hours would help them sleep more, reduce fatigue and lead to fewer serious medical errors.

For instance, in 2012 a poll by the Mayo Clinic found that interns’ fatigue and stress triggered motor vehicle incidents.

But in a study they report online this week in in JAMA Internal Medicine, Sanjay V. Desai, Assistant Professor of Medicine at Johns Hopkins University School of Medicine in Baltimore, and colleagues, say there is insufficient evidence to support the new restrictions.

Instead, they say unintended consequences of the new regulations could be making patients less safe and compromising interns’ training.

They found that limiting the number of hours medical trainees can work continuously failed to increase the amount of sleep they got per week and dramatically increased the number of potentially dangerous “handoffs” of patients from one trainee to another.

They also found that reduced working hours led to reduced training time.

Desai, who is also director of the internal medicine residency program at The Johns Hopkins Hospital, says in a statement:

“The consequences of these sweeping regulations are potentially very serious.”

“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,” he adds.

However, he and his colleagues also urge that more research is needed to understand the additional impact of reduced work hours on patient safety and quality of training.

Desai says the 16-hour limit was put in place without clear evidence of whether it would improve patient safety and outcomes.

“We need a rigorous study,” he says. “We need data to inform this critical issue. Now is the time to collect it.”

For their own recent study, Desay and colleagues compared three different work patterns in the months leading up to the 2011 changes.

They randomly assigned interns to one of three groups and followed them for three months.

One group had a work pattern that complied to the 2003 model of being on call every fourth night with a 30-hour duty limit.

The other two groups worked 2011-compliant models, one where the interns were on call every fifth night but worked only 16 hours straight, and the other being a “night float” schedule, where interns worked a regular week on the night shift that was no more than 16 hours.

But while Desay and colleagues found that compared with the interns on the 30-hour shifts, those on the 16-hour limit schedule did sleep on average 3 more hours in the 48 hours covering their on-call stretch, there was no difference in the amount of sleep the two groups got over a week.

So, even though the 2011-compliant pattern gave each intern 14 extra hours out of the hospital, they only used 3 of those for sleeping.

“We don’t know if that’s enough of a physiologically meaningful increase in sleep to improve patient safety,” says Desai.

Handoff is where the responsibility for the care of a patient transfers from one physician or caregiver to another. The goal is to provide accurate, up to date information about the patient’s care plan, treatment, current condition and any new or anticipated changes.

Evidence suggests that the more handoffs there are during a patient’s time in care, the less continuity of care and the more room for errors, such as in medication, treatment and communication.

Desai and colleagues found that the minimal number of handoffs between interns was 3 for those working the 30-hour shifts and as high as 9 for those working the 16-hour shifts.

Another way to look at this effect is to measure the minimal number of different interns caring for a given patient during a three-day stay. For the 30-hour shift this was 3, for the 16-hour shift this was 5.

However, although the figures don’t seem good, there is no evidence that higher handoff rates and numbers of carers for the 16-hour shifts worsens patient care or patient satisfaction.

But Desai and colleagues did find that interns and nurses perceived that the 30-hour model delivered a higher quality of care.

In fact, because they perceived quality of care became so poor in the night float pattern, they stopped it early.

Desai says their findings suggest the 16-hour model greatly reduces training opportunity.

He says an important facet of intern training that he sees at Johns Hopkins is attending rounds. These used to take place for 3 or 4 hours every morning, with trainees being quizzed or instructed on individual patient care as they followed senior physicians from bedside to bedside.

But now, even though they form the core of patient care and intern training, time spent on rounds has halved in order to fit the new schedules.

Also, before the new restrictions, interns used to do all the patient admissions and would spend the first 24 hours following the patient’s progress.

Now, says Desai, there are times when interns can’t admit patients, and can’t follow their progress through their initial assessments in the hospital.

Desai says the current rigidity of the ACGME rules is stifling innovation, and he would like to see them relaxed if the evidence shows they are not working.

“Dramatic policy changes, such as the move to 16 hours, without a better understanding of their implications are concerning,” says Desai.

“Training for the next generation of physicians is at risk,” he warns.

Written by Catharine Paddock PhD