What Is the Effect of ACGME Duty Hours Regulations?

Does limiting the number of hours doctors work affect patient outcome, improve safety, or affect the education of otolaryngologists? Indeed, what sort of effect are the Accreditation Council for Graduate Medical Education (ACGME) duty hour regulations having?

The answer depends on whom you ask, although the bottom line is that there still needs to be more study on the topic, including looking at whether the way duty hours are now implemented is the most effective and scientifically proven method.

Duty hour regulations were introduced in 2003 with the intent of reducing physician fatigue on the job and improving patient safety. According to the ACGME Web site (www.acgme.org ), duty hours limit resident duty hours to a maximum of 80 hours a week, including in-house calls, averaged over four weeks. Residents must be given one day off out of seven, averaged over four weeks, and cannot be scheduled for in-house call more than once every three nights, again averaged over four weeks. Furthermore, duty periods cannot last for more than 24 hours, although residents may remain on duty for six additional hours to transfer patients. It is up to individual institutions to determine how to implement the rules.

According to Christopher P. Landrigan, MD, MPH, Assistant Professor of Pediatrics and Medicine at Harvard Medical School in Boston, who has a special interest in patient safety and duty hours, while the intent of ACGME duty hours regulations are on the right track, they are not very helpful in their present state.

The ACGME changes themselves were not much of a change for most specialities. The standards require no more than 80 hours per week averaged over four weeks. This means that in practice you could have a 100-hour workweek for three weeks in a row as long as the next week was 20 hours…so it’s possible to have very long work weeks, he told ENToday in an interview.

They still allow work shifts of up to 30 hours in a row, which is a limit that’s completely not evidence-based and runs contrary to everything we know about human circadian biology and the ability to adapt to long hours, he said. Indeed, one of his own studies shows that this happens. A study of 220 residents who daily logged their hours showed that 24- to 30-hour shifts remained common.

Need for Shorter Shifts

Shorter work hours are important for reducing fatigue in physicians, as well as reducing medical errors. Evidence shows that there is a sharp drop in performance after 12 to 16 hours on duty, and by the 24-hour mark, people perform at the same level as somebody who is legally drunk with a blood alcohol of 0.10 percent, Dr. Landrigan said.

The current ACGME standards have loopholes that still allow for extra-long shifts. Because residents commonly work long hours, it is not surprising that many studies don’t show improvements in patient mortality or outcome, or a reduction in errors. Fatigued physicians are also more likely to be involved in traffic accidents-indicating that problems extend outside the hospital. The rules need to help guide centers on how shifts should be managed. There are good models for this in areas such as the airline industries, Dr. Landrigan said.

When it comes to issues such as resident training, exposure to patient volume, and continuity of care, there are no simple answers. A fundamental restructuring of residency programs needs to be done, and studies need to help find the best ways to do this. Still, numerous institutions have eliminated 24-hour shifts, including the Brigham and Women’s Hospital Department of Surgery; the Medical ICU at St. Luke’s Medical Center in New York; the University of Pennsylvania Internal Medicine Program; and the Pediatric ICU fellowship at Children’s Hospital, Boston.

It’s also worth examining what other countries are doing. New Zealand, for instance, has a 16-hour shift limit that has been mandated for 20 years, and it’s one of the highest quality health care systems in the world, Dr. Landrigan said.

Currently, a committee of the US Institute of Medicine is reviewing the issue of duty hours, and will release recommendations for improvement. Dr. Landrigan is coauthor of a recent article in JAMA (Sept. 10, 2008) that offers suggestions on how to make duty hour programs more effective (see sidebar on page 6).

Duty Hour Restrictions Can Be Implemented in an ENT Service

According to a small study on the topic presented at the spring Combined Otolaryngology Spring Meeting, duty hours can be implemented successfully in an otolaryngology program. The study focused on a program with 15 residents at the University of Virginia (UVA). It showed that duty hours had little effect on patient mortality and readmission rates, and that otolaryngology residents had no change in performance on otolaryngology training examination (OTE) scores. Findings were presented by David Shonka, MD, from the Department of Otolaryngology at UVA in Charlottesville.

The study was a retrospective analysis of duty hour violations. We looked at the type of violation, and documented the violation as a function of service, he said. Resident education was measured by looking at the average total operative volume of the graduating chiefs from the four years preceding implementation of the duty hour regulations and comparing it with that of the four years following implementation. OTE scores were also compared before and after implementation of the duty hours regulations.

The authors tallied a total of 529 violations the first year after duty hour rules were implemented. This number dramatically decreased in the succeeding years, with most occurring during PGY-2 and intern years. Most occurred on the head and neck oncology rotation, followed by general surgery rotations. The 80-hour and 30-hour rules constituted only 1.5% to 2.1% of total violations. The study showed most violations were of the 10-hour rule. This is commonly violated when residents stay late to see the end of a long case and come in early the next morning to round on patients, Dr. Shonka said.

Residents had no change in operative volume after duty hour regulation implementation. In addition, there was no change in OTE scores, Dr. Shonka said. He noted that increased free time to study may have been offset by decreased time in the hospital and fewer opportunities to participate in continuity of care. In addition, even with more time off, there is no guarantee that residents will study or sleep more.

As for patient care, mortality rates did not change in the three years preceding implementation, compared with the three years afterward. He noted that one study in the medical literature suggests that this sort of finding could be due to a relative decrease in continuity of care that offset any improvements from decreased fatigue. There was also no change in hospital readmission rates.

Although the actual patient length of stay did not change, however, there was a significant increase in the length-of-stay index following the duty hours implementation. The index is a measure of the University of Virginia Health System against other academic medical centers in the country. Other studies in the literature found a decrease in length of stay with no difference in in-hospital mortality, Dr. Shonka said.

Overall, Dr. Shonka concluded that no significant improvement occurred in the metrics we measured as a result of these regulations. In general, problems such as medical errors can still occur and some studies have shown no change in patient outcomes. Additionally, resident burnout continues to be a problem. He cautioned that the current study did not evaluate resident burnout or quality of life, and duty hour regulations may not be the entire story.

IOM Issues Duty Hour Recommendations

The Institute of Medicine of the National Academies (IOM) recently released its recommendations on duty hours. It suggests an increase in the number of mandatory days off, restricts moonlighting during off-hours, suggests changes to the length of shifts-and much more.

The report acknowledges that altering residents’ work hours alone will not guarantee patient safety, but it could substantially reduce errors by reducing fatigue. It suggests that there should be greater supervision of residents by experienced physicians, and that there should be limits on patient caseloads according to residents’ levels of experience and specialty. It also suggests that centers need to ensure that there is a sufficient overlap of time during shift changes to ensure that the handing over of patients from one doctor to another goes smoothly.

The report does not recommend a greater reduction in work hours from the maximum 80 hours set by the ACGME. However, it does acknowledge that there is no single model of schedule that will fit all training facilities or specialties. To address this, the IOM offers two options for extended shifts, and keeps the choice of working up to an 80-hour averaged workweek.

The IOM notes that a lack of adherence to duty hour limits is common and underreported. There should be changes to ACGME monitoring such as unannounced visits and strong whistle-blowing processes to encourage resident reporting of violations, and pressure to work too long, the report says.

As for education-related issues, the report recommends keeping patient loads for residents at more manageable levels by reducing the number of non-education-related burdens on residents and improving supervision of residents with more frequent consultations between residents and their supervisors.

The committee recommends that Residency Review Committees (RRCs) set specialty-specific guidelines for the number of patients residents should be permitted to treat during a shift, based on the level of residents’ competency and patient characteristics.

The report attempts to help change the culture around error detection. It recommends that residents should be taught error detection, correction, reporting, and monitoring so they can participate fully in the hospital’s quality improvement efforts.

There will be costs associated with implementing the recommendations, such as hiring additional staff at various levels. Along with the changes, the IOM recommends creating programs to monitor and evaluate the effectiveness of the changes, and follow-up to help fine-tune duty hour programs.

Some of the key changes in recommendations include:

• Maximum shifts should be no more than 30 hours, which includes admitting patients for up to 16 hours plus a five-hour protected sleep period between 10 PM and 8 AM. (Remaining hours would be for transitions and educational activities.)
• The maximum in-hospital on-call frequency would be every third night, but with no averaging.
• The minimum time off between scheduled shifts would be 10 hours after day shifts, 12 hours after night shifts, and 14 hours after any extended duty period of 30 hours.
• There is now a maximum frequency of in-hospital night-shifts: a four-night maximum; 48 hours off after three or four nights of consecutive duty.
• Internal and external moonlighting both count against the 80-hour weekly limit. All other duty hour limits apply to moonlighting in combination with scheduled work.

 

Further details of the recommendations can be found at the IOM Web site at www.iom.edu/CMS/3809/48553/60449.aspx .

Making Duty Hour Regulations More Effective

According to Christopher P. Landrigan, MD, MPH, there are several factors that can help make reduced duty hours more effective.

The current ACGME regulations don’t go far enough in terms of the types of recommendations, and don’t necessarily lead to decreased physician fatigue or improved performance overall, he said. Indeed, one study showed that residents working 24-hour shifts made 36% more serious errors and 460% more serious diagnostic errors compared with those working 16-hour shifts.

Dr. Landrigan was coauthor of an article in a recent edition of JAMA (Sept. 10, 2008) which highlights ways to improve duty hour effectiveness:

1. Move to a 16- to 18-hour shift limit. Eliminate 24-hour shifts.
2. Implement a mandatory overnight sleep program to allow residents enough protected time to sleep (ideally, seven to eight hours) when they are at their circadian nadirs.
3. Rotate shifts in a clockwise manner to allow for easier circadian adjustment.
4. Schedule shorter shifts, but allow for substantial shift overlap to minimize any discontinuity of care.
5. Redesign the flow of patients and assignment to teams. This can allow better workflow over time.
6. Improve sign-out procedures-structured computerized tools can help with this.
7. Make sure there is adequate staffing and supervision.

A useful resource doctors can turn to for developing safe schedules is the Harvard Work Hours Health and Safety Group, which has information for developing safe schedules: http://workhoursandsafety.org .

©2009 The Triological Society