What’s New in the Patient Safety World

April 2019

iCOMPARE Study on Resident Work Hour Rules

 

 

There is no question that fatigue has a detrimental impact on healthcare workers (see our many columns listed below on that topic). Way back in the 1990’s the Bell Commission in New York State led to restriction on resident work hours. At the time we asked Dr. Bell what empirical evidence was there that such restrictions would improve patient care. His response was that the NYSDOH received more incident reports about care on nights or weekends. We pointed out that those are also times when care is often rendered by physicians who are less familiar with patients. We’ve often framed the question as “Do I want to be cared for by a sleepy resident who knows me or by an alert resident who knows very little about me?”. So, the question has always been whether patient outcomes are more impacted by fatigue or by discontinuity of care and inadequate handoffs.

 

New York State’s restriction on resident work hours was subsequently adopted (with some minor adjustments) by the ACGME (Accreditation Council for Graduate Medical Education) in 2003. Since the ACGME policies were put in place, there have been multiple attempts to measure the impact on patient care, but results have been mixed. In our many columns (listed below) on the conflicting studies on the impact of housestaff workhour restrictions on patient safety we’ve laid our hopes for better answers on two ongoing randomized trials, one in surgery (the FIRST trial) and one in internal medicine (the iCOMPARE trial).

 

We discussed the results of the FIRST (surgical residency) trial (Bilimoria 2016) in our March 2016 What's New in the Patient Safety World column “Does the Surgical Resident Hours Study Answer Anything?”.

 

Now, results of the iCOMPARE trial have been published (Silber 2019, Basner 2019). iCOMPARE involved 63 internal-medicine residency programs that were randomized to a group with standard ACGME duty hours or to a group with more flexible duty-hour rules that did not specify limits on shift length or mandatory time off between shifts (but still complied with the 80 hour per week restriction).

 

The primary outcome measure, change in 30-day mortality, was not significantly different between the two groups (Silber 2019). Differences in changes between the flexible programs and the standard programs in the unadjusted rate of readmission at 7 days, patient safety indicators, and Medicare payments were also not significantly different.

 

The authors conclude that allowing program directors flexibility in adjusting duty-hour schedules for trainees did not adversely affect 30-day mortality or several other measured outcomes of patient safety

 

The second paper from the iCOMPARE trial looked at the effects of flexible scheduling vs. strict scheduling on sleep, sleepiness, and alertness of medical trainees (Basner 2019). The researchers found no significant difference between the groups in total sleep duration (as measured by actigraphy) or sleepiness (as measured by the Karolinska Sleepiness Scale). But noninferiority of the flexible group for alertness (as measured by the brief computerized Psychomotor Vigilance Test) was not established.

 

The conclusion is that there was no more chronic sleep loss or sleepiness across trial days among interns in flexible programs than among those in standard programs. But both those measures were averages over time. Those in flexible-hour programs averaged 2.23 hours less sleep during night calls and the average was increased by sleeping more hours on days off. Also, those in flexible programs reported less alertness and more sleepiness after extended night shifts than during day shifts.

 

Last year the iCOMPARE trial published results of its impact on educational aspects and resident satisfaction with the flexible policies vs. standard duty-hour policies (Desai 2018). There were no significant between-group differences in the mean percentages of time that interns spent in direct patient care and education nor in trainees’ perceptions of an appropriate balance between clinical demands and education. Scores on in-training examinations also did not differ significantly between groups. But a survey of interns revealed that those in flexible programs were more likely to report dissatisfaction with multiple aspects of training, including educational quality (odds ratio 1.67), overall well-being (OR 2.47), and how the program affects their personal lives with friends and family (OR, 6.11).

 

Perhaps not surprisingly, directors of flexible programs were less likely to report dissatisfaction with multiple educational processes, including time for bedside teaching.

 

The bottom line of that paper is that interns in flexible programs were less satisfied with their educational experience than were their peers in standard programs, but program directors were more satisfied.

 

In the editorial accompanying the FIRST trial results, John Birkmeyer had pointed out that much of the work formerly done primarily by residents is now done primarily by others (Birkmeyer 2016). For example, there are often board-certified intensivists in the ICU’s and many associate providers working with multidisciplinary teams. We’ll add that many hospitals also have hospitalists covering larger portions of the patient population. And many hospitals have more in-house attending availability at night.

 

Interestingly, there has been little publication on the impact of resident work-hour restrictions on attending physicians. One study looked at whether more attending involvement in morning work rounds might improve patient safety (Finn 2018). They found that there was no significant difference in medical error rate with this increased supervision. But interns were less likely to speak up in the presence of an attending on work rounds and interns felt less efficient and less autonomous (residents also felt less autonomous). But attending physicians rated the quality of care higher when they participated on work rounds.

 

The editorial accompanying the current iCOMPARE papers (Rosenbaum 2019) also points out that the patient perspective has been left out. It would not have been possible to correlate HCAHPS survey data from Medicare with the small randomized groups. We might also note that patient families, who may only be able to visit the patient in the evening, may find it difficult to speak to a physician sufficiently knowledgeable about the patient.

 

So, have we answered our fundamental question? We now have results of both the FIRST and iCOMPARE trials that show flexible resident work-hour policies have similar patient outcomes and resident educational values compared to the strict ACGME policies. That’s reassuring. It pretty much answers the question that we raised from the beginning: the issue of fatigue vs. increased handoffs/discontinuity is a wash. The authors of the safety article on iCOMPARE conclude that allowing program directors flexibility in adjusting duty-hour schedules for trainees did not adversely affect 30-day mortality or several other measured outcomes of patient safety. But both studies have shown that residents have more negative perceptions of the impact of the flexible policies on their personal lives and overall well-being. Given that, we actually see little reason for the ACGME to alter its recommendations regarding resident work hours.

 

 

Some of our other columns on housestaff workhour restrictions:

 

December 2008           “IOM Report on Resident Work Hours”

February 26, 2008       “Nightmares: The Hospital at Night”

January 2010               “Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety

January 2011               “No Improvement in Patient Safety: Why Not?”

November 2011          “Restricted Housestaff Work Hours and Patient Handoffs”

January 3, 2012           “Unintended Consequences of Restricted Housestaff Hours”

June 2012                    “Surgeon Fatigue”

November 2012          “The Mid-Day Nap”

December 10, 2013     “Better Handoffs, Better Results”

April 22, 2014             “Impact of Resident Workhour Restrictions”

January 2015               “More Data on Effect of Resident Workhour Restrictions”

August 2015               “Surgical Resident Duty Reform and Postoperative Outcomes”

September 2015          “Surgery Previous Night Does Not Impact Attending Surgeon Next Day”

March 2016                 “Does the Surgical Resident Hours Study Answer Anything?”

 

 

Some of our other columns on the role of fatigue in Patient Safety:

 

November 9, 2010      “12-Hour Nursing Shifts and Patient Safety”

April 26, 2011             “Sleeping Air Traffic Controllers: What About Healthcare?”

February 2011             “Update on 12-hour Nursing Shifts”

September 2011          “Shiftwork and Patient Safety

November 2011          “Restricted Housestaff Work Hours and Patient Handoffs”

January 2012               “Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety

January 3, 2012           “Unintended Consequences of Restricted Housestaff Hours”

June 2012                    “June 2012 Surgeon Fatigue”

November 2012          “The Mid-Day Nap”

November 13, 2012    “The 12-Hour Nursing Shift: More Downsides”

July 29, 2014              “The 12-Hour Nursing Shift: Debate Continues”

October 2014              “Another Rap on the 12-Hour Nursing Shift”

December 2, 2014       “ANA Position Statement on Nurse Fatigue”

August 2015               “Surgical Resident Duty Reform and Postoperative Outcomes”

September 2015          “Surgery Previous Night Does Not Impact Attending Surgeon Next Day”

September 29, 2015    “More on the 12-Hour Nursing Shift”

September 6, 2016      “Napping Debate Rekindled”

April 18, 2017             “Alarm Response and Nurse Shift Duration”

July 11, 2017              “The 12-Hour Shift Takes More Hits”

February 13, 2018       “Interruptions in the ED”

April 2018                   “Radiologists Get Fatigued, Too”

August 2018               “Burnout and Medical Errors”

September 4, 2018      “The 12-Hour Nursing Shift: Another Nail in the Coffin”

 

 

References:

 

 

Bilimoria KY, Chung JW, Hedges LV, et al. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training. N Engl J Med 2016; published online first February 2, 2016

http://www.nejm.org/doi/full/10.1056/NEJMoa1515724?query=TOC

 

 

Silber JH, Bellini LM, Shea JA, et al. Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules. N Engl J Med 2019; 380: 905-914

https://www.nejm.org/doi/full/10.1056/NEJMoa1810642

 

 

Basner M, Asch DA, Shea JA, et al. Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med 2019; 380: 915-923

https://www.nejm.org/doi/full/10.1056/NEJMoa1810641

 

 

Desai SV, Asch DA, Bellini LM, et al. Education Outcomes in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med 2018; 378: 1494-1508

https://www.nejm.org/doi/full/10.1056/NEJMoa1800965

 

 

Finn KM, Metlay JP, Chang Y, et al. Effect of Increased Inpatient Attending Physician Supervision on Medical Errors, Patient Safety, and Resident Education. A Randomized Clinical Trial. JAMA Intern Med 2018; Published online June 4, 2018

https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2682517

 

 

Birkmeyer JD. Surgical Resident Duty-Hour Rules - Weighing the New Evidence (editorial). N Engl J Med 2016; published online first February 2, 2016

http://www.nejm.org/doi/full/10.1056/NEJMe1516572?query=TOC

 

 

Rosenbaum L, Lamas D. Eyes Wide Open — Examining the Data on Duty-Hour Reform. N Engl J Med 2019; 380: 969-970

https://www.nejm.org/doi/full/10.1056/NEJMe1817497

 

 

 

 

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