Patient outcomes were not adversely affected when medical residency programs were given more flexibility with duty-hour standards, according to a study published in The New England Journal of Medicine.
In this cluster-randomized noninferiority trial (ClinicalTrials.gov identifier: NCT02274818), investigators compared patient outcomes in 63 internal medicine residency programs during the pretrial and trial years. Randomized to a 1:1 ratio, 31 programs were grouped by those following standard duty-hour rules, and 32 were grouped by having flexible duty hours that allowed directors to extend work-hour limits beyond 16 hours. Investigators selected claims for patients aged ≥65.5 years who were admitted with one of 17 qualifying medical conditions (N=189,176). Patient outcomes were obtained from Medicare inpatient, outpatient, physician part B, home health agency, and hospice files. Centers for Medicare and Medicaid Services master beneficiary summary files were used to collect beneficiary demographics, vital status, and insurance information, and a validated date of death, if applicable.
The primary outcome of the study, change in 30-day mortality, was noninferior among patients in the flexible programs (12.5% in the trial year vs 12.6% in the pretrial year) compared with patients in the standard programs (12.2% in the trial year vs 12.7% in the pretrial year). Noninferiority was significant for the between-group difference in percentage points (one-sided 95% CI, 0.93%; P =.03).
In terms of secondary outcomes, there were noninferior results in risk-adjusted 30-day mortality in both the unadjusted and risk-adjusted analyses of 7-day readmissions, Agency for Healthcare Research & Quality patient safety indicators, and Medicare payments in the flexible programs. Although the rate of a prolonged length of hospital stay did not meet the noninferiority margin, researchers noted that with a baseline rate of 61% in the standard programs, a margin of 1 percentage point was highly conservative.
There was no apparent harm to patients when more flexibility with duty-hour standards was given to programs. However, this study did not evaluate what happens when trainees work extended shifts. The flexible programs were given the latitude but were not required to use extended shifts. The researchers believed that the varied use of extended shifts was a strength of this pragmatic trial.
Researchers suggested that allowing program directors to have discretion in making their own schedules without continuous duty-hour limits did not result in worse patient outcomes.
Silber JH, Bellini LM, Shea JA, et al; iCOMPARE Research Group. Patient safety outcomes under flexible and standard resident duty-hour rules. N Engl J Med. 2019;380(10):905-914.