This trial is active, not recruiting.

Conditions patient safety, resident work hours
Treatment flexible duty hours
Sponsor Northwestern University
Collaborator American College of Surgeons
Start date July 2014
End date June 2017
Trial size 152 participants
Trial identifier NCT02050789, FIRST Trial


Resident duty hour requirements in the U.S. are still evolving as stakeholders continue to debate how best to (re)structure postgraduate medical education.

There is concern that current restrictions may be detrimental to patient care and resident training. To investigate these issues, the investigators will be conducting a one-year, prospective randomized trial to examine how flexibility of duty hour requirements affects patient care when compared to current resident duty hour requirements. Further information about the study is available on the FIRST Trial website http://www.thefirsttrial.org/.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
(No Intervention)
Programs will continue adhering to current ACGME requirements.
The intent of the intervention arm is to allow flexibility in surgical resident duty hours and improve continuity of care.
flexible duty hours Waiver from current duty hour requirements by the ACGME.
If a hospital is assigned to the intervention arm, all categorical and preliminary general surgery residents in that general surgery program will switch to the flexible duty hours while at an enrolled hospital.

Primary Outcomes

Death or Serious Morbidity
time frame: 30 days

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - General Surgery Residency Programs participating in ACS NSQIP Exclusion Criteria: - Childrens' and VA Hospitals

Additional Information

Official title Allowing Flexibility in Surgical Resident Duty Hours Trial
Principal investigator Karl Y. Bilimoria, MD MS
Description Residency programs will be randomized to either (1) an intervention arm that eliminates several Accreditation Council for Graduate Medical Education (ACGME) duty hour requirements or (2) to a usual care arm where programs will continue adhering to current ACGME requirements. Programs in the intervention arm will be granted a waiver from current duty hour requirements by the ACGME and allowed to eliminate all resident duty hour rules with the following exceptions: Duty hours limited to 80 hours/week averaged over 4 weeks, minimum of one free day (no duty)/week averaged over 4 weeks, may not take in-house call more frequently than every 3rd night, averaged over 4 weeks, allowed to increase duty requirement flexibility for chief residents. The intent of the intervention arm is to allow flexibility in surgical resident duty hours and improve continuity of care. Subsequently, the investigators will compare multiple postoperative outcomes between the two study arms using data collected through the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). The results of this study will provide high-quality empirical evidence upon which to base resident duty hour requirements in the future. Updated April 1, 2014 Detailed statistical analysis plan available on the FIRST Trial website. http://www.thefirsttrial.org/Approval/Approval A listing of the 152 ACS-NSQIP hospitals that have elected to participate in the FIRST Trial is available on the FIRST Trial website. http://www.thefirsttrial.org/Hospitals/Hospitals Updated July 14, 2014 Post-Randomization documents available for control and intervention arms on FIRST Trial website. http://www.thefirsttrial.org/PostRandomization/PostRandomization Updated August 2014 'FIRST Trial-Policies & Procedures Survey for Program Directors' survey administered to general surgery program directors via Survey Monkey. Updated January 2015 Resident survey regarding duty hour policies and procedures administered at the end of the annual ABS In-Training Examination (ABSITE®). Updated April 1, 2015 The Data Safety Monitoring Board (DSMB) was convened March 10, 2015 to review the results of planned interim analysis. After review, they voted to allow the FIRST Trial to continue. All other aspects of the trial are on track. Updated May 24, 2016 Results from the study were released February 2, 2016 and the study has been extended for an additional year, through the 2016-2017 academic year.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Northwestern University.