|Flexibility In duty hour Requirements for Surgical Trainees Trial|
|"the FIRST trial"|
Resident duty hours are still evolving as the debate continues of how best to balance the development of clinical judgment, technical skills, patient ownership, and professionalism while mitigating fatigue and its effect on patient safety and resident wellbeing. Despite the considerable time, effort, and cost that have been utilized to pass and implement regulatory actions regarding resident work hours, it remains unclear whether these limitations impact patient care and outcomes.
To that end, the ABS and ACS have developed plans for a prospective trial to examine how increasing flexibility of surgical resident duty hour requirements affects patient care, surgical outcomes, and resident perceptions. Hospitals will be randomized to either an intervention group with flexibility of duty hour restrictions (elimination of many duty hour requirements) or a control group with continued adherence to current requirements. If randomized to the intervention arm, programs will be granted a waiver from current duty hour requirements by the ACGME. All participating hospitals will be required to give consent and acknowledge that they may be randomized to either arm of this study. Should a hospital be randomized to the control group, they will continue operating within the current work hour environment with no new changes to policy. Hospitals within the intervention arm will be granted the ability to relax several current hour requirements during the study period and the year after the study period (two years total). Surgical outcomes will then be compared between the intervention and usual care study arms.
The intent of the intervention arm is to allow flexibility in surgical resident duty hours and improve continuity of care. Programs in the intervention arm will be:
Only hospitals participating in the ACS National Surgical Quality Improvement Program (ACS NSQIP) are eligible to enroll in this study, as ACS NSQIP will be the data collection infrastructure. The study will examine patients undergoing general surgery operations based on the standard ACS NSQIP CPT list of general surgery procedures during the study period. Additional subset analyses will be performed, and we will compare multiple postoperative outcomes between the two study arms. Data collection will run from July 1, 2014 through June 30, 2015. We will also continue to collect data until June 30, 2016.
In addition, a survey will be administered at the 2015 American Board of Surgery In-Training Examination (ABSITE) to assess and compare resident perceptions of their wellbeing, patient safety, continuity of care, and adequacy of training between the two study groups.
ACGME Study Suggesting Worse Outcomes in Surgical Patients with Current Duty Hour Restrictions
Letter Endorsing FIRST Trial from Dr. Nasca, ACGME CEO
Dr. Thomas Nasca, ACGME CEO - Letter to the GME Community regarding the FIRST and iCOMPARE trials
Endorsement of the FIRST Trial from the VA
JAMA Surgery Commentary Article regarding the FIRST Trial
JAMA Surgery First Trial Protocol Paper