title: Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Protocol: A National Cluster-Randomized Trial of Resident Duty Hour Policies.
abstract: OBJECTIVE
  Debate continues regarding whether to further restrict resident duty hour policies, but little high-level evidence is available to guide policy changes.
  
  
  OBJECTIVE
  To inform decision making regarding duty hour policies, the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial is being conducted to evaluate whether changing resident duty hour policies to permit greater flexibility in work hours affects patient postoperative outcomes, resident education, and resident well-being.
  
  
  METHODS
  Pragmatic noninferiority cluster-randomized trial of general surgery residency programs with 2 study arms. Participating in the study are Accreditation Council for Graduate Medical Education (ACGME)-approved US general surgery residency programs (n = 118), their affiliated hospitals (n = 154), surgical residents and program directors, and general surgery patients from July 1, 2014, to June 30, 2015, with additional patient safety outcomes collected through June 30, 2016. The data collection platform for patient outcomes is the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP), thus only hospitals participating in the ACS NSQIP were included.
  
  
  METHODS
  In the usual care arm, programs adhered to current ACGME resident duty hour standards. In the intervention arm, programs were allowed to deviate from current standards regarding maximum shift lengths and minimum time off between shifts through an ACGME waiver.
  
  
  METHODS
  Death or serious morbidity within 30 days of surgery measured through ACS NSQIP, as well as resident satisfaction and well-being measured through a survey delivered at the time of the 2015 American Board of Surgery in Training Examination (ABSITE).
  
  
  RESULTS
  A total of 118 general surgery residency programs and 154 hospitals were enrolled in the FIRST Trial and randomized. Fifty-nine programs (73 hospitals) were randomized to the usual care arm and 59 programs (81 hospitals) were randomized to the intervention arm. Intent-to-treat analysis will be used to estimate the effectiveness of assignment to the intervention arm on patient outcomes, resident education, and resident well-being compared with the usual care arm. Several sensitivity analyses will be performed to determine whether there were differential effects when examining only inpatients, high-risk patients, and emergent/urgent cases.
  
  
  CONCLUSIONS
  To our knowledge, the FIRST Trial is the first national randomized clinical trial of duty hour policies. Results of this study may be informative to policymakers and other stakeholders engaged in restructuring graduate medical training to enhance the quality of patient care and resident education.
  
  
  BACKGROUND
  clinicaltrials.org Identifier: NCT02050789.
authors.affiliation: Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois2Center for Healthcare Studies in the Institute for Public Health and Medicine, Feinberg School of Medi.
authors.forename: Karl Y
authors.initials: KY
authors.lastname: Bilimoria
authors.affiliation: Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Jeanette W
authors.initials: JW
authors.lastname: Chung
authors.affiliation: Department of Biostatics, Northwestern University, Evanston, Illinois.
authors.forename: Larry V
authors.initials: LV
authors.lastname: Hedges
authors.affiliation: Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Allison R
authors.initials: AR
authors.lastname: Dahlke
authors.affiliation: Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Remi
authors.initials: R
authors.lastname: Love
authors.affiliation: American College of Surgeons, Chicago, Illinois.
authors.forename: Mark E
authors.initials: ME
authors.lastname: Cohen
authors.affiliation: Department of Surgery, Vanderbilt University, Nashville, Tennessee.
authors.forename: John
authors.initials: J
authors.lastname: Tarpley
authors.affiliation: Department of Surgery, Southern Illinois University, Springfield.
authors.forename: John
authors.initials: J
authors.lastname: Mellinger
authors.affiliation: Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: David M
authors.initials: DM
authors.lastname: Mahvi
authors.affiliation: Center for Surgery and Health Economics, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
authors.forename: Rachel R
authors.initials: RR
authors.lastname: Kelz
authors.affiliation: American College of Surgeons, Chicago, Illinois.
authors.forename: Clifford Y
authors.initials: CY
authors.lastname: Ko
authors.affiliation: American College of Surgeons, Chicago, Illinois.
authors.forename: David B
authors.initials: DB
authors.lastname: Hoyt
authors.affiliation: American Board of Surgery, Philadelphia, Pennsylvania.
authors.forename: Frank H
authors.initials: FH
authors.lastname: Lewis
mesh_terms: D000328:Adult; D016000:Cluster Analysis; D004503:Education, Medical, Graduate / Q000592:standards*; D005260:Female; D013502:General Surgery / Q000193:education*; D006801:Humans; D007396:Internship and Residency / Q000592:standards*; D008297:Male; D010561:Personnel Staffing and Scheduling / Q000592:standards*; D010820:Physicians / Q000523:psychology; D011050:Policy Making; D014481:United States; D014940:Work Schedule Tolerance / Q000523:psychology*; D016526:Workload / Q000592:standards*