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Special Communication |

Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Protocol A National Cluster-Randomized Trial of Resident Duty Hour Policies

Karl Y. Bilimoria, MD, MS1,2,3; Jeanette W. Chung, PhD1; Larry V. Hedges, PhD4; Allison R. Dahlke, MPH1; Remi Love, BS1; Mark E. Cohen, PhD3; John Tarpley, MD5; John Mellinger, MD6; David M. Mahvi, MD1; Rachel R. Kelz, MD, MSCE7; Clifford Y. Ko, MD, MS, MSHS3; David B. Hoyt, MD3; Frank H. Lewis, MD8
[+] Author Affiliations
1Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
2Center for Healthcare Studies in the Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
3American College of Surgeons, Chicago, Illinois
4Department of Biostatics, Northwestern University, Evanston, Illinois
5Department of Surgery, Vanderbilt University, Nashville, Tennessee
6Department of Surgery, Southern Illinois University, Springfield
7Center for Surgery and Health Economics, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia
8American Board of Surgery, Philadelphia, Pennsylvania
JAMA Surg. 2016;151(3):273-281. doi:10.1001/jamasurg.2015.4990.
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Importance  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.

Design, Setting, and Participants  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.

Interventions  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.

Main Outcomes and Measures  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 and Relevance  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.

Trial Registration  clinicaltrials.org Identifier: NCT02050789

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Figure 1.
FIRST Trial Enrollment Diagram

ACGME indicates Accreditation Council for Graduate Medical Education; ACS, American College of Surgeons; FIRST, Flexibility in Duty Hour Requirements for Surgical Trainees; and NSQIP, National Surgical Quality Improvement Program.

aThe categories are not mutually exclusive; thus, the number of exclusions for each category do not sum to 116.

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Figure 2.
FIRST Trial Timeline

ABSITE indicates American Board of Surgery in Training Examination; ACGME, Accreditation Council for Graduate Medical Education.

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Figure 3.
Data Collection Plan

ABSITE indicates American Board of Surgery in Training Examination; PD, program director.

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