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Flexibility In Duty Hour Requirements for Surgical Trainees Trial - "the FIRST Trial" (FIRST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02050789
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : September 13, 2017
Sponsor:
Collaborators:
American College of Surgeons
American Board of Surgery
Accreditation Council for Graduate Medical Education
Information provided by (Responsible Party):
Karl Bilimoria, Northwestern University

Tracking Information
First Submitted Date  ICMJE January 24, 2014
First Posted Date  ICMJE January 31, 2014
Last Update Posted Date September 13, 2017
Study Start Date  ICMJE July 2014
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
Death or Serious Morbidity [ Time Frame: 30 days ]
The primary outcome for the trial is a composite measure of Death or Serious Morbidity.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
Death [ Time Frame: 30 days ]
Change History Complete list of historical versions of study NCT02050789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
Serious Morbidity [ Time Frame: 30 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Flexibility In Duty Hour Requirements for Surgical Trainees Trial - "the FIRST Trial"
Official Title  ICMJE Allowing Flexibility in Surgical Resident Duty Hours Trial
Brief Summary

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/.

Detailed 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.

Additional programs were enrolled in the one-year extension study.

March 10, 2017

The Accreditation Council for Graduate Medical Education (ACGME) released a final set of revisions to the professional standards all accredited US residency and fellowship programs follow in preparing today's physicians for a lifetime of practice. The new model also directly addresses requests from medical educators and residents by recognizing the risk of burnout and depression for physicians. Programs and institutions will be responsible for prioritizing physician well-being, ensuring protected time with patients, minimizing non-physician obligations, and ensuring that residents have the opportunity to access medical and dental care.

The total number of clinical and educational hours for residents has not changed. Starting the 2017-2018 academic year, the standards require that all programs and residents adhere to the maximum limits averaged over four weeks:

  • a maximum of 80 hours per week
  • one day free from clinical experience or education in seven
  • in-house call no more frequent than every third night
  • a maximum of 24 continuous work hours for all residents.

Updated September 12, 2017

Resident survey data collected with the 2016 and 2017 ABSITE Survey were collected and analyzed. Topics that emerged for further qualitative and quantitative analysis are as follows:

  • Gender differences in resident outcomes
  • Burnout and psychological wellbeing among residents
  • Coercion and the decision to stay longer shifts within the flexible arm
  • Needle stick and motor vehicle accident rates among US General Surgery residents
  • Residency preparation (readiness) and the effects on burnout and wellbeing
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Patient Safety
  • Resident Work Hours
Intervention  ICMJE Behavioral: flexible duty hours
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.
Other Names:
  • Waiver from current duty hour requirements by the ACGME.
  • Allowed to eliminate all resident duty hour rules except:
  • Duty hours limited to 80 hrs/week averaged over 4 weeks.
  • Min of 1 free day (no duty)/week averaged over 4 weeks.
  • No in-house call > every 3rd night, averaged over 4 weeks.
  • Can increase chief residents duty requirements.
Study Arms  ICMJE
  • No Intervention: Usual Care Arm
    Programs will continue adhering to current ACGME requirements.
  • Experimental: Intervention Arm
    The intent of the intervention arm is to allow flexibility in surgical resident duty hours and improve continuity of care.
    Intervention: Behavioral: flexible duty hours
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2014)
152
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2014)
100
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • General Surgery Residency Programs participating in ACS NSQIP

Exclusion Criteria:

  • Childrens' and VA Hospitals
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02050789
Other Study ID Numbers  ICMJE FIRST Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karl Bilimoria, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • American College of Surgeons
  • American Board of Surgery
  • Accreditation Council for Graduate Medical Education
Investigators  ICMJE
Principal Investigator: Karl Y. Bilimoria, MD MS Northwestern University, American College of Surgeons
PRS Account Northwestern University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP