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Trial record 1 of 1 for:    NCT02050789
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Flexibility In Duty Hour Requirements for Surgical Trainees Trial - "the FIRST Trial" (FIRST)

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT02050789
First received: January 24, 2014
Last updated: May 24, 2016
Last verified: May 2016
  Purpose

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/.


Condition Intervention
Patient Safety Resident Work Hours Behavioral: flexible duty hours

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Allowing Flexibility in Surgical Resident Duty Hours Trial

Further study details as provided by Karl Bilimoria, Northwestern University:

Primary Outcome Measures:
  • Death or Serious Morbidity [ Time Frame: 30 days ]
    The primary outcome for the trial is a composite measure of Death or Serious Morbidity.


Enrollment: 152
Study Start Date: July 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • General Surgery Residency Programs participating in ACS NSQIP

Exclusion Criteria:

  • Childrens' and VA Hospitals
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050789

Sponsors and Collaborators
Northwestern University
American College of Surgeons
American Board of Surgery
Accreditation Council for Graduate Medical Education
Investigators
Principal Investigator: Karl Y. Bilimoria, MD MS Northwestern University, American College of Surgeons