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

September 12, 2017 updated by: Karl Bilimoria, Northwestern University

Allowing Flexibility in Surgical Resident Duty Hours Trial

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/.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • General Surgery Residency Programs participating in ACS NSQIP

Exclusion Criteria:

  • Childrens' and VA Hospitals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death or Serious Morbidity
Time Frame: 30 days
The primary outcome for the trial is a composite measure of Death or Serious Morbidity.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

American College of Surgeons
Accreditation Council for Graduate Medical Education
American Board of Surgery

Investigators

  • Principal Investigator: Karl Y. Bilimoria, MD MS, Northwestern University, American College of Surgeons

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • FIRST Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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