NCT02050789

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/.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

January 24, 2014

Last Update Submit

September 12, 2017

Conditions

Patient SafetyResident Work Hours

Outcome Measures

Primary Outcomes (1)

  • Death or Serious Morbidity

    The primary outcome for the trial is a composite measure of Death or Serious Morbidity.

    30 days

Study Arms (2)

Usual Care Arm

NO INTERVENTION

Programs will continue adhering to current ACGME requirements.

Intervention Arm

EXPERIMENTAL

The intent of the intervention arm is to allow flexibility in surgical resident duty hours and improve continuity of care.

Behavioral: flexible duty hours

Interventions

flexible duty hoursBEHAVIORAL

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.

Also known as: 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.
Intervention Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • General Surgery Residency Programs participating in ACS NSQIP

You may not qualify if:

  • Childrens' and VA Hospitals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Saadat LV, Dahlke AR, Rajaram R, Kreutzer L, Love R, Odell DD, Bilimoria KY, Yang AD. Program Director Perceptions of Surgical Resident Training and Patient Care under Flexible Duty Hour Requirements. J Am Coll Surg. 2016 Jun;222(6):1098-105. doi: 10.1016/j.jamcollsurg.2016.03.026. Epub 2016 Apr 4.

    PMID: 27234632DERIVED

  • Bilimoria KY, Chung JW, Hedges LV, Dahlke AR, Love R, Cohen ME, Hoyt DB, Yang AD, Tarpley JL, Mellinger JD, Mahvi DM, Kelz RR, Ko CY, Odell DD, Stulberg JJ, Lewis FR. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training. N Engl J Med. 2016 Feb 25;374(8):713-27. doi: 10.1056/NEJMoa1515724. Epub 2016 Feb 2.

    PMID: 26836220DERIVED

  • Bilimoria KY, Chung JW, Hedges LV, Dahlke AR, Love R, Cohen ME, Tarpley J, Mellinger J, Mahvi DM, Kelz RR, Ko CY, Hoyt DB, Lewis FH. Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Protocol: A National Cluster-Randomized Trial of Resident Duty Hour Policies. JAMA Surg. 2016 Mar;151(3):273-81. doi: 10.1001/jamasurg.2015.4990.

    PMID: 26720622DERIVED

Related Links

Study Officials

  • Karl Y. Bilimoria, MD MS

    Northwestern University, American College of Surgeons

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 31, 2014

Study Start

July 1, 2014

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

September 13, 2017

Record last verified: 2017-09