We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02050789
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02050789
First Posted: January 31, 2014
Last Update Posted: September 13, 2017
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.
Collaborators:
American College of Surgeons
American Board of Surgery
Accreditation Council for Graduate Medical Education
Information provided by (Responsible Party):
Karl Bilimoria, Northwestern University
  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: None (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
Study Completion Date: June 30, 2017
Primary Completion Date: June 30, 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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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