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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

Study Description
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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/.


Condition or disease Intervention/treatment Phase
Patient Safety Resident Work Hours Behavioral: flexible duty hours Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
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
Study Start Date : July 2014
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017
Arms and Interventions
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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.


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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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
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Principal Investigator: Karl Y. Bilimoria, MD MS Northwestern University, American College of Surgeons
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Karl Bilimoria, Assistant Professor of Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT02050789    
Other Study ID Numbers: FIRST Trial
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017