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

• Sponsor: Northwestern University
• 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

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

  Show Detailed Description

Study Design

• 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

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

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

• 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

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

More Information

Additional Information:

Flexibility In duty hour Requirements for Surgical Trainees Trial - "The FIRST Trial" 

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

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.

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.

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.

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