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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|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|
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.
- Death or Serious Morbidity [ Time Frame: 30 days ]The primary outcome for the trial is a composite measure of Death or Serious Morbidity.
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
|Principal Investigator:||Karl Y. Bilimoria, MD MS||Northwestern University, American College of Surgeons|