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The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data - "The SECOND Trial" (SECOND)

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ClinicalTrials.gov Identifier: NCT03739723
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : August 21, 2019
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

Tracking Information
First Submitted Date  ICMJE November 9, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
Burnout [ Time Frame: 1 Year ]
The primary outcome for the trial is reported rates of general surgery resident burnout.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data - "The SECOND Trial"
Official Title  ICMJE The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data (SECOND) Trial
Brief Summary Due to a number of factors, including power differentials and adverse events, residents are susceptible to mistreatment (i.e., discrimination, harassment, and abuse) and toxic outcomes (i.e., burnout, attrition, and suicide). Our subsequent work following the FIRST Trial identified considerable variation in program-level rates of resident-reported burnout, severe stress, gender discrimination, racial discrimination, sexual harassment, and verbal abuse. To investigate these issues, the SECOND Trial will include a national mixed-methods analysis of and a pragmatic randomized trial to improve resident program culture and wellness.
Detailed Description

The prospective, pragmatic randomized trial will include approximately 320 surgical residency programs across the United States. Participating programs will be randomized to the intervention or usual care arm. The intervention arm (vs. usual care) will receive program-specific cultural outcomes reports and a Surgical Culture Toolkit at the start of the trial as well as participate in Coaching Calls and In-Person Meetings to help facilitate and support intervention uptake throughout the trial period.

To assess the individual efficacy of the reports in regards to decreasing rates of mistreatment and toxic outcomes, the reports will be given to programs approximately 2 months to 6 months prior to toolkit dissemination. Prior to toolkit dissemination, programs will have the opportunity to fully review the report, form internal teams to address the issues, and mobilize necessary resources in preparation of receiving the toolkit. A comprehensive list of all activities performed after report dissemination will be kept at a program level. Toolkit dissemination to intervention programs will occur within 6 months of report dissemination. Coaching Calls and In-Person Meetings will be held at a variety of time points during the trial. The usual care arm will continue to perform their normal quality improvement activities.

Subsequently, the investigators will compare multiple postoperative outcomes between the two study arms using data collected from an annual resident survey.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Surgical Residency Workplace Culture
Intervention  ICMJE Other: Resource allocation to improve general surgery residency program culture
If a hospital/program is assigned to the intervention arm, they will receive numerous resources including a program-specific cultural outcomes report, a surgical culture toolkit, coaching calls, and in-person meetings to help improve their general surgery residency program culture.
Study Arms  ICMJE
  • No Intervention: Usual Care Arm
    Programs will continue to conduct normal quality improvement activities.
  • Experimental: Intervention Arm
    The intent of the intervention arm is to provide programs with resources to inform and improve surgical residency culture.
    Intervention: Other: Resource allocation to improve general surgery residency program culture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
262
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • General Surgery Residency Programs in the United States

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karl Bilimoria, MD, MS 312-503-3829 kbilimoria@nm.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03739723
Other Study ID Numbers  ICMJE SECOND Trial
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karl Bilimoria, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • American College of Surgeons
  • American Board of Surgery
  • Accreditation Council for Graduate Medical Education
Investigators  ICMJE Not Provided
PRS Account Northwestern University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP