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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

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.

Condition or disease Intervention/treatment Phase
Surgical Residency Workplace Culture Other: Resource allocation to improve general surgery residency program culture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data (SECOND) Trial
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Burnout [ Time Frame: 1 Year ]
    The primary outcome for the trial is reported rates of general surgery resident burnout.



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 in the United States

Exclusion Criteria:

  • None

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): NCT03739723


Contacts
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Contact: Karl Bilimoria, MD, MS 312-503-3829 kbilimoria@nm.org

Locations
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United States, Illinois
Northwestern University Surgical Outcomes and Quality Improvement Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Daniela Amortegui, MA    312-503-3929    second@northwestern.edu   
Sub-Investigator: Karl Bilimoria, MD, MS         
Sub-Investigator: Yue-Yung Hu, MD, MPH         
Sponsors and Collaborators
Northwestern University
American College of Surgeons
American Board of Surgery
Accreditation Council for Graduate Medical Education

Additional Information:
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Responsible Party: Karl Bilimoria, Professor of Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT03739723    
Other Study ID Numbers: SECOND Trial
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No