The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data - "The SECOND Trial" (SECOND)
Primary Purpose
Surgical Residency, Workplace Culture, Mistreatment
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resource allocation to improve surgical learning environments
Sponsored by
About this trial
This is an interventional health services research trial for Surgical Residency
Eligibility Criteria
Inclusion Criteria:
- Surgery training programs in the United States
Exclusion Criteria:
- None
Sites / Locations
- Northwestern University Surgical Outcomes and Quality Improvement Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Arm
Intervention Arm
Arm Description
Programs will continue to conduct normal educational activities.
The intent of the intervention arm is to provide programs with data and resources to inform and improve surgical learning environments and resident wellness.
Outcomes
Primary Outcome Measures
Burnout
The primary outcome for the trial is reported rates of general surgery resident burnout.
Secondary Outcome Measures
Full Information
NCT ID
NCT03739723
First Posted
November 9, 2018
Last Updated
January 23, 2023
Sponsor
Northwestern University
Collaborators
American College of Surgeons, American Board of Surgery, Accreditation Council for Graduate Medical Education
1. Study Identification
Unique Protocol Identification Number
NCT03739723
Brief Title
The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data - "The SECOND Trial"
Acronym
SECOND
Official Title
The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data (SECOND) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
American College of Surgeons, American Board of Surgery, Accreditation Council for Graduate Medical Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Due to a number of factors, residents are susceptible to mistreatment (i.e., discrimination, harassment, and abuse) and toxic outcomes (i.e., burnout, attrition, and suicidality). Our work following the FIRST Trial identified considerable variation in program-level rates of resident-reported burnout, 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 cluster-randomized controlled trial to improve the resident learning environment and trainee wellness.
Detailed Description
The prospective, pragmatic cluster-randomized controlled trial will include approximately 320 surgical training programs across the United States. Participating programs will be randomized to the intervention or control arm. The intervention arm (vs. control) will receive program-specific reports about their learning environment and residents' well-being, as well as access to a Wellness Toolkit of ready-to-implement interventions. We will provide implementation support 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 for 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 webinars and in-person/virtual conferences will be held at a variety of time points during the trial. The control arm will continue to perform their normal educational (including potential wellness) activities.
The investigators will compare multiple outcomes between the two study arms using data collected from an annual resident survey.
Extension of this work is anticipated to surgical subspecialty training programs (e.g., vascular surgery, cardiothoracic surgery). Eligible subspecialty programs will be assigned as per the randomization scheme of corresponding general surgery programs at their institution. Similar protocols will be in place for surgical subspecialties, with modifications to investigate specialty-specific survey items and interventions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Residency, Workplace Culture, Mistreatment, Burnout
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Programs will continue to conduct normal educational activities.
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
The intent of the intervention arm is to provide programs with data and resources to inform and improve surgical learning environments and resident wellness.
Intervention Type
Other
Intervention Name(s)
Resource allocation to improve surgical learning environments
Intervention Description
If a hospital/program is assigned to the intervention arm, they will receive numerous resources including a program-specific learning environment and resident well-being report, a Wellness Toolkit, coaching webinars, and in-person/virtual conferences to help improve their surgery learning environment and residents' well-being.
Primary Outcome Measure Information:
Title
Burnout
Description
The primary outcome for the trial is reported rates of general surgery resident burnout.
Time Frame
1 Year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Surgery training programs in the United States
Exclusion Criteria:
None
Facility Information:
Facility Name
Northwestern University Surgical Outcomes and Quality Improvement Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data - "The SECOND Trial"
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