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

NCT ID: NCT03739723

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Surgical Residency Workplace Culture Mistreatment Burnout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control Arm

Programs will continue to conduct normal educational activities.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

The intent of the intervention arm is to provide programs with data and resources to inform and improve surgical learning environments and resident wellness.

Group Type EXPERIMENTAL

Resource allocation to improve surgical learning environments

Intervention Type OTHER

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.

Interventions

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Resource allocation to improve surgical learning environments

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Surgery training programs in the United States

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American College of Surgeons

OTHER

Sponsor Role collaborator

American Board of Surgery

OTHER

Sponsor Role collaborator

Accreditation Council for Graduate Medical Education

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Karl Bilimoria, MD

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Indiana University Surgical Outcomes and Quality Improvement Center

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Janczewski LM, Buchheit JT, Golisch KB, Amortegui D, Mackiewicz N, Eng JS, Turner PL, Johnson JK, Bilimoria KY, Hu YY. Contemporary Evaluation of Work-Life Integration and Well-Being in US Surgical Residents: A National Mixed-Methods Study. J Am Coll Surg. 2024 Dec 1;239(6):515-526. doi: 10.1097/XCS.0000000000001135. Epub 2024 Nov 15.

Reference Type DERIVED
PMID: 38920301 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Related Links

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https://thefirsttrial.org/

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

http://thesecondtrial.org/

Surgical Education Culture Optimization through targeted interventions based on National comparative Data (SECOND) Trial

Other Identifiers

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SECOND Trial

Identifier Type: -

Identifier Source: org_study_id

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