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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Burnout; Surgical Residency; Workplace Culture; Mistreatment
• Intervention / Treatment: Other: Resource allocation to improve surgical learning environments

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.

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Surgical Outcomes and Quality Improvement Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Surgery training programs in the United States

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Programs will continue to conduct normal educational activities.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Burnout	The primary outcome for the trial is reported rates of general surgery resident burnout.	1 Year

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: American College of Surgeons; Accreditation Council for Graduate Medical Education; American Board of Surgery

Publications and helpful links

Helpful Links

• Flexibility In duty hour Requirements for Surgical Trainees Trial - "The FIRST Trial"
• Surgical Education Culture Optimization through targeted interventions based on National comparative Data (SECOND) Trial

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological
• Other Study ID Numbers: SECOND Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No