Educational Interventions for Surgical Residency Wellness

(SECOND Trial)

Recruiting at 1 trial location

Overseen By Karl Bilimoria, MD, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

215 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

Are You a Good Fit for This Trial?

This trial is for surgery training programs in the United States. It aims to address issues like burnout, discrimination, harassment, and abuse among surgical residents. There are no specific exclusion criteria mentioned, so all such programs may be eligible.

Inclusion Criteria

Surgery training programs in the United States

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Report Review and Preparation

Programs receive reports about their learning environment and residents' well-being, review them, form internal teams, and mobilize resources in preparation for receiving the Wellness Toolkit.

2-6 months

Toolkit Dissemination and Implementation

Intervention programs receive the Wellness Toolkit and implementation support to facilitate intervention uptake. Coaching webinars and conferences are held.

6 months

Follow-up

Participants are monitored for changes in rates of mistreatment and toxic outcomes, with data collected from an annual resident survey.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Resource allocation to improve surgery training program culture
• Resource allocation to improve surgical learning environments

Trial Overview The SECOND Trial is testing whether allocating resources to improve the learning environments of surgical residents can reduce negative outcomes like burnout and mistreatment. The study will use national data comparisons and a randomized controlled design.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

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 II: Control Arm Active Control 1 Intervention

Programs will continue to conduct normal educational activities.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

American College of Surgeons

Collaborator

Trials

18

Recruited

60,400+

American Board of Surgery

Collaborator

Trials

2

Recruited

370+

Accreditation Council for Graduate Medical Education

Collaborator

Trials

5

Recruited

660+