NCT03739723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

November 9, 2018

Last Update Submit

April 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Burnout

    The primary outcome for the trial is reported rates of general surgery resident burnout.

    1 Year

Study Arms (2)

Control Arm

NO INTERVENTION

Programs will continue to conduct normal educational activities.

Intervention Arm

EXPERIMENTAL

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

Interventions

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 Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Surgery training programs in the United States

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Surgical Outcomes and Quality Improvement Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 14, 2018

Study Start

June 1, 2019

Primary Completion

July 1, 2024

Study Completion

December 31, 2024

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations