Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03739723 |
| Other study ID # |
SECOND Trial |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Indiana University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
