The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data - "The SECOND Trial" (SECOND)
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|ClinicalTrials.gov Identifier: NCT03739723|
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Surgical Residency Workplace Culture||Other: Resource allocation to improve general surgery residency program culture||Not Applicable|
The prospective, pragmatic randomized trial will include approximately 320 surgical residency programs across the United States. Participating programs will be randomized to the intervention or usual care arm. The intervention arm (vs. usual care) will receive program-specific cultural outcomes reports and a Surgical Culture Toolkit at the start of the trial as well as participate in Coaching Calls and In-Person Meetings to 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 of 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 Calls and In-Person Meetings will be held at a variety of time points during the trial. The usual care arm will continue to perform their normal quality improvement activities.
Subsequently, the investigators will compare multiple postoperative outcomes between the two study arms using data collected from an annual resident survey.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||262 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data (SECOND) Trial|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
No Intervention: Usual Care Arm
Programs will continue to conduct normal quality improvement activities.
Experimental: Intervention Arm
The intent of the intervention arm is to provide programs with resources to inform and improve surgical residency culture.
Other: Resource allocation to improve general surgery residency program culture
If a hospital/program is assigned to the intervention arm, they will receive numerous resources including a program-specific cultural outcomes report, a surgical culture toolkit, coaching calls, and in-person meetings to help improve their general surgery residency program culture.
- Burnout [ Time Frame: 1 Year ]The primary outcome for the trial is reported rates of general surgery resident burnout.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739723
|Contact: Karl Bilimoria, MD, MSfirstname.lastname@example.org|
|United States, Illinois|
|Northwestern University Surgical Outcomes and Quality Improvement Center||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Daniela Amortegui, MA 312-503-3929 email@example.com|
|Sub-Investigator: Karl Bilimoria, MD, MS|
|Sub-Investigator: Yue-Yung Hu, MD, MPH|