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临床试验/NCT03739723
NCT03739723已完成不适用

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

Indiana University2 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2019年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
215
试验地点
2
主要终点
Burnout

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Surgery training programs in the United States

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Resource allocation to improve surgical learning environments (Other)

结局指标

主要结局

Burnout

时间窗: 1 Year

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karl Bilimoria, MD

Professor of Surgery

Indiana University

研究点 (2)

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