Can a Mindfulness Curriculum Prevent Burnout During Pediatric Internship? A Multi-center Cluster Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 358
- 试验地点
- 2
- 主要终点
- Change in physician burnout from baseline to 6-month follow-up
研究概览
简要总结
A triad of exhaustion, depersonalization and inefficacy, physician burnout is an epidemic among trainees associated with delivering poor quality care. Training programs are desperate for evidence-based programs that can prevent burnout during residency. Mindfulness training programs can reduce burnout among primary care physicians, but have not been tested during physician training. Pilot testing of a novel mindfulness curriculum during pediatric internship was found to be feasible to implement.
The primary objective of this study is to determine if implementing a novel 6-month mindfulness curriculum comprised of seven 1-hour sessions can reduce physician burnout and increase mindfulness practice and empathy. A multicenter cluster randomized controlled trial will be conducted among interns training in programs of various sizes and regions to address this objective. The investigators hypothesize that completing a mindfulness curriculum during internship will reduce interns' levels of physician burnout and increase their mindfulness practice and empathy.
Within pairs in pediatric residency programs matched on size (a proxy for burnout), clusters of interns in each program will be randomized to experience either the mindfulness curriculum over a 6-month period (intervention) or receive the usual educational curriculum (control). During a 15-month study period, burnout, mindfulness and empathy will be assessed using validated measures at baseline, 6- and 15-month follow-up. The impact of the intervention will be determined by comparing physician burnout, empathy and mindfulness scores between interns in the intervention and control groups. This methodologically rigorous multi-center cluster RCT will determine if implementing an innovative 6-month mindfulness curriculum reduces pediatric interns' burnout and improves empathy and mindfulness practice.
详细描述
Rationale and Purpose: The unacceptably high prevalence of burnout during residency has made training programs desperate for evidence-based programs designed to prevent burnout during residency. Mindfulness training programs have been shown to reduce burnout and depression among primary care physicians as well as in a myriad of other professions. The investigators' longitudinal pilot test of implementing an innovative mindfulness curriculum in a large busy pediatric internship was determined to be feasible and acceptable. However, the absence of a control group, small sample size, and single residency program site limited the detection of meaningful statistically significant differences in levels of burnout, mindfulness, or empathy that could have generalizable value.
Study Objectives: A methodologically rigorous study will be conducted to determine if a 6-month mindfulness curriculum implemented during pediatric internship can reduce physician burnout and increase mindfulness practice and empathy. The investigators hypothesize that completing a mindfulness curriculum during internship will reduce interns' levels of physician burnout and increase their mindfulness practice and empathy.
Outcome Measures: The primary outcome measure will be physician burnout, assessed by the emotional-exhaustion sub-scale of Maslach Burnout Inventory (MBI). Many studies use this sub-scale as the sole measure of burnout because "emotional-exhaustion is considered the most central aspect of burnout." Secondary outcomes will include: burnout as a dichotomous measure, defined as emotional exhaustion scores >=27 or depersonalization scores >=10, per MBI guidelines; participants' levels of mindfulness, based on the Five Facet Mindfulness Questionnaire; and empathy, assessed by the Jefferson Scale of Physician Empathy. These measures were selected based on prior conceptual frameworks and the model of factors related to burnout.
Study Design: A large multi-center, stratified, cluster, randomized, controlled trial of the 7-session mindfulness curriculum in pediatric residency programs will be implemented and analyzed. To ensure that interns training in the same program have the same educational experience, clustered randomization will be conducted centrally using a computer-generated random allocation sequence. After pairing pediatric residency programs based on size as a proxy for baseline burnout, the clusters of interns in each program will be randomized to experience either: 1) the enhanced mindfulness curriculum over a 6-month period or 2) usual educational curriculum (control). Control group subjects will be blinded to knowing what the intervention group received, but the intervention subjects will not be blinded to participating in the mindfulness sessions.
Study Intervention: Programs randomized to the intervention arm will be asked to deliver the mindfulness curriculum to interns over their first 6 months of training (from July through December of the academic year)following the MINDI facilitator guide, which includes facilitator preparation materials, frequently asked questions, and detailed instructions for running the seven sessions of the mindfulness curriculum. . The lack of a robust impact on mindfulness practice in the previous pilot implementation of the MINDI curriculum suggests that hour-long mindfulness sessions delivered once a month over 6 months may not be a frequent enough intervention to change interns' behavior. Thus, the investigators will enhance the intervention by including 10 minutes of guided meditation at the start of regularly scheduled clinical didactic sessions (e.g. noontime conference) two weeks after each of the 7 MINDI sessions. Programs randomized to the control arm will not change their current curriculum but will be given the facilitator guide after the study is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All members of the intern class (e.g. post-graduate year 1) of pediatric residency programs who enrolled in this study will be eligible to participate in this study.
排除标准
- 未提供
研究组 & 干预措施
MINDI mindfulness curriculum
The intervention is a seven-session mindfulness curriculum to be delivered over six months to pediatric interns.
干预措施: MINDI mindfulness curriculum (Other)
Control
Usual education.
干预措施: Control (Other)
结局指标
主要结局
Change in physician burnout from baseline to 6-month follow-up
时间窗: Will be measured at baseline and 6-month follow-up
Physician burnout will be measured using the Maslach Burnout Inventory.
Change in physician burnout from baseline to 15-month follow-up
时间窗: Will be measured at baseline and 15-month follow-up
Physician burnout will be measured with the Maslach Burnout Inventory.
次要结局
- Change in empathy from baseline to 6 mo follow-up(Will be measured at baseline and both 6-month follow-up)
- Change in empathy from baseline to 15 mo follow-up(Will be measured at baseline and 6-month follow-up)
- Change in mindfulness from baseline to 6 mo follow-up(Will be measured at baseline and 15-month follow-up)
- Change in mindfulness from baseline to 15 mo follow-up(Will be measured at baseline and 15-month follow-up)
