Clinical Trial: Multi-center Cluster RCT of a Mindfulness Curriculum During Pediatric Internship.

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Can a Mindfulness Curriculum Prevent Burnout During Pediatric Internship? A Multi-center Cluster Randomized Controlled Trial.

Brief Summary:

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 an

Detailed Summary:

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 measure
Sponsor: Boston Medical Center

Current Primary Outcome:

• Change in physician burnout from baseline to 6-month follow-up [ Time Frame: 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 [ Time Frame: Will be measured at baseline and 15-month follow-up ]
  Physician burnout will be measured with the Maslach Burnout Inventory.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in empathy from baseline to 6 mo follow-up [ Time Frame: Will be measured at baseline and both 6-month follow-up ]
  Empathy will be measured using the Jefferson Scale of Physician Empathy and/or Davis's Interpersonal Reactivity Index.
• Change in empathy from baseline to 15 mo follow-up [ Time Frame: Will be measured at baseline and 6-month follow-up ]
  Empathy will be measured using the Jefferson Scale of Physician Empathy and/or Davis's Interpersonal Reactivity Index.
• Change in mindfulness from baseline to 6 mo follow-up [ Time Frame: Will be measured at baseline and 15-month follow-up ]
  Mindfulness, a mental state achieved by focusing one's awareness on the present moment while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations, will be measured using the Five Facet Mindfulness Questionnaire.
• Change in mindfulness from baseline to 15 mo follow-up [ Time Frame: Will be measured at baseline and 15-month follow-up ]
  Mindfulness, a mental state achieved by focusing one's awareness on the present moment while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations, will be measured using the Five Facet Mindfulness Questionnaire.

Original Secondary Outcome: Same as current

Information By: Boston Medical Center

Dates:
Date Received: May 4, 2017
Date Started: June 10, 2017
Date Completion: October 1, 2018
Last Updated: May 9, 2017
Last Verified: May 2017