Does a Mindfulness Curriculum Prevent Physician Burnout During Pediatric Internship?
Primary Purpose
Burnout, Professional
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MINDI mindfulness curriculum
Control
Sponsored by
About this trial
This is an interventional prevention trial for Burnout, Professional focused on measuring mindfulness curriculum
Eligibility Criteria
Inclusion Criteria: 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.
Exclusion Criteria: None.
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MINDI mindfulness curriculum
Control
Arm Description
The intervention is a seven-session mindfulness curriculum to be delivered over six months to pediatric interns.
Usual education.
Outcomes
Primary Outcome Measures
Change in physician burnout from baseline to 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
Physician burnout will be measured with the Maslach Burnout Inventory.
Secondary Outcome Measures
Change in empathy from baseline to 6 mo 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
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
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
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.
Full Information
NCT ID
NCT03148626
First Posted
May 4, 2017
Last Updated
January 28, 2019
Sponsor
Boston Medical Center
Collaborators
Boston Children's Hospital, UCSF Benioff Children's Hospital Oakland, Children's Hospital Medical Center, Cincinnati, Floating Hospital for Children, Nationwide Children's Hospital, MaineHealth, Saint Peters University Hospital, University of California, Davis, University of Florida, University of Massachusetts, Worcester, Seattle Children's Hospital, Advocate Lutheran General Hospital, University of Pittsburgh, Loyola University Chicago
1. Study Identification
Unique Protocol Identification Number
NCT03148626
Brief Title
Does a Mindfulness Curriculum Prevent Physician Burnout During Pediatric Internship?
Official Title
Can a Mindfulness Curriculum Prevent Burnout During Pediatric Internship? A Multi-center Cluster Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
January 28, 2019 (Actual)
Study Completion Date
January 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
Boston Children's Hospital, UCSF Benioff Children's Hospital Oakland, Children's Hospital Medical Center, Cincinnati, Floating Hospital for Children, Nationwide Children's Hospital, MaineHealth, Saint Peters University Hospital, University of California, Davis, University of Florida, University of Massachusetts, Worcester, Seattle Children's Hospital, Advocate Lutheran General Hospital, University of Pittsburgh, Loyola University Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 and mindfulness practice.
Detailed Description
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.
Study Procedures: Subjects in the intervention arm will experience the seven-session mindfulness curriculum over a 6-month period. These sessions will be delivered during the routine didactic schedule that the residency program uses to educate their interns (e.g. noon conferences and/or weekly educational afternoons, etc). Subjects in the Control arm will receive the usual educational curriculum. The investigators will assess independent and dependent measures by inviting subjects to complete voluntary, de-identified surveys three times duringthe one-year study period: at baseline (before the 1st MINDI session, which may be given during intern orientation), and at 6-months and then 15-months after course initiation. Non-investigator staff will offer a modest incentive to subjects who return completed surveys to maximize the completion rates.
Statistical Methods: The numbers and rates of physician burnout, and the mean, median, and range of the scores for mindfulness, empathy, and the emotional-exhaustion sub-scale of burnout will be calculated. Bivariate comparisons will be done between these outcome measures and selected demographic measures. Comparisons between the control and intervention groups will be performed using chi-square tests for dichotomous outcomes (such as burnout) and t-tests for continuous measures. Multivariate clustered logistic and linear regressions analysis will be conducted to determine independent predictors of dichotomous outcomes and continuous measures, while controlling for randomization group assignment and dependent measures associated with the outcomes. the size of clusters in the study to vary since cluster randomization of nequal numbers of subjects typically produces uneven group-sizes. All unadjusted and adjusted regressions will be clustered on residency program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional
Keywords
mindfulness curriculum
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multi-center cluster randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
358 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MINDI mindfulness curriculum
Arm Type
Experimental
Arm Description
The intervention is a seven-session mindfulness curriculum to be delivered over six months to pediatric interns.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Usual education.
Intervention Type
Other
Intervention Name(s)
MINDI mindfulness curriculum
Intervention Description
A seven-session mindfulness curriculum implemented over six-months during pediatric internship.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Usual Education
Primary Outcome Measure Information:
Title
Change in physician burnout from baseline to 6-month follow-up
Description
Physician burnout will be measured using the Maslach Burnout Inventory.
Time Frame
Will be measured at baseline and 6-month follow-up
Title
Change in physician burnout from baseline to 15-month follow-up
Description
Physician burnout will be measured with the Maslach Burnout Inventory.
Time Frame
Will be measured at baseline and 15-month follow-up
Secondary Outcome Measure Information:
Title
Change in empathy from baseline to 6 mo follow-up
Description
Empathy will be measured using the Jefferson Scale of Physician Empathy and/or Davis's Interpersonal Reactivity Index.
Time Frame
Will be measured at baseline and both 6-month follow-up
Title
Change in empathy from baseline to 15 mo follow-up
Description
Empathy will be measured using the Jefferson Scale of Physician Empathy and/or Davis's Interpersonal Reactivity Index.
Time Frame
Will be measured at baseline and 6-month follow-up
Title
Change in mindfulness from baseline to 6 mo follow-up
Description
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.
Time Frame
Will be measured at baseline and 15-month follow-up
Title
Change in mindfulness from baseline to 15 mo follow-up
Description
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.
Time Frame
Will be measured at baseline and 15-month follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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.
Exclusion Criteria: None.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Sox, MD, MS
Organizational Affiliation
Boston Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35072694
Citation
Fraiman YS, Cheston CC, Cabral HJ, Allen C, Asnes AG, Barrett JT, Batra M, Bernstein W, Bleeker T, Dietz PM, Lewis J, Li ST, Ma TM, Mahan JD, Michelson CD, Poynter SE, Vining MA, Watson K, Sox CM. Effect of a Novel Mindfulness Curriculum on Burnout During Pediatric Internship: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2022 Apr 1;176(4):365-372. doi: 10.1001/jamapediatrics.2021.5740.
Results Reference
derived
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Does a Mindfulness Curriculum Prevent Physician Burnout During Pediatric Internship?
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