Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03148626 |
Other study ID # |
H-36221 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 13, 2017 |
Est. completion date |
January 28, 2019 |
Study information
Verified date |
January 2019 |
Source |
Boston Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.