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IMPORTANCE Mindfulness curricula can improve physician burnout, but implementation Supplemental content
during residency presents challenges.
MAIN OUTCOMES AND MEASURES The primary outcome was emotional exhaustion (EE) as
measured by the Maslach Burnout Inventory 9-question EE subscale (range, 7-63; higher
scores correspond to greater perceived burnout). Secondary outcomes were
depersonalization, personal accomplishment, and burnout. The study assessed mindfulness
with the Five Facet Mindfulness Questionnaire and empathy with the Interpersonal Reactivity
Index subscales of perspective taking and empathetic concern. Surveys were implemented at
baseline, month 6, and month 15.
RESULTS Of the 365 interns invited to participate, 340 (93.2%; 255 [75.0%] female; 51
[15.0%] 30 years or older) completed surveys at baseline; 273 (74.8%) also participated at
month 6 and 195 (53.4%) at month 15. Participants included 194 (57.1%) in the Mindfulness
Intervention for New Interns and 146 (42.9%) in the control arm. Analyses were adjusted for
baseline outcome measures. Both arms’ EE scores were higher at 6 and 15 months than at
baseline, but EE did not significantly differ by arm in multivariable analyses (6 months: 35.4 vs
32.4; adjusted difference, 3.03; 95% CI, −0.14 to 6.21; 15 months: 33.8 vs 32.9; adjusted
difference, 1.42; 95% CI, −2.42 to 5.27). None of the 6 secondary outcomes significantly
differed by arm at month 6 or month 15.
CONCLUSIONS AND RELEVANCE A novel mindfulness curriculum did not significantly affect EE,
burnout, empathy, or mindfulness immediately or 9 months after curriculum
implementation. These findings diverge from prior nonrandomized studies of mindfulness
interventions, emphasizing the importance of rigorous study design and suggesting that
additional study is needed to develop evidence-based methods to reduce trainee burnout.
(Reprinted) 365
© 2022 American Medical Association. All rights reserved.
B
urnout is a triad of emotional exhaustion (EE), deper-
sonalization, and feelings of inefficacy.1 Between 39% Key Points
and 75% of pediatric trainees experience burnout, with
Question Can a novel mindfulness curriculum designed for
a worsening trend in prevalence during the past few decades.2-5 implementation in residency that does not require facilitator
Burnout affects physicians’ well-being, performance during training reduce burnout among pediatric interns?
training, risk of suicide, and patient care. Physicians with burn-
Findings This cluster randomized clinical trial found that the levels
out are more likely to make medical errors and be less empa-
of emotional exhaustion, depersonalization, burnout, empathy,
thetic, and the patients of physicians with burnout are less and mindfulness among pediatric interns who completed the
likely to adhere to medical plans.6-11 Physician burnout costs 6-month mindfulness curriculum did not significantly differ from
the US health care system approximately $4.6 billion per year those assigned to social lunches both immediately after
related to physician turnover and reduced productivity.12 completing the training experience and 9 months later.
Mindfulness, a state of nonjudgmental awareness in the Meaning A novel mindfulness curriculum did not affect pediatric
present moment, can prevent burnout. Mindfulness curri- interns’ levels of burnout, empathy, and mindfulness compared
cula can reduce burnout among physicians and other with social time only, suggesting that additional study is needed to
professionals.13-18 Mindfulness is the only evidence-based ap- develop evidence-based methods to reduce trainee burnout.
proach to reduce burnout included in an Accreditation Coun-
cil for Graduate Medical Education and American Academy of
Pediatrics call for systems-level change to address trainee Intervention Arm
burnout.19 Although mindfulness curricula are effective, po- A 6-step approach to curricular design informed the devel-
tential barriers to implementing mindfulness curricula in- opment of MINdI.22,23 The MINdI curriculum easily inte-
clude time required by the trainees and availability of facili- grates into existing 1-hour didactic time ubiquitous among
tators with content expertise. Small single-center trials17,18,20,21 training programs and requires no additional facilitator
of mindfulness have found variable effects. We know of no pub- training.22 Intervention programs received the MINdI facili-
lished multicenter randomized clinical trials of mindfulness tator manual and all necessary curriculum implementation
curricula that target trainee burnout. To assess the effective- supplies. The intervention was delivered monthly, starting
ness of a novel mindfulness curriculum that does not require during the first quarter of the intern year and continuing for
prior facilitator training, Mindfulness Intervention for New In- 6 months, for a total of 7 sessions; programs were encour-
terns (MINdI),22 on burnout among pediatric interns, we con- aged to facilitate interns’ attendance at MINdI sessions,
ducted a multicenter cluster randomized clinical trial. We hy- although attendance was not required.
pothesized that interns training in programs randomized to the The MINdI curriculum was developed by a multidisciplinary
mindfulness curriculum would have less burnout than in- team of medical education experts, residency program leader-
terns randomized to the control arm. ship, a chief resident, mindfulness practitioners, and trainees.
Briefly, each session begins with a social lunch, followed by a min-
ute of silence, introductory remarks regarding the mindfulness
exercise, a mindfulness exercise, and a debriefing period. The cur-
Methods riculum is designed to provide mindfulness exercises that can eas-
Study Sample and Randomization ily be integrated into a medical trainee’s day or highlight a unique
We conducted a pragmatic, multicenter, stratified cluster ran- aspect of mindfulness that can be beneficial to medical trainees.
domized clinical trial of a mindfulness curriculum during pe- In addition to the monthly curriculum, intervention programs
diatric internship. See Supplement 1 for full trial protocol. We were encouraged to invite participants to conduct a short mind-
recruited 15 US pediatric residency programs to participate in fulness refresher, a 10-minute prerecorded body scan exercise,
this study and sent surveys to 365 eligible interns (Figure 1). 2 weeks after each MINdI session.
All sites’ institutional review boards approved the study. To
be eligible for inclusion, each participating pediatric resi- Control Arm
dency program agreed to be randomized to have their interns In the active control arm, participants were scheduled to at-
experience the MINdI curriculum or social lunches. From June tend 6 interns-only, 1-hour social lunches that involved no
14 to September 29, 2017, pediatric and medicine-pediatric in- mindfulness activities, as other mindfulness curricula ran-
terns training in study programs gave implied written con- domized clinical trials have done.18
sent by returning the baseline survey. All data were deidenti-
fied. This study followed the Consolidated Standards of Outcomes
Reporting Trials (CONSORT) reporting guideline. Outcomes were measured through surveys at baseline,
After pairing programs by location and size, we used a month 6, and month 15. The Maslach Burnout Inventory
random-number generator to assign, within a pair, each program’s Human Services Survey was used under license with Mind
cluster of interns to experience a novel 7-session MINdI curricu- Garden Inc. The primary outcome (EE) was measured using
lum or an active control experience of nondidactic social lunch. the Maslach Burnout Inventory 9-question EE subscale
Because an odd number of programs participated, we created 1 (range, 7-63; higher scores correspond to higher degrees of
dummy variable for paired randomization. Each program’s interns perceived burnout). 1 Prespecified secondary outcomes
had the same arm-specific unblinded training experience. included dichotomized burnout and the Maslach Burnout
366 JAMA Pediatrics April 2022 Volume 176, Number 4 (Reprinted) jamapediatrics.com
Statistical Analysis
To examine whether subject characteristics varied by study arm
while addressing hierarchical effects of cluster randomiza- were performed in PROC MI via a multiple imputation with
tion, we conducted bivariate linear generalized estimating chained equations approach with fully conditional specifi-
equations and logistic regressions clustered on center. To es- cation. Data were imputed when missing at baseline given
timate the between-group difference in outcome between the variables with fully observed values. Then the baseline data
randomized groups while addressing hierarchical effects of and fully observed variables at 6 months were used to
cluster randomization, we used multivariate generalized es- impute values for variables with missing data at 6 months.
timating equations and logistic regressions clustered on cen- This process continued in a similar fashion, with prior data
ter. All regressions included study arm, independent mea- and variables fully observed at 15 months used to impute
sures that significantly differed by study arm, or measures that missing values at 15 months. We report effect sizes as linear
were of a priori clinical interest, including self-identified gen- regression coefficients quantifying differences in means or
der and age. Race and ethnicity data were not collected be- in logistic model odds ratios (ORs) with 95% CIs, as well as
cause we did not consider race or ethnicity to be significantly 2-sided P values for primary outcome analyses. A 2-sided
associated with burnout during the study design. To address P < .05 was considered statistically significant.
the concern of including independent variables possibly in the Setting 1 − β = 0.8 and 2-sided α = .05, our a priori
causal pathway, we performed additional sensitivity analy- power calculations determined that at least 139 participants
ses without these variables and that included only baseline per group were needed to determine a 0.29 difference in
variables. mean EE to be statistically significant, a threshold selected
In addition, analyses of data at month 6 and/or month 15 because a meta-analysis 30 found that burnout reduction
controlled for the outcome at baseline, baseline survey month, interventions significantly lowered EE scores by 0.28. These
prior weekend off at month 6, inpatient or intensive care ro- c alculations, however, did not account for possible
tation at month 15, and an arm × survey period interaction term clustering by site. Had this been done, applying a reason-
based on prior data.29 If the arm × survey month interaction able intraclass correlation of 0.01 would have yielded a
term was statistically significant, we conducted stratified analy- required enrollment sample with an additional 256 partici-
ses of the month 6 and month 15 data. If the interaction term pants to achieve 80% power with a 2-sided α = .05. This
was not significant, then we removed the interaction term and addition of participants to the sample would not have been
conducted longitudinal analyses comparing the pooled out- feasible, however, given the planned study period. We note
comes at month 6 and month 15 while controlling for that our sample as implemented was larger than other ran-
baseline. domized clinical trials of mindfulness curricula that have
Because 29.8% of data was missing, we conducted all intended to address burnout. We have provided 95% CIs
multivariable analyses on 20 imputed data sets created with all estimates of group differences so that readers can
using individual-level data following standard imputation judge the precision, or lack thereof, of our findings in this
procedures using PROC MI and PROC MI ANALYZE in SAS sample, in particular with respect to prior research14-17 with
software, version 9.4 (SAS Institute Inc). These imputations smaller samples.
jamapediatrics.com (Reprinted) JAMA Pediatrics April 2022 Volume 176, Number 4 367
368 JAMA Pediatrics April 2022 Volume 176, Number 4 (Reprinted) jamapediatrics.com
Burnout, %
30 60
burnout, depersonalization (mean [SD] scores, 11.9 [5.0] for
the MINdI arm and 11.0 [4.8] for the control arm), mindful-
20 40
ness (mean [SD] scores, 126.6 [16.4] for the MINdI arm and
126.5 [16.1] for the control arm), empathetic concerns (mean
10 20
[SD] scores, 18.0 [2.0] for the MINdI arm and 17.9 [2.2] for
the control arm), or perspective taking (mean [SD] scores
0 0
19.4 [3.0] for the MINdI arm and 19.2 [2.8] for the control June July-September
arm). Month of baseline survey
No significant differences by arm were found in prior mind-
MINdI indicates Mindfulness Intervention for New Interns.
fulness training (31.6% in the MINdI arm and 29.0% in the con-
trol arm) or practice (15.5% in the MINdI arm and 17.8% in the
control arm) at baseline. Multivariable longitudinal analyses
revealed that levels of mindfulness (adjusted difference, −1.07;
95% CI, −5.27 to 3.13), empathetic concerns (adjusted differ- Discussion
ence, 0.27; 95% CI, −0.54 to 1.08), perspective taking (ad-
justed difference, 0.74; 95% CI, −0.53 to 2.02), and personal Our multicenter cluster randomized clinical trial of a novel mind-
accomplishment (adjusted difference, 0.14; 95% CI, −1.70 to fulness curriculum implemented early in pediatric internship
1.98) did not significantly differ by arm between month 6 and found that the intervention did not significantly affect interns’
month 15. The arm × period interaction term was statistically EE, depersonalization, burnout, personal accomplishment, mind-
significant in multivariable longitudinal analyses conducted fulness, or empathy immediately after curriculum implementa-
to the effect of arm on depersonalization (P < .001) and burn- tion and 15 months later. After the 6-month curriculum was com-
out (P = .004); subsequent multivariable analyses stratified by pleted, MINdI participants were significantly more likely than con-
period revealed that these outcomes did not significantly dif- trols to report knowing how to apply mindfulness techniques and
fer by arm at month 15. their evidence, as well as having a positive attitude about mind-
At month 6, multivariable analyses identified significant fulness and believing it benefited their life. Fifteen months after
increases in report of knowing the evidence to support mind- curriculum implementation, the only measure with a statistically
fulness (adjusted OR, 3.23; 95% CI, 1.63-6.39), how to apply significant between-arm difference was in knowledge of the evi-
mindfulness (adjusted OR, 3.99; 95% CI, 3.25-4.90), the be- dence supporting the use of mindfulness.
lief that mindfulness benefited their life (adjusted OR, 2.51; 95% In contrast to prior studies14,15,17,18 of mindfulness curricu-
CI, 1.03-6.11), and having a positive attitude toward mindful- lum, our study found no changes in burnout rates or levels of EE,
ness (adjusted OR, 2.60; 95% CI, 1.67-4.07). Most of these depersonalization, mindfulness, or empathy between interven-
changes were not persistent over time. Self-reported fre- tion and control participants. Our study intervention differs from
quency of mindfulness practice at baseline and month 6 did prior studies14,15 in a number of important ways. First, our cur-
not significantly differ by arm (adjusted OR, 1.48; 95% CI, 0.72- riculum was not facilitated by an experienced mindfulness prac-
3.02). The odds of using these techniques more after the cur- titioner. Recognizing the limitation of facilitation by a local con-
riculum did not significantly differ by arm between month 6 tentexpertonthefeasibilityofwidespreaddisseminationofmind-
and month 15 (adjusted OR, 1.02; 95% CI, 0.57-1.82). The fulness curricula, our curriculum relied on a scripted curriculum
arm × period interaction term was statistically significant that did not require a content expert to facilitate education. How-
(P < .001) in multivariable longitudinal analyses conducted to ever, our results prompt us to question the potential effect of
test the effect of arm on reporting to know how to apply, be- greater facilitator experience in mindfulness training on curricu-
lief in the benefit of, and having a positive attitude toward lum effectiveness.
mindfulness; subsequent multivariable analyses stratified by Second, prior curricula have been more robust compared
period revealed that none of these outcomes significantly dif- with MINdI.13-15,21,30,31 For example, the mindfulness-based
fered by arm at month 15. stress reduction curriculum published by Krasner et al14 was
In the sensitivity analyses in which time-dependent vari- composed of an 8-week intensive phase that included 2.5 hours
ables were removed, the results relating to intervention ef- per week and a 7-hour retreat followed by a 2.5-hour per month
fects were similar to those described above and in the tables maintenance period for 10 months. In contrast, our 7-session
of our regression models. monthly curriculum was specifically designed to integrate into
jamapediatrics.com (Reprinted) JAMA Pediatrics April 2022 Volume 176, Number 4 369
Table 2. Impact of the MINdI Curriculum on Continuous Measures of Burnout, Mindfulness, and Empathy at Baseline, Month 6, and Month 15a
preexisting residency didactic time. It is possible our curricu- Finally, selection bias may have influenced prior
lum may not have been robust enough to induce a change in cohort studies13-16 conducted among physicians who chose
behavior and objective metrics of burnout, mindfulness, or em- to participate in the mindfulness training that found
pathy, although changes in mindfulness-related knowledge and mindfulness to be associated with decreased burnout.
attitudes were apparent. Although programs were encour- Small studies and those among medical trainees have often
aged to take attendance, it was not required. Thus, we have failed to show large or statistically significant effects of
no consistent data on how many training sessions each intern mindfulness on objective measures of burnout, empathy, or
experienced. We wonder whether there could be a dose mindfulness.13,16,17,20,21,30
response in the mindfulness training that we are not able to
assess in which more participation may have led to better out- Limitations
comes among trainees. This study has several limitations. First, cluster randomiza-
In our study population, most participants in both arms tion resulted in an imbalance in gender and baseline personal
had scores indicating burnout at baseline, and burnout wors- accomplishment between study arms. Second, our study is lim-
ened during the study period. Because most participants com- ited by missing data, a common limitation that may intro-
pleted the baseline survey before internship began, efforts to duce bias into the results; to address this, we estimated miss-
reduce burnout among trainees should be integrated into un- ing values by multiple imputation, which may have resulted
dergraduate medical education. Despite reporting increased in underestimation of SEs. Third, our sample size was based
mindfulness-related knowledge and positive attitudes to- on power calculations that did not account for possible clus-
ward mindfulness after completing the curriculum, partici- tering by site. Thus, findings of clinical importance that were
pants did not report corresponding increases in mindfulness not statistically significant should be cautiously interpreted
practice or objective measures of mindfulness. Perhaps com- and their precision judged by the widths of their 95% CIs.
peting demands and priorities early in medical training, in- Fourth, our pragmatic trial design allowed variation in month
cluding a primary focus on increasing clinical competence, per- of the intervention and control experiences and survey imple-
sistently outweighed prioritization of new self-care techniques mentation, so temporal trends in burnout during training may
to prevent burnout. have influenced intervention efficacy and our findings.
370 JAMA Pediatrics April 2022 Volume 176, Number 4 (Reprinted) jamapediatrics.com
Table 3. Impact of the MINdI Curriculum on Dichotomous Measure of Burnout and Mindfulness-Related Knowledge,
Behavior, and Attitudes at Baseline, Month 6, and Month 15a
The mixed results of our methodologically rigorous driven more at a systems level than a personal one, and in
cluster randomized clinical trial of MINdI may indicate that the context of pediatric internship, efforts to reduce burn-
trainees face unique challenges in integrating mindfulness out should focus more on system reform than personal
knowledge into behavior change. The study demonstrated training.21,30,32
that improvements in mindfulness-related knowledge and
attitudes failed to translate into effects on burnout, empa-
thy, and mindfulness. Although we cannot be sure why the
intervention did not have its intended effect, we hypoth-
Conclusions
esize 2 explanations. First, although MINdI was robust This multicenter cluster randomized clinical trial of a novel
enough to affect knowledge and attitudes, it was not strong mindfulness curriculum demonstrated that the intervention
enough to affect distal outcomes. Second, our study identi- did not significantly affect measures of burnout, mindful-
fied higher rates of burnout than previously reported in the ness, or empathy among pediatric interns training across the
literature of pediatric trainees. It is possible that the high US. However, intervention participants reported improved
levels of burnout we detected represent a meaningful tem- mindfulness-related knowledge, behaviors, and attitudes. The
poral shift and the diminished efficacy of individual-level mixed results of this large, multicenter randomized clinical trial
interventions, such as mindfulness, to address epidemic suggest that there is a need for further study, mechanism elu-
levels of burnout. Burnout in medical training may be cidation for behavior change, and curriculum optimization.
ARTICLE INFORMATION Children’s Hospital, Boston, Massachusetts Benioff Children’s Hospital Oakland, Oakland
Accepted for Publication: October 4, 2021. (Fraiman); Department of Pediatrics, Harvard (Allen); Yale-New Haven Hospital, New Haven,
Published Online: January 24, 2022. Medical School, Boston, Massachusetts (Fraiman); Connecticut (Asnes); Floating Hospital for Children–
doi:10.1001/jamapediatrics.2021.5740 Boston Medical Center, Department of Pediatrics, Tufts Medical Center, Boston, Massachusetts
Author Affiliations: Department of Neonatology, Boston University School of Medicine, Boston, (Barrett); Division of Emergency Medicine,
Beth Israel Deaconess Medical Center, Boston, Massachusetts (Cheston, Michelson, Sox); Department of Pediatrics, Boston Children’s
Massachusetts (Fraiman); Division of Newborn Deparment of Biostatistics, Boston University Hospital, Boston, Massachusetts (Barrett);
Medicine, Department of Pediatrics, Boston School of Public Health, Boston, Massachusetts Department of Pediatrics, The Children’s Hospital at
(Cabral); University of California, San Francisco Montefiore, Bronx, New York (Barrett); Division of
jamapediatrics.com (Reprinted) JAMA Pediatrics April 2022 Volume 176, Number 4 371
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372 JAMA Pediatrics April 2022 Volume 176, Number 4 (Reprinted) jamapediatrics.com