Burnout, ProfessionalNCT03148626
Does a Mindfulness Curriculum Prevent Physician Burnout During Pediatric Internship?
A study testing MINDI mindfulness curriculum in people with Burnout, Professional, run by Boston Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- MINDI mindfulness curriculum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 358 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2017to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can a Mindfulness Curriculum Prevent Burnout During Pediatric Internship? A Multi-center Cluster Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Burnout, Professional
- Being tested
- MINDI mindfulness curriculum, Control
- Keywords
- mindfulness curriculum
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDI mindfulness curriculumOther
A seven-session mindfulness curriculum implemented over six-months during pediatric internship.
ControlOther
Usual Education
| Study group | Role | What they receive |
|---|---|---|
| MINDI mindfulness curriculum | Experimental | The intervention is a seven-session mindfulness curriculum to be delivered over six months to pediatric interns. Receives: Other: MINDI mindfulness curriculum |
| Control | Placebo comparator | Usual education. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physician burnout from baseline to 6-month follow-up
Physician burnout will be measured using the Maslach Burnout Inventory.
Measured: Will be measured at baseline and 6-month follow-up
Change in physician burnout from baseline to 15-month follow-up
Physician burnout will be measured with the Maslach Burnout Inventory.
Measured: Will be measured at baseline and 15-month follow-up
Secondary outcomes (4)
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.
Measured: Will be measured at baseline and both 6-month follow-up
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.
Measured: Will be measured at baseline and 6-month follow-up
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.
Measured: Will be measured at baseline and 15-month follow-up
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.
Measured: Will be measured at baseline and 15-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start13 Jun 2017
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Colin Sox, MD, MS, Study director, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148626
- Sponsor's protocol ID
- H-36221
- Status last verified
- Jan 2019
- First submitted
- 4 May 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35072694
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Mindfulness Curriculum Prevent Burnout During Pediatric Internship? A Multi-center Cluster Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03148626
- Acronym / sponsor ID
- H-36221
- Conditions
- Burnout, Professional
- Keywords
- mindfulness curriculum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- 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
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| MINDI mindfulness curriculum | Experimental | Other: MINDI mindfulness curriculumThe intervention is a seven-session mindfulness curriculum to be delivered over six months to pediatric interns. |
| Control | Placebo comparator | Other: ControlUsual education. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MINDI mindfulness curriculumA seven-session mindfulness curriculum implemented over six-months during pediatric internship. | Other | MINDI mindfulness curriculum |
| ControlUsual Education | Other | Control |
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.
4 secondary outcomes
Change in empathy from baseline to 6 mo follow-up
Time frame: Will be measured at baseline and both 6-month follow-up
Change in empathy from baseline to 15 mo follow-up
Time frame: Will be measured at baseline and 6-month follow-up
Change in mindfulness from baseline to 6 mo follow-up
Time frame: Will be measured at baseline and 15-month follow-up
Change in mindfulness from baseline to 15 mo follow-up
Time frame: Will be measured at baseline and 15-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Derived from this study: PubMed 35072694Fraiman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Sox, MD, MS study director
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINDI mindfulness curriculum in people with Burnout, Professional, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physician burnout from baseline to 6-month follow-up (time frame: Will be measured at baseline and 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.