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Does a Mindfulness Curriculum Prevent Physician Burnout During Pediatric Internship?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03148626
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : January 30, 2019
Sponsor:
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
Maine Medical Center
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
Information provided by (Responsible Party):
Boston Medical Center

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.


Condition or disease Intervention/treatment Phase
Burnout, Professional Other: MINDI mindfulness curriculum Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Can a Mindfulness Curriculum Prevent Burnout During Pediatric Internship? A Multi-center Cluster Randomized Controlled Trial.
Actual Study Start Date : June 13, 2017
Actual Primary Completion Date : January 28, 2019
Actual Study Completion Date : January 28, 2019

Arm Intervention/treatment
Experimental: MINDI mindfulness curriculum
The intervention is a seven-session mindfulness curriculum to be delivered over six months to pediatric interns.
Other: MINDI mindfulness curriculum
A seven-session mindfulness curriculum implemented over six-months during pediatric internship.

Placebo Comparator: Control
Usual education.
Other: Control
Usual Education




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148626


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Boston Children’s Hospital
UCSF Benioff Children’s Hospital Oakland
Children's Hospital Medical Center, Cincinnati
Floating Hospital for Children
Nationwide Children's Hospital
Maine Medical Center
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
Investigators
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Study Director: Colin Sox, MD, MS Boston Medical Center
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT03148626    
Other Study ID Numbers: H-36221
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
mindfulness curriculum
Additional relevant MeSH terms:
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Burnout, Professional
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms
Occupational Stress
Occupational Diseases