This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 3 of 8 for:    triad pittsburgh

Does a Mindfulness Curriculum Prevent Physician Burnout During Pediatric Internship?

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Colin Sox, Boston Medical Center
Sponsor:
Collaborators:
Boston Children’s Hospital
Children's Hospital & Research Center 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
Children's Hospital of Pittsburgh
Loyola University Chicago
Information provided by (Responsible Party):
Colin Sox, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT03148626
First received: May 4, 2017
Last updated: June 20, 2017
Last verified: June 2017
  Purpose

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 Intervention
Burnout, Professional Other: MINDI mindfulness curriculum Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multi-center cluster randomized controlled trial
Masking: No masking
Primary Purpose: Prevention
Official Title: Can a Mindfulness Curriculum Prevent Burnout During Pediatric Internship? A Multi-center Cluster Randomized Controlled Trial.

Further study details as provided by Colin Sox, Boston Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 300
Actual Study Start Date: June 13, 2017
Estimated Study Completion Date: October 1, 2018
Estimated Primary Completion Date: October 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03148626

Contacts
Contact: Colin Sox 617-414-3829 colin.sox@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Colin Sox, MD, MS    617-414-3829    colin.sox@bmc.org   
Sub-Investigator: Yarden Fraiman, MD         
Sub-Investigator: Kate Michelson, MD, MEd         
Sub-Investigator: Christine Cheston, MD         
Sponsors and Collaborators
Boston Medical Center
Boston Children’s Hospital
Children's Hospital & Research Center 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
Children's Hospital of Pittsburgh
Loyola University Chicago
Investigators
Principal Investigator: Colin Sox, MD, MS Boston Medical Center
  More Information

Responsible Party: Colin Sox, Assistant Professor of Pediatrics, Boston Medical Center
ClinicalTrials.gov Identifier: NCT03148626     History of Changes
Other Study ID Numbers: H-36221
Study First Received: May 4, 2017
Last Updated: June 20, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Colin Sox, Boston Medical Center:
mindfulness curriculum

Additional relevant MeSH terms:
Burnout, Professional
Occupational Diseases

ClinicalTrials.gov processed this record on June 23, 2017