Does a Mindfulness Curriculum Prevent Physician Burnout During Pediatric Internship?

NCT03148626 | Completed

• 1 other identifier: H-36221
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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.

Conditions

Burnout, Professional

Keywords

mindfulness curriculum

Outcome Measures

Primary Outcomes (2)

• Change in physician burnout from baseline to 6-month follow-up

  Physician burnout will be measured using the Maslach Burnout Inventory.

  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.

  Will be measured at baseline and 15-month follow-up

Secondary Outcomes (4)

• Change in empathy from baseline to 6 mo follow-up

  Will be measured at baseline and both 6-month follow-up

• Change in empathy from baseline to 15 mo follow-up

  Will be measured at baseline and 6-month follow-up

• Change in mindfulness from baseline to 6 mo follow-up

  Will be measured at baseline and 15-month follow-up

• Change in mindfulness from baseline to 15 mo follow-up

  Will be measured at baseline and 15-month follow-up

Study Arms (2)

MINDI mindfulness curriculum

EXPERIMENTAL

The intervention is a seven-session mindfulness curriculum to be delivered over six months to pediatric interns.

Other: MINDI mindfulness curriculum

Control

PLACEBO COMPARATOR

Usual education.

Other: Control

Interventions

MINDI mindfulness curriculum OTHER

A seven-session mindfulness curriculum implemented over six-months during pediatric internship.

MINDI mindfulness curriculum

Control OTHER

Usual Education

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Boston Medical Center: lead
• Boston Children's Hospital: collaborator
• UCSF Benioff Children's Hospital Oakland: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Floating Hospital for Children: collaborator
• Nationwide Children's Hospital: collaborator
• MaineHealth: collaborator
• Saint Peters University Hospital: collaborator
• University of California, Davis: collaborator
• University of Florida: collaborator
• University of Massachusetts, Worcester: collaborator
• Seattle Children's Hospital: collaborator
• Advocate Lutheran General Hospital: collaborator
• University of Pittsburgh: collaborator
• Loyola University Chicago: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 35072694 DERIVED

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Colin Sox, MD, MS

  Boston Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center cluster randomized controlled trial

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 11, 2017
• Study Start: June 13, 2017
• Primary Completion: January 28, 2019
• Study Completion: January 28, 2019
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)