NCT04305886

Brief Summary

A randomized trial of an interprofessional intervention to reduce burnout and enhance professional engagement in physicians, certified nurse midwives, and nurse practitioners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 3, 2020

Last Update Submit

March 10, 2020

Conditions

Burnout, Professional

Outcome Measures

Primary Outcomes (8)

  • Burnout

    Change from baseline in 2 item Maslach Burnout Inventory scores before and after the intervention. Minimum score: 2; Maximum score: 14 Higher score = more burnt out (worse outcome)

    Change over the three month study period. Baseline measurement and immediately after final intervention.

  • Stress from Uncertainty

    Change in scores on Physician Response to Uncertainty Scale before and after intervention Minimum score: 6; Maximum score: 90 Higher score = increased stress due to uncertainty (worse outcome)

    Change over the three month study period. Baseline measurement and immediately after final intervention.

  • Work Engagement

    Change in scores on Utrecht Work Engagement Scale before and after intervention Minimum score: 0; Maximum score: 54 Higher score = higher engagement at work (better outcome)

    Change over the three month study period. Baseline measurement and immediately after final intervention.

  • Urine oxytocin

    Change from baseline in the level of urine oxytocin before and after each intervention. This is an exploratory study so the maximum and minimum values are not known, and any change up or down is interesting.

    Two samples were taken one hour apart at baseline, and this was repeated three months later.

  • Salivary Oxytocin

    Change from baseline in the level of salivary oxytocin before and after each intervention. This is an exploratory study so the maximum and minimum values are not known, and any change up or down is interesting.

    Two samples were taken one hour apart at baseline, and this was repeated three months later

  • Salivary Cortisol

    Change from baseline in the level of salivary cortisol before and after each intervention. This is an exploratory study so the maximum and minimum values are not known, and any change up or down is interesting.

    Two samples were taken one hour apart at baseline, and this was repeated three months later

  • Hair Cortisol

    Change from baseline in hair cortisol levels. Maximum and minimum levels are not known and any change up or down is interesting.

    Change over the three month study period. Baseline measurement and immediately after final intervention.

  • Work Empowerment Scale

    Minimum score: 12; Maximum score: 84 Change from baseline on Work Empowerment Scale before and after intervention. Higher score = higher empowerment at work (better outcome)

    Change over the three month study period. Baseline measurement and immediately after final intervention.

Study Arms (2)

Intervention

EXPERIMENTAL

Providers were placed in small groups and given the intervention of a discussion guide to facilitate discussion.

Other: Discussion Guide

Control

NO INTERVENTION

Providers were placed in small groups and not given a discussion guide to facilitate discussion.

Interventions

Discussion GuideOTHER

Written list of prompts to facilitate discussion

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Physican in the Department of Obstetrics and Gynecology at Massachusetts General Hospital
  • Nurse Practitioner in the Department of Obstetrics and Gynecology at Massachusetts General Hospital
  • Certified Nurse Midwife in the Department of Obstetrics and Gynecology at Massachusetts General Hospital

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co- Investigator

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 12, 2020

Study Start

May 1, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

March 12, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)