NCT05194410

Brief Summary

This study is a randomized controlled trial that will look at whether virtual, team-based exercise improves burnout, sense of community, and mentorship connections among medical students, residents, fellows, and physicians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
422

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

December 30, 2021

Last Update Submit

August 26, 2024

Conditions

Keywords

Burnout, ProfessionalBurnout, StudentCommunity BuildingMentorshipExercise

Outcome Measures

Primary Outcomes (12)

  • Change from Baseline Burnout at 3 months

    Measured via the 2-item Maslach Burnout Inventory (MBI) The MBI is a 22-item survey that covers 3 areas: Emotional Exhaustion (EE), Depersonalization (DP), and low sense of Personal Accomplishment (PA). Each subscale includes multiple questions with frequency rating choices of Never, A few times a year or less, Once a month or less, A few times a month, Once a week, A few times a week, or Every day. The use of 2 single items from the MBI may also be used. Item 8 ("I feel burned out from my work",) and item 10 ("I have become more callous toward people since I took this job") correlate strongly with the emotional exhaustion and depersonalization subscale scores and concurrent validity has been demonstrated (J Gen Intern Med 2012;27:1445-52. J Gen Inter Med 2009;24:1318-21.) Individuals meet burnout criteria if they have high scores on either the EE (total score of 27 or higher) or DP (total score of 10 or higher) subscales.

    0 and 3 months

  • Change from Baseline Burnout at 6 months

    Measured via the 2-item Maslach Burnout Inventory (MBI) The MBI is a 22-item survey that covers 3 areas: Emotional Exhaustion (EE), Depersonalization (DP), and low sense of Personal Accomplishment (PA). Each subscale includes multiple questions with frequency rating choices of Never, A few times a year or less, Once a month or less, A few times a month, Once a week, A few times a week, or Every day. The use of 2 single items from the MBI may also be used. Item 8 ("I feel burned out from my work",) and item 10 ("I have become more callous toward people since I took this job") correlate strongly with the emotional exhaustion and depersonalization subscale scores and concurrent validity has been demonstrated (J Gen Intern Med 2012;27:1445-52. J Gen Inter Med 2009;24:1318-21.) Individuals meet burnout criteria if they have high scores on either the EE (total score of 27 or higher) or DP (total score of 10 or higher) subscales.

    0 and 6 months

  • Change in Burnout from 3 to 6 months

    Measured via the 2-item Maslach Burnout Inventory (MBI) The MBI is a 22-item survey that covers 3 areas: Emotional Exhaustion (EE), Depersonalization (DP), and low sense of Personal Accomplishment (PA). Each subscale includes multiple questions with frequency rating choices of Never, A few times a year or less, Once a month or less, A few times a month, Once a week, A few times a week, or Every day. The use of 2 single items from the MBI may also be used. Item 8 ("I feel burned out from my work",) and item 10 ("I have become more callous toward people since I took this job") correlate strongly with the emotional exhaustion and depersonalization subscale scores and concurrent validity has been demonstrated (J Gen Intern Med 2012;27:1445-52. J Gen Inter Med 2009;24:1318-21.) Individuals meet burnout criteria if they have high scores on either the EE (total score of 27 or higher) or DP (total score of 10 or higher) subscales.

    3 and 6 months

  • Change from Baseline Sense of Community at 3 months

    Measured via the Stanford Professional Fulfillment Index The Stanford Professional Fulfillment Index (PFI) is a 16-item survey that covers burnout (work exhaustion and interpersonal disengagement) and professional fulfillment. Response options are on a five-point Likert scale ("not at all true" to "completely true" for professional fulfillment items and "not at all" to "extremely" for work exhaustion and interpersonal disengagement items.) Items are scored 0 to 4. Each dimension is treated as a continuous variable. Scale scores are calculated by averaging the item scores of all the items within the corresponding scale. Scale scores can then be multiplied by 25 to create a scale range from 0 to 100. Higher score on the professional fulfillment scale is more favorable while higher scores on the work exhaustion or interpersonal disengagement scales are less favorable.

    0 and 3 months

  • Change from Baseline Sense of Community at 6 months

    Measured via the Stanford Professional Fulfillment Index The Stanford Professional Fulfillment Index (PFI) is a 16-item survey that covers burnout (work exhaustion and interpersonal disengagement) and professional fulfillment. Response options are on a five-point Likert scale ("not at all true" to "completely true" for professional fulfillment items and "not at all" to "extremely" for work exhaustion and interpersonal disengagement items.) Items are scored 0 to 4. Each dimension is treated as a continuous variable. Scale scores are calculated by averaging the item scores of all the items within the corresponding scale. Scale scores can then be multiplied by 25 to create a scale range from 0 to 100. Higher score on the professional fulfillment scale is more favorable while higher scores on the work exhaustion or interpersonal disengagement scales are less favorable.

    0 and 6 months

  • Change in Sense of Community from 3 to 6 months

    Measured via the Stanford Professional Fulfillment Index The Stanford Professional Fulfillment Index (PFI) is a 16-item survey that covers burnout (work exhaustion and interpersonal disengagement) and professional fulfillment. Response options are on a five-point Likert scale ("not at all true" to "completely true" for professional fulfillment items and "not at all" to "extremely" for work exhaustion and interpersonal disengagement items.) Items are scored 0 to 4. Each dimension is treated as a continuous variable. Scale scores are calculated by averaging the item scores of all the items within the corresponding scale. Scale scores can then be multiplied by 25 to create a scale range from 0 to 100. Higher score on the professional fulfillment scale is more favorable while higher scores on the work exhaustion or interpersonal disengagement scales are less favorable.

    3 and 6 months

  • Change from Baseline Mentorship Connections at 3 months

    Measured via unvalidated survey "How many meaningful relationships would you say you have with \[medical students, residents/fellows, attendings\]? A meaningful relationship could include any of the following: a) someone you'd get coffee/meal with, b) someone you'd be comfortable talking about career/life advice, c) someone you would be comfortable catching up with, etc."

    0 and 3 months

  • Change from Baseline Mentorship Connections at 6 months

    Measured via unvalidated survey "How many meaningful relationships would you say you have with \[medical students, residents/fellows, attendings\]? A meaningful relationship could include any of the following: a) someone you'd get coffee/meal with, b) someone you'd be comfortable talking about career/life advice, c) someone you would be comfortable catching up with, etc."

    0 and 6 months

  • Change in Mentorship Connections from 3 to 6 months

    Measured via unvalidated survey "How many meaningful relationships would you say you have with \[medical students, residents/fellows, attendings\]? A meaningful relationship could include any of the following: a) someone you'd get coffee/meal with, b) someone you'd be comfortable talking about career/life advice, c) someone you would be comfortable catching up with, etc."

    3 and 6 months

  • Change from Baseline Burnout (Mayo) at 3 months

    Measured via the Mayo Wellbeing Index The Mayo Wellbeing Index aims to identify distress in a variety of dimensions (burnout, fatigue, low mental/physical quality of life, depression, anxiety/stress). It has separate medical student, resident/fellow, and physicians versions and is a 7-item instrument with yes/no response categories. A total score is calculated by adding the number of 'yes' responses. In a sample of physicians, medical students, and US workers, every one point increase in score resulted in a step-wise increased probability of distress and risk for adverse personal and professional consequence. Score range is 0 to 7, and threshold score to identify individuals in distress is 4 or higher for medical students, 5 or higher for residents, 4 or higher for practicing physicians, and 2 or higher for other US workers.

    0 and 3 months

  • Change from Baseline Burnout (Mayo) at 6 months

    Measured via the Mayo Wellbeing Index The Mayo Wellbeing Index aims to identify distress in a variety of dimensions (burnout, fatigue, low mental/physical quality of life, depression, anxiety/stress). It has separate medical student, resident/fellow, and physicians versions and is a 7-item instrument with yes/no response categories. A total score is calculated by adding the number of 'yes' responses. In a sample of physicians, medical students, and US workers, every one point increase in score resulted in a step-wise increased probability of distress and risk for adverse personal and professional consequence. Score range is 0 to 7, and threshold score to identify individuals in distress is 4 or higher for medical students, 5 or higher for residents, 4 or higher for practicing physicians, and 2 or higher for other US workers.

    0 and 6 months

  • Change in Burnout (Mayo) from 3 to 6 months

    Measured via the Mayo Wellbeing Index The Mayo Wellbeing Index aims to identify distress in a variety of dimensions (burnout, fatigue, low mental/physical quality of life, depression, anxiety/stress). It has separate medical student, resident/fellow, and physicians versions and is a 7-item instrument with yes/no response categories. A total score is calculated by adding the number of 'yes' responses. In a sample of physicians, medical students, and US workers, every one point increase in score resulted in a step-wise increased probability of distress and risk for adverse personal and professional consequence. Score range is 0 to 7, and threshold score to identify individuals in distress is 4 or higher for medical students, 5 or higher for residents, 4 or higher for practicing physicians, and 2 or higher for other US workers.

    3 and 6 months

Secondary Outcomes (8)

  • Engagement in First Half of Study

    3 months

  • Engagement in Second Half of Study

    6 months

  • Change in Baseline Exercise at 3 months

    0 and 3 months

  • Change in Baseline Exercise at 6 months

    0 and 6 months

  • Change in Exercise from 3 to 6 months

    3 and 6 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

6 months of virtual, team-based exercise

Behavioral: First 3 months of virtual, team-based exerciseBehavioral: Second 3 months of virtual, team-based exercise

Control

OTHER

3 months of usual exercise and then 3 months of virtual, team-based exercise

Behavioral: Second 3 months of virtual, team-based exercise

Interventions

Participants will be randomized onto mixed teams of medical students, residents, fellows, and attendings and registered for the virtual, team-based exercise intervention on FitRankings.com. All exercise (including walking, biking, lifting, yoga, and 40+ exercises) will be tracked via user's smartwatches (ie Apple, Garmin), smartphone fitness apps (ie MapMyRun), or manual upload, converted into Metabolic Equivalent of a Task (MET) minutes, and displayed on online leaderboards. Group activities will be encouraged by awarding raffle tickets for prizes to those who submit pictures with their teammates.

Intervention

Same as above

ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Harvard Medical Students (HMS)
  • Massachusetts General Hospital (MGH) Residents, Fellows, or Attendings

You may not qualify if:

  • Non HMS Students or MGH Residents, Fellows, or Attendings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harvard Medical School

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

MeSH Terms

Conditions

Burnout, ProfessionalBurnout, PsychologicalMotor Activity

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Logan Briggs, BA

    Harvard Medical School (HMS and HSDM)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 30, 2021

First Posted

January 18, 2022

Study Start

July 18, 2021

Primary Completion

May 31, 2024

Study Completion

July 31, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations