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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05194410
Other study ID # 2021P000825
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 18, 2021
Est. completion date July 31, 2024

Study information

Verified date November 2023
Source Harvard Medical School (HMS and HSDM)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Participants will be randomized to either a control group or an intervention group. The intervention group will be further randomized onto teams that will exercise for 3 months. 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. Primary outcomes will be burnout, sense of community, and mentorship connections, with the hypothesis that getting everyone together for this team-based exercise will improve these metrics. After 3 months, both the control and intervention group will be enrolled in 3 months of the intervention to assess secondary outcomes: long-term burnout, sense of community, and mentorship connections, as well as adherence.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 422
Est. completion date July 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Harvard Medical Students (HMS) - Massachusetts General Hospital (MGH) Residents, Fellows, or Attendings Exclusion Criteria: - Non HMS Students or MGH Residents, Fellows, or Attendings

Study Design


Intervention

Behavioral:
First 3 months of virtual, team-based exercise
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.
Second 3 months of virtual, team-based exercise
Same as above

Locations

Country Name City State
United States Harvard Medical School Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Harvard Medical School (HMS and HSDM) Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Engagement in First Half of Study Registration of >0 Metabolic Equivalent of a Task (MET) minutes on FitRankings platform 3 months
Secondary Engagement in Second Half of Study Registration of >0 Metabolic Equivalent of a Task (MET) minutes on FitRankings platform 6 months
Secondary Change in Baseline Exercise at 3 months On average, how many days per week do you exercise for 30 minutes or more? (0-7 days) 0 and 3 months
Secondary Change in Baseline Exercise at 6 months On average, how many days per week do you exercise for 30 minutes or more? (0-7 days) 0 and 6 months
Secondary Change in Exercise from 3 to 6 months On average, how many days per week do you exercise for 30 minutes or more? (0-7 days) 3 and 6 months
Secondary Change in Baseline Comfortability at work at 3 months How comfortable do you feel about working with [medical students, residents/fellows, attending physicians] at your affiliated hospital?
(1=not at all, 2=slightly, 3=moderately, 4=very, 5=extremely)
0 and 3 months
Secondary Change in Baseline Comfortability at work at 6 months How comfortable do you feel about working with [medical students, residents/fellows, attending physicians] at your affiliated hospital?
(1=not at all, 2=slightly, 3=moderately, 4=very, 5=extremely)
0 and 6 months
Secondary Change in Comfortability at work from 3 to 6 months How comfortable do you feel about working with [medical students, residents/fellows, attending physicians] at your affiliated hospital?
(1=not at all, 2=slightly, 3=moderately, 4=very, 5=extremely)
3 and 6 months
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