- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04466423
Intervention Trial to Increase Meaning in Work and Reduce Burnout
July 7, 2020 updated by: Colin West, Mayo Clinic
Intervention Trial Designed to Promote Collegiality and Mutual Support at Work as a Way to Increase Meaning in Work and Reduce Burnout
Collegiality is a one of the great virtues of physician-hood.
Mutual support from colleagues to help deal with the challenges of being a physician has long helped physicians manage the stress related to practicing medicine and helped physicians derive meaning from their work.
Unfortunately, increased productivity expectations and other changes to the practice of medicine over the last several decades have decreased the time physicians have to interact with colleagues and eroded the fabric of collegiality.
Recent studies suggest burnout affects nearly half of U.S. physicians at any given point in time and has substantial personal and professional consequences.
The steps organizations can take to promote collegiality are unknown.
The goal of the present study is to evaluate the ability of an organizational intervention to encourage collegiality, shared experience, connectedness, and mutual support.
This study builds on two prior intervention studies directed by the Mayo Clinic Department of Medicine Program on Physician Well-Being, the first focusing on a small group facilitated well-being curriculum and the second focusing on individual electronic tasks to prompt positive reflection and gratitude.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Senior Associate Consultants and Consultants in the Mayo Clinic Department of Medicine will be eligible for this study.
Exclusion Criteria:
- None beyond inclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Small group intervention
Those randomized to the immediate intervention arm will be asked to meet approximately every other week for 6 months, covering 12 sessions.
We will ask each group to meet in a relatively private setting (e.g., a restaurant near campus or a reserved meeting room), rather than more public spaces (e.g.
river room, cafeteria) where interruptions are more likely.
|
The first 15 minutes of each session will be semi-structured discussion involving i) check in and ii) dialogue about the assigned question.
Group leaders will be provided 3-4 discussion questions for each session.
The group (or the leader) can choose the one they are most interested in and will then spend 10-15 minutes discussing the question together.
Questions will touch on key themes for discussion (see the attached topics list) and are derived from our previous intervention studies.
The remainder of the time can be used for socializing and building relationships with colleagues.
|
|
Placebo Comparator: Control
Participants randomized to Arm 2 (delayed intervention) will be "wait listed" to begin sessions 6 months after the start of the study.
This participation will be optional.
|
The first 15 minutes of each session will be semi-structured discussion involving i) check in and ii) dialogue about the assigned question.
Group leaders will be provided 3-4 discussion questions for each session.
The group (or the leader) can choose the one they are most interested in and will then spend 10-15 minutes discussing the question together.
Questions will touch on key themes for discussion (see the attached topics list) and are derived from our previous intervention studies.
The remainder of the time can be used for socializing and building relationships with colleagues.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Burnout
Time Frame: 12 month outcomes
|
Maslach Burnout Inventory results
|
12 month outcomes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms
Time Frame: 12 month outcomes
|
PRIME-MD
|
12 month outcomes
|
|
Quality of life
Time Frame: 12 month outcomes
|
LASA QOL
|
12 month outcomes
|
|
Job satisfaction
Time Frame: 12 month outcomes
|
PJSS
|
12 month outcomes
|
|
Meaning at work
Time Frame: 12 month outcomes
|
EWS
|
12 month outcomes
|
|
Social support
Time Frame: 12 month outcomes
|
Social Provisions Scale
|
12 month outcomes
|
|
Social isolation
Time Frame: 12 month outcomes
|
PROMIS Social Isolation
|
12 month outcomes
|
|
Job turnover
Time Frame: 12 month outcomes
|
Single item asking about 2-year plans to leave current practice
|
12 month outcomes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Colin West, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
July 7, 2020
First Submitted That Met QC Criteria
July 7, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
July 10, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-004834
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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