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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Small group meetings (COMPASS: COlleagues Meeting to Promote And Sustain Satisfaction)
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.
Behavioral: Small group meetings (COMPASS: COlleagues Meeting to Promote And Sustain Satisfaction)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Burnout
Time Frame: 12 month outcomes
Maslach Burnout Inventory results
12 month outcomes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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