Burnout, ProfessionalNCT04305886
Interprofessional Group Intervention to Promote Faculty Wellbeing and Engagement
A study testing Discussion Guide in people with Burnout, Professional, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
A randomized trial of an interprofessional intervention to reduce burnout and enhance professional engagement in physicians, certified nurse midwives, and nurse practitioners. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Discussion Guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
A randomized trial of an interprofessional intervention to reduce burnout and enhance professional engagement in physicians, certified nurse midwives, and nurse practitioners.
Read the detailed description
To test the hypothesis that an intervention involving self-facilitated interprofessional group meetings would result in improvement in wellbeing and to determine whether use of a written curriculum provided increased benefit, the following study is conducted:
Practicing clinical faculty in the Department of Obstetrics and Gynecology at the Massachusetts General Hospital were recruited to participate in three monthly small groups over dinner. Participants were randomized to a control group, which met without any specified guidelines for discussion content, or to receive an intervention which consisted of a one-page discussion guide addressing themes relevant to challenges in the healthcare environment: reframing challenging patient interactions; embracing uncertainty in work; and coping with errors, near misses, and bad outcomes. Outcomes included burnout, empowerment and engagement in work, stress from uncertainty assessed using validated metrics, and perception of of collegiality and community.
All participants were also offered the option of participating in evaluation of biomarkers. To test the hypothesis that an increased sense of bonding and relational connection, and reduced stress levels would be reflected by changes in hormone levels during the meeting and over the course of the study. Faculty who opted into this portion of the study gave the following samples:
Urine Oxytocin before and after the first and third group meetings Salivary Oxytocin before and after the first and third group meetings Salivary Cortisol before and after the first and third group meetings Hair Cortisol at the beginning of the study and at the end of the study (a roughly three month interval).
An optional focus group was conducted after the three monthly sessions.
All participants signed a consent form prior to participating in the study.
- Conditions
- Burnout, Professional
- Being tested
- Discussion Guide
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discussion GuideOther
Written list of prompts to facilitate discussion
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Providers were placed in small groups and given the intervention of a discussion guide to facilitate discussion. Receives: Other: Discussion Guide |
| Control | No intervention | Providers were placed in small groups and not given a discussion guide to facilitate discussion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Change over the three month study period. Baseline measurement and immediately after final intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 May 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Hata, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305886
- Sponsor's protocol ID
- 2018P000415
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interprofessional Group Intervention to Promote Faculty Wellbeing and Engagement
- ClinicalTrials.gov ID
- NCT04305886
- Acronym / sponsor ID
- 2018P000415
- Conditions
- Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized trial of an interprofessional intervention to reduce burnout and enhance professional engagement in physicians, certified nurse midwives, and nurse practitioners.
Detailed description
To test the hypothesis that an intervention involving self-facilitated interprofessional group meetings would result in improvement in wellbeing and to determine whether use of a written curriculum provided increased benefit, the following study is conducted:
Practicing clinical faculty in the Department of Obstetrics and Gynecology at the Massachusetts General Hospital were recruited to participate in three monthly small groups over dinner. Participants were randomized to a control group, which met without any specified guidelines for discussion content, or to receive an intervention which consisted of a one-page discussion guide addressing themes relevant to challenges in the healthcare environment: reframing challenging patient interactions; embracing uncertainty in work; and coping with errors, near misses, and bad outcomes. Outcomes included burnout, empowerment and engagement in work, stress from uncertainty assessed using validated metrics, and perception of of collegiality and community.
All participants were also offered the option of participating in evaluation of biomarkers. To test the hypothesis that an increased sense of bonding and relational connection, and reduced stress levels would be reflected by changes in hormone levels during the meeting and over the course of the study. Faculty who opted into this portion of the study gave the following samples:
Urine Oxytocin before and after the first and third group meetings Salivary Oxytocin before and after the first and third group meetings Salivary Cortisol before and after the first and third group meetings Hair Cortisol at the beginning of the study and at the end of the study (a roughly three month interval).
An optional focus group was conducted after the three monthly sessions.
All participants signed a consent form prior to participating in the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Discussion GuideProviders were placed in small groups and given the intervention of a discussion guide to facilitate discussion. |
| Control | No intervention | –Providers were placed in small groups and not given a discussion guide to facilitate discussion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discussion GuideWritten list of prompts to facilitate discussion | Other | Intervention |
Primary outcome
Burnout
Time frame: Change over the three month study period. Baseline measurement and immediately after final intervention.
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)
Stress from Uncertainty
Time frame: Change over the three month study period. Baseline measurement and immediately after final intervention.
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)
Work Engagement
Time frame: Change over the three month study period. Baseline measurement and immediately after final intervention.
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)
Urine oxytocin
Time frame: Two samples were taken one hour apart at baseline, and this was repeated three months later.
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.
Salivary Oxytocin
Time frame: Two samples were taken one hour apart at baseline, and this was repeated three months later
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.
Salivary Cortisol
Time frame: Two samples were taken one hour apart at baseline, and this was repeated three months later
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.
Hair Cortisol
Time frame: Change over the three month study period. Baseline measurement and immediately after final intervention.
Change from baseline in hair cortisol levels. Maximum and minimum levels are not known and any change up or down is interesting.
Work Empowerment Scale
Time frame: Change over the three month study period. Baseline measurement and immediately after final intervention.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussion Guide in people with Burnout, Professional, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burnout (time frame: Change over the three month study period. Baseline measurement and immediately after final intervention.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.