Physician Well-beingPhase 2NCT01159977
Trial Evaluating the Effect of Facilitated Small Group Sessions on Physician Well-Being, Job Satisfaction, and Professionalism
A Phase 2 study testing Facilitated small groups, Unstructured time. and Usual practice in people with Physician Well-being and Physician Job Satisfaction, run by Mayo Clinic at 1 site in United States.
Trial summary
The study purpose is to evaluate the effect of a small group discussion based intervention on physician well-being, job satisfaction, and professionalism. Participants will be put in one of 3 groups by chance (as in the flip of a coin). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physician Well-being, Physician Job Satisfaction
- What is being tested?
- Facilitated small groups, Unstructured time. and Usual practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2012
- Phase
- Phase 2
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Senior Associate Consultant or Consultant in the Mayo Clinic Department of Medicine.
Who cannot join
- No clinical effort.
Trial locations and contacts
1 site in 1 country.
About this study
The study purpose is to evaluate the effect of a small group discussion based intervention on physician well-being, job satisfaction, and professionalism. Participants will be put in one of 3 groups by chance (as in the flip of a coin). A computerized selection process will be used to assign participants to the study groups. There is a 1 in 3 chance of being assigned at random to either of the 3 groups.
The first study group will meet once every two weeks for 9 months (from September 2010 through June 2011) from 12:30 pm until 2:00 pm. These meetings will be small group discussion sessions with groups of no more than 15 participants. Lunch will be provided for the first 30 minutes, and group discussion during the next 1 hour will be guided by the session facilitator around such topics as work-life balance, meaning in work, medical mistakes, spirituality, and unmet patient needs. However, the discussions will be open forums, and the groups themselves will help decide on topics relevant to the group. The 1 hour of protected non-clinical time every other week required for this group will be funded by the study.
Read more
The second study group will also have 1 hour of protected non-clinical time provided every other week for the same 9 months. This study group will not participate in small group discussions, but may use the protected time for professional tasks as they wish.
Participants in the third study group will continue with their current work practices, but will be provided with protected time to complete study surveys. If group sizes are too small after recruitment to allow a complete study of all three groups, the third study group will be removed and participants will be randomly assigned to one of the first two study groups only.
Participants in all groups will be asked to complete a quarterly survey on well-being, job satisfaction, and professionalism. Follow-up surveys will also be administered 3 months and 1 year after the conclusion of the small group sessions. Each survey is expected to take approximately 20-30 minutes to complete.
- Conditions
- Physician Well-being, Physician Job Satisfaction
- Being tested
- Facilitated small groups, Unstructured time., Usual practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated small groupsBehavioural
1 hour sessions every 2 weeks for small groups of 9 participants, 19 sessions over 9 months.
Unstructured time.Behavioural
1 protected hour every 2 weeks for 9 months, without small group structure.
Usual practiceBehavioural
No protected time provided.
| Study group | Role | What they receive |
|---|---|---|
| Facilitated small group | Experimental | Facilitated small groups. Receives: Behavioral: Facilitated small groups |
| Unstructured protected time | Active comparator | Same time provided as for facilitated small groups, but without structure. Receives: Behavioral: Unstructured time. |
| Usual practice | Placebo comparator | No protected time. Receives: Behavioral: Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician burnout
Burnout measured by the Maslach Burnout Inventory.
Measured: September 2010 - June 2012
Secondary outcomes (1)
Physician job satisfaction
Job satisfaction measured by validated scales.
Measured: September 2010 - June 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physician Well-beingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin West, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159977
- Sponsor's protocol ID
- 09-008232
- Status last verified
- Nov 2012
- First submitted
- 8 Jul 2010
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
West CP, Dyrbye LN, Rabatin JT, Call TG, Davidson JH, Multari A, Romanski SA, Hellyer JM, Sloan JA, Shanafelt TD. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):527-33. doi: 10.1001/jamainternmed.2013.14387.
PubMed 24515493
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Evaluating the Effect of Facilitated Small Group Sessions on Physician Well-Being, Job Satisfaction, and Professionalism
- ClinicalTrials.gov ID
- NCT01159977
- Acronym / sponsor ID
- 09-008232
- Conditions
- Physician Well-being, Physician Job Satisfaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Jul 2010 (estimated)
- 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.
The study purpose is to evaluate the effect of a small group discussion based intervention on physician well-being, job satisfaction, and professionalism. Participants will be put in one of 3 groups by chance (as in the flip of a coin). A computerized selection process will be used to assign participants to the study groups. There is a 1 in 3 chance of being assigned at random to either of the 3 groups.
The first study group will meet once every two weeks for 9 months (from September 2010 through June 2011) from 12:30 pm until 2:00 pm. These meetings will be small group discussion sessions with groups of no more than 15 participants. Lunch will be provided for the first 30 minutes, and group discussion during the next 1 hour will be guided by the session facilitator around such topics as work-life balance, meaning in work, medical mistakes, spirituality, and unmet patient needs. However, the discussions will be open forums, and the groups themselves will help decide on topics relevant to the group. The 1 hour of protected non-clinical time every other week required for this group will be funded by the study.
The second study group will also have 1 hour of protected non-clinical time provided every other week for the same 9 months. This study group will not participate in small group discussions, but may use the protected time for professional tasks as they wish.
Participants in the third study group will continue with their current work practices, but will be provided with protected time to complete study surveys. If group sizes are too small after recruitment to allow a complete study of all three groups, the third study group will be removed and participants will be randomly assigned to one of the first two study groups only.
Participants in all groups will be asked to complete a quarterly survey on well-being, job satisfaction, and professionalism. Follow-up surveys will also be administered 3 months and 1 year after the conclusion of the small group sessions. Each survey is expected to take approximately 20-30 minutes to complete.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Facilitated small group | Experimental | Behavioral: Facilitated small groupsFacilitated small groups. |
| Unstructured protected time | Active comparator | Behavioral: Unstructured time.Same time provided as for facilitated small groups, but without structure. |
| Usual practice | Placebo comparator | Behavioral: Usual practiceNo protected time. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Senior Associate Consultant or Consultant in the Mayo Clinic Department of Medicine.
Key exclusion criteria (1 listed)
- No clinical effort.
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 |
|---|---|---|
| Facilitated small groups1 hour sessions every 2 weeks for small groups of 9 participants, 19 sessions over 9 months. | Behavioural | Facilitated small group |
| Unstructured time.1 protected hour every 2 weeks for 9 months, without small group structure. | Behavioural | Unstructured protected time |
| Usual practiceNo protected time provided. | Behavioural | Usual practice |
Primary outcome
Physician burnout
Time frame: September 2010 - June 2012
Burnout measured by the Maslach Burnout Inventory.
1 secondary outcome
Physician job satisfaction
Time frame: September 2010 - June 2012
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 15 Nov 2012.
- Derived from this study: PubMed 24515493West CP, Dyrbye LN, Rabatin JT, Call TG, Davidson JH, Multari A, Romanski SA, Hellyer JM, Sloan JA, Shanafelt TD. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):527-33. doi: 10.1001/jamainternmed.2013.14387.
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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 Phase 2 study testing Facilitated small groups, Unstructured time. and Usual practice in people with Physician Well-being and Physician Job Satisfaction, run by Mayo Clinic 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 1 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 15 Nov 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physician burnout (time frame: September 2010 - June 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01159977, which also lists 1 linked publication.
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 15 Nov 2012.