Patient Care TeamNCT06011239
Family Teams: A Study to Promote Team Collaboration in Family Medicine Clinics
A study testing Team-building processes in people with Patient Care Team and Psychological Well-Being, run by University of Michigan at 5 sites in United States.
Trial summary
This project includes an intervention in five Michigan Medicine family medicine clinics which is designed to improve staff collaboration across different job roles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Care Team, Psychological Well-Being, Occupational Burnout
- What is being tested?
- Team-building processes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Sep 2023to 20 Oct 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Staff in the roles of medical assistant, nurse, clerical staff, or clinician (physician, nurse practitioner, and physician assistant)
- Must work in one of five family medicine clinics at the University of Michigan.
Who cannot join
- administrative clinic director at each site (managerial)
- Staff outside of the above roles such as a dietician, social worker, pharmacist
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan-Domino Farms
Ann Arbor, Michigan, 48106
University of Michigan- Briarwood
Ann Arbor, Michigan, 48108
Uniiversity of Michigan- Chelsea
Chelsea, Michigan, 48118
University of Michigan-Dexter
Dexter, Michigan, 48130
University of Michigan-Ypsilanti
Ypsilanti, Michigan, 48198
About this study
This project includes an intervention in five Michigan Medicine family medicine clinics which is designed to improve staff collaboration across different job roles.
Read the detailed description
The primary intervention asks staff to meet with others in the same role and to consider the following questions:
- The Ask: When staff are busy or overwhelmed by work, what tasks can others do (people in each of these groups) to help make your job better or easier?
- The Offer: When people in other groups are busy or overwhelmed, what tasks can your group do to help make staff jobs better or easier?
After this information is collected, at an in-person meeting of all staff and faculty, the study team will divide everyone into groups by clinic and then by the four roles. The study team will hand out the idea list and ask participants to review the list, discuss whether there are new or additional ideas which should be added, and then prioritize staffs top five "asks" and top five "offers" for staff role.
Negotiation of asks/offers: The study team will hold 1-4 subsequent brief meetings at each clinic where staff are again sub-divided into four groups by role. Each group will review the asks from people in other roles and decide whether these are actions that staff can help with or whether there are barriers. The clinic champions will work with the groups to address barriers (which could include lack of information, lack of training, disagreements about need, etc). The ultimate goal will be for groups to come to consensus agreement on at least three ways staff can assist people in other roles. In some clinics this may be straightforward and require just one meeting. In other clinics, it may take several meetings.
Implementation: Once the asks and offers are finalized, it will be up to the physician champions to help promote these agreements at the clinic, follow up with staff and with the nursing, medical assistants, and clerical champions to ensure that people are following thru with commitments to help, and trouble shoot problems that come up.
Coordination with Leadership: a department leader will serve as the liaison between the clinic champions and members of leadership that oversee clinical functions. This leader meets regularly with these leadership groups and will help troubleshoot challenges to implementing the asks and offers which need higher-level approval or input.
Ongoing process improvement: Over time, the study team will send up to four brief, anonymous surveys to all staff asking whether the staff are indeed doing the things that staff committed to do and whether other role groups are following thru on the commitments. This provides an opportunity for people to identify and report problems. This data will be anonymously fed back to the physician champion that is tasked to troubleshoot and address the problems identified, working with the liaison as appropriate. This will likely require continuous process improvement and revisiting to ensure success.
Evaluation: The study team proposes to measure burnout and team centeredness using anonymous on-line surveys.
Brief surveys: At several points during the year, the investigators will send out brief surveys. These ask for the clinic and job role and then ask participant to rate how much effort they have made to help others, how much effort others have made to help them, and if there are open-ended comment about what is or is not working. This information will be used to improve the intervention at each clinic.
Qualitative interviews regarding clinic culture will also be conducted with the project champions at each clinic who are helping to implement the project.
This study is Institutional review board (IRB) exempt and will have a waiver of documentation of informed consent with survey completion representing consent.
- Being tested
- Team-building processes
- Keywords
- family medicine, team function, burnout, compassion
- Medical subject headings
- Psychological Well-Being, Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team-building processesBehavioural
All staff in one of the four role groups (medical assistants (MAs); clerical/administrative staff; nursing staff; and physicians/nurse practitioners/physician assistants) will be sent an anonymous survey. The survey will ask staff to consider what help participants wish to ask for and what help participants can offer to staff in the other three roles at times when people are busy or overwhelmed. These ideas will be combined into a typed "idea list" for each role and then staff in clinics will discuss. Once these are finalized the clinics will implement these.
At several points during the year, the study team will send out brief surveys. These surveys will collect the clinic and job role and ask participant to rate how much effort has been made in different ways, and if there are open-ended comments about what is or is not working. This information will be used to improve the intervention at each clinic.
| Study group | Role | What they receive |
|---|---|---|
| Survey participants | Experimental | All participants in the study will be in a single arm, divided by clinic. Receives: Behavioral: Team-building processes |
| Clinic Staff | No intervention | "Project champions" at each clinic who are helping to implement the project. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Team Development measure
The Team Development Measure is a 31-item questionnaire designed to the domains of communication, roles and goals, cohesion, and team primacy. Each question has four response options (strongly disagree, disagree, agree, strongly agree). Summary scores are transformed to a 0-100 scale to provide a score of team functioning and cohesiveness with a higher score indicating a better-functioning team. This measure has been validated in primary care settings and has strong psychometric properties.
Measured: Months 0, 12, 18
Team Compassion Behavior survey
The Team Compassion Behavior survey is a 6-question instrument adapted for teams from a longer individual compassion instrument. It is scored on a 5-point scale (almost never, seldom, sometimes, often, almost always) and summed for a total range of 6-30 point, with a higher score indicating more compassionate team behavior.
Measured: Months 0, 12, 18
Burnout
The study team will use the first 10 questions of the Mini Z 3.0 (the 11th question is open-ended) to measure burnout across staff in all roles. It has just minor changes from the earlier MiniZ versions and has good performance with two subscales for supportive work environment and electronic medical record (EMR) stress. Each question has a 5-scale response option. Subscale 1 (supportive work environment) sums the responses to questions 1-7 and has a range of 7-35 with a score of 28 or higher indicating a highly supportive workplace. Subscale 2 (EMR stress) sums responses to questions 8-10 and has a range of 3-15 with a score of 12 or higher indicating a workplace with manageable EMR stress.
Measured: Months 0, 12, 18
Satisfaction with Intervention
There are several open-ended questions to assess what is working well with the project, what could be improved, and any other comments about the intervention. There is also a question asking how participants feel about the project (5-point scale ranging from extremely negative to extremely positive).
Measured: Months 0, 12, 18
Participation Effort
This survey asks to report how much effort participants have made to help other groups in clinic and how much effort each of the other groups have made to help them. These questions have a 5-point scale (none at all, a little, a moderate amount, a lot, a great deal). These surveys also ask two open ended questions: problems with the intervention and what is not working in clinic with respect to the project and what is working well. This data will help the study team do continuous quality improvement within the clinics to ensure that the agreed-upon help is actually occurring.
Measured: Months 0, 12, 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start8 Sep 2023
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patient Care TeamStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Non-randomised
- Intervention model
- Single group
- Model description
- The study will recruit all staff except the clinic managers at each of five family medicine clinics within our academic family medicine department.
- Masking
- None (open label)
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Gold, University of Michigan
- Investigators
- Katherine Gold, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011239
- Sponsor's protocol ID
- HUM00239209
- Status last verified
- Nov 2025
- First submitted
- 18 Aug 2023
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stock R, Mahoney E, Carney PA. Measuring team development in clinical care settings. Fam Med. 2013 Nov-Dec;45(10):691-700.
PubMed 24347186Wee EXM, Fehr R. Compassion during difficult times: Team compassion behavior, suffering, supervisory dependence, and employee voice during COVID-19. J Appl Psychol. 2021 Dec;106(12):1805-1820. doi: 10.1037/apl0001001.
PubMed 34968091Pommier E, Neff KD, Toth-Kiraly I. The Development and Validation of the Compassion Scale. Assessment. 2020 Jan;27(1):21-39. doi: 10.1177/1073191119874108. Epub 2019 Sep 13.
PubMed 31516024Linzer M, McLoughlin C, Poplau S, Goelz E, Brown R, Sinsky C; AMA-Hennepin Health System (HHS) burnout reduction writing team. The Mini Z Worklife and Burnout Reduction Instrument: Psychometrics and Clinical Implications. J Gen Intern Med. 2022 Aug;37(11):2876-2878. doi: 10.1007/s11606-021-07278-3. Epub 2022 Jan 19. No abstract available.
PubMed 35048290
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Teams: A Study to Promote Team Collaboration in Family Medicine Clinics
- ClinicalTrials.gov ID
- NCT06011239
- Acronym / sponsor ID
- HUM00239209
- Keywords
- family medicine, team function, burnout, compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 25 Aug 2023 (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.
This project includes an intervention in five Michigan Medicine family medicine clinics which is designed to improve staff collaboration across different job roles.
Detailed description
The primary intervention asks staff to meet with others in the same role and to consider the following questions:
- The Ask: When staff are busy or overwhelmed by work, what tasks can others do (people in each of these groups) to help make your job better or easier?
- The Offer: When people in other groups are busy or overwhelmed, what tasks can your group do to help make staff jobs better or easier?
After this information is collected, at an in-person meeting of all staff and faculty, the study team will divide everyone into groups by clinic and then by the four roles. The study team will hand out the idea list and ask participants to review the list, discuss whether there are new or additional ideas which should be added, and then prioritize staffs top five "asks" and top five "offers" for staff role.
Negotiation of asks/offers: The study team will hold 1-4 subsequent brief meetings at each clinic where staff are again sub-divided into four groups by role. Each group will review the asks from people in other roles and decide whether these are actions that staff can help with or whether there are barriers. The clinic champions will work with the groups to address barriers (which could include lack of information, lack of training, disagreements about need, etc). The ultimate goal will be for groups to come to consensus agreement on at least three ways staff can assist people in other roles. In some clinics this may be straightforward and require just one meeting. In other clinics, it may take several meetings.
Implementation: Once the asks and offers are finalized, it will be up to the physician champions to help promote these agreements at the clinic, follow up with staff and with the nursing, medical assistants, and clerical champions to ensure that people are following thru with commitments to help, and trouble shoot problems that come up.
Coordination with Leadership: a department leader will serve as the liaison between the clinic champions and members of leadership that oversee clinical functions. This leader meets regularly with these leadership groups and will help troubleshoot challenges to implementing the asks and offers which need higher-level approval or input.
Ongoing process improvement: Over time, the study team will send up to four brief, anonymous surveys to all staff asking whether the staff are indeed doing the things that staff committed to do and whether other role groups are following thru on the commitments. This provides an opportunity for people to identify and report problems. This data will be anonymously fed back to the physician champion that is tasked to troubleshoot and address the problems identified, working with the liaison as appropriate. This will likely require continuous process improvement and revisiting to ensure success.
Evaluation: The study team proposes to measure burnout and team centeredness using anonymous on-line surveys.
Brief surveys: At several points during the year, the investigators will send out brief surveys. These ask for the clinic and job role and then ask participant to rate how much effort they have made to help others, how much effort others have made to help them, and if there are open-ended comment about what is or is not working. This information will be used to improve the intervention at each clinic.
Qualitative interviews regarding clinic culture will also be conducted with the project champions at each clinic who are helping to implement the project.
This study is Institutional review board (IRB) exempt and will have a waiver of documentation of informed consent with survey completion representing consent.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will recruit all staff except the clinic managers at each of five family medicine clinics within our academic family medicine department.
| Arm | Type | Receives |
|---|---|---|
| Survey participants | Experimental | Behavioral: Team-building processesAll participants in the study will be in a single arm, divided by clinic. |
| Clinic Staff | No intervention | –"Project champions" at each clinic who are helping to implement the project. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Staff in the roles of medical assistant, nurse, clerical staff, or clinician (physician, nurse practitioner, and physician assistant)
- Must work in one of five family medicine clinics at the University of Michigan.
Key exclusion criteria (2 listed)
- administrative clinic director at each site (managerial)
- Staff outside of the above roles such as a dietician, social worker, pharmacist
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 |
|---|---|---|
| Team-building processesAll staff in one of the four role groups (medical assistants (MAs); clerical/administrative staff; nursing staff; and physicians/nurse practitioners/physician assistants) will be sent an anonymous survey. The survey will ask staff to consider what help participants wish to ask for and what help participants can offer to staff in the other three roles at times when people are busy or overwhelmed. These ideas will be combined into a typed "idea list" for each role and then staff in clinics will discuss. Once these are finalized the clinics will implement these. At several points during the year, the study team will send out brief surveys. These surveys will collect the clinic and job role and ask participant to rate how much effort has been made in different ways, and if there are open-ended comments about what is or is not working. This information will be used to improve the intervention at each clinic. | Behavioural | Survey participants |
Primary outcome
Team Development measure
Time frame: Months 0, 12, 18
The Team Development Measure is a 31-item questionnaire designed to the domains of communication, roles and goals, cohesion, and team primacy. Each question has four response options (strongly disagree, disagree, agree, strongly agree). Summary scores are transformed to a 0-100 scale to provide a score of team functioning and cohesiveness with a higher score indicating a better-functioning team. This measure has been validated in primary care settings and has strong psychometric properties.
Team Compassion Behavior survey
Time frame: Months 0, 12, 18
The Team Compassion Behavior survey is a 6-question instrument adapted for teams from a longer individual compassion instrument. It is scored on a 5-point scale (almost never, seldom, sometimes, often, almost always) and summed for a total range of 6-30 point, with a higher score indicating more compassionate team behavior.
Burnout
Time frame: Months 0, 12, 18
The study team will use the first 10 questions of the Mini Z 3.0 (the 11th question is open-ended) to measure burnout across staff in all roles. It has just minor changes from the earlier MiniZ versions and has good performance with two subscales for supportive work environment and electronic medical record (EMR) stress. Each question has a 5-scale response option. Subscale 1 (supportive work environment) sums the responses to questions 1-7 and has a range of 7-35 with a score of 28 or higher indicating a highly supportive workplace. Subscale 2 (EMR stress) sums responses to questions 8-10 and has a range of 3-15 with a score of 12 or higher indicating a workplace with manageable EMR stress.
Satisfaction with Intervention
Time frame: Months 0, 12, 18
There are several open-ended questions to assess what is working well with the project, what could be improved, and any other comments about the intervention. There is also a question asking how participants feel about the project (5-point scale ranging from extremely negative to extremely positive).
Participation Effort
Time frame: Months 0, 12, 18
This survey asks to report how much effort participants have made to help other groups in clinic and how much effort each of the other groups have made to help them. These questions have a 5-point scale (none at all, a little, a moderate amount, a lot, a great deal). These surveys also ask two open ended questions: problems with the intervention and what is not working in clinic with respect to the project and what is working well. This data will help the study team do continuous quality improvement within the clinics to ensure that the agreed-upon help is actually occurring.
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 Nov 2025.
- Background: PubMed 24347186Stock R, Mahoney E, Carney PA. Measuring team development in clinical care settings. Fam Med. 2013 Nov-Dec;45(10):691-700.
- Background: PubMed 34968091Wee EXM, Fehr R. Compassion during difficult times: Team compassion behavior, suffering, supervisory dependence, and employee voice during COVID-19. J Appl Psychol. 2021 Dec;106(12):1805-1820. doi: 10.1037/apl0001001.
- Background: PubMed 31516024Pommier E, Neff KD, Toth-Kiraly I. The Development and Validation of the Compassion Scale. Assessment. 2020 Jan;27(1):21-39. doi: 10.1177/1073191119874108. Epub 2019 Sep 13.
- Background: PubMed 35048290Linzer M, McLoughlin C, Poplau S, Goelz E, Brown R, Sinsky C; AMA-Hennepin Health System (HHS) burnout reduction writing team. The Mini Z Worklife and Burnout Reduction Instrument: Psychometrics and Clinical Implications. J Gen Intern Med. 2022 Aug;37(11):2876-2878. doi: 10.1007/s11606-021-07278-3. Epub 2022 Jan 19. No abstract available.
- 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.
Katherine Gold, MD principal investigator
University of Michigan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team-building processes in people with Patient Care Team and Psychological Well-Being, run by University of Michigan at 5 sites 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 2 inclusion and 2 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 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Team Development measure (time frame: Months 0, 12, 18). The study lists 5 primary outcomes in all. 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 NCT06011239, which also lists 4 linked publications.
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 Nov 2025.