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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06011239
Other study ID # HUM00239209
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 8, 2023
Est. completion date November 30, 2024

Study information

Verified date September 2023
Source University of Michigan
Contact Katherine J Gold, MD
Phone 734-998-2449
Email ktgold@umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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. This study is Institutional review board (IRB) exempt and will have a waiver of documentation of informed consent with survey completion representing consent.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - administrative clinic director at each site (managerial) - Staff outside of the above roles such as a dietician, social worker, pharmacist

Study Design


Intervention

Behavioral:
Team-building processes
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.

Locations

Country Name City State
United States University of Michigan- Briarwood Ann Arbor Michigan
United States University of Michigan-Domino Farms Ann Arbor Michigan
United States Uniiversity of Michigan- Chelsea Chelsea Michigan
United States University of Michigan-Dexter Dexter Michigan
United States University of Michigan-Ypsilanti Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (4)

Linzer 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. — View Citation

Pommier 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. — View Citation

Stock R, Mahoney E, Carney PA. Measuring team development in clinical care settings. Fam Med. 2013 Nov-Dec;45(10):691-700. — View Citation

Wee 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Months 0, 6, 12
Primary 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. Months 0, 6, 12
Primary 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. Months 0, 6, 12
Primary 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). Months 6, 12
Primary 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. Months 3, 4, 8, 10
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