NCT06011239

Brief Summary

This project includes an intervention in five Michigan Medicine family medicine clinics which is designed to improve staff collaboration across different job roles.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
614

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

September 8, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

August 18, 2023

Last Update Submit

November 7, 2025

Conditions

Keywords

family medicineteam functionburnoutcompassion

Outcome Measures

Primary Outcomes (5)

  • 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, 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.

    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.

    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).

    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.

    Months 0, 12, 18

Other Outcomes (1)

  • Clinic Culture

    1 month

Study Arms (2)

Survey participants

EXPERIMENTAL

All participants in the study will be in a single arm, divided by clinic.

Behavioral: Team-building processes

Clinic Staff

NO INTERVENTION

"Project champions" at each clinic who are helping to implement the project.

Interventions

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.

Survey participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • administrative clinic director at each site (managerial)
  • Staff outside of the above roles such as a dietician, social worker, pharmacist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Michigan-Domino Farms

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan- Briarwood

Ann Arbor, Michigan, 48108, United States

Location

Uniiversity of Michigan- Chelsea

Chelsea, Michigan, 48118, United States

Location

University of Michigan-Dexter

Dexter, Michigan, 48130, United States

Location

University of Michigan-Ypsilanti

Ypsilanti, Michigan, 48198, United States

Location

Related Publications (4)

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

    PMID: 24347186BACKGROUND
  • 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.

    PMID: 34968091BACKGROUND
  • 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.

    PMID: 31516024BACKGROUND
  • 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.

    PMID: 35048290BACKGROUND

MeSH Terms

Conditions

Psychological Well-BeingBurnout, ProfessionalBurnout, Psychological

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorOccupational StressOccupational DiseasesStress, PsychologicalBehavioral Symptoms

Study Officials

  • Katherine Gold, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The study will recruit all staff except the clinic managers at each of five family medicine clinics within our academic family medicine department.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Family Medicine and of Obstetrics and Gynecology

Study Record Dates

First Submitted

August 18, 2023

First Posted

August 25, 2023

Study Start

September 8, 2023

Primary Completion

October 20, 2025

Study Completion

October 20, 2025

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations