- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07435753
Leadership ThriveCircles (Leadership)
Leadership ThriveCircles for Well-Being at University of Colorado School of Medicine (CU SOM)
Study Overview
Status
Intervention / Treatment
Detailed Description
The goal of this project is to design, implement, and evaluate a creative, sustainable leadership development program - Leadership Thrive Circles - focused on helping supervisors: 1) lead with respect and inclusion by ensuring all team members feel valued and welcome; 2) communicate openly and transparently, 3) seek input regularly, 4) support each person's professional growth and aspirations, and 5) express genuine appreciation and gratitude for their contributions. This program will be grounded in evidence-based leadership practices that support professional well-being and help reduce burnout among healthcare professionals.
A core premise of this initiative is that leader well-being is foundational to team well-being. Leaders who experience fulfillment, support, psychological safety, and manageable stress are better positioned to model healthy behaviors, build supportive environments, and promote well-being among their direct reports. Thus, Leadership Thrive Circles is also intentionally designed to strengthen the well-being of leaders themselves-recognizing that investing in leaders produces positive ripple effects across entire teams and departments.
There is a recognized need for leadership development. While there is substantial evidence highlighting the importance of leadership in healthcare-and the core skills leaders should demonstrate with their teams-there remains a gap in programs tailored specifically to the unique needs of CU SOM leaders.
In addition, emerging research underscores that leader well-being directly influences workplace culture, team functioning, and the well-being and retention of faculty and staff. Leaders facing high stress, burnout, or misalignment may struggle to provide effective support, communication, and recognition-factors that the CU SOM well-being data consistently identifies as essential to a healthy, high-functioning environment. Addressing leader well-being is therefore not only beneficial for leaders themselves but also essential for promoting the well-being of their direct reports. Leadership Thrive Circles aims to fill this dual need by equipping leaders with both the skills and the personal well-being resources required to lead healthy, thriving teams.
The objectives are to: 1) Strengthen leadership competencies among CU SOM faculty who have at least five direct reports. 2) Promote meaningful behavior change in leadership practices among these leaders. 3) Foster a culture of peer support as leaders integrate new skills into their daily workflows. 4) Evaluate the program's implementation process and its effectiveness in achieving desired outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natalie V Schwatka, PhD MS
- Phone Number: 13037244607
- Email: natalie.schwatka@cuanschutz.edu
Study Contact Backup
- Name: Liselotte Dyrbye, MD MPHE
- Email: liselotte.dyrbye@cuanschtuz.edu
Study Locations
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-
Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medical Campus
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Contact:
- Natalie V Schwatka, PhD MS
- Phone Number: 3037244607
- Email: natalie.schwatka@cuanschutz.edu
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Contact:
- Liselotte Dyrbye, MD MPHE
- Email: liselotte.dyrbye@cuanschutz.edu
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Principal Investigator:
- Natalie V Schwatka, PhD MS
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Sub-Investigator:
- Liselotte Dyrbye, MD MPHE
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Sub-Investigator:
- Carol Brown, PhD
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Sub-Investigator:
- Amy Schamberg, EdS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Leader
- CU SOM faculty member who is either a physician, advanced practice provider, licensed mental health professional, research scientist or other CU SOM faculty member
- Works at least half time
- Has at least 5 employees who directly report to them
- Not participating in the CU Thrive Circle intervention (like this leadership program but NOT for those in a leadership role)
- Willingness to participate in the breadth of the leadership program
- Able to participate in the in-person sessions
Employee
o Direct report of a leader who is in the program
Exclusion Criteria:
- Does not fit the criteria outlined above
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No intervention
Leaders are waitlisted and participate in the CU Thrive Leadership Circles after the intervention group
|
|
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Experimental: CU Thrive Leadership Circles
The CU SOM leadership program is based on the Wellness-Centered Leadership framework and Mayo Clinic Leadership Index behaviors, using a Colleagues Meeting to Promote and Sustain Satisfaction (COMPASS)-style peer group model to build leadership skills and community.
Leaders complete brief pre-work and on-the-job practice challenges delivered through an online dashboard, then participate in facilitated peer sessions to discuss implementation successes and barriers.
Sessions are led by trained leader-facilitators, with researchers not present, and include structured agendas to support consistent implementation and skill development.
|
The CU SOM leadership program is based on the Wellness-Centered Leadership framework and Mayo Clinic Leadership Index behaviors, using a COMPASS-style peer group model to build leadership skills and community.
Leaders complete brief pre-work and on-the-job practice challenges delivered through an online dashboard, then participate in facilitated peer sessions to discuss implementation successes and barriers.
Sessions are led by trained leader-facilitators, with researchers not present, and include structured agendas to support consistent implementation and skill development.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Leadership
Time Frame: Change from baseline to immediately after the intervention and at 3-months follow-up
|
Mayo Clinic Leadership Index (MLI) - a validated, self-report instrument developed at Mayo Clinic that asks healthcare professionals to rate their direct-report supervisor across key dimensions of well-being centered leadership, including inclusion, communication, empowerment, professional development, and recognition.
The instrument is a 9-item questionnaire.
Each item is scored on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree").
|
Change from baseline to immediately after the intervention and at 3-months follow-up
|
|
Professional fulfillment
Time Frame: Change from baseline to immediately after the intervention and at 3-months follow-up
|
Stanford Professional Fulfillment Index (PFI) - a validated instrument designed to measure professional fulfillment (positive aspects of work) among physicians and other healthcare professionals.
It includes 6 items assessing intrinsic positive reward from work (e.g., meaningfulness, satisfaction, sense of contribution).
It was measured on a Not at all true (0), Somewhat true (1), Moderately true (2), Very true (3), Completely true (4) scale.
|
Change from baseline to immediately after the intervention and at 3-months follow-up
|
|
Leadership self-efficacy
Time Frame: Change from baseline to immediately after the intervention and at 3-months follow-up
|
Leadership self-efficacy was measured with a modified version of the Mayo Leadership Index to assess their confidence in enacting each of the leadership behaviors.
8-items from the Mayo Leadership Index were modified to start with "I feel confident I can…" and were measured with the following scale: Strongly Agree (5), Agree (4), Neither Agree nor Disagree (3), Disagree (2), Strongly Disagree (1) scale.
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Change from baseline to immediately after the intervention and at 3-months follow-up
|
|
Burnout
Time Frame: Change from baseline to immediately after the intervention and at 3-months follow-up
|
Maslach Burnout Inventory (MBI) - Human Services Survey for Medical Personnel (MBI-HSS MP) is a 22-item survey that covers 3 areas: Emotional Exhaustion (EE, range 0-54, higher score greater EE), Depersonalization (DP, range 0 - 30, higher score greater DP), and low sense of Personal Accomplishment (PA, range 0 -48, higher score greater PA).
Each subscale includes multiple questions with frequency rating choices of Never, A few times a year or less, Once a month or less, A few times a month, Once a week, A few times a week, or Every day.
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Change from baseline to immediately after the intervention and at 3-months follow-up
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Belonging
Time Frame: Change from baseline to immediately after the intervention and at 3-months follow-up
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Adapted from the belonging assessment used in Hunderfund et al., Sense of Belonging Among Medical Students, Residents, and Fellows: Associations with Burnout, Recruitment Retention, and Learning Environment.
Two items capturing participants' self-reported sense of belonging within key institutional contexts - within the school and their unit.
This was assessed on a 1 = Strongly disagree to 5 = Strongly agree scale.
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Change from baseline to immediately after the intervention and at 3-months follow-up
|
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Social isolation
Time Frame: Change from baseline to immediately after the intervention and at 3-months follow-up
|
Social isolation - the Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item short form of the social isolation scale was used.
It was measured on a Never (0), Rarely (1), Sometimes (2), Often (3), Always (4) scale.
|
Change from baseline to immediately after the intervention and at 3-months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
General self-efficacy
Time Frame: Change from baseline to immediately after the intervention and at 3-months follow-up
|
General self-efficacy measures an individual's broad, stable belief in their own capacity to cope with a variety of challenging demands, and has been identified as an influential variable related to adaptation to stress and chronic illness.
This was measured with Romppel et al.'s (2013) measure.
It has 6-items measured with a Not at all true (1), Hardly true (2), Moderately true (3), Exactly true (4) scale.
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Change from baseline to immediately after the intervention and at 3-months follow-up
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Organizational health climate
Time Frame: Change from baseline to immediately after the intervention and at 3-months follow-up
|
Organizational health climate assessment includes 10 questions assessing their organization and supervisors engagement in practices that support employee health.
It was measured using a Strongly Agree (5), Agree (4), Neither Agree nor Disagree (3), Disagree (2), Strongly Disagree (1) scale.
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Change from baseline to immediately after the intervention and at 3-months follow-up
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Intent to leave
Time Frame: Change from baseline to immediately after the intervention and at 3-months follow-up
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This outcome is assessed via a single self-report survey item developed for this study to capture an individual's perceived likelihood of leaving employment with the CU SOM within the next two years.
The item is designed to serve as a pragmatic indicator of turnover intention, a commonly reported correlate of well-being, job satisfaction, and organizational climate in healthcare workforce research.Higher scores indicate a greater self-reported likelihood of leaving CU SOM within the next two years (i.e., stronger turnover intention).
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Change from baseline to immediately after the intervention and at 3-months follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Natalie V Schwatka, PhD MS, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-0009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
De-identified datasets and supporting materials (such as the study protocol, survey instruments, interview guides, and analytic codebooks) will be made available to qualified researchers upon reasonable request and approval of a data use agreement, in accordance with IRB requirements and participant consent.
Because qualitative interview transcripts may contain potentially identifying contextual information, access to full transcripts may be limited or provided in redacted or coded form.
Requests must include a brief proposal describing the planned use of the data and plans to maintain confidentiality. Data will be shared via secure electronic transfer.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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