NCT07435753

Brief Summary

This study aims to strengthen leadership competencies among CU SOM faculty who have at least five direct reports by promoting meaningful behavior change in leadership practices and fostering a culture of peer support, to advance employee well-being and help reduce burnout among healthcare professionals. 125 leaders will take part in a six-month leadership development program consisting of 6 self-paced learning focus areas and 6 in-person sessions with peers to discuss. The investigators will evaluate the program's implementation process and its effectiveness in achieving desired outcomes.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

February 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

February 21, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

LeadershipBurnoutHealthcare workforceProfessional fulfillmentIntent to leaveBelongingLeadership intervention

Outcome Measures

Primary Outcomes (6)

  • Burnout

    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.

    Change from baseline to immediately after the intervention and at 3-months follow-up

  • Leadership

    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

    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

    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.

    Change from baseline to immediately after the intervention and at 3-months follow-up

  • Belonging

    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.

    Change from baseline to immediately after the intervention and at 3-months follow-up

  • Social isolation

    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 Outcomes (3)

  • Organizational health climate

    Change from baseline to immediately after the intervention and at 3-months follow-up

  • General self-efficacy

    Change from baseline to immediately after the intervention and at 3-months follow-up

  • Intent to leave

    Change from baseline to immediately after the intervention and at 3-months follow-up

Study Arms (2)

CU Thrive Leadership Circles

EXPERIMENTAL

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.

Behavioral: CU Thrive Leadership Circles

No intervention

NO INTERVENTION

Leaders are waitlisted and participate in the CU Thrive Leadership Circles after the intervention group

Interventions

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.

CU Thrive Leadership Circles

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Does not fit the criteria outlined above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Natalie V Schwatka, PhD MS

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie V Schwatka, PhD MS

CONTACT

Liselotte Dyrbye, MD MPHE

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 21, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual participant data underlying published results will be shared in de-identified form. This includes quantitative survey data and qualitative interview data with direct identifiers removed and sensitive content redacted as needed to protect participant confidentiality.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available beginning after publication of primary study results and for up to 5 years thereafter.
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.

Locations