Clozapine CHAMPION-ECHO (Center for Help and Assistance for Maryland Prescribers- Improving Outcomes Network Using Extension for Community Healthcare Outcomes); Randomized Educational Study to Improve Clozapine Prescribing Through a Project ECHO Model
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 266
- Locations
- 1
- Primary Endpoint
- Change in Clozapine Prescriptions Using Medicaid Claims Data
Study Overview
Brief Summary
In a randomized controlled design with approximately 26 biweekly sessions over 12 months, the investigators propose to test the effectiveness of an ECHO-based intervention for improving the use of clozapine in people eligible for clozapine. The sessions will include: 1) active dissemination of knowledge and information by an expert "hub" followed by 2) clozapine case presentations and vignettes submitted by the "spokes".
This intervention, Clozapine CHAMPION-ECHO (Center for Help and Assistance for Maryland Prescribers- Improving Outcomes Network using Extension for Community Healthcare Outcomes, will be referred to as "CHAMPION" throughout.. To minimize ANC monitoring barriers and maximize recruitment, the investigators will provide Food and Drug Administration (FDA)-cleared ANC point of care (POC) monitoring devices to all study sites, including those in the control condition. The investigators will enroll at least 300 prescribers and additional clinical team members (up to 300) from up to 60 mental health clinics (MHCs) and other treatment sites; approximately half the participants will be randomized to CHAMPION and half randomized to enhanced treatment as usual (ETAU).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Located at a site in the State of Maryland with at least 3 prescribers at the site.
- •Prescribers/clinical team should be licensed in the State of Maryland and have prescribed antipsychotics previously.
- •Between the ages of 22 and 85 years old
- •Willing to participate in pre- and post-testing
- •Willing to agree to try to participate in the CHAMPION sessions
Exclusion Criteria
- •Not willing to participate in CHAMPION Sessions
Arms & Interventions
ECHO Intervention
Project ECHO (Extension for Community Healthcare Outcomes) based intervention 26 CME educational sessions. The sessions will include: 1) active dissemination of knowledge and information by an expert followed by 2) clozapine case presentations and vignettes. 1.25 hour long. Also consultation line and ATHELAS device.
Intervention: ECHO Intervention (Other)
eTAU
Consultation line and ATHELAS Device only
Intervention: eTAU (Other)
Outcomes
Primary Outcomes
Change in Clozapine Prescriptions Using Medicaid Claims Data
Time Frame: Baseline and endpoint changes after 12 month intervention
The data outcome is new clozapine prescriptions by provider based on a variable linking provider ID to percent of clozapine prescriptions.
Change in Prescriber Knowledge of Clozapine Use
Time Frame: Baseline and endpoint changes after 12 month intervention
A 52 item Multiple Choice Questionnaire will be used to assess knowledge. The knowledge-based test questions will consist of 2 questions per 26 topic areas and will conform to best practices and guidelines for design of the questions. The total mean score will range from 0-52 with higher scores being better outcome. The questions were developed and validated by the team.
Change in Self-reported Competence for Clozapine Use
Time Frame: Baseline and endpoint changes after 12 month intervention
We will use a mean score on a Visual Analog Scale (VAS) (0-100 mm) for overall competence with higher scores being better outcome.
Secondary Outcomes
No secondary outcomes reported
Investigators
Deanna Kelly
Cheif Treatment Research Program
University of Maryland, Baltimore