N/A
Completed N=266
Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.
Schizophrenia Schizoaffective
Source: ClinicalTrials.gov NCT04325386 ↗
Enrolled (actual)
266
Serious AEs
—
Results posted
Aug 2025
Primary outcomePrimary: Change in Clozapine Prescriptions Using Medicaid Claims Data — 9.4; 10.8; 11.8; 9.5 Mean percent of Clozapine prescriptions
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clozapine Prescriptions Using Medicaid Claims Data |
9.4; 10.8; 11.8; 9.5 | — |
| PRIMARY Change in Prescriber Knowledge of Clozapine Use |
63; 66; 71; 67 | — |
| PRIMARY Change in Self-reported Competence for Clozapine Use |
55.3; 59.0; 68.4; 71.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04325386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.