Adults 22 to 85, any sex, with Schizophrenia Schizoaffective. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Clozapine Prescriptions Using Medicaid Claims DataPrimary· 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.
Mean percent of Clozapine prescriptions among antipsychotic prescribing Pre Intervention
Group
Value
95% CI
ECHO Intervention
9.4
± 0.70
eTAU
10.8
± 0.79
Mean percent of Clozapine prescriptions among antipsychotic prescribing Post intervention
Group
Value
95% CI
ECHO Intervention
11.8
± 0.92
eTAU
9.5
± 0.90
Change in Prescriber Knowledge of Clozapine UsePrimary· 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.
Pre Intervention
Group
Value
95% CI
Echo Intervention
63
± 12
eTAU
66
± 11
Post Intervention
Group
Value
95% CI
Echo Intervention
71
± 17
eTAU
67
± 12
Change in Self-reported Competence for Clozapine UsePrimary· 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.
Pre Sessions
Group
Value
95% CI
ECHO Intervention
55.3
± 21.0
eTAU
59.0
± 20.5
Post Sessions
Group
Value
95% CI
ECHO Intervention
68.4
± 22.3
eTAU
71.4
± 19.2
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Maryland, Baltimore
Last refreshed: 12 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04325386.