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NCT04325386 · ClinicalTrials.gov registry record · NA
Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.
A NA study of Schizophrenia Schizoaffective, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 266
- Enrollment target
- 1
- Study location
NCT04325386: Completed NA study of Schizophrenia Schizoaffective, sponsored by University of Maryland, Baltimore.
NCT04325386 is a NA study of Schizophrenia Schizoaffective that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 266 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04325386, a NA study of Schizophrenia Schizoaffective, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 266 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
The data outcome is new clozapine prescriptions by provider based on a variable linking provider ID to percent of clozapine prescriptions.
Conditions Studied
Interventions
- OTHER ECHO Intervention
- OTHER eTAU
Study Locations (1)
Maryland
- Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP) - Catonsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2020-02-01 |
| Est. Completion | 2024-09-20 |
| Phase | NA |
What the finished NCT04325386 record still lists
NCT04325386 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Schizophrenia Schizoaffective appearing as the primary indexed condition, and to 2 interventions - of which ECHO Intervention is the first listed.
NCT04325386 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04325386 about?
NCT04325386 is a clinical study titled "Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.". 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 knowl...
What is the current status of trial NCT04325386?
This trial is currently completed. It is a NA study. The enrollment target is 266 participants. The study started on 2020-02-01. Estimated completion is 2024-09-20.
What conditions does trial NCT04325386 study?
This clinical trial studies the following conditions: Schizophrenia Schizoaffective.
What interventions are being tested in trial NCT04325386?
The interventions under investigation include: ECHO Intervention (OTHER), eTAU (OTHER).
Who is sponsoring clinical trial NCT04325386?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04325386 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04325386's enrollment target sits among peer trials
266 395th of 2000 higher than 1,606 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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