Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2024-09-20

Brief Summary

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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).

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Detailed Description

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Conditions

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Schizophrenia Schizoaffective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators will compare an educational intervention between prescribers who individually enrolled from participating clinics.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ECHO Intervention

Intervention Type OTHER

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.

eTAU

Consultation line and ATHELAS Device only

Group Type PLACEBO_COMPARATOR

eTAU

Intervention Type OTHER

Consultation Line and ATHELAS device only

Interventions

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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 Type OTHER

eTAU

Consultation Line and ATHELAS device only

Intervention Type OTHER

Eligibility Criteria

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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