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Completed

NCT Number: NCT04325386

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 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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Key information

Conditions

Schizophrenia Schizoaffective Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)

Catonsville, Maryland, 21228, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECHO Intervention

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

Other

Consultation Line and ATHELAS device only

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Acronym: CHAMPION

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 27, 2020
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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