Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.

NCT04325386 | Completed Results

• 1 other identifier: HP-00087399
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Schizophrenia Schizoaffective

Outcome Measures

Primary Outcomes (3)

• Change in Clozapine Prescriptions Using Medicaid Claims Data

  The data outcome is new clozapine prescriptions by provider based on a variable linking provider ID to percent of clozapine prescriptions.

  Baseline and endpoint changes after 12 month intervention

• Change in Prescriber Knowledge of Clozapine Use

  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.

  Baseline and endpoint changes after 12 month intervention

• Change in Self-reported Competence for Clozapine Use

  We will use a mean score on a Visual Analog Scale (VAS) (0-100 mm) for overall competence with higher scores being better outcome.

  Baseline and endpoint changes after 12 month intervention

Study Arms (2)

ECHO Intervention

EXPERIMENTAL

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.

Other: ECHO Intervention

eTAU

PLACEBO COMPARATOR

Consultation line and ATHELAS Device only

Other: eTAU

Interventions

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.

ECHO Intervention

eTAU OTHER

Consultation Line and ATHELAS device only

eTAU

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not willing to participate in CHAMPION Sessions

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

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

Catonsville, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Deanna L. Kelly, PharmD, BCPP
• Organization: University of Maryland, Baltimore

dlkelly@som.umaryland.edu

410-402-6861

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cheif Treatment Research Program

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

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: March 27, 2020
• Study Start: February 1, 2020
• Primary Completion: June 7, 2023
• Study Completion: September 20, 2024
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-08

Locations

US (1)