Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use. (CHAMPION)

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

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 60 outpatient mental health clinics (OMHCs) and other treatment sites; approximately half the OHMCs will be randomized to CHAMPION and half randomized to enhanced treatment as usual (ETAU).

Study Overview

• Status: Active, not recruiting
• Conditions: Schizophrenia Schizoaffective
• Intervention / Treatment: Other: Education Sessions; Other: No Education Session

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Catonsville, Maryland, United States, 21228
      • Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education sessions; Project ECHO (Extension for Community Healthcare Outcomes) based intervention sessions for improving the use of clozapine in people with treatment-resistant schizophrenia. The sessions will include: 1) active dissemination of knowledge and information by an expert followed by 2) clozapine case presentations and vignettes.	Other: Education Sessions; Project ECHO (Extension for Community Healthcare Outcomes) based intervention sessions for improving the use of clozapine in people with treatment-resistant schizophrenia. The sessions will include: 1) active dissemination of knowledge and information by an expert followed by 2) clozapine case presentations and vignettes.
Placebo Comparator: No education sessions	Other: No Education Session; No Education Session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 clozapine prescriptions. The outcome is the increase in the proportion of patients treated with clozapine for those in the care of prescribers randomized to the CHAMPION relative to the ETAU condition.	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. 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). We will have one for overall competence and then one for each of the 26 topic areas. Overall, self report scores and the global self report scores will be used.	Baseline and endpoint changes after 12 month intervention

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: HP-00087399

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No