Schizophrenia SchizoaffectiveCHAMPIONNCT04325386
Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.
A study testing ECHO Intervention and eTAU in people with Schizophrenia Schizoaffective, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Schizoaffective
- What is being tested?
- ECHO Intervention and eTAU
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not willing to participate in CHAMPION Sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
Catonsville, Maryland, 21228
About this study
Official 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
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
- Being tested
- ECHO Intervention, eTAU
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHO InterventionOther
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.
eTAUOther
Consultation Line and ATHELAS device only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ECHO Intervention |
| eTAU | Placebo comparator | Consultation line and ATHELAS Device only Receives: Other: eTAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and endpoint changes after 12 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Feb 2020
- Primary completion7 Jun 2023
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Schizophrenia SchizoaffectiveStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will compare an educational intervention between prescribers who individually enrolled from participating clinics.
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deanna Kelly, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325386
- Sponsor's protocol ID
- HP-00087399
- Acronym
- CHAMPION
- Status last verified
- Aug 2025
- First submitted
- 11 Feb 2020
- Last updated
- 12 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04325386
- Acronym / sponsor ID
- CHAMPION / HP-00087399
- Conditions
- Schizophrenia Schizoaffective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Posted 12 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will compare an educational intervention between prescribers who individually enrolled from participating clinics.
| Arm | Type | Receives |
|---|---|---|
| ECHO Intervention | Experimental | Other: ECHO InterventionProject 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 | Placebo comparator | Other: eTAUConsultation line and ATHELAS Device only |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing to participate in CHAMPION Sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECHO InterventionProject 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 |
| eTAUConsultation Line and ATHELAS device only | Other | eTAU |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECHO Intervention and eTAU in people with Schizophrenia Schizoaffective, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clozapine Prescriptions Using Medicaid Claims Data (time frame: Baseline and endpoint changes after 12 month intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.