Trial Outcomes & Findings for Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use. (NCT NCT04325386)
NCT ID: NCT04325386
Last Updated: 2025-08-12
Results Overview
The data outcome is new clozapine prescriptions by provider based on a variable linking provider ID to percent of clozapine prescriptions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
266 participants
Primary outcome timeframe
Baseline and endpoint changes after 12 month intervention
Results posted on
2025-08-12
Participant Flow
As per grant and protocol all outcomes are by participant level no analysis by site.
Unit of analysis: Clinics
Participant milestones
| Measure |
ECHO Intervention
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.
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.
|
Enhanced Treatment As Usual (eTAU)
No Education Session: No Education Session
|
|---|---|---|
|
Overall Study
STARTED
|
126 21
|
140 22
|
|
Overall Study
COMPLETED
|
126 21
|
140 22
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clozapine CHAMPION-ECHO Educational Study to Improve Clozapine Use.
Baseline characteristics by cohort
| Measure |
Education Sessions
n=126 Participants
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.
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.
|
No Education Sessions
n=140 Participants
No Education Session: No Education Session
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
39 year or less
|
47 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
16 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Customized
60 years or more
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
71 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=5 Participants
|
140 participants
n=7 Participants
|
266 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and endpoint changes after 12 month interventionThe data outcome is new clozapine prescriptions by provider based on a variable linking provider ID to percent of clozapine prescriptions.
Outcome measures
| Measure |
ECHO Intervention
n=126 Participants
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
n=140 Participants
No Education Session. Consultation Line and ATHELAS Device only
|
|---|---|---|
|
Change in Clozapine Prescriptions Using Medicaid Claims Data
Mean percent of Clozapine prescriptions among antipsychotic prescribing Pre Intervention
|
9.4 Mean percent of Clozapine prescriptions
Standard Error 0.70
|
10.8 Mean percent of Clozapine prescriptions
Standard Error 0.79
|
|
Change in Clozapine Prescriptions Using Medicaid Claims Data
Mean percent of Clozapine prescriptions among antipsychotic prescribing Post intervention
|
11.8 Mean percent of Clozapine prescriptions
Standard Error 0.92
|
9.5 Mean percent of Clozapine prescriptions
Standard Error 0.90
|
PRIMARY outcome
Timeframe: Baseline and endpoint changes after 12 month interventionA 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.
Outcome measures
| Measure |
ECHO Intervention
n=126 Participants
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
n=140 Participants
No Education Session. Consultation Line and ATHELAS Device only
|
|---|---|---|
|
Change in Prescriber Knowledge of Clozapine Use
Pre Intervention
|
63 Percentage of Correct responses reported
Standard Deviation 12
|
66 Percentage of Correct responses reported
Standard Deviation 11
|
|
Change in Prescriber Knowledge of Clozapine Use
Post Intervention
|
71 Percentage of Correct responses reported
Standard Deviation 17
|
67 Percentage of Correct responses reported
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Baseline and endpoint changes after 12 month interventionWe will use a mean score on a Visual Analog Scale (VAS) (0-100 mm) for overall competence with higher scores being better outcome.
Outcome measures
| Measure |
ECHO Intervention
n=126 Participants
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
n=140 Participants
No Education Session. Consultation Line and ATHELAS Device only
|
|---|---|---|
|
Change in Self-reported Competence for Clozapine Use
Pre Sessions
|
55.3 score on a scale
Standard Deviation 21.0
|
59.0 score on a scale
Standard Deviation 20.5
|
|
Change in Self-reported Competence for Clozapine Use
Post Sessions
|
68.4 score on a scale
Standard Deviation 22.3
|
71.4 score on a scale
Standard Deviation 19.2
|
Adverse Events
Education Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Education Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Deanna L. Kelly, PharmD, BCPP
University of Maryland, Baltimore
Phone: 410-402-6861
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place