Schizophrenia is one of the leading causes of disability worldwide and the burden of this disease on individual health and society at large is substantial. While new pharmacological treatments are emerging, no treatment has yet to rival the efficacy of clozapine. Yet the number of people with schizophrenia who are prescribed clozapine is <5% nationally, despite its recommended use in about 30-50% of people with treatment-resistant schizophrenia. Arguably, clozapine is one of the most underutilized evidence-based treatments in psychiatry and optimization of its use would improve patient outcomes and lower treatment costs. Many barriers contribute to clozapine underutilization; however, our pilot data and data from others show that lack of prescriber competence to use clozapine and challenging logistics for absolute neutrophil counts (ANC) monitoring outside of the office are two of the greatest barriers to clozapine use. Further, pilot data shows that prescriber self-reported competence in using clozapine correlates with their prescription of clozapine. Therefore, without improving competence, changes in prescribing of clozapine are unlikely to occur. In the last 15 years, a unique, structured and empirically validated tele-mentoring model has emerged called Project ECHO (Extension for Community Healthcare Outcomes). ECHO is a ?hub? and ?spoke? sharing network led by an expert academic team (the ?hub?) that uses multipoint video conferencing to conduct virtual clinics with non-expert prescribers (the ?spokes?) located in areas outside the academic hub site. The use of ECHO has been shown to significantly improve best-practice specialty care in sites that lack expertise in a variety of disease states. Importantly, multiple studies have established its efficacy in improving prescriber competence, the ?target mechanism,? we hypothesize to be linked to increased clozapine prescribing. In a randomized controlled design with 26 biweekly sessions over 12 months, we propose to test the effectiveness of an ECHO-based intervention, ?CHAMPION?, that includes 1.25 hours sessions which include: 1) active dissemination of knowledge and information by an expert ?hub? followed by 2) clozapine case presentations and vignettes submitted by the ?spokes?. To minimize ANC monitoring barriers and maximize recruitment, we will provide Food and Drug Administration (FDA)-approved ANC point of care (POC) monitoring devices to all study sites, including those in the control condition (the PI has been extensively involved with the development and testing of the POC device). We will enroll 300 prescribers from 60 outpatient mental health clinics (OMHCs); half the OHMCs will be randomized to CHAMPION and half randomized to enhanced treatment as usual (ETAU). Our primary outcomes are to increase clozapine use and persistence of clozapine (measured by analysis of Medicaid prescription data), to measure changes in prescriber knowledge and self-reported competence scores for using clozapine, and to test if self-reported competence scores mediate clozapine prescribing as our identified ?target.?

Public Health Relevance

Clozapine is the most underutilized evidence-based treatment in psychiatry and optimized use of this medication could produce improved outcomes and lower treatment costs in schizophrenia. We plan to test the effectiveness of a structured telementoring intervention for clozapine at outpatient mental health clinics (OMHC) throughout the State of Maryland using a randomized controlled clinical trial design (300 prescribers at 60 sites randomized to intervention or enhanced treatment as usual (control)). The proposed telementoring intervention is an innovative medical education and consultation delivery model (15 minutes didactic and 1- hour consultation session) that has been shown to increase prescriber self-reported competence. We will measure change in clozapine prescribing and will test whether prescriber self-reported competence mediates the change in prescribing behavior. We will also examine prescribing outcomes in underserved African- American minority patients.

National Institute of Health (NIH)
National Institute of Mental Health (NIMH)
Method to Extend Research in Time (MERIT) Award (R37)
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Special Emphasis Panel (ZMH1)
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Juliano-Bult, Denise M
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University of Maryland Baltimore
Schools of Medicine
United States
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