MIAMI BEACH – Implementing an online decision support tool was one pivotal component of a highly effective structured program to aid community-based prescribers treating those with their first episode of schizophrenia. Members of an investigative team comparing the structured program to usual care shared their findings during a panel session at a meeting of the American Society of Clinical Psychopharmacology, formerly known as the New Clinical Drug Evaluation Unit meeting.
The lifetime prevalence of schizophrenia is less than 1%, and the number of first episodes of schizophrenia each year also is low. This is a core challenge in treatment, said session leader Dr. Delbert G. Robinson of the Hofstra North Shore-LIJ School of Medicine, Glen Oaks, N.Y. Many community prescribers have experience treating schizophrenia as a chronic illness, but few will have much exposure to early-phase illness.
Dr. Delbert Robinson
To determine the most effective way for these community prescribers to provide effective treatment for those newly diagnosed with schizophrenia, the National Institute of Mental Health tested usual care against a structured program in RAISE-ETP (Recovery After Initial Schizophrenia Episode–Early Treatment Program). The multistate, multisite controlled trial used cluster randomization at 34 community clinical sites in 21 states.
The study compared current care to the NAVIGATE model, a structured, team-based, multifaceted approach to treating newly diagnosed schizophrenia. Treatment protocols in early schizophrenia differ from more established disease, Dr. Robinson said. For example, recommended initial antipsychotic dosing is lower. Further, implementing NAVIGATE meant that investigators had to persuade prescribers at nonacademic community centers to change their habits – not an easy task.
During the study period, 3,939 visits occurred using COMPASS, the computerized encounter and decision support tool developed by the study team. This cloud-based online system included a comprehensive previsit questionnaire completed by patients, as well as an encounter form to be completed by the clinician with patient input during the visit. COMPASS emphasized shared decision making; for example, visit priorities were set jointly by prescriber and patient, said Dr. Eric D. Achtyes of Michigan State University, Grand Rapids.
Further, decision support tools prompt prescribers to turn first to evidence-based initial medication choices and doses for early schizophrenia, said Dr. Achtyes, director of the division of psychiatry and behavioral medicine at the university’s College of Human Medicine.
Overall, 404 subjects were enrolled in the two arms, of whom 223 were cluster-randomized to the NAVIGATE arm. Subjects aged 15-40 years who had experienced their first episode of psychosis and had a diagnosis in the schizophrenia spectrum were eligible if they had not taken more than 6 months of antipsychotic medication at enrollment. Mean age of the participants was 23, and about three-quarters of enrollments occurred subsequent to a psychiatric hospitalization. More than half of participants had dyslipidemia or were overweight or obese, about half smoked, and more than 10% had metabolic syndrome – numbers that are “very concerning” for such a young cohort, said Nina R. Schooler, Ph.D., professor of psychiatry and behavioral sciences at SUNY (State University of New York) Downstate Medical Center, Brooklyn.
Data analysis is ongoing, but initial results show that NAVIGATE participants stay in treatment significantly longer than do those receiving usual care. The research team is examining odds ratios for receiving a first-line antipsychotic in any given month and tracking trends in psychosocial care over time for the two study arms, Dr. Schooler said.
The cluster design had advantages in “the ease of operation” in terms of doing the study, Dr. Schooler said in an interview. “Each study site had only had one protocol to learn, one study design to run, and one set of trainings for staff to complete. However, data analysis is more complex with cluster randomization. Dr. Robinson noted that the design “vastly simplified the life of the site but shifted the burden to the central team.” The study used a blended assessment model, with some evaluations conducted on site and others conducted by centralized evaluators, another study strength, Dr. Schooler said.
Discussant Dr. Joseph P. McEvoy commended the panelists for their important work in this area. Especially important is the emphasis on rational implementation of evidence-based treatment in early schizophrenia within a framework achievable with current resources, said Dr. McEvoy, I.W. Case Distinguished Professor of Psychiatry at Georgia Regents University, Augusta. He noted that the Substance Abuse and Mental Health Services Administration has allocated per-state funding for demonstration projects that build on the NAVIGATE model.
The National Institute of Mental Health funded the study. Dr. Robinson reported ties with Otsuka; Dr. Achtyes disclosed ties with Roche, Janssen, AssurEx Health, and Otsuka; Dr. Schooler has ties with Roche, Sunovion, EnVivo/Forum, Genentech, Otsuka, and Neurocrine; and Dr. McEvoy reported ties with several pharmaceutical companies.