A Patient-Centered Antipsychotic Medication Adherence Intervention Results From a Randomized Controlled Trial Jeffrey M. Pyne, MD, Ellen P. Fischer, PhD, Dinesh Mittal, MD, and Richard Owen, MD Abstract: The purpose of this study was to develop and test a patient-centered and sustainable antipsychotic medication adherence intervention. The study de- sign was a randomized controlled trial. Data from 61 patients diagnosed with schizophrenia or schizoaffective disorder were analyzed. The intervention in- cluded a checklist of barriers, facilitators, and motivators (BFM) for taking anti- psychotic medications. The results of the checklist were summarized and a note was placed in the electronic medical record (EMR) and a hard copy was given to the patient. However, less than half of the BFM progress notes were placed in the EMR before the clinician visit as planned. The intervention significantly im- proved adherence at 6 months but not at 12 months and the intervention's effect on total Positive and Negative Syndrome Scale scores was not statistically signif- icant. The BFM intervention is promising, but future studies are needed to im- prove the integration of the BFM intervention into typical clinic workflow. Key Words: Schizophrenia, antipsychotic, medication, adherence, intervention, patient-centered (J Nerv Ment Dis 2017;00: 00–00) R ecent meta-analyses and other reviews confirm that antipsychotic medications are efficacious treatments for schizophrenia (Johnsen and Jørgensen, 2008; Leucht et al., 2009). However, efficacious anti- psychotic regimens frequently do not achieve their goals because non- adherence rates approach 50% or higher (Cramer and Rosenheck, 1998; Lacro et al., 2002). In a naturalistic study, previously stable pa- tients with schizophrenia who discontinued their medication on their own experienced a 93% rate of relapse within 1 year (Wistedt, 1981). In the Clinical Antipsychotic Trials of Intervention Effectiveness study, 74% of patients discontinued their antipsychotic medication within 18 months either on their own or following the advice of their clinician (Lieberman et al., 2005). Nonadherence to antipsychotic medication treatment leads to a variety of clinical and economic problems, including psychotic relapse, increased clinic and emergency room visits, hospitali- zation, and increasing health care costs (Owen et al., 1996; Terkelsen and Menikoff, 1995; Weiden and Olfson, 1995; Wistedt, 1981). In addition, there is evidence that nonadherence to antipsychotic medications sub- stantially impairs health-related quality of life and functioning (Lehman et al., 1995). Many antipsychotic medication adherence interventions have been tested but few have been successful and none has been widely adopted (Barkhof et al., 2012; Byerly et al., 2007; Zygmunt et al., 2002). Those interventions proven successful in randomized controlled trials tended to take a multipronged approach and have a strong patient- centered focus, that is, using behavioral tailoring, patient activation, and motivational interviewing (Boczkowski et al., 1985; Gray et al., 2016; Kelly and Scott, 1990; Kemp et al., 1998; Velligan et al., 2008); psychoeducation groups delivered separately to patients and family members (Pitschel-Walz et al., 2006); or nurse care management (Gray et al., 2001). However, these interventions have not been sustained or widely adopted most likely because of the significant additional cost, for example, home visits and additional personnel. Financial incentives were also effective in improving adherence to treatment with long acting (depot) antipsychotic medications (Priebe et al., 2013). A recent review found evidence to support the feasibility of smartphone use in patients diagnosed with schizophrenia and other psychotic disorders, but limited efficacy data (Firth and Torous, 2015). Our overall goal was to develop and test a practical and sustainable patient-centered antipsychotic medication adherence intervention that could be used within “real-world” clinical settings. Given that maintaining antipsychotic medication adherence re- mains a critical and unresolved challenge for patients, providers, and systems of care, we involved patients and other stakeholders in assessing the barriers, facilitators, and motivators (BFM) associated with taking antipsychotic medications as prescribed and then assessed the agreement between patients and providers regarding these factors (Pyne et al., 2006). Data analysis indicated that there was poor patient/provider agreement regarding factors affecting medication taking. Therefore, we elected to develop an intervention to improve patient/ provider communication through the use of a checklist of BFM for taking antipsychotic medications that was completed by patients and shared with providers. We organized our intervention development efforts using the intervention mapping process (Bartholomew et al., 1998), which is a stepwise method for developing and implementing interventions that have been successfully used to develop and test behavior change inter- ventions (Alewijnse et al., 2002; Koekkoek et al., 2010; Schmid et al., 2010; Sterk, 2002). The intervention mapping process for this study in- cluded the following steps: (1) a needs and capacities assessment of the at-risk group (patients) and the capacities of patients and providers, (2) definition of proximal intervention objectives and the behavioral and environmental changes necessary to meet them, (3) a review of available interventions and practical strategies to address the problem, (4) intervention development, (5) intervention implementation, and (6) intervention evaluation (Bartholomew et al., 1998; 2000). The development of the BFM intervention is described else- where in more detail (Pyne et al., 2014). The BFM intervention was de- signed to a) identify BFMs for taking antipsychotic medications for an individual patient using the BFM checklist, b) provide specific sugges- tions for addressing the patient-identified barriers, and c) communicate this information to mental health providers via electronic medical re- cord (EMR) notes. The BFM intervention is consistent with expert Center for Mental Healthcare and Outcomes Research and South Central Mental Ill- ness Research, Education and Clinical Center, Central Arkansas Veterans Health- care System, North Little Rock; and Division of Health Services Research, Department of Psychiatry, College of Medicine, University of Arkansas for Med- ical Sciences, Little Rock, Arkansas. Send reprint requests to Jeffrey M. Pyne, MD, Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Healthcare System, 2200 Fort Roots Drive, North Little Rock, AR 72114. E‐mail: jmpyne@uams.edu. This study was supported by Veterans Affairs Health Services Research and Development Service Grant IIR 03-257-1. ClinicalTrials.gov Identifier: NCT00144027. Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved. ISSN: 0022-3018/17/0000–0000 DOI: 10.1097/NMD.0000000000000766 ORIGINAL ARTICLE The Journal of Nervous and Mental Disease • Volume 00, Number 00, Month 2017 www.jonmd.com 1