A randomized controlled trial of customized adherence enhancement (CAE-E): study protocol for a hybrid effectiveness-implementation project

Jennifer B Levin, Farren Briggs, Carol Blixen, Mark Bauer, Douglas Einstadter, Jeffrey M Albert, Celeste Weise, Nicole Woods, Edna Fuentes-Casiano, Kristin A Cassidy, Julie Rentsch, Kaylee Sarna, Martha Sajatovic, Jennifer B Levin, Farren Briggs, Carol Blixen, Mark Bauer, Douglas Einstadter, Jeffrey M Albert, Celeste Weise, Nicole Woods, Edna Fuentes-Casiano, Kristin A Cassidy, Julie Rentsch, Kaylee Sarna, Martha Sajatovic

Abstract

Background: Mood-stabilizing medications are a cornerstone of treatment for people with bipolar disorder, though approximately half of these individuals are poorly adherent with their medication, leading to negative and even severe health consequences. While a variety of approaches can lead to some improvement in medication adherence, there is no single approach that has superior adherence enhancement and limited data on how these approaches can be implemented in clinical settings. Existing data have shown an increasing need for virtual delivery of care and interactive telemedicine interventions may be effective in improving adherence to long-term medication.

Methods: Customized adherence enhancement (CAE) is a brief, practical bipolar-specific approach that identifies and targets individual patient adherence barriers for intervention using a flexibly administered modular format that can be delivered via telehealth communications. CAE is comprised of up to four standard treatment modules including Psychoeducation, Communication with Providers, Medication Routines, and Modified Motivational Interviewing. Participants will attend assigned module sessions with an interventionist based on their reasons for non-adherence and will be assessed for adherence, functioning, bipolar symptoms, and health resource use across a 12-month period. Qualitative and quantitative data will also be collected to assess barriers and facilitators to CAE implementation and reach and adoption of CAE among clinicians in the community.

Discussion: The proposed study addresses the need for practical adherence interventions that are effective, flexible, and designed to adapt to different settings and patients. By focusing on a high-risk, vulnerable group of people with bipolar disorder, and refining an evidence-based approach that will integrate into workflow of public-sector care and community mental health clinics, there is substantial potential for improving bipolar medication adherence and overall health outcomes on a broad level.

Trial registration: The study was registered on ClinicalTrials.gov NCT04622150 on November 9, 2020.

Keywords: Bipolar disorder; Manic-depressive disorder; Medication adherence; Randomized controlled trial; Telehealth.

Conflict of interest statement

M.S. has research grants from Otsuka, Alkermes, Nuromate, the International Society of Bipolar Disorders (ISBD), National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC). M.S. is a consultant to Alkermes, Otsuka, Janssen, Neurocrine, Bracket, Health Analytics and Frontline Medical Communications and has received publication royalties from Springer Press, Johns Hopkins University Press, Oxford Press, UpToDate. J. L. has research grant support from the National Institutes of Health (NIH). The remaining authors declare that they have no competing interests.

© 2022. The Author(s).

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