Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults

Abstract

Background: Patients with chronic conditions are often responsible for self-managing complex, multi-drug regimens with minimal professional clinical support. While numerous interventions to promote and support medication adherence have been tested, most have had limited success or have been too resource-intensive for real-world implementation.

Objective: To compare the effectiveness of multiple low-cost, technology-enabled strategies, alone and in combination, for promoting medication regimen adherence among older adults.

Methods: Older, English or Spanish-speaking patients on complex drug regimens (N=1505) will be recruited from a community health system in Chicago, IL. Enrolled patients will be randomized to one of four study arms, receiving either: 1) enhanced usual care alone; 2) daily medication reminders via SMS text messages; 3) medication monitoring via a patient portal-based assessment; or 4) both SMS text message reminders and portal-based medication monitoring. The primary outcome of the study is medication adherence, which will be assessed via multiple measures at baseline, 2months, and 6months. The effect of intervention strategies on clinical markers (hemoglobin A1c, blood pressure, cholesterol level), as well as intervention fidelity and the barriers and costs of implementation will also be evaluated.

Conclusions: This randomized controlled trial will evaluate the impact of various low-cost intervention strategies on adherence to complex medication regimens and will explore barriers to implementation. If the studied intervention strategies are shown to be effective, then these approaches could be effectively deployed across a diverse range of clinical settings and patient populations.

Clinical trial registration: This trial is registered on clinicaltrials.govNCT02820753.

Keywords: Chronic conditions; Health literacy; Medication adherence.

Conflict of interest statement

Conflicts of Interest and Disclosures: Stacy Bailey has served as a consultant to Merck, Sharp & Dohme Corp and Luto LLC for work unrelated to this manuscript. She has also received grant support via her institution from Merck, Sharp & Dohme Corp and Eli Lilly and Company. Michael Wolf has served as a consultant to Merck, Sharp & Dohme Corp, Abbvie, Vivus, Inc., Luto LLC, Anheuser Busch Imbev, DenverHealth, and Teva Pharmaceuticals for work unrelated to this manuscript. He also has received grant support via his institution from Merck, Sharp & Dohme Corp, Eli Lilly and Company, Abbvie, and UnitedHealthcare. Ruth Parker has received grant support from Merck, Sharp & Dohme. Surrey Walton has served as a consultant to Merck, Sharp & Dohme, Abbott and Abbvie, and Baxter for work unrelated to this manuscript. Amisha Wallia has received grant support via her institution from Merck, Sharp & Dohme Corp and Eli Lilly and company. Dr. Wallia also serves as an adjudicator for Lexicon Therapeutics and a consultant for GLytec. Alastair J.J. Wood has served as a consultant to various drug companies and is a partner at Symphony Capital LLC. None of his consulting or work at Symphony Capital was related to the content or topic of this manuscript. Other study authors have no conflicts of interest to disclose.

Copyright © 2017 Elsevier Inc. All rights reserved.

Figures

Figure 1

Study Design