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

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, 2 months, and 6 months. 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.