Interventions Supporting Long-term Adherence and Decreasingcardiovascularevents(ISLAND): Pragmatic randomized trial protocol

Background

Guidelines recommend cardiac rehabilitation (CR) and long-term use of cardiac medications for most patients who have had a myocardial infarction (MI), but adherence to these secondary prevention treatments is sub-optimal.

Methods/Design

This is a multi-center, pragmatic, three-arm randomized trial. Eligible patients are randomized postMI to usual care or one of two intervention arms. Patients in the first intervention arm receive mailouts sent on behalf of their cardiologist at 4, 8, 20, 32, and 44 weeks post-MI; content is designed to address determinants of adherence, and facilitate discussion between the patient and their health care team. Patients in the second intervention arm receive mail-outs plus automated interactive voice response system (IVRS) phone calls 2 weeks after each letter, as well as a telephone call by trained lay health workers if the IVRS identifies challenges with adherence. Outcomes are assessed 12 months post-MI via patient self-report and administrative data sources. Co-primary outcomes are adherence to cardiac medications and completion of CR. Secondary outcomes include cardiovascular events and mortality. An embedded, theory-informed process evaluation will explore the mechanism of action; an economic evaluation is also planned.

Discussion

We describe a complete program evaluation of a highly pragmatic, health-system intervention to support adherence to recommended treatments. Research ethics boards approved waiver of consent for patients enrolled in the trial with provision of multiple opportunities to opt-out and a debrief at the time of outcome assessment. The methods used here may provide a model for similar interventions.