Interventions Supporting Long-term Adherence aNd Decreasing cardiovascular events: Pragmatic randomized trial protocol

• Published in: The American heart journal 2017-08, Vol.190, p.64-75
• Main Authors: Ivers, Noah M, Schwalm, J-D, Witteman, Holly O, Presseau, Justin, Taljaard, Monica, McCready, Tara, Bosiak, Beth, Cunningham, Jennifer, Smarz, Shelley, Desveaux, Laura, Tu, Jack V, Atzema, Clare, Oakes, Garth H, Isaranuwatchai, Wanrudee, Grace, Sherry L, Bhatia, Sacha, Natarajan, Madhu, Grimshaw, Jeremy M
• Format: Article
• Language: English
• Subjects: Adhesion; Aged; Ambulatory care; Automation; Cardiovascular; Cardiovascular Agents - therapeutic use; Cardiovascular disease; Cardiovascular diseases; Consent; Coronary artery; Coronary artery disease; Coronary Artery Disease - epidemiology; Coronary Artery Disease - therapy; Cost analysis; Ethics; Evaluation; Female; Follow-Up Studies; Health; Health care; Heart; Heart attacks; Heart diseases; Humans; Incidence; Interactive systems; Intervention; Mail; Male; Medical personnel; Medication Adherence; Mortality; Myocardial infarction; Ontario - epidemiology; Outcome Assessment (Health Care); Patients; Quality of life; Rehabilitation; Research ethics; Secondary Prevention - methods; Surveillance; Survival Rate - trends; Telephone calls; Time Factors; Workers
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2017.05.007

Abstract 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 This is a multi-center, pragmatic, three-arm randomized trial. Eligible patients (n = 2742) with obstructive coronary artery disease are randomized post-MI to usual care or one of two intervention arms. Patients in the first intervention arm receive mail-outs 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. Conclusions 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. Trial registration Clinicaltrials.gov: NCT02382731 Trial funding Ontario Ministry of Health and Long Term Care and the Canadian Institutes of Health Research's Strategy for Patient Oriented Research, through the Ontario Strategy for Patient Oriented Research Support Unit.