Interventions Supporting Long-term Adherence aNd Decreasing cardiovascular events (ISLAND): Pragmatic randomized trial protocol - 01/08/17
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Abstract |
Background |
Guidelines recommend cardiac rehabilitation 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 suboptimal.
Methods |
This is a multicenter, pragmatic, 3-arm randomized trial. Eligible patients (n = 2,742) with obstructive coronary artery disease are randomized post-MI to usual care or 1 of 2 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 telephone calls 2 weeks after each letter, as well as a telephone call by trained lay health workers if the interactive voice response system 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 cardiac rehabilitation. 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.
Le texte complet de cet article est disponible en PDF.Abbreviations : CCN, CR, HAPA, ICES, IVRS, LHW, MI, PHRI
Plan
RCT No. NCT02382731 |
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Trial registration: ClinicalTrials.gov: NCT02382731 |
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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. |
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N.M.I. is supported by New Investigator Awards from the Canadian Institutes of Health Research and the Department of Family and Community Medicine at the University of Toronto. J.M.G. is supported by a Tier 1 Canada Research Chair in Health Knowledge Transfer and Uptake. H.O.W. is supported by a Fonds de recherche du Québec-Santé Resaerch Scholar Junior 1 career development award. |
Vol 190
P. 64-75 - août 2017 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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