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

dc.contributor.authorIvers, Noah
dc.contributor.authorWitteman, Holly
dc.contributor.authorPresseau, Justin
dc.contributor.authorTaljaard, Monica
dc.contributor.authorMcCready, Tara
dc.contributor.authorBosiak, Beth
dc.contributor.authorCunningham, Jennifer
dc.contributor.authorSmarz, Shelley
dc.contributor.authorDesveaux, Laura
dc.contributor.authorTu, Jack V.
dc.contributor.authorAtzema, Clare
dc.contributor.authorOakes, Garth
dc.contributor.authorIsaranuwatchai, Wanrudee
dc.contributor.authorGrace, Sherry
dc.contributor.authorBhatia, R Sacha
dc.contributor.authorNatarajan, Madhu Kailash
dc.contributor.authorGrimshaw, Jeremy
dc.date.accessioned2025-06-05T22:01:29Z
dc.date.available2025-06-05T22:01:29Z
dc.date.issued2017-06-03
dc.description© 2017. This accepted manuscript is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.description.abstractBackground 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.
dc.description.sponsorshipTrial 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 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.
dc.identifier.citationIvers, N., Schwalm, J.-D., Witteman, H. O., Presseau, J., Taljaard, M., McCready, T., Bosiak, B., Cunningham, J., Smarz, S., Desveaux, L., Tu, J. V., Atzema, C., Oakes, G., Isaranuwatchai, W., Grace, S. L., Bhatia, R. S., Natarajan, M., & Grimshaw, J. M. (2017). Interventions Supporting Long-term Adherence aNd Decreasing cardiovascular events (ISLAND): Pragmatic randomized trial protocol. The American Heart Journal, 190, 64–75. https://doi.org/10.1016/j.ahj.2017.05.007
dc.identifier.issn0002-8703
dc.identifier.issn1097-6744
dc.identifier.otherNCT02382731
dc.identifier.urihttp://dx.doi.org/10.1016/j.ahj.2017.05.007
dc.identifier.urihttps://hdl.handle.net/10315/42911
dc.language.isoen
dc.publisherElsevier
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectMyocardial infarction
dc.subjectAdherence
dc.subjectCardiac rehabilitation
dc.subjectSecondary prevention
dc.subjectBehavioural interventions
dc.titleInterventions Supporting Long-term Adherence and Decreasingcardiovascularevents(ISLAND): Pragmatic randomized trial protocol
dc.typeArticle

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