Noah Ivers1, J-D Schwalm2, Holly O Witteman3, Justin Presseau4, Monica Taljaard4, Tara McCready5, Beth Bosiak6, Jennifer Cunningham5, Shelley Smarz5, Laura Desveaux6, Jack V Tu7, Clare Atzema8, Garth Oakes9, Wanrudee Isaranuwatchai10, Sherry L Grace11, R Sacha Bhatia12, Madhu Natarajan2, Jeremy M Grimshaw13. 1. Department of Family and Community Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Institute for Health System Solutions and Women's College Research Institute, Women's College Hospital, Toronto, Ontario, Canada; Institute of Clinical Evaluative Sciences, Toronto, Ontario, Canada. Electronic address: noah.ivers@utoronto.ca. 2. Division of Cardiology, Department of Medicine, Hamilton Health Sciences, Hamilton, Ontario, Canada; Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada. 3. Department of Family and Emergency Medicine, Faculty of Medicine, Laval University, Quebec City, Quebec, Canada; Office of Education and Professional Development, Faculty of Medicine, Laval University, Quebec City, Quebec, Canada; Université Laval Research Institute for Primary Care and Health Services (CERSSPL-UL), Quebec City, Quebec, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. 4. Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada; School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Canada. 5. Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada. 6. Institute for Health System Solutions and Women's College Research Institute, Women's College Hospital, Toronto, Ontario, Canada. 7. Institute of Clinical Evaluative Sciences, Toronto, Ontario, Canada; Division of Cardiology, Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada. 8. Institute of Clinical Evaluative Sciences, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Division of Emergency Medicine, Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, Ontario, Canada. 9. Cardiac Care Network of Ontario, Toronto, Ontario, Canada. 10. Centre for Excellence in Economic Analysis Research, St Michael's Hospital and Institute of Health Policy, Management and Evaluation, University of Toronto, Ontario, Canada. 11. School of Kinesiology and Health Science, York University, Toronto, Ontario, Canada; Cardiorespiratory Fitness Team, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada. 12. Institute of Clinical Evaluative Sciences, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Division of Cardiology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; WCH Institute for Health System Solutions and Women's College Research Institute, Women's College Hospital, Toronto, Ontario, Canada. 13. Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada; Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
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.
RCT Entities:
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.
Authors: Nicola McCleary; Noah M Ivers; J-D Schwalm; Holly O Witteman; Monica Taljaard; Laura Desveaux; Zachary Bouck; Sherry L Grace; Jeremy M Grimshaw; Justin Presseau Journal: J Behav Med Date: 2022-05-20
Authors: Carolina Santiago de Araújo Pio; Gabriela Ss Chaves; Philippa Davies; Rod S Taylor; Sherry L Grace Journal: Cochrane Database Syst Rev Date: 2019-02-01