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American Heart Journal

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Interventions Supporting Long-term Adherence aNd Decreasing cardiovascular events (ISLAND): Pragmatic randomized trial protocol - 01/08/17

Doi : 10.1016/j.ahj.2017.05.007 
Noah Ivers, MD, PhD a, b, c, ⁎ , J-D Schwalm, MD, MSc, FRCP(C) d, e, Holly O. Witteman, PhD f, g, h, i, Justin Presseau, PhD j, k, Monica Taljaard, PhD j, k, Tara McCready, PhD, MBA e, Beth Bosiak, BComm, BA, MSc b, Jennifer Cunningham e, Shelley Smarz, MA, MBA e, Laura Desveaux, PhD, MScPT b, Jack V. Tu, MD, PhD c, l, m, Clare Atzema, MD, MSc, FRCPC c, m, n, Garth Oakes, PhD o, Wanrudee Isaranuwatchai, PhD p, Sherry L. Grace, PhD q, r, R. Sacha Bhatia, MD,MBA c, m, s, t, Madhu Natarajan, MD, MSc d, e, Jeremy M. Grimshaw, MBChB, PhD j, u
a Department of Family and Community Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada 
b Institute for Health System Solutions and Women's College Research Institute, Women's College Hospital, Toronto, Ontario, Canada 
c Institute of Clinical Evaluative Sciences, Toronto, Ontario, Canada 
d Division of Cardiology, Department of Medicine, Hamilton Health Sciences, Hamilton, Ontario, Canada 
e Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada 
f Department of Family and Emergency Medicine, Faculty of Medicine, Laval University, Quebec City, Quebec, Canada 
g Office of Education and Professional Development, Faculty of Medicine, Laval University, Quebec City, Quebec, Canada 
h Université Laval Research Institute for Primary Care and Health Services (CERSSPL-UL), Quebec City, Quebec, Canada 
i Ottawa Hospital Research Institute, Ottawa, Ontario, Canada 
j Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada 
k School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Canada 
l Division of Cardiology, Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, Ontario, Canada 
m Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada 
n Division of Emergency Medicine, Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, Ontario, Canada 
o Cardiac Care Network of Ontario, Toronto, Ontario, Canada 
p Centre for Excellence in Economic Analysis Research, St Michael's Hospital and Institute of Health Policy, Management and Evaluation, University of Toronto, Ontario, Canada 
q School of Kinesiology and Health Science, York University, Toronto, Ontario, Canada 
r Cardiorespiratory Fitness Team, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada 
s Division of Cardiology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada 
t WCH Institute for Health System Solutions and Women's College Research Institute, Women's College Hospital, Toronto, Ontario, Canada 
u Department of Medicine, University of Ottawa, Ottawa, ON, Canada 

⁎Reprint requests: Noah M. Ivers, MD, PhD, Family Practice Health Centre, Institute for Health Systems Solutions and Virtual Care, and Women's College Research Institute, Women's College Hospital, 76 Grenville St, Toronto, ON, Canada M5S1B2.Family Practice Health CentreInstitute for Health Systems Solutions and Virtual Care, and Women's College Research Institute, Women's College Hospital76 Grenville StTorontoONM5S1B2Canada

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
 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.
 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.


© 2017  Elsevier Inc. Tous droits réservés.
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Vol 190

P. 64-75 - août 2017 Retour au numéro
Article précédent Article précédent
  • Implantable cardiac monitors in high-risk post-infarction patients with cardiac autonomic dysfunction and moderately reduced left ventricular ejection fraction: Design and rationale of the SMART-MI trial
  • Wolfgang Hamm, Konstantinos D. Rizas, Lukas von Stülpnagel, Nikolay Vdovin, Steffen Massberg, Stefan Kääb, Axel Bauer
| Article suivant Article suivant
  • High-sensitivity C-reactive protein is an independent marker of abnormal coronary vasoreactivity in patients with non-obstructive coronary artery disease
  • Jaskanwal D.S. Sara, Megha Prasad, Ming Zhang, Ryan J. Lennon, Joerg Herrmann, Lilach O. Lerman, Amir Lerman

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