Protocol for a randomised controlled trial evaluating the effects of providing essential medicines at no charge: the Carefully seLected and Easily Accessible at No Charge Medicines (CLEAN Meds) trial.

Michael Law, Andreas Laupacis, Karen Tu, Kevin E Thorpe, Frank M Sullivan, Baiju R Shah, Andrew David Pinto, Paul Oh, Steve Morgan, Danielle Martin, Braden Manns, Muhammad M Mamdani, Nav Persaud, Peter Jüni, Stephen W Hwang, Tara Gomes, Richard H Glazier, Andrew Boozary, Norman Umali, Yathavan Rajakulasingam, Michael Sergio Taglione, Winny Li, Haroon Ahmad, Taehoon Lee

Journal: BMJ open 2018;7(5):e015686

PMID: 28611089

Free Full Text on HighWire View on PubMed

Abstract

INTRODUCTION

Cost-related non-adherence to medicines is common in low-income, middle-income and high-income countries such as Canada. Medicine non-adherence is associated with poor health outcomes and increased mortality. This randomised trial will test the impact of a carefully selected list of essential medicines at no charge (compared with usual medicine access) in primary care patients reporting cost-related non-adherence.

METHODS AND ANALYSIS

This is an open-label, parallel two-arm, superiority, individually randomised controlled trial conducted in three primary care sites (one urban, two rural) in Ontario, Canada, that was codesigned by a community guidance panel. Adult patients (≥18 years) who report cost-related non-adherence to medicines are eligible to participate in the study. Participants will be randomised to receive free and convenient access to a carefully selected list of 125 essential medicines (based on the WHO's Model List of Essential Medicines) or usual means of medicine access. Care for patients in both groups will otherwise be unchanged. The primary outcome of this trial is adherence to appropriately prescribed medicines. Secondary outcomes include medicine adherence, appropriate prescribing, blood pressure, haemoglobin A1c, low-density lipoprotein cholesterol, patient-oriented outcomes and healthcare costs. All participants will be followed for at least 12 months.

ETHICS AND DISSEMINATION

Ethics approval was obtained in all three participating sites. Results of the main trial and secondary outcomes will be submitted for publication in a peer-reviewed journal and discussed with members of the public and decision makers.

TRIAL REGISTRATION NUMBER

NCT02744963.

Address: Department of Family and Community Medicine, St Michael's Hospital, Toronto, Canada.; Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.; Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.; Department of Medicine, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.; Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, United States.; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.; Institute for Clinical Evaluative Sciences, Toronto, Canada.; Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada.; Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Canada.; Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada.; Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.; Centre for Healthcare Analytics Research and Training, St Michael's Hospital, Toronto, Canada.; Department of Community Health Science, Cumming School of Medicine, University of Calgary, Calgary, Canada.; Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Canada.; Interdisciplinary Chronic Disease Collaboration, Cumming School of Medicine, University of Calgary, Calgary, Canada.; Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.; Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, Canada.; Centre for Health Services and Policy Research, University of British Columbia, Vancouver, Canada.; Toronto Rehabilitation Institute, University Health Network, Toronto, Canada.; Department of Research and Innovation, North York General Hospital, Toronto, Canada.; Central Primary Care and Population Health Research Program, Institute for Clinical Evaluative Sciences, Toronto, Canada.; Toronto Western Hospital Family Health Team, University Health Network, Toronto, Canada.

DOI: 10.1136/bmjopen-2016-015686

Link outs

Free resources

Full Text Sources:

Medical:

https://clinicaltrials.gov/search?term=AREA%5BRefe...

Other Literature Sources:

https://scite.ai/reports/28611089

MeSH Terms: Adolescent, Adult, Aged, Drug Costs, Drugs, Essential, Female, Health Care Costs, Humans, Logistic Models, Male, Middle Aged, Ontario, Primary Health Care, Quality of Life, Research Design, Self Report, Young Adult, Assessment of Medication Adherence