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

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

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.

Keywords: appropriate prescribing; essential medicines; medicine adherence; medicine costs; patient-oriented outcomes; randomized controlled trial.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
The design and timeline of the trial. BP, blood pressure; HbA1c, haemoglobin A1c; LDL-C, low-density lipoprotein cholesterol.; EMR, electronic medical record

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