PT  - JOURNAL ARTICLE
AU  - Nav Persaud
AU  - Taehoon Lee
AU  - Haroon Ahmad
AU  - Winny Li
AU  - Michael Sergio Taglione
AU  - Yathavan Rajakulasingam
AU  - Norman Umali
AU  - Andrew Boozary
AU  - Richard H Glazier
AU  - Tara Gomes
AU  - Stephen W Hwang
AU  - Peter Jüni
AU  - Michael Law
AU  - Muhammad M Mamdani
AU  - Braden Manns
AU  - Danielle Martin
AU  - Steve Morgan
AU  - Paul Oh
AU  - Andrew David Pinto
AU  - Baiju R Shah
AU  - Frank M Sullivan
AU  - Kevin E Thorpe
AU  - Karen Tu
AU  - Andreas Laupacis
TI  - 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
AID  - 10.1136/bmjopen-2016-015686
DP  - 2017 May 01
TA  - BMJ Open
PG  - e015686
VI  - 7
IP  - 5
4099  - http://bmjopen.bmj.com/content/7/5/e015686.short
4100  - http://bmjopen.bmj.com/content/7/5/e015686.full
SO  - BMJ Open2017 May 01; 7
AB  - 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.