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General practice / Family practice
Protocol
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
  1. Nav Persaud1,2,3,
  2. Taehoon Lee2,
  3. Haroon Ahmad4,
  4. Winny Li5,
  5. Michael Sergio Taglione5,
  6. Yathavan Rajakulasingam2,
  7. Norman Umali2,
  8. Andrew Boozary3,6,
  9. Richard H Glazier1,2,3,7,8,
  10. Tara Gomes1,2,8,9,10,
  11. Stephen W Hwang2,5,8,
  12. Peter Jüni5,11,
  13. Michael Law12,
  14. Muhammad M Mamdani2,5,8,9,10,13,
  15. Braden Manns14,15,16,17,
  16. Danielle Martin1,18,
  17. Steve Morgan19,
  18. Paul Oh20,
  19. Andrew David Pinto1,2,3,7,
  20. Baiju R Shah5,8,
  21. Frank M Sullivan8,21,
  22. Kevin E Thorpe2,7,
  23. Karen Tu1,8,10,22,23,
  24. Andreas Laupacis1,2,8
  1. 1 Department of Family and Community Medicine, St Michael's Hospital, Toronto, Canada
  2. 2 Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada
  3. 3 Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada
  4. 4 Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  5. 5 Department of Medicine, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada
  6. 6 Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, United States
  7. 7 Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
  8. 8 Institute for Clinical Evaluative Sciences, Toronto, Canada
  9. 9 Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada
  10. 10 Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Canada
  11. 11 Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Canada
  12. 12 Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada
  13. 13 Centre for Healthcare Analytics Research and Training, St Michael’s Hospital, Toronto, Canada
  14. 14 Department of Community Health Science, Cumming School of Medicine, University of Calgary, Calgary, Canada
  15. 15 Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Canada
  16. 16 Interdisciplinary Chronic Disease Collaboration, Cumming School of Medicine, University of Calgary, Calgary, Canada
  17. 17 Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada
  18. 18 Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women’s College Hospital, Toronto, Canada
  19. 19 Centre for Health Services and Policy Research, University of British Columbia, Vancouver, Canada
  20. 20 Toronto Rehabilitation Institute, University Health Network, Toronto, Canada
  21. 21 Department of Research and Innovation, North York General Hospital, Toronto, Canada
  22. 22 Central Primary Care and Population Health Research Program, Institute for Clinical Evaluative Sciences, Toronto, Canada
  23. 23 Toronto Western Hospital Family Health Team, University Health Network, Toronto, Canada
  1. Correspondence to Dr. Nav Persaud; nav.persaud{at}utoronto.ca

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.

  • appropriate prescribing
  • essential medicines
  • medicine adherence
  • medicine costs
  • patient-oriented outcomes
  • randomized controlled trial

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-015686

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    Footnotes

    • Contributors All authors contributed substantially to conception and the design of the protocol, all revised the manuscript critically for important intellectual content, all approved the final manuscript, and all are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

    • Funding The trial is funded by the Ontario SPOR Support Unit and the Canadian Institutes of Health Research.

    • Competing interests None declared.

    • Patient consent The protocol does not contain personal medical information about an identifiable living individual and does not require patients' explicit consent.

    • Ethics approval Ethics approval for the conduct of this study was obtained from the St Michaels Research Ethics Board, the Huron Shores Family Health Team Research Ethics Committee and the Laurentian University Research Ethics Board.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Correction notice This paper has been amended since it was published Online First. Owing to a scripting error, some of the publisher names in the references were replaced with 'BMJ Publishing Group'. This only affected the full text version, not the PDF. We have since corrected these errors and the correct publishers have been inserted into the references.