Randomized Controlled Trial

. 2017 Jun 12;7(5):e015686.

doi: 10.1136/bmjopen-2016-015686.

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^{1

2

3}, Taehoon Lee², Haroon Ahmad⁴, Winny Li⁵, Michael Sergio Taglione⁵, Yathavan Rajakulasingam², Norman Umali², Andrew Boozary^{3

6}, Richard H Glazier^{1

2

3

7

8}, Tara Gomes^{1

2

8

9

10}, Stephen W Hwang^{2

5

8}, Peter Jüni^{5

11}, Michael Law¹², Muhammad M Mamdani^{2

5

8

9

10

13}, Braden Manns^{14

15

16

17}, Danielle Martin^{1

18}, Steve Morgan¹⁹, Paul Oh²⁰, Andrew David Pinto^{1

2

3

7}, Baiju R Shah^{5

8}, Frank M Sullivan^{8

21}, Kevin E Thorpe^{2

7}, Karen Tu^{1

8

10

22

23}, Andreas Laupacis^{1

2

8}

Affiliations

¹ Department of Family and Community Medicine, St Michael's Hospital, Toronto, Canada.
² Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.
³ Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.
⁴ Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
⁵ Department of Medicine, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.
⁶ Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, United States.
⁷ Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
⁸ Institute for Clinical Evaluative Sciences, Toronto, Canada.
⁹ Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada.
¹⁰ Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Canada.
¹¹ Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada.
¹² Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.
¹³ Centre for Healthcare Analytics Research and Training, St Michael's Hospital, Toronto, Canada.
¹⁴ Department of Community Health Science, Cumming School of Medicine, University of Calgary, Calgary, Canada.
¹⁵ Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Canada.
¹⁶ Interdisciplinary Chronic Disease Collaboration, Cumming School of Medicine, University of Calgary, Calgary, Canada.
¹⁷ Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.
¹⁸ Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, Canada.
¹⁹ Centre for Health Services and Policy Research, University of British Columbia, Vancouver, Canada.
²⁰ Toronto Rehabilitation Institute, University Health Network, Toronto, Canada.
²¹ Department of Research and Innovation, North York General Hospital, Toronto, Canada.
²² Central Primary Care and Population Health Research Program, Institute for Clinical Evaluative Sciences, Toronto, Canada.
²³ Toronto Western Hospital Family Health Team, University Health Network, Toronto, Canada.

PMID: 28611089
PMCID: PMC5623428
DOI: 10.1136/bmjopen-2016-015686

Randomized Controlled Trial

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 et al. BMJ Open. 2017.

. 2017 Jun 12;7(5):e015686.

doi: 10.1136/bmjopen-2016-015686.

Authors

Affiliations

¹ Department of Family and Community Medicine, St Michael's Hospital, Toronto, Canada.
² Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.
³ Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.
⁴ Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
⁵ Department of Medicine, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.
⁶ Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, United States.
⁷ Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
⁸ Institute for Clinical Evaluative Sciences, Toronto, Canada.
⁹ Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada.
¹⁰ Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Canada.
¹¹ Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada.
¹² Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.
¹³ Centre for Healthcare Analytics Research and Training, St Michael's Hospital, Toronto, Canada.
¹⁴ Department of Community Health Science, Cumming School of Medicine, University of Calgary, Calgary, Canada.
¹⁵ Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Canada.
¹⁶ Interdisciplinary Chronic Disease Collaboration, Cumming School of Medicine, University of Calgary, Calgary, Canada.
¹⁷ Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.
¹⁸ Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, Canada.
¹⁹ Centre for Health Services and Policy Research, University of British Columbia, Vancouver, Canada.
²⁰ Toronto Rehabilitation Institute, University Health Network, Toronto, Canada.
²¹ Department of Research and Innovation, North York General Hospital, Toronto, Canada.
²² Central Primary Care and Population Health Research Program, Institute for Clinical Evaluative Sciences, Toronto, Canada.
²³ Toronto Western Hospital Family Health Team, University Health Network, Toronto, Canada.

PMID: 28611089
PMCID: PMC5623428
DOI: 10.1136/bmjopen-2016-015686

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.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

**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

See this image and copyright information in PMC

References

1. Bowry AD, Shrank WH, Lee JL, et al. . A systematic review of adherence to cardiovascular medications in resource-limited settings. J Gen Intern Med 2011;26:1479–91. 10.1007/s11606-011-1825-3 - DOI - PMC - PubMed
1. Laba TL, Essue B, Kimman M, et al. . Understanding patient Preferences in Medication Nonadherence: a Review of Stated Preference Data. Patient 2015;8:385–95. 10.1007/s40271-014-0099-3 - DOI - PubMed
1. Lexchin J, Grootendorst P. Effects of prescription drug user fees on drug and health services use and on health status in vulnerable populations: a systematic review of the evidence. Int J Health Serv 2004;34:101–22. 10.2190/4M3E-L0YF-W1TD-EKG0 - DOI - PubMed
1. Goldman DP, Joyce GF, Zheng Y. Prescription drug cost sharing: associations with medication and medical utilization and spending and health. JAMA 2007;298:61–9. 10.1001/jama.298.1.61 - DOI - PMC - PubMed
1. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med 2005;353:487–97. 10.1056/NEJMra050100 - DOI - PubMed

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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical