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

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, 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 ShahFrank M. Sullivan, Kevin E Thorpe, Karen Tu, Andreas Laupacis

School of Medicine

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	e015686
Number of pages	8
Journal	BMJ Open
Volume	7
Issue number	5
DOIs	https://doi.org/10.1136/bmjopen-2016-015686
Publication status	Published - 12 Jun 2017

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Final published version, 529 KBLicence: CC BY-NC

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Persaud, N., Lee, T., Ahmad, H., Li, W., Taglione, M. S., Rajakulasingam, Y., Umali, N., Boozary, A., Glazier, R. H., Gomes, T., Hwang, S. W., Jüni, P., Law, M., Mamdani, M. M., Manns, B., Martin, D., Morgan, S., Oh, P., Pinto, A. D., ... Laupacis, A. (2017). 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. BMJ Open, 7(5), Article e015686. https://doi.org/10.1136/bmjopen-2016-015686

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title = "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",

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.",

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

note = "NP, RHG and ADP were supported as Clinician Scientists by the Department of Family and Community Medicine at the University of Toronto and at St Michael's Hospital. NP is supported by a fellowship from Physicians Services Incorporated Foundation. KT was supported as a Clinician Scientist by the Department of Family and Community Medicine at the University of Toronto and at Toronto Western Hospital. ML received salary support through a Canada Research Chair and a Michael Smith Foundation for Health Research Scholar Award.",

year = "2017",

month = jun,

day = "12",

doi = "10.1136/bmjopen-2016-015686",

language = "English",

volume = "7",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group Ltd",

number = "5",

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Persaud, N, Lee, T, Ahmad, H, Li, W, Taglione, MS, Rajakulasingam, Y, Umali, N, Boozary, A, Glazier, RH, Gomes, T, Hwang, SW, Jüni, P, Law, M, Mamdani, MM, Manns, B, Martin, D, Morgan, S, Oh, P, Pinto, AD, Shah, BR, Sullivan, FM, Thorpe, KE, Tu, K & Laupacis, A 2017, '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', BMJ Open, vol. 7, no. 5, e015686. https://doi.org/10.1136/bmjopen-2016-015686

TY - JOUR

T1 - Protocol for a randomised controlled trial evaluating the effects of providing essential medicines at no charge

T2 - the Carefully seLected and Easily Accessible at No Charge Medicines (CLEAN Meds) trial

AU - Persaud, Nav

AU - Lee, Taehoon

AU - Ahmad, Haroon

AU - Li, Winny

AU - Taglione, Michael Sergio

AU - Rajakulasingam, Yathavan

AU - Umali, Norman

AU - Boozary, Andrew

AU - Glazier, Richard H

AU - Gomes, Tara

AU - Hwang, Stephen W

AU - Jüni, Peter

AU - Law, Michael

AU - Mamdani, Muhammad M

AU - Manns, Braden

AU - Martin, Danielle

AU - Morgan, Steve

AU - Oh, Paul

AU - Pinto, Andrew David

AU - Shah, Baiju R

AU - Sullivan, Frank M.

AU - Thorpe, Kevin E

AU - Tu, Karen

AU - Laupacis, Andreas

N1 - NP, RHG and ADP were supported as Clinician Scientists by the Department of Family and Community Medicine at the University of Toronto and at St Michael's Hospital. NP is supported by a fellowship from Physicians Services Incorporated Foundation. KT was supported as a Clinician Scientist by the Department of Family and Community Medicine at the University of Toronto and at Toronto Western Hospital. ML received salary support through a Canada Research Chair and a Michael Smith Foundation for Health Research Scholar Award.

PY - 2017/6/12

Y1 - 2017/6/12

N2 - 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.

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.

U2 - 10.1136/bmjopen-2016-015686

DO - 10.1136/bmjopen-2016-015686

M3 - Article

C2 - 28611089

SN - 2044-6055

VL - 7

JO - BMJ Open

JF - BMJ Open

IS - 5

M1 - e015686

ER -

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

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