Effect on treatment adherence of distributing essential medicines at no charge: the CLEAN Meds randomized clinical trial

Navindra Persaud; Michael Bedard; Andrew S. Boozary; Richard H. Glazier; Tara Gomes; Stephen W. Hwang; Peter Jüni; Michael R. Law; Muhammad M. Mamdani; Braden J. Manns; Danielle Martin; Steven G. Morgan; Paul I. Oh; Andrew D. Pinto; Baiju R. Shah; Frank Sullivan; Norman Umali; Kevin E. Thorpe; Karen Tu; Andreas Laupacis; for the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team

doi:10.1001/jamainternmed.2019.4472

Effect on treatment adherence of distributing essential medicines at no charge: the CLEAN Meds randomized clinical trial

Navindra Persaud^*, Michael Bedard, Andrew S. Boozary, Richard H. Glazier, Tara Gomes, Stephen W. Hwang, Peter Jüni, Michael R. Law, Muhammad M. Mamdani, Braden J. Manns, Danielle Martin, Steven G. Morgan, Paul I. Oh, Andrew D. Pinto, Baiju R. Shah, Frank Sullivan, Norman Umali, Kevin E. Thorpe, Karen Tu, Andreas Laupacisfor the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team

^*Corresponding author for this work

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

Abstract

Importance: Nonadherence to treatment with medicines is common globally, even for life-saving treatments. Cost is one important barrier to access, and only some jurisdictions provide medicines at no charge to patients.

Objective: To determine whether providing essential medicines at no charge to outpatients who reported not being able to afford medicines improves adherence.

Design, Setting, and Participants: A multicenter, unblinded, parallel, 2-group, superiority, outcomes assessor-blinded, individually randomized clinical trial conducted at 9 primary care sites in Ontario, Canada, enrolled 786 patients between June 1, 2016, and April 28, 2017, who reported cost-related nonadherence. Follow-up occurred at 12 months. The primary analysis was performed using an intention-to-treat principle.

Interventions: Patients were randomly allocated to receive free medicines on a list of essential medicines in addition to otherwise usual care (n = 395) or usual medicine access and usual care (n = 391).

Main Outcomes and Measures: The primary outcome was adherence to treatment with all medicines that were appropriately prescribed for 1 year. Secondary outcomes were hemoglobin A_1c level, blood pressure, and low-density lipoprotein cholesterol levels 1 year after randomization in participants taking corresponding medicines.

Results: Among the 786 participants analyzed (439 women and 347 men; mean [SD] age, 51.7 [14.3] years), 764 completed the trial. Adherence to treatment with all medicines was higher in those randomized to receive free distribution (151 of 395 [38.2%]) compared with usual access (104 of 391 [26.6%]; difference, 11.6%; 95% CI, 4.9%-18.4%). Control of type 1 and 2 diabetes was not significantly improved by free distribution (hemoglobin A_1c, -0.38%; 95% CI, -0.76% to 0.00%), systolic blood pressure was reduced (-7.2 mm Hg; 95% CI, -11.7 to -2.8 mm Hg), and low-density lipoprotein cholesterol levels were not affected (-2.3 mg/dL; 95% CI, -14.7 to 10.0 mg/dL).

Conclusions and Relevance: The distribution of essential medicines at no charge for 1 year increased adherence to treatment with medicines and improved some, but not other, disease-specific surrogate health outcomes. These findings could help inform changes to medicine access policies such as publicly funding essential medicines.

Trial Registration: ClinicalTrials.gov identifier: NCT02744963.

Original language	English
Pages (from-to)	27-34
Number of pages	8
Journal	JAMA Internal Medicine
Volume	180
Issue number	1
Early online date	7 Oct 2019
DOIs	https://doi.org/10.1001/jamainternmed.2019.4472
Publication status	Published - Jan 2020

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Copyright © 2019 Persaud N et al. JAMA Internal Medicine. This is an open access article distributed under the terms of the CC-BY License.
Final published version, 247 KBLicence: CC BY

Frank Sullivan
- fms20st-andrews.acuk
- School of Medicine - Professor of Primary Care Medicine
- Sir James Mackenzie Institute for Early Diagnosis
- Population and Behavioural Science Division
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Persaud, N., Bedard, M., Boozary, A. S., Glazier, R. H., Gomes, T., Hwang, S. W., Jüni, P., Law, M. R., Mamdani, M. M., Manns, B. J., Martin, D., Morgan, S. G., Oh, P. I., Pinto, A. D., Shah, B. R., Sullivan, F., Umali, N., Thorpe, K. E., Tu, K., ... for the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team (2020). Effect on treatment adherence of distributing essential medicines at no charge: the CLEAN Meds randomized clinical trial. JAMA Internal Medicine, 180(1), 27-34. https://doi.org/10.1001/jamainternmed.2019.4472

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title = "Effect on treatment adherence of distributing essential medicines at no charge: the CLEAN Meds randomized clinical trial",

abstract = "Importance: Nonadherence to treatment with medicines is common globally, even for life-saving treatments. Cost is one important barrier to access, and only some jurisdictions provide medicines at no charge to patients.Objective: To determine whether providing essential medicines at no charge to outpatients who reported not being able to afford medicines improves adherence.Design, Setting, and Participants: A multicenter, unblinded, parallel, 2-group, superiority, outcomes assessor-blinded, individually randomized clinical trial conducted at 9 primary care sites in Ontario, Canada, enrolled 786 patients between June 1, 2016, and April 28, 2017, who reported cost-related nonadherence. Follow-up occurred at 12 months. The primary analysis was performed using an intention-to-treat principle.Interventions: Patients were randomly allocated to receive free medicines on a list of essential medicines in addition to otherwise usual care (n = 395) or usual medicine access and usual care (n = 391).Main Outcomes and Measures: The primary outcome was adherence to treatment with all medicines that were appropriately prescribed for 1 year. Secondary outcomes were hemoglobin A1c level, blood pressure, and low-density lipoprotein cholesterol levels 1 year after randomization in participants taking corresponding medicines. Results: Among the 786 participants analyzed (439 women and 347 men; mean [SD] age, 51.7 [14.3] years), 764 completed the trial. Adherence to treatment with all medicines was higher in those randomized to receive free distribution (151 of 395 [38.2%]) compared with usual access (104 of 391 [26.6%]; difference, 11.6%; 95% CI, 4.9%-18.4%). Control of type 1 and 2 diabetes was not significantly improved by free distribution (hemoglobin A1c, -0.38%; 95% CI, -0.76% to 0.00%), systolic blood pressure was reduced (-7.2 mm Hg; 95% CI, -11.7 to -2.8 mm Hg), and low-density lipoprotein cholesterol levels were not affected (-2.3 mg/dL; 95% CI, -14.7 to 10.0 mg/dL). Conclusions and Relevance: The distribution of essential medicines at no charge for 1 year increased adherence to treatment with medicines and improved some, but not other, disease-specific surrogate health outcomes. These findings could help inform changes to medicine access policies such as publicly funding essential medicines. Trial Registration: ClinicalTrials.gov identifier: NCT02744963.",

author = "Navindra Persaud and Michael Bedard and Boozary, {Andrew S.} and Glazier, {Richard H.} and Tara Gomes and Hwang, {Stephen W.} and Peter J{\"u}ni and Law, {Michael R.} and Mamdani, {Muhammad M.} and Manns, {Braden J.} and Danielle Martin and Morgan, {Steven G.} and Oh, {Paul I.} and Pinto, {Andrew D.} and Shah, {Baiju R.} and Frank Sullivan and Norman Umali and Thorpe, {Kevin E.} and Karen Tu and Andreas Laupacis and {for the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team}",

note = "This work is supported by grant 381409 from the Canadian Institutes for Health Research, the Ontario SPOR Support Unit that is supported by the Canadian Institutes of Health Research and the Province of Ontario, the Canada Research Chairs program, and the St Michael{\textquoteright}s Hospital Foundation.",

year = "2020",

month = jan,

doi = "10.1001/jamainternmed.2019.4472",

language = "English",

volume = "180",

pages = "27--34",

journal = "JAMA Internal Medicine",

issn = "2168-6106",

publisher = "American Medical Association",

number = "1",

}

Persaud, N, Bedard, M, Boozary, AS, Glazier, RH, Gomes, T, Hwang, SW, Jüni, P, Law, MR, Mamdani, MM, Manns, BJ, Martin, D, Morgan, SG, Oh, PI, Pinto, AD, Shah, BR, Sullivan, F, Umali, N, Thorpe, KE, Tu, K, Laupacis, A & for the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team 2020, 'Effect on treatment adherence of distributing essential medicines at no charge: the CLEAN Meds randomized clinical trial', JAMA Internal Medicine, vol. 180, no. 1, pp. 27-34. https://doi.org/10.1001/jamainternmed.2019.4472

TY - JOUR

T1 - Effect on treatment adherence of distributing essential medicines at no charge

T2 - the CLEAN Meds randomized clinical trial

AU - Persaud, Navindra

AU - Bedard, Michael

AU - Boozary, Andrew S.

AU - Glazier, Richard H.

AU - Gomes, Tara

AU - Hwang, Stephen W.

AU - Jüni, Peter

AU - Law, Michael R.

AU - Mamdani, Muhammad M.

AU - Manns, Braden J.

AU - Martin, Danielle

AU - Morgan, Steven G.

AU - Oh, Paul I.

AU - Pinto, Andrew D.

AU - Shah, Baiju R.

AU - Sullivan, Frank

AU - Umali, Norman

AU - Thorpe, Kevin E.

AU - Tu, Karen

AU - Laupacis, Andreas

AU - for the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team

N1 - This work is supported by grant 381409 from the Canadian Institutes for Health Research, the Ontario SPOR Support Unit that is supported by the Canadian Institutes of Health Research and the Province of Ontario, the Canada Research Chairs program, and the St Michael’s Hospital Foundation.

PY - 2020/1

Y1 - 2020/1

N2 - Importance: Nonadherence to treatment with medicines is common globally, even for life-saving treatments. Cost is one important barrier to access, and only some jurisdictions provide medicines at no charge to patients.Objective: To determine whether providing essential medicines at no charge to outpatients who reported not being able to afford medicines improves adherence.Design, Setting, and Participants: A multicenter, unblinded, parallel, 2-group, superiority, outcomes assessor-blinded, individually randomized clinical trial conducted at 9 primary care sites in Ontario, Canada, enrolled 786 patients between June 1, 2016, and April 28, 2017, who reported cost-related nonadherence. Follow-up occurred at 12 months. The primary analysis was performed using an intention-to-treat principle.Interventions: Patients were randomly allocated to receive free medicines on a list of essential medicines in addition to otherwise usual care (n = 395) or usual medicine access and usual care (n = 391).Main Outcomes and Measures: The primary outcome was adherence to treatment with all medicines that were appropriately prescribed for 1 year. Secondary outcomes were hemoglobin A1c level, blood pressure, and low-density lipoprotein cholesterol levels 1 year after randomization in participants taking corresponding medicines. Results: Among the 786 participants analyzed (439 women and 347 men; mean [SD] age, 51.7 [14.3] years), 764 completed the trial. Adherence to treatment with all medicines was higher in those randomized to receive free distribution (151 of 395 [38.2%]) compared with usual access (104 of 391 [26.6%]; difference, 11.6%; 95% CI, 4.9%-18.4%). Control of type 1 and 2 diabetes was not significantly improved by free distribution (hemoglobin A1c, -0.38%; 95% CI, -0.76% to 0.00%), systolic blood pressure was reduced (-7.2 mm Hg; 95% CI, -11.7 to -2.8 mm Hg), and low-density lipoprotein cholesterol levels were not affected (-2.3 mg/dL; 95% CI, -14.7 to 10.0 mg/dL). Conclusions and Relevance: The distribution of essential medicines at no charge for 1 year increased adherence to treatment with medicines and improved some, but not other, disease-specific surrogate health outcomes. These findings could help inform changes to medicine access policies such as publicly funding essential medicines. Trial Registration: ClinicalTrials.gov identifier: NCT02744963.

AB - Importance: Nonadherence to treatment with medicines is common globally, even for life-saving treatments. Cost is one important barrier to access, and only some jurisdictions provide medicines at no charge to patients.Objective: To determine whether providing essential medicines at no charge to outpatients who reported not being able to afford medicines improves adherence.Design, Setting, and Participants: A multicenter, unblinded, parallel, 2-group, superiority, outcomes assessor-blinded, individually randomized clinical trial conducted at 9 primary care sites in Ontario, Canada, enrolled 786 patients between June 1, 2016, and April 28, 2017, who reported cost-related nonadherence. Follow-up occurred at 12 months. The primary analysis was performed using an intention-to-treat principle.Interventions: Patients were randomly allocated to receive free medicines on a list of essential medicines in addition to otherwise usual care (n = 395) or usual medicine access and usual care (n = 391).Main Outcomes and Measures: The primary outcome was adherence to treatment with all medicines that were appropriately prescribed for 1 year. Secondary outcomes were hemoglobin A1c level, blood pressure, and low-density lipoprotein cholesterol levels 1 year after randomization in participants taking corresponding medicines. Results: Among the 786 participants analyzed (439 women and 347 men; mean [SD] age, 51.7 [14.3] years), 764 completed the trial. Adherence to treatment with all medicines was higher in those randomized to receive free distribution (151 of 395 [38.2%]) compared with usual access (104 of 391 [26.6%]; difference, 11.6%; 95% CI, 4.9%-18.4%). Control of type 1 and 2 diabetes was not significantly improved by free distribution (hemoglobin A1c, -0.38%; 95% CI, -0.76% to 0.00%), systolic blood pressure was reduced (-7.2 mm Hg; 95% CI, -11.7 to -2.8 mm Hg), and low-density lipoprotein cholesterol levels were not affected (-2.3 mg/dL; 95% CI, -14.7 to 10.0 mg/dL). Conclusions and Relevance: The distribution of essential medicines at no charge for 1 year increased adherence to treatment with medicines and improved some, but not other, disease-specific surrogate health outcomes. These findings could help inform changes to medicine access policies such as publicly funding essential medicines. Trial Registration: ClinicalTrials.gov identifier: NCT02744963.

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DO - 10.1001/jamainternmed.2019.4472

M3 - Article

C2 - 31589276

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SN - 2168-6106

VL - 180

SP - 27

EP - 34

JO - JAMA Internal Medicine

JF - JAMA Internal Medicine

IS - 1

ER -

Effect on treatment adherence of distributing essential medicines at no charge: the CLEAN Meds randomized clinical trial

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