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

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Date
01/2020
Author
Persaud, Navindra
Bedard, Michael
Boozary, Andrew S.
Glazier, Richard H.
Gomes, Tara
Hwang, Stephen W.
Jüni, Peter
Law, Michael R.
Mamdani, Muhammad M.
Manns, Braden J.
Martin, Danielle
Morgan, Steven G.
Oh, Paul I.
Pinto, Andrew D.
Shah, Baiju R.
Sullivan, Frank
Umali, Norman
Thorpe, Kevin E.
Tu, Karen
Laupacis, Andreas
for the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team
Keywords
RA0421 Public health. Hygiene. Preventive Medicine
Internal Medicine
NDAS
BDC
R2C
~DC~
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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.
Citation
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 , 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
Publication
JAMA Internal Medicine
Status
Peer reviewed
DOI
https://doi.org/10.1001/jamainternmed.2019.4472
ISSN
2168-6106
Type
Journal article
Rights
Copyright © 2019 Persaud N et al. JAMA Internal Medicine. This is an open access article distributed under the terms of the CC-BY License.
Description
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.
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  • University of St Andrews Research
URI
http://hdl.handle.net/10023/18722

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