Abstract
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. To determine whether providing essential medicines at no charge to outpatients who reported not being able to afford medicines improves adherence. 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. 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). 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. 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). 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. ClinicalTrials.gov identifier: NCT02744963.
Highlights
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
Control of type 1 and 2 diabetes was not significantly improved by free distribution, 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)
Study Design The Carefully Selected and Accessible at No Charge Medicines (CLEAN Meds) trial is a multicenter, unblinded, parallel, 2-group, superiority, outcomes assessor–blinded, individually randomized clinical trial with 1:1 allocation conducted at 9 primary care sites in Ontario, Canada, that enrolled patients between June 1, 2016, and April 28, 2017
Summary
Study Design The Carefully Selected and Accessible at No Charge Medicines (CLEAN Meds) trial is a multicenter, unblinded, parallel, 2-group, superiority, outcomes assessor–blinded, individually randomized clinical trial with 1:1 allocation conducted at 9 primary care sites in Ontario, Canada, that enrolled patients between June 1, 2016, and April 28, 2017. The trial was registered with ClinicalTrials.gov (NCT02744963) and a protocol has been published.[12] The trial is reported in accordance with the 2010 CONSORT statement[13] and the intervention is described using the TIDieR (Template for Intervention Description and Replication) checklist.[14] After registration with ClinicalTrials. Gov, publication of the protocol, and initiation of the study, the duration of the trial was extended from 12 to 24 months when additional funding was obtained After registration with ClinicalTrials. gov, publication of the protocol, and initiation of the study, the duration of the trial was extended from 12 to 24 months when additional funding was obtained
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