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

Persaud, Nav; Lee, Taehoon; Ahmad, Haroon; Li, Winny; Taglione, Michael Sergio; Rajakulasingam, Yathavan; Umali, Norman; Boozary, Andrew; Glazier, Richard H.; Gomes, Tara; Hwang, Stephen W.; Jüni, Peter; Law, Michael R.; Mamdani, Muhammad; Manns, Braden; Martin, Danielle; Morgan, Steve; Oh, Paul; Pinto, Andrew D.; Shah, Baiju R.; Sullivan, Frank; Thorpe, Kevin E.; Tu, Karen; Laupacis, Andreas

doi:10.1136/bmjopen-2016-015686

Cited by 7 publications

(6 citation statements)

References 34 publications

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“…This trial was a multicenter, open-label, parallel 2-arm, superiority, individually randomized controlled trial with 1:1 allocation that was conducted at 9 primary care sites in Ontario, Canada and approved by St. Michael’s Research Ethics Board, the Huron Shores Family Health Team Research Ethics Committee, and the Laurentian University Research Ethics Board [ 10 ]. The trial was registered (NCT02744963), and a detailed protocol was published [ 11 ]. After trial initiation, the trial was extended from 1 to 2 years when additional funding became available; the first year results were published, and after the first year, we stopped using electronic bottle cap devices to measure adherence as participants in both groups did not return the devices for data collection [ 10 ].…”

Section: Methodsmentioning

confidence: 99%

Adherence at 2 years with distribution of essential medicines at no charge: The CLEAN Meds randomized clinical trial

Persaud

Bedard

Boozary³

et al. 2021

PLoS Med

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Background Adherence to medicines is low for a variety of reasons, including the cost borne by patients. Some jurisdictions publicly fund medicines for the general population, but many jurisdictions do not, and such policies are contentious. To our knowledge, no trials studying free access to a wide range of medicines have been conducted. Methods and findings We randomly assigned 786 primary care patients who reported not taking medicines due to cost between June 1, 2016 and April 28, 2017 to either free distribution of essential medicines (n = 395) or to usual medicine access (n = 391). The trial was conducted in Ontario, Canada, where hospital care and physician services are publicly funded for the general population but medicines are not. The trial population was mostly female (56%), younger than 65 years (83%), white (66%), and had a low income from wages as the primary source (56%). The primary outcome was medicine adherence after 2 years. Secondary outcomes included control of diabetes, blood pressure, and low-density lipoprotein (LDL) cholesterol in patients taking relevant treatments and healthcare costs over 2 years. Adherence to all appropriate prescribed medicines was 38.7% in the free distribution group and 28.6% in the usual access group after 2 years (absolute difference 10.1%; 95% confidence interval (CI) 3.3 to 16.9, p = 0.004). There were no statistically significant differences in control of diabetes (hemoglobin A1c 0.27; 95% CI −0.25 to 0.79, p = 0.302), systolic blood pressure (−3.9; 95% CI −9.9 to 2.2, p = 0.210), or LDL cholesterol (0.26; 95% CI −0.08 to 0.60, p = 0.130) based on available data. Total healthcare costs over 2 years were lower with free distribution (difference in median CAN$1,117; 95% CI CAN$445 to CAN$1,778, p = 0.006). In the free distribution group, 51 participants experienced a serious adverse event, while 68 participants in the usual access group experienced a serious adverse event (p = 0.091). Participants were not blinded, and some outcomes depended on participant reports. Conclusions In this study, we observed that free distribution of essential medicines to patients with cost-related nonadherence substantially increased adherence, did not affect surrogate health outcomes, and reduced total healthcare costs over 2 years. Trial registration ClinicalTrials.gov NCT02744963.

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Section: Methodsmentioning

confidence: 99%

Adherence at 2 years with distribution of essential medicines at no charge: The CLEAN Meds randomized clinical trial

Persaud

Bedard

Boozary³

et al. 2021

PLoS Med

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“…All study outcome questions, including the open-ended question, were developed by a community guidance panel (CGP) for the trial20 and were pilot tested before being implemented 17. The study was approved by the Research Ethics Board of St Michael’s Hospital where data collection was conducted from March 2017 to October 2018 by trained research assistants who had previously completed certifications in Canada Good Clinical Practice and Tri-Council Policy Statement 2.…”

Section: Methodsmentioning

confidence: 99%

“…The purpose of this qualitative concept mapping study was to describe and represent experiences relating to accessing medicines that were reported by participants during the first year of a randomised controlled trial of free medicine distribution 17 18. Concept mapping is a participatory methodology used to visually represent the ideas or thoughts of an individual or group and it is suitable for analysing responses to open-ended survey questions 19.…”

Section: Introductionmentioning

confidence: 99%

“…Concept mapping is a participatory methodology used to visually represent the ideas or thoughts of an individual or group and it is suitable for analysing responses to open-ended survey questions 19. The trial included people who reported not taking a prescribed medicine for a chronic condition because of the cost and were randomly allocated to either continue their poor access or to have free distribution of essential medicines 17 18. Thus, the reported experiences include those of people who have poor medicine access and those who have improved access, similar to what might happen if there was a change in public policy surrounding medicine access.…”

Section: Introductionmentioning

confidence: 99%

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Exploring the experiences of people in Ontario, Canada who have trouble affording medicines: a qualitative concept mapping study

et al. 2019

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ObjectivesThe experiences of people who report cost-related medicine non-adherence are not well documented. We aimed to present experiences relating to accessing medicines reported by the participants in a randomised controlled trial of free medicine distribution.MethodsThe trial consisted of primary care patients from a large urban family practice and three rural family practices who reported cost-related medicine non-adherence. Participants were randomly allocated to continue their poor access (control) or to receive free and easily accessible medicines (intervention). As part of data collection for the first year of the trial, participants were asked closed and open-ended questions to assess their adherence to medication, health outcomes and their experiences in relation to medicine accessibility. We conducted a qualitative concept mapping study in which we analysed and summarised participants’ responses to the open-ended question on a concept map to visually present their experiences relating to accessing medicines.ResultsOf the 524 trial participants contacted, 198 (38%) responded to the open-ended question. The concept map contains clusters that represent eight types of experiences of participants related to medicine access including stress, relationship with doctor, health impact, quality of life, sacrificing other essentials, medicines are expensive, financial impact and adherence. These experiences fall under two major themes, experiences relating to personal finances and experiences relating to well-being, which are bridged by a central cluster of adherence.ConclusionsThe experiences shared by the participants demonstrate that access to medicines impacts people’s finances and well-being as well as their adherence to prescribed medicines. These results indicate that effects on personal finances and general well-being should be measured for interventions and policy changes aimed at improving medicine access.Trial registration numberThis article is linked to the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) randomised controlled trial (trial registration number: NCT02744963).

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“…The views expressed by participants in this study may not reflect those of the general population because all participants had trouble affording medicines; however, they represented situations similar to more than 1 million Canadians. 4,21 People who experience cost-related nonadherence are those most likely to be affected by policy change. Trial participants also do not represent every possible medical condition and people taking specific medicines (eg, anti-rejection treatment) might have definite views about whether they should be included in the list.…”

Section: Limitationsmentioning

confidence: 99%

Acceptability of a short list of essential medicines to patients and prescribers

et al. 2022

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Objective To determine the acceptability of providing free access to only a short list of medicines used in the Carefully seLected and Easily Accessible at No charge Medications (CLEAN Meds) trial.Design A multimethod explanatory sequential design including interviews with trial participants and focus groups with prescribers. Setting Ontario.Participants Participants in the intervention arm of the CLEAN Meds trial and primary care providers who prescribed medicines to those in the intervention arm of the trial. Main outcome measuresThe number of trial participants in each prescription category (ie, prescribed no off-list medicine, prescribed 1 off-list medicine, or prescribed 2 or more off-list medicines) and the acceptability of the list to both participants and prescribers.Results There were 395 participants in the intervention group of the CLEAN Meds trial, but 16 participants withdrew consent or were not prescribed any medicines during the first 12 months of the trial, resulting in a total of 379 participants in the quantitative component of this study. Of the 2648 total prescriptions, 2349 (89%) were for medications that were on or had an equivalent covered by the list. Random sampling was used to select 5 participants to interview from each prescription category. A total of 19 prescribers participated in the focus groups. Themes from participant interviews included the following: having access to medicines on the list was a relief, participants trusted health care professionals to switch medicines and to decide which medicines should be on a publicly funded list, and a short list of essential medicines should be publicly funded. Major themes from the prescribers' focus groups related to the process of developing the list, support for the list, and publicly funding a short list of essential medicines in Canada. ConclusionThe consensus among trial participants and prescribers is that the short list of medicines used in the trial is comprehensive and provides access to medicines commonly prescribed.This article has been peer reviewed. Cet article a fait l'objet d'une révision par des pairs.

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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

Cited by 7 publications

References 34 publications

Adherence at 2 years with distribution of essential medicines at no charge: The CLEAN Meds randomized clinical trial

Adherence at 2 years with distribution of essential medicines at no charge: The CLEAN Meds randomized clinical trial

Exploring the experiences of people in Ontario, Canada who have trouble affording medicines: a qualitative concept mapping study

Acceptability of a short list of essential medicines to patients and prescribers

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