Clinical trial NCT02744963: Carefully seLected and Easily Accessible at No Charge Medications
Official title: Carefully seLected and Easily Accessible at No Charge Medications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medication Adherence
Inappropriate Prescribing
Diabetes
Hypertension
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: The Ontario Spor Support Unit
First posted: 2016-04-20
Enrollment: 784
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial evaluates the effect of providing primary care patients with free and convenient access to a set of essential medicines. Half of the participants will receive free and convenient access to these essential medicines, while the other half will have usual access to medicines.

Detailed description: Medication adherence is one important determinant of health outcomes. Approximately one half of treatments for chronic disease are not taken as directed. Cost is one of several important causes of poor adherence and it is particularly important for vulnerable people.

The size of many formularies makes it difficult for clinicians to know the safest and most effective medications to prescribe. This may partially explain poor medication selection. Short lists of essential medications have improved the the quality of prescribing.

Eligibility criteria: Inclusion Criteria:

* Cost related medicine non-adherence during last 12 months

Exclusion Criteria:

* Family member living at same address of patient who is already enrolled in this trial
* Patient joined practice during last 6 months

Primary outcomes:
measure: Appropriate medicine adherence
timeFrame: During entire study period (24 months)
Secondary outcomes:
measure: Percentage (%) of prescriptions that are appropriate.
timeFrame: During entire study period (24 months)
measure: Percentage (%) of prescriptions that are adhered to.
timeFrame: During entire study period (24 months)
measure: Hemoglobin A1c levels in patients with diabetes (adjusted for baseline)
timeFrame: Assessed between months 21 and 24 inclusive
measure: Blood pressure in hypertensive patients (adjusted for baseline)
timeFrame: Assessed between months 21 and 24 inclusive
measure: LDL cholesterol levels in patients taking a statin (adjusted for baseline
timeFrame: Assessed between months 21 and 24 inclusive
measure: Healthcare costs including medication costs
timeFrame: During entire study period (24 months)
Other outcomes:
measure: Count of healthcare encounters
timeFrame: During entire study period (24 months)
Locations:
city: Assiginack
country: Canada
facility: Municipality of Assiginack Family Health Team
state: Ontario
city: Blind River
country: Canada
facility: Huron Shores Family Health Team
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital Academic Family Health Team
state: Ontario
Study officials:
References:
citation: Persaud N, Bedard M, Boozary A, Glazier RH, Gomes T, Hwang SW, Juni P, Law MR, Mamdani M, Manns B, Martin D, Morgan SG, Oh P, Pinto AD, Shah BR, Sullivan F, Umali N, Thorpe KE, Tu K, Laupacis A; Carefully seLected and Easily Accessible at No Charge Medications (CLEAN Meds) study team. Adherence at 2 years with distribution of essential medicines at no charge: The CLEAN Meds randomized clinical trial. PLoS Med. 2021 May 21;18(5):e1003590. doi: 10.1371/journal.pmed.1003590. eCollection 2021 May.
citation: Charles O, Woods H, Ally M, Manns B, Shah BR, Wang R, Persaud N. Effect of free distribution of medicines on the process of care for adult patients with type 1 and type 2 diabetes and hypertension: post hoc analysis of randomised controlled trial findings. BMJ Open. 2021 Mar 15;11(3):e042046. doi: 10.1136/bmjopen-2020-042046.
citation: Yaphe H, Adekoya I, Steiner L, Maraj D, O'Campo P, Persaud N. Exploring the experiences of people in Ontario, Canada who have trouble affording medicines: a qualitative concept mapping study. BMJ Open. 2019 Dec 29;9(12):e033933. doi: 10.1136/bmjopen-2019-033933.
citation: Persaud N, Bedard M, Boozary AS, Glazier RH, Gomes T, Hwang SW, Juni 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; Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team. Effect on Treatment Adherence of Distributing Essential Medicines at No Charge: The CLEAN Meds Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):27-34. doi: 10.1001/jamainternmed.2019.4472.
citation: Persaud N, Lee T, Ahmad H, Li W, Taglione MS, Rajakulasingam Y, Umali N, Boozary A, Glazier RH, Gomes T, Hwang SW, Juni 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. 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. 2017 Jun 12;7(5):e015686. doi: 10.1136/bmjopen-2016-015686.