Carefully seLected and Easily Accessible at No Charge Medications

Not Applicable

• Conditions: Diabetes; Medication Adherence; Inappropriate Prescribing; Hypertension
• Interventions: Other: Free and convenient medicine access

• Registration Number: NCT02744963
• Lead Sponsor: Unity Health Toronto

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.

Study Timeline

• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-20
• Study Start: 2016-06
• Primary Completion: 2019-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-04-28
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 784

Inclusion Criteria

• Cost related medicine non-adherence during last 12 months

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free and convenient medicine access	Free and convenient medicine access	Free access to a list of essential medicines. Medicines are either mailed to the patient or dispensed at the point of care.

Primary Outcome Measures

Name	Time	Method
Appropriate medicine adherence	During entire study period (24 months)	The percentage of patients taking medicines that are both (1) appropriate based on explicit criteria and (2) taken as prescribed or adhered to for 80 % of doses

Secondary Outcome Measures

Name	Time	Method
Percentage (%) of prescriptions that are adhered to.	During entire study period (24 months)
Healthcare costs including medication costs	During entire study period (24 months)
Percentage (%) of prescriptions that are appropriate.	During entire study period (24 months)
Hemoglobin A1c levels in patients with diabetes (adjusted for baseline)	Assessed between months 21 and 24 inclusive
LDL cholesterol levels in patients taking a statin (adjusted for baseline	Assessed between months 21 and 24 inclusive
Blood pressure in hypertensive patients (adjusted for baseline)	Assessed between months 21 and 24 inclusive

Trial Locations

Locations (3)

Huron Shores Family Health Team; 🇨🇦 Blind River, Ontario, Canada

Municipality of Assiginack Family Health Team; 🇨🇦 Assiginack, Ontario, Canada

St Michael's Hospital Academic Family Health Team; 🇨🇦 Toronto, Ontario, Canada