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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02744963
Other study ID # 15-114
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date December 2020

Study information

Verified date April 2020
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 784
Est. completion date December 2020
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Free and convenient medicine access


Locations

Country Name City State
Canada Municipality of Assiginack Family Health Team Assiginack Ontario
Canada Huron Shores Family Health Team Blind River Ontario
Canada St Michael's Hospital Academic Family Health Team Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto The Ontario Spor Support Unit

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Count of healthcare encounters Includes ambulatory visits, emergency department visits, hospital admission, investigations and other healthcare utilization. During entire study period (24 months)
Primary Appropriate medicine adherence 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 During entire study period (24 months)
Secondary Percentage (%) of prescriptions that are appropriate. During entire study period (24 months)
Secondary Percentage (%) of prescriptions that are adhered to. During entire study period (24 months)
Secondary Hemoglobin A1c levels in patients with diabetes (adjusted for baseline) Assessed between months 21 and 24 inclusive
Secondary Blood pressure in hypertensive patients (adjusted for baseline) Assessed between months 21 and 24 inclusive
Secondary LDL cholesterol levels in patients taking a statin (adjusted for baseline Assessed between months 21 and 24 inclusive
Secondary Healthcare costs including medication costs During entire study period (24 months)
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