Carefully seLected and Easily Accessible at No Charge Medications

Hypertension Clinical Trial

— CLEAN-Meds  

Official title:

Carefully seLected and Easily Accessible at No Charge Medications

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02744963
• Other study ID #: 15-114
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Inappropriate Prescribing
• Medication Adherence

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)