Carefully seLected and Easily Accessible at No Charge Medications (CLEAN-Meds)

April 27, 2020 updated by: Unity Health Toronto
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

784

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Assiginack, Ontario, Canada, P0P 1N0
        • Municipality of Assiginack Family Health Team
      • Blind River, Ontario, Canada, P0R 1B0
        • Huron Shores Family Health Team
      • Toronto, Ontario, Canada, M5B 1W8
        • St Michael's Hospital Academic Family Health Team

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Free and convenient medicine access
No Intervention: Usual medicine access
Usual access to medicines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriate medicine adherence
Time Frame: 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
During entire study period (24 months)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count of healthcare encounters
Time Frame: During entire study period (24 months)
Includes ambulatory visits, emergency department visits, hospital admission, investigations and other healthcare utilization.
During entire study period (24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

The Ontario Spor Support Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data will be made available at the time of study completion.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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