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

Sponsor
Unity Health Toronto (Other)
Overall Status
Unknown status
CT.gov ID
NCT02744963
Collaborator
The Ontario Spor Support Unit (Other)
784
3
2
54
261.3
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Free and convenient medicine access
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
784 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Carefully seLected and Easily Accessible at No Charge Medications
Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Percentage (%) of prescriptions that are appropriate. [During entire study period (24 months)]

  2. Percentage (%) of prescriptions that are adhered to. [During entire study period (24 months)]

  3. Hemoglobin A1c levels in patients with diabetes (adjusted for baseline) [Assessed between months 21 and 24 inclusive]

  4. Blood pressure in hypertensive patients (adjusted for baseline) [Assessed between months 21 and 24 inclusive]

  5. LDL cholesterol levels in patients taking a statin (adjusted for baseline [Assessed between months 21 and 24 inclusive]

  6. Healthcare costs including medication costs [During entire study period (24 months)]

Other Outcome Measures

  1. Count of healthcare encounters [During entire study period (24 months)]

    Includes ambulatory visits, emergency department visits, hospital admission, investigations and other healthcare utilization.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Municipality of Assiginack Family Health Team Assiginack Ontario Canada P0P 1N0
2 Huron Shores Family Health Team Blind River Ontario Canada P0R 1B0
3 St Michael's Hospital Academic Family Health Team Toronto Ontario Canada M5B 1W8

Sponsors and Collaborators

  • Unity Health Toronto
  • The Ontario Spor Support Unit

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Unity Health Toronto
ClinicalTrials.gov Identifier:
NCT02744963
Other Study ID Numbers:
  • 15-114
First Posted:
Apr 20, 2016
Last Update Posted:
Apr 28, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2020