Carefully seLected and Easily Accessible at No Charge Medications (CLEAN-Meds)
Primary Purpose
Medication Adherence, Inappropriate Prescribing, Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Free and convenient medicine access
Sponsored by

About this trial
This is an interventional health services research trial for Medication Adherence
Eligibility Criteria
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
Sites / Locations
- Municipality of Assiginack Family Health Team
- Huron Shores Family Health Team
- St Michael's Hospital Academic Family Health Team
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Free and convenient medicine access
Usual medicine access
Arm Description
Free access to a list of essential medicines. Medicines are either mailed to the patient or dispensed at the point of care.
Usual access to medicines.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Percentage (%) of prescriptions that are appropriate.
Percentage (%) of prescriptions that are adhered to.
Hemoglobin A1c levels in patients with diabetes (adjusted for baseline)
Blood pressure in hypertensive patients (adjusted for baseline)
LDL cholesterol levels in patients taking a statin (adjusted for baseline
Healthcare costs including medication costs
Full Information
NCT ID
NCT02744963
First Posted
April 5, 2016
Last Updated
April 27, 2020
Sponsor
Unity Health Toronto
Collaborators
The Ontario Spor Support Unit
1. Study Identification
Unique Protocol Identification Number
NCT02744963
Brief Title
Carefully seLected and Easily Accessible at No Charge Medications
Acronym
CLEAN-Meds
Official Title
Carefully seLected and Easily Accessible at No Charge Medications
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
The Ontario Spor Support Unit
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Inappropriate Prescribing, Diabetes, Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
784 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Free and convenient medicine access
Arm Type
Experimental
Arm Description
Free access to a list of essential medicines. Medicines are either mailed to the patient or dispensed at the point of care.
Arm Title
Usual medicine access
Arm Type
No Intervention
Arm Description
Usual access to medicines.
Intervention Type
Other
Intervention Name(s)
Free and convenient medicine access
Primary Outcome Measure Information:
Title
Appropriate medicine adherence
Description
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
Time Frame
During entire study period (24 months)
Secondary Outcome Measure Information:
Title
Percentage (%) of prescriptions that are appropriate.
Time Frame
During entire study period (24 months)
Title
Percentage (%) of prescriptions that are adhered to.
Time Frame
During entire study period (24 months)
Title
Hemoglobin A1c levels in patients with diabetes (adjusted for baseline)
Time Frame
Assessed between months 21 and 24 inclusive
Title
Blood pressure in hypertensive patients (adjusted for baseline)
Time Frame
Assessed between months 21 and 24 inclusive
Title
LDL cholesterol levels in patients taking a statin (adjusted for baseline
Time Frame
Assessed between months 21 and 24 inclusive
Title
Healthcare costs including medication costs
Time Frame
During entire study period (24 months)
Other Pre-specified Outcome Measures:
Title
Count of healthcare encounters
Description
Includes ambulatory visits, emergency department visits, hospital admission, investigations and other healthcare utilization.
Time Frame
During entire study period (24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Municipality of Assiginack Family Health Team
City
Assiginack
State/Province
Ontario
ZIP/Postal Code
P0P 1N0
Country
Canada
Facility Name
Huron Shores Family Health Team
City
Blind River
State/Province
Ontario
ZIP/Postal Code
P0R 1B0
Country
Canada
Facility Name
St Michael's Hospital Academic Family Health Team
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be made available at the time of study completion.
Citations:
PubMed Identifier
34019540
Citation
Persaud N, Bedard M, Boozary A, Glazier RH, Gomes T, Hwang SW, Juni P, Law MR, Mamdani M, Manns B, Martin D, Morgan SG, Oh P, Pinto AD, Shah BR, Sullivan F, Umali N, Thorpe KE, Tu K, Laupacis A; Carefully seLected and Easily Accessible at No Charge Medications (CLEAN Meds) study team. Adherence at 2 years with distribution of essential medicines at no charge: The CLEAN Meds randomized clinical trial. PLoS Med. 2021 May 21;18(5):e1003590. doi: 10.1371/journal.pmed.1003590. eCollection 2021 May.
Results Reference
derived
PubMed Identifier
33722866
Citation
Charles O, Woods H, Ally M, Manns B, Shah BR, Wang R, Persaud N. Effect of free distribution of medicines on the process of care for adult patients with type 1 and type 2 diabetes and hypertension: post hoc analysis of randomised controlled trial findings. BMJ Open. 2021 Mar 15;11(3):e042046. doi: 10.1136/bmjopen-2020-042046.
Results Reference
derived
PubMed Identifier
31888944
Citation
Yaphe H, Adekoya I, Steiner L, Maraj D, O'Campo P, Persaud N. Exploring the experiences of people in Ontario, Canada who have trouble affording medicines: a qualitative concept mapping study. BMJ Open. 2019 Dec 29;9(12):e033933. doi: 10.1136/bmjopen-2019-033933.
Results Reference
derived
PubMed Identifier
31589276
Citation
Persaud N, Bedard M, Boozary AS, Glazier RH, Gomes T, Hwang SW, Juni P, Law MR, Mamdani MM, Manns BJ, Martin D, Morgan SG, Oh PI, Pinto AD, Shah BR, Sullivan F, Umali N, Thorpe KE, Tu K, Laupacis A; Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team. Effect on Treatment Adherence of Distributing Essential Medicines at No Charge: The CLEAN Meds Randomized Clinical Trial. JAMA Intern Med. 2019 Oct 7;180(1):27-34. doi: 10.1001/jamainternmed.2019.4472. Online ahead of print.
Results Reference
derived
PubMed Identifier
28611089
Citation
Persaud N, Lee T, Ahmad H, Li W, Taglione MS, Rajakulasingam Y, Umali N, Boozary A, Glazier RH, Gomes T, Hwang SW, Juni P, Law M, Mamdani MM, Manns B, Martin D, Morgan S, Oh P, Pinto AD, Shah BR, Sullivan FM, Thorpe KE, Tu K, Laupacis A. Protocol for a randomised controlled trial evaluating the effects of providing essential medicines at no charge: the Carefully seLected and Easily Accessible at No Charge Medicines (CLEAN Meds) trial. BMJ Open. 2017 Jun 12;7(5):e015686. doi: 10.1136/bmjopen-2016-015686.
Results Reference
derived
Learn more about this trial
Carefully seLected and Easily Accessible at No Charge Medications
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