NCT02744963

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
784

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

3.5 years

First QC Date

April 5, 2016

Last Update Submit

April 27, 2020

Conditions

Medication AdherenceInappropriate PrescribingDiabetesHypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Percentage (%) of prescriptions that are appropriate.

    During entire study period (24 months)

  • Percentage (%) of prescriptions that are adhered to.

    During entire study period (24 months)

  • Hemoglobin A1c levels in patients with diabetes (adjusted for baseline)

    Assessed between months 21 and 24 inclusive

  • Blood pressure in hypertensive patients (adjusted for baseline)

    Assessed between months 21 and 24 inclusive

  • LDL cholesterol levels in patients taking a statin (adjusted for baseline

    Assessed between months 21 and 24 inclusive

  • +1 more secondary outcomes

Other Outcomes (1)

  • Count of healthcare encounters

    During entire study period (24 months)

Study Arms (2)

Free and convenient medicine access

EXPERIMENTAL

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

Usual medicine access

NO INTERVENTION

Usual access to medicines.

Interventions

Free and convenient medicine accessOTHER
Free and convenient medicine access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cost related medicine non-adherence during last 12 months

You may not qualify if:

  • Family member living at same address of patient who is already enrolled in this trial
  • Patient joined practice during last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Municipality of Assiginack Family Health Team

Assiginack, Ontario, P0P 1N0, Canada

Location

Huron Shores Family Health Team

Blind River, Ontario, P0R 1B0, Canada

Location

St Michael's Hospital Academic Family Health Team

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (7)

  • 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, Wu F, Laupacis A; CLEAN Meds study team. Effect of Free Medicine Distribution on Health Care Costs in Canada Over 3 Years: A Secondary Analysis of the CLEAN Meds Randomized Clinical Trial. JAMA Health Forum. 2023 May 5;4(5):e231127. doi: 10.1001/jamahealthforum.2023.1127.

    PMID: 37234014DERIVED

  • Hess M, Wang R, Workentin A, Woods H, Persaud N. Effect of free medicine distribution on ability to make ends meet: post hoc quantitative subgroup analysis and qualitative thematic analysis. BMJ Open. 2022 Dec 22;12(12):e061726. doi: 10.1136/bmjopen-2022-061726.

    PMID: 36549740DERIVED

  • 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.

    PMID: 34019540DERIVED

  • 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.

    PMID: 33722866DERIVED

  • 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.

    PMID: 31888944DERIVED

  • 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. 2020 Jan 1;180(1):27-34. doi: 10.1001/jamainternmed.2019.4472.

    PMID: 31589276DERIVED

  • 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.

    PMID: 28611089DERIVED

MeSH Terms

Conditions

Medication AdherenceDiabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 20, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

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

Locations

CA(3)