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Medication AdherenceCLEAN-MedsNCT02744963

Carefully seLected and Easily Accessible at No Charge Medications

A study testing Free and convenient medicine access in people with Medication Adherence and Inappropriate Prescribing, run by Unity Health Toronto at 3 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Free and convenient medicine access
Could I receive a placebo?
No, everyone receives an active treatment
How many people
784 participants
Where
3 sitesCanada
Study dates
Jun 2016to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Cost related medicine non-adherence during last 12 months

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Municipality of Assiginack Family Health Team

    Assiginack, Ontario, P0P 1N0

  • Huron Shores Family Health Team

    Blind River, Ontario, P0R 1B0

  • St Michael's Hospital Academic Family Health Team

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Free and convenient medicine access
Medical subject headings
Medication Adherence, Diabetes Mellitus, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Free and convenient medicine accessOther

Study groups in NCT02744963
Study groupRoleWhat they receive
Free and convenient medicine accessExperimentalFree access to a list of essential medicines. Medicines are either mailed to the patient or dispensed at the point of care.
Receives: Other: Free and convenient medicine access
Usual medicine accessNo interventionUsual access to medicines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: During entire study period (24 months)

Secondary outcomes (6)

  1. Percentage (%) of prescriptions that are appropriate.

    Measured: During entire study period (24 months)

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

    Measured: During entire study period (24 months)

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

    Measured: Assessed between months 21 and 24 inclusive

  4. Blood pressure in hypertensive patients (adjusted for baseline)

    Measured: Assessed between months 21 and 24 inclusive

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

    Measured: Assessed between months 21 and 24 inclusive

  6. Healthcare costs including medication costs

    Measured: During entire study period (24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2019
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
784 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02744963
Sponsor's protocol ID
15-114
Acronym
CLEAN-Meds
Status last verified
Apr 2020
First submitted
5 Apr 2016
Last updated
28 Apr 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Individual participant data will be made available at the time of study completion.

Publications

  • 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.

    PubMed 37234014

  • 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.

    PubMed 36549740

  • 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.

    PubMed 34019540

  • 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.

    PubMed 33722866

  • 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.

    PubMed 31888944

  • 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.

    PubMed 31589276

  • 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.

    PubMed 28611089

Questions about this trial

What is this clinical trial studying?

A study testing Free and convenient medicine access in people with Medication Adherence and Inappropriate Prescribing, run by Unity Health Toronto at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Appropriate medicine adherence (time frame: During entire study period (24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02744963, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.

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