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

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ClinicalTrials.gov Identifier: NCT02744963
Recruitment Status : Active, not recruiting
First Posted : April 20, 2016
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
The Ontario Spor Support Unit
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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
Medication Adherence Inappropriate Prescribing Diabetes Hypertension Other: Free and convenient medicine access Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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


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

Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744963


Locations
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Canada, Ontario
Municipality of Assiginack Family Health Team
Assiginack, Ontario, Canada, P0P 1N0
Huron Shores Family Health Team
Blind River, Ontario, Canada, P0R 1B0
St Michael's Hospital Academic Family Health Team
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
The Ontario Spor Support Unit

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02744963     History of Changes
Other Study ID Numbers: 15-114
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be made available at the time of study completion.
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases