Carefully seLected and Easily Accessible at No Charge Medications (CLEAN-Meds)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02744963|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2016
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence Inappropriate Prescribing Diabetes Hypertension||Other: Free and convenient medicine access||Not Applicable|
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. At least 2.4 million adult Canadians report cost related nonadherence to medications. 31 % of prescriptions in Quebec are not filled and those of highest cost are least likely to be filled. Providing full drug coverage may improve medication adherence and clinical outcomes, particularly for vulnerable individuals and those with chronic diseases.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||784 participants|
|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 :||April 2018|
|Estimated Study Completion Date :||April 2018|
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.
- Appropriate medicine adherence [ Time Frame: During entire study period (12 months) ]The percentage of prescriptions that are both (1) appropriate based on explicit criteria and (2) taken as prescribed or adhered to for 80 % of doses
- Percentage (%) of prescriptions that are appropriate. [ Time Frame: During entire study period (12 months) ]
- Percentage (%) of prescriptions that are adhered to. [ Time Frame: During entire study period (12 months) ]
- Hemoglobin A1c levels in patients with diabetes (adjusted for baseline) [ Time Frame: Assessed between months 9 and 12 inclusive ]
- Blood pressure in hypertensive patients (adjusted for baseline) [ Time Frame: Assessed between months 9 and 12 inclusive ]
- LDL cholesterol levels in patients taking a statin (adjusted for baseline [ Time Frame: Assessed between months 9 and 12 inclusive ]
- Healthcare costs including medication costs [ Time Frame: During entire study period (12 months) ]
- Count of healthcare encounters [ Time Frame: During entire study period (12 months) ]Includes ambulatory visits, emergency department visits, hospital admission, investigations and other healthcare utilization.
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
|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|