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| Name | Class |
|---|---|
| The Ontario Spor Support Unit | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual medicine access | No Intervention | Usual access to medicines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free and convenient medicine access | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| Measure | Description | Time Frame |
|---|---|---|
| Count of healthcare encounters | Includes ambulatory visits, emergency department visits, hospital admission, investigations and other healthcare utilization. | During entire study period (24 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Municipality of Assiginack Family Health Team | Assiginack | Ontario | P0P 1N0 | Canada | ||
| Huron Shores Family Health Team |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37234014 | Derived | 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. | |
| 36549740 |
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Individual participant data will be made available at the time of study completion.
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| 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 |
| Healthcare costs including medication costs | During entire study period (24 months) |
| Blind River |
| Ontario |
| P0R 1B0 |
| Canada |
| St Michael's Hospital Academic Family Health Team | Toronto | Ontario | M5B 1W8 | Canada |
| Derived |
| 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. |
| 34019540 | Derived | 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. |
| 33722866 | Derived | 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. |
| 31888944 | Derived | 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. |
| 31589276 | Derived | 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. |
| 28611089 | Derived | 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. |
| D001519 | Behavior |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |