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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
| Canadian Stroke Prevention Intervention Network | OTHER |
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The purpose of this study is to compare the effectiveness of prescribing oral anticoagulation therapy by pharmacist intervention compared to enhanced usual care in participants with unrecognized AF and/or known AF but not taking blood thinners.
Background:
AF is the most common arrhythmia and the leading cause of stroke. Despite robust evidence oral anticoagulation (OAC) therapy is effective and safe for stroke prevention in patients with AF; there is a lack of real-world application. Alternative strategies to deliver stroke prevention therapy need to be explored. Although pharmacists' prescribing of antihypertensive and lipid lowering drug therapy has been shown to increase adherence to guideline-based targets and warfarin management improve control of international normalized ratios in anticoagulation clinics, the role of pharmacist initiation of OAC therapy compared to usual care in AF patients for stroke prevention in a community setting is unclear.
In this study, the investigators will screen participants presenting to community pharmacies to identify participants with unrecognized AF and/or known AF but not taking blood thinners or not on optimal OAC therapy and randomize care to either the pharmacist or enhanced usual care (family physician notification by pharmacist).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Pharmacist Arm | Experimental | OAC therapy will be initiated/adjusted by the community pharmacist in accordance to the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation. |
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| Enhanced Usual Care Arm | Active Comparator | Pharmacist will be refer participants to their physician in regards to OAC therapy for atrial fibrillation. The pharmacist will provide a current medication list to the physician as well as notification of a new diagnosis of atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticoagulants | Drug | Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with the Canadian Cardiovascular Society Guidelines for Atrial Fibrillation. |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal Oral Anticoagulant (OAC) Therapy for Atrial Fibrillation Stroke Prevention | Proportion of participants receiving optimal OAC therapy in accordance with the Canadian Cardiovascular Society Guidelines for Atrial Fibrillation in the early intervention arm compared to the delayed intervention arm. Optimal defined as a new prescription for OAC in a previously untreated AF or known AF who should be on an OAC or adjustment of an existing OAC prescription. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of AF | To determine the prevalence of participants with unrecognized AF eligible for OAC therapy and those with AF who should be on OAC therapy but are either not on or their existing OAC prescriptions; require adjustment due to contraindications, or sub-optimal levels (hereafter referred to those with "actionable" AF) | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roopinder Sandhu, MD, MPH | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2E1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39046741 | Derived | Sandhu RK, Fradette M, Lin M, Youngson E, Lau D, Bungard TJ, Tsuyuki RT, Dolovich L, Healey JS, McAlister FA. Stroke Risk Reduction in Atrial Fibrillation Through Pharmacist Prescribing: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2421993. doi: 10.1001/jamanetworkopen.2024.21993. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000925 | Anticoagulants |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Prospective, open-label, randomized, stepped wedge trial design. Participants will be randomized to "early" (day 0-90) versus "delayed" pharmacist intervention (starting day 90-180).
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| Patient Satisfaction with Pharmacists Services | Assessed using the validated Participant Satisfaction with Pharmacists Services Questionnaire (consists of 22 questions with 4 point Likert scale). | 3 months |
| Qualitative Assessment of Implementation by Pharmacist | Assessed using the questionnaire developed by the SEARCH-AF study | Through study completion, an average of 1 year |
| Healthcare Utilization | To determine the number of hospital, emergency department and physician visits related to AF | One year |
| Healthcare Utilization | To determine the number of laboratory testing performed related to oral anticoagulation therapy | One year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D015110 |
| 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |