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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This is a prospective, single-arm, feasibility pilot study of 20 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) recruited from a total of 4 retail and outpatient community pharmacies. Eligible participants will be enrolled in a 3-month active intervention of pharmacist-led OAC management. Participants will be passively followed for an additional 9 months to determine safety endpoints.
Oral anticoagulation therapy for stroke prevention in AF is safe and effective but under-utilized. Optimal delivery of existing therapies would prevent AF-related stroke. Therefore alternative strategies to increase adherence to current guidelines for OAC use for AF stroke prevention should be explored.
Accumulating data indicate that pharmacist-led or pharmacist-collaborative care in cardiovascular disease monitoring, risk factor control, and medication optimization leads to greater adherence to guideline-directed targets and improved outcomes.
In this prospective, single-arm, feasiblity pilot study the investigators intend to enroll 20 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) from a total of 4 retail and outpatient community pharmacies in Los Angeles. Eligible participants will be enrolled in a 3-month active intervention of pharmacist-led OAC management. Participants will be passively followed for an additional 9 months to determine safety endpoints.
The primary objective(s) will be to determine the prevalence of 'actionable' AF in the community and the proportion of patients receiving guideline concordant OAC therapy at 3 months. Secondary outcomes include: patient satisfaction with pharmacist services (at 3 months), pharmacists' perspective on study implementation (at 1 month and 3 months), OAC adherence (at 12 months), and healthcare utilization (at 12 months).
This research will generate new knowledge on an innovative, and potentially sustainable stroke prevention strategy to increase evidence-based use of OAC therapy in patients with AF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist Intervention Arm | Experimental | Pharmacist to prescribe/monitor/manage oral anticoagulation therapy for atrial fibrillation stroke prophylaxis (under collaborative practice agreement with participants primary care provider) in accordance with ACC/AHA/HRS Guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral anticoagulant | Drug | Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with ACC/AHA/HRS Guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Optimal OAC Therapy | To determine the proportion of patients with 'actionable AF' receiving optimal OAC therapy at 3 months. | At 3 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 'Actionable' AF Prevalence | To determine the prevalence of patients with 'actionable AF' | At 12 months |
| Medication Adherence (NOAC) | To assess OAC adherence (i.e. proportion of days covered (PDC) for NOACS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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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, single-arm, feasibility pilot study
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|
| At 12 months |
| Medication Adherence (Warfarin) | To assess OAC adherence (i.e. time in the therapeutic range (TTR) for warfarin) | At 12 months |
| Patient Satisfaction with Pharmacist Services | To assess patient satisfaction with pharmacist services using 22-item questionnaire | At 3 months |
| Qualitative Review of Program Implementation | To perform a qualitative review of program implementation by surveying pharmacists about their experiences with 11-item questionnaire | At 1 month and 3 months post-implementation |
| Healthcare Utilization | To assess healthcare utilization (i.e. the number of physician visits, specialist visits, ED visits, and hospitalizations) | At 12 months |
| 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 |