A Trial of Pharmacist Management of Oral Anticoagulation THerapy Versus Enhanced Usual CARe in the communitY for AF

Stroke Clinical Trial

— APOTHECARYAF  

Official title:

A Trial of Pharmacist Management of Oral Anticoagulation THerapy Versus Enhanced Usual CARe in the communitY for AF (APOTHECARY AF Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04907825
• Other study ID #: 00000850
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: Cedars-Sinai Medical Center
• Contact: Roopinder K Sandhu, MD
• Phone: 424-315-4519
• Email: roopinder.sandhu[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, open-label, cluster-randomized controlled trial of 400 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) from a total of 40 retail and outpatient community pharmacies. Participants will be randomized (by pharmacy) to either to an intervention arm of pharmacist-led OAC management versus an enhanced usual care arm, wherein physicians receive notification of 'actionable' AF and patients are advised to schedule a physician clinic visit. The primary objective will be to determine the difference in proportion of patients with 'actionable AF' receiving guideline concordant OAC therapy at 3 months in those randomized to intervention arm versus control arm.

Description:

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, open-label, cluster-randomized controlled trial the investigators intend to enroll 400 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) from a total of 40 retail and outpatient community pharmacies in Los Angeles. Participants will be randomized (by pharmacy) to either to an intervention arm of pharmacist-led OAC management versus an enhanced usual care arm, wherein physicians receive notification of 'actionable' AF and patients are advised to schedule a physician clinic visit. The primary objective will be to determine the difference in proportion of patients with 'actionable AF' receiving guideline concordant OAC therapy at 3 months in those randomized to intervention arm versus control arm. Secondary outcomes include: patient satisfaction with pharmacist services (at 3 months), pharmacists' perspective on study implementation (at study end), and OAC adherence (at 1 year). In an exploratory aim, the investigators will assess healthcare utilization and clinical outcomes at 1 year.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Age > 60 years

2. Men (CHADS-VASc score =2) AND Women (CHADS-VASc score =3)

3. AF and not on OAC therapy but eligible

4. AF and on sub-optimal or inappropriate OAC therapy

5. Written informed consent

Exclusion Criteria:

1. AF on optimal OAC therapy

2. OAC required for other conditions (i.e. DVT/PE, PCI in prior year, left ventricular thrombus, etc.)

3. Currently taking two antiplatelet agents

4. Uncontrolled hypertension (defined as SBP =160 mmHg x 2 BP readings measured at screening)

5. End-stage renal disease (CrCl <15 ml/min or dialysis)

6. Major surgery in prior month (defined as surgery requiring general anesthesia and overnight inpatient hospital stay)

7. History of "major bleeding" in prior year (defined as overt bleeding at critical site including intracranial, intraspinal, intraocular, pericardial, GI bleed, bleed requiring hospitalization, bleed resulting in =20 g/L drop in hemoglobin or requiring transfusion of =2 units packed cells)

8. Excess alcohol intake (=8 alcoholic drinks/week)

9. Inability to read or understand English or Spanish

10. Participants considered unreliable by the Investigator or designated pharmacy team member concerning the requirements of follow-up, or those with foreshortened life expectancy precluding 3-month follow-up

11. Severe cognitive impairment (=5 errors on the Short Portable Mental Status Questionnaire)

12. Pregnant women

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Drug:
• Oral anticoagulant
Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with ACC/AHA/HRS Guidelines

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal OAC Therapy	To determine the difference in proportion of patients with 'actionable AF' receiving optimal OAC therapy at 3 months in those randomized to intervention arm versus control arm.	At 3 months
Secondary	'Actionable' AF Prevalence	To determine the prevalence of patients with 'actionable AF'	Through study completion, an average of 1 year
Secondary	Medication Adherence (NOAC)	To assess OAC adherence (i.e. proportion of days covered (PDC) for NOACS)	At 12 months
Secondary	Medication Adherence (Warfarin)	To assess OAC adherence (i.e. time in the therapeutic range (TTR) for warfarin)	At 12 months
Secondary	Patient Satisfaction with Pharmacist Services	To assess patient satisfaction with pharmacist services using 22-item questionnaire	At 3 months
Secondary	Qualitative Review of Program Implementation	To perform a qualitative review of program implementation by surveying pharmacists about their experiences with 11-item questionnaire	Through study completion, an average of 1 year
Secondary	Healthcare Utilization	To assess healthcare utilization (i.e. the number of physician visits, specialist visits, ED visits, and hospitalizations)	At 12 months