Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing

NCT03126214 | Completed Phase 4 DMC

• 1 other identifier: 0024466
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Stroke

Keywords

atrial fibrillation; stroke; oral anticoagulation therapy; pharmacist case management

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Prevalence of AF

  Through study completion, an average of 1 year

• Patient Satisfaction with Pharmacists Services

  3 months

• Qualitative Assessment of Implementation by Pharmacist

  Through study completion, an average of 1 year

• Healthcare Utilization

  One year

• Healthcare Utilization

  One year

Study Arms (2)

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.

Drug: Anticoagulants

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

Drug: Anticoagulants

Interventions

Anticoagulants DRUG

Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with the Canadian Cardiovascular Society Guidelines for Atrial Fibrillation.

Also known as: warfarin and novel oral anticoagulants

Active Pharmacist Arm; Enhanced Usual Care Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years with one additional stroke risk factor (hypertension, diabetes, heart failure history of or left ventricular ejection fraction \<0.40), previous stroke or transient ischemic attack).
• Atrial fibrillation and not on oral anticoagulation (OAC) therapy but eligible
• Atrial fibrillation on sub-optimal OAC

You may not qualify if:

• Uncontrolled hypertension (defined as average SBP ≥ 160 mmHg \[2 readings taken at time of screening\]).
• End stage renal disease (CrCl \< 15 ml/min)
• Valvular Heart Disease including those with prosthetic valve, mitral stenosis (moderate to severe) or valve repair.
• Excess alcohol intake (males: ≥ 28 units/week, females: ≥ 21 units/week. One unit of alcohol = 8 oz beer, 1 oz hard liquor or 4 oz wine).
• Intracranial bleed at any point.
• History of "Major Bleeding" at any point (defined as overt bleeding at a critical site including intracranial, intraspinal, intraocular, pericardial, or retroperitoneal; or bleed requiring hospitalization).
• Foreshortened life-expectancy or severe comorbidities precluding study follow-up period
• Unable to read/understand English
• Severe cognitive impairment (defined as score ≥ 5 on the Short Portable Mental Status Questionnaire)

Sponsors & Collaborators

• University of Alberta: lead
• Heart and Stroke Foundation of Canada: collaborator
• Canadian Stroke Prevention Intervention Network: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Publications (1)

• 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.

  PMID: 39046741 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Anticoagulants; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Roopinder Sandhu, MD, MPH

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 24, 2017
• Study Start: February 1, 2018
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)