Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing (PIAAFRx)

Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing: Program for the Identification of 'Actionable' AF (PIAAF) Rx Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Drug: Anticoagulants

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2E1
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Pharmacist Arm; 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; Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with the Canadian Cardiovascular Society Guidelines for Atrial Fibrillation.; Other Names: warfarin and novel oral anticoagulants
Active Comparator: Enhanced Usual Care Arm; 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; Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with the Canadian Cardiovascular Society Guidelines for Atrial Fibrillation.; Other Names: warfarin and novel oral anticoagulants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Heart and Stroke Foundation of Canada; Canadian Stroke Prevention Intervention Network
• Investigators: Principal Investigator: Roopinder Sandhu, MD, MPH, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: stroke; atrial fibrillation; oral anticoagulation therapy; pharmacist case management
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Atrial Fibrillation; Warfarin; Anticoagulants
• Other Study ID Numbers: 0024466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No