Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing

Stroke Clinical Trial

— PIAAFRx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126214
• Other study ID #: 0024466
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

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

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Canadian Stroke Prevention Intervention Network, Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Qualitative Assessment of Implementation by Pharmacist	Assessed using the questionnaire developed by the SEARCH-AF study	Through study completion, an average of 1 year
Secondary	Healthcare Utilization	To determine the number of hospital, emergency department and physician visits related to AF	One year
Secondary	Healthcare Utilization	To determine the number of laboratory testing performed related to oral anticoagulation therapy	One year