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

Primary Purpose

Atrial Fibrillation, Stroke

Status
Active
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Anticoagulants
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, stroke, oral anticoagulation therapy, pharmacist case management

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active Pharmacist Arm

Enhanced Usual Care Arm

Arm Description

OAC therapy will be initiated/adjusted by the community pharmacist in accordance to the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Patient Satisfaction with Pharmacists Services
Assessed using the validated Participant Satisfaction with Pharmacists Services Questionnaire (consists of 22 questions with 4 point Likert scale).
Qualitative Assessment of Implementation by Pharmacist
Assessed using the questionnaire developed by the SEARCH-AF study
Healthcare Utilization
To determine the number of hospital, emergency department and physician visits related to AF
Healthcare Utilization
To determine the number of laboratory testing performed related to oral anticoagulation therapy

Full Information

First Posted
April 12, 2017
Last Updated
August 16, 2023
Sponsor
University of Alberta
Collaborators
Heart and Stroke Foundation of Canada, Canadian Stroke Prevention Intervention Network
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1. Study Identification

Unique Protocol Identification Number
NCT03126214
Brief Title
Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing
Acronym
PIAAFRx
Official Title
Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing: Program for the Identification of 'Actionable' AF (PIAAF) Rx Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Heart and Stroke Foundation of Canada, Canadian Stroke Prevention Intervention Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
Keywords
atrial fibrillation, stroke, oral anticoagulation therapy, pharmacist case management

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Pharmacist Arm
Arm Type
Experimental
Arm Description
OAC therapy will be initiated/adjusted by the community pharmacist in accordance to the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation.
Arm Title
Enhanced Usual Care Arm
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Anticoagulants
Other Intervention Name(s)
warfarin and novel oral anticoagulants
Intervention Description
Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with the Canadian Cardiovascular Society Guidelines for Atrial Fibrillation.
Primary Outcome Measure Information:
Title
Optimal Oral Anticoagulant (OAC) Therapy for Atrial Fibrillation Stroke Prevention
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Prevalence of AF
Description
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)
Time Frame
Through study completion, an average of 1 year
Title
Patient Satisfaction with Pharmacists Services
Description
Assessed using the validated Participant Satisfaction with Pharmacists Services Questionnaire (consists of 22 questions with 4 point Likert scale).
Time Frame
3 months
Title
Qualitative Assessment of Implementation by Pharmacist
Description
Assessed using the questionnaire developed by the SEARCH-AF study
Time Frame
Through study completion, an average of 1 year
Title
Healthcare Utilization
Description
To determine the number of hospital, emergency department and physician visits related to AF
Time Frame
One year
Title
Healthcare Utilization
Description
To determine the number of laboratory testing performed related to oral anticoagulation therapy
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roopinder Sandhu, MD, MPH
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing

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