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Completed

NCT Number: NCT03126214

Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Anticoagulants

Drug

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

Primary outcomes

  1. Optimal Oral Anticoagulant (OAC) Therapy for Atrial Fibrillation Stroke Prevention

    Time frame: 3 months

    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 outcomes

  1. Prevalence of AF

    Time frame: Through study completion, an average of 1 year

    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)

  2. Patient Satisfaction with Pharmacists Services

    Time frame: 3 months

    Assessed using the validated Participant Satisfaction with Pharmacists Services Questionnaire (consists of 22 questions with 4 point Likert scale).

  3. Qualitative Assessment of Implementation by Pharmacist

    Time frame: Through study completion, an average of 1 year

    Assessed using the questionnaire developed by the SEARCH-AF study

  4. Healthcare Utilization

    Time frame: One year

    To determine the number of hospital, emergency department and physician visits related to AF

  5. Healthcare Utilization

    Time frame: One year

    To determine the number of laboratory testing performed related to oral anticoagulation therapy

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Stroke Prevention Intervention Network
  • Heart and Stroke Foundation of Canada

Registry information

Official study title

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

Acronym: PIAAFRx

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Apr 24, 2017
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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