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Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing (PIAAF Rx)

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ClinicalTrials.gov Identifier: NCT03126214
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Canadian Stroke Prevention Intervention Network
Information provided by (Responsible Party):
Roopinder Sandhu, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Drug: Anticoagulants Phase 4

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  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing: Program for the Identification of 'Actionable' AF (PIAAF) Rx Study
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: warfarin and novel oral anticoagulants




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126214


Contacts
Contact: Miriam Fradette, BSc. Pharm 780-492-2652 miriam.fradette@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2E1
Contact: Miriam Fradette    780-492-2652    miriam.fradette@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Heart and Stroke Foundation of Canada
Canadian Stroke Prevention Intervention Network
Investigators
Principal Investigator: Roopinder Sandhu, MD, MPH University of Alberta

Responsible Party: Roopinder Sandhu, Assistant Professor of Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT03126214     History of Changes
Other Study ID Numbers: 0024466
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roopinder Sandhu, University of Alberta:
atrial fibrillation
stroke
oral anticoagulation therapy
pharmacist case management

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Anticoagulants