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

Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing

Sponsors

Lead sponsor: University of Alberta

Collaborator: Heart and Stroke Foundation of Canada
Canadian Stroke Prevention Intervention Network

Source 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.

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).

Overall Status Unknown status
Start Date February 1, 2018
Completion Date September 1, 2019
Primary Completion Date May 1, 2019
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Optimal Oral Anticoagulant (OAC) Therapy for Atrial Fibrillation Stroke Prevention 3 months
Secondary Outcome
Measure Time Frame
Prevalence of AF Through study completion, an average of 1 year
Patient Satisfaction with Pharmacists Services 3 months
Qualitative Assessment of Implementation by Pharmacist Through study completion, an average of 1 year
Healthcare Utilization One year
Healthcare Utilization One year
Enrollment 370
Condition
Intervention

Intervention type: Drug

Intervention name: Anticoagulants

Description: 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

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)

Gender: All

Minimum age: 65 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Roopinder Sandhu, MD, MPH Principal Investigator University of Alberta
Overall Contact

Last name: Miriam Fradette, BSc. Pharm

Phone: 780-492-2652

Email: [email protected]

Location
facility status contact
University of Alberta Recruiting Miriam Fradette 780-492-2652 [email protected]
Location Countries

Canada

Verification Date

May 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Alberta

Investigator full name: Roopinder Sandhu

Investigator title: Assistant Professor of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Active Pharmacist Arm

Arm group type: Experimental

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 group label: Enhanced Usual Care Arm

Arm group type: Active Comparator

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

Acronym PIAAF Rx
Patient Data No
Study Design Info

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).

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov