Clinical trial NCT03126214: Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing
Official title: Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing: Program for the Identification of 'Actionable' AF (PIAAF) Rx Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Stroke
Keywords: atrial fibrillation
stroke
oral anticoagulation therapy
pharmacist case management
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: Canadian Stroke Prevention Intervention Network
First posted: 2017-04-24
Enrollment: 79
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

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).

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)

Primary outcomes:
measure: Optimal Oral Anticoagulant (OAC) Therapy for Atrial Fibrillation Stroke Prevention
timeFrame: 3 months
Secondary outcomes:
measure: Prevalence of AF
timeFrame: Through study completion, an average of 1 year
measure: Patient Satisfaction with Pharmacists Services
timeFrame: 3 months
measure: Qualitative Assessment of Implementation by Pharmacist
timeFrame: Through study completion, an average of 1 year
measure: Healthcare Utilization
timeFrame: One year
measure: Healthcare Utilization
timeFrame: One year
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Roopinder Sandhu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: