Improving Stroke Prevention Therapy for Patients With Atrial Fibrillation in Primary Care

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: quality improvement toolkit

• Registration Number: NCT01927445
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

The objective of this project is to increase the proportion of patients with AF that receive adequate stroke prevention therapy. Over half of patients with AF who suffer strokes are permanently disabled. Yet there remains a large portion of patients who do not receive appropriate stroke prevention therapy. The investigators hypothesize that a toolkit of quality improvement strategies in primary care could increase the proportion of patients with atrial fibrillation appropriately treated with stroke prevention therapy. The investigators' goal is to ensure the toolkit of interventions can be easily incorporated into day-to-day practice in primary care and can be readily and broadly disseminated if successful.

Detailed Description

The prevalence of atrial fibrillation (AF) is growing as the population ages and 15% of all strokes are already attributed to AF. Unfortunately, half of patients with AF do not receive prescriptions for anticoagulation to prevent stroke due to a variety of system, provider, and patient-level barriers. The investigators will conduct a pragmatic, cluster-randomized controlled trial to test a 'toolkit' of quality improvement interventions in primary care. In keeping with the recommendations of the chronic care model to simultaneously facilitate proactive care by providers and activate patients, the toolkit includes provider- focused strategies (education, audit and feedback, electronic medical record-based tools including decision support and reminders) plus patient-directed strategies (educational letters and reminders). Thirty three primary care clinics will be randomized to the intervention or usual care. The trial will last 12 months and will be powered to show a difference of 10% in the primary outcome of proportion of patients receiving guideline-concordant care for stroke prevention. Analysis will be blind to allocation.

Study Timeline

• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-22
• Study Start: 2014-08
• Primary Completion: 2017-04
• Study Completion: 2017-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Physicians are participants in the Electronic Medical Record Administrative-data Linked Database (EMRALD).
• Patients are rostered to participating physicians, with a diagnosis in the chart of atrial fibrillation

Exclusion Criteria

• Physicians who do not consent to data sharing
• Patients who change physicians during the course of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
quality improvement toolkit	quality improvement toolkit	The toolkit includes provider-focused strategies (education, audit and feedback, electronic decision support and reminders) plus patient-directed strategies (educational letters and reminders).

Primary Outcome Measures

Name	Time	Method
Proportion of patients with AF receiving guideline-concordant stroke prevention therapy	one year	Patients with risk factors for stroke (ie. CHADS2 \>1 or age \>65) who are prescribed anticoagulants and patients with no risk factors for stroke (ie. CHADS2 = 0 and age \<65) who are not prescribed anticoagulants will be considered to be receiving guideline concordant therapy. (For patients with CHADS2 = 1 but aged \< 65 the guideline recommendations are unclear, so these patients will not be considered in the primary analysis. For example, in patients with AF and hypertension at a younger age, anticoagulation or aspirin or no treatment would each be reasonable.)

Secondary Outcome Measures

Name	Time	Method
proportion of patients taking warfarin in therapeutic range	one year	patients must have INR measured 8 times during the year and therapeutic range assessed using Rosendaal method
proportion of patients taking a novel anticoagulant with appropriate dosing	one year	Dabigatran, rivaroxaban and apixaban should be dose-adjusted in renal failure and avoided if estimated creatinine clearance is \<30. Lower dose dabigatran is recommended for patients over 80.
proportion receiving aspirin	one year
proportion receiving clopidogrel	one year
proportion achieving target blood pressure	one year	target defined as \<130/80 for patients with diabetes, \<150/80 for patients over 80, and \<140/90 for all others

Trial Locations

Locations (1)

Institute for Clinical Evaluative Sciences; 🇨🇦 Toronto, Ontario, Canada