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

Atrial Fibrillation Clinical Trial

Official title:

Improving Stroke Prevention Therapy for Patients With Atrial Fibrillation in Primary Care: Protocol for a Pragmatic, Cluster-randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927445
• Other study ID #: G-13-0001873
• Status: Completed
• Phase: N/A
• First received: August 14, 2013
• Last updated: October 3, 2017
• Start date: August 2014
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• quality improvement toolkit
educational and informatics-based interventions, including brief guideline summary, decision support and audit and feedback

Locations

Country	Name	City	State
Canada	Institute for Clinical Evaluative Sciences	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with AF receiving guideline-concordant stroke prevention therapy	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.)	one year
Secondary	proportion of patients taking warfarin in therapeutic range	patients must have INR measured 8 times during the year and therapeutic range assessed using Rosendaal method	one year
Secondary	proportion of patients taking a novel anticoagulant with appropriate dosing	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.	one year
Secondary	proportion receiving aspirin		one year
Secondary	proportion receiving clopidogrel		one year
Secondary	proportion achieving target blood pressure	target defined as <130/80 for patients with diabetes, <150/80 for patients over 80, and <140/90 for all others	one year