Clinical trial NCT01927445: Improving Stroke Prevention Therapy for Patients With Atrial Fibrillation in Primary Care
Official title: Improving Stroke Prevention Therapy for Patients With Atrial Fibrillation in Primary Care: Protocol for a Pragmatic, Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2013-08-22
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with AF receiving guideline-concordant stroke prevention therapy
timeFrame: one year
Secondary outcomes:
measure: proportion of patients taking warfarin in therapeutic range
timeFrame: one year
measure: proportion of patients taking a novel anticoagulant with appropriate dosing
timeFrame: one year
measure: proportion receiving aspirin
timeFrame: one year
measure: proportion receiving clopidogrel
timeFrame: one year
measure: proportion achieving target blood pressure
timeFrame: one year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Institute for Clinical Evaluative Sciences
state: Ontario
Study officials:
affiliation: ICES
name: Karen Tu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee TM, Ivers NM, Bhatia S, Butt DA, Dorian P, Jaakkimainen L, Leblanc K, Legge D, Morra D, Valentinis A, Wing L, Young J, Tu K. Improving stroke prevention therapy for patients with atrial fibrillation in primary care: protocol for a pragmatic, cluster-randomized trial. Implement Sci. 2016 Dec 3;11(1):159. doi: 10.1186/s13012-016-0523-2.