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Completed

NCT Number: NCT01927445

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Clinical Evaluative Sciences

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quality improvement toolkit

Other

educational and informatics-based interventions, including brief guideline summary, decision support and audit and feedback

Primary outcomes

  1. Proportion of patients with AF receiving guideline-concordant stroke prevention therapy

    Time frame: 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 outcomes

  1. proportion of patients taking warfarin in therapeutic range

    Time frame: one year

    patients must have INR measured 8 times during the year and therapeutic range assessed using Rosendaal method

  2. proportion of patients taking a novel anticoagulant with appropriate dosing

    Time frame: 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.

  3. proportion receiving aspirin

    Time frame: one year

  4. proportion receiving clopidogrel

    Time frame: one year

  5. proportion achieving target blood pressure

    Time frame: one year

    target defined as <130/80 for patients with diabetes, <150/80 for patients over 80, and <140/90 for all others

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Heart and Stroke Foundation of Ontario

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2013
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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