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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: quality improvement toolkit

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 Type: Interventional
• Enrollment (Actual): 5000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Institute for Clinical Evaluative Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; No standardized intervention for management of patients with atrial fibrillation. Instead participants receive interventions for management of chronic kidney disease.
Experimental: 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).	Other: quality improvement toolkit; educational and informatics-based interventions, including brief guideline summary, decision support and audit and feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
proportion receiving aspirin		one year
proportion receiving clopidogrel		one year
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Heart and Stroke Foundation of Ontario
• Investigators: Principal Investigator: Karen Tu, MD, ICES

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (Estimate): August 22, 2013

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: G-13-0001873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO