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

NCT ID: NCT01927445

Last Updated: 2017-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-06-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Usual care

No standardized intervention for management of patients with atrial fibrillation. Instead participants receive interventions for management of chronic kidney disease.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

quality improvement toolkit

Intervention Type: OTHER

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

Interventions

quality improvement toolkit

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Tu, MD

Role: PRINCIPAL_INVESTIGATOR

ICES

Locations

Institute for Clinical Evaluative Sciences

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 27912776 (View on PubMed)

Other Identifiers

G-13-0001873

Identifier Type: -

Identifier Source: org_study_id