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

NCT01927445 | Completed

• 1 other identifier: G-13-0001873
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• proportion of patients taking warfarin in therapeutic range

  one year

• proportion of patients taking a novel anticoagulant with appropriate dosing

  one year

• proportion receiving aspirin

  one year

• proportion receiving clopidogrel

  one year

• proportion achieving target blood pressure

  one year

Study Arms (2)

Usual care

NO INTERVENTION

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

quality improvement toolkit

EXPERIMENTAL

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

Interventions

quality improvement toolkit OTHER

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

quality improvement toolkit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Physicians who do not consent to data sharing
• Patients who change physicians during the course of the study

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

Institute for Clinical Evaluative Sciences

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 27912776 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Karen Tu, MD

  ICES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 22, 2013
• Study Start: August 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)