Improving stroke prevention therapy for patients with atrial fibrillation in primary care: protocol for a pragmatic, cluster-randomized trial

Theresa M Lee; Noah M Ivers; Sacha Bhatia; Debra A Butt; Paul Dorian; Liisa Jaakkimainen; Kori Leblanc; Dan Legge; Dante Morra; Alissia Valentinis; Laura Wing; Jacqueline Young; Karen Tu

doi:10.1186/s13012-016-0523-2

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.

Authors

Theresa M Lee^{1

2}, Noah M Ivers^{3

4

5

6

7}, Sacha Bhatia^{3

4

7

8}, Debra A Butt^{6

9}, Paul Dorian^{8

10}, Liisa Jaakkimainen^{3

4

6

11}, Kori Leblanc^{12

13}, Dan Legge³, Dante Morra^{8

12

14}, Alissia Valentinis^{6

15}, Laura Wing³, Jacqueline Young³, Karen Tu^{3

4

6

16}

Affiliations

¹ Institute for Clinical Evaluation Sciences, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada. tmh.lee@mail.utoronto.ca.
² Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, ON, M5T 3M6, Canada. tmh.lee@mail.utoronto.ca.
³ Institute for Clinical Evaluation Sciences, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada.
⁴ Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, ON, M5T 3M6, Canada.
⁵ Department of Family and Community Medicine, Women's College Hospital, 77 Grenville St, Toronto, ON, M5S 1B3, Canada.
⁶ Department of Family and Community Medicine, University of Toronto, 500 University Avenue, 5th Floor, Toronto, ON, M5G 1V7, Canada.
⁷ Women's College Hospital Institute for Health System Solutions and Virtual Care, 76 Grenville St, Toronto, ON, M5S 1B2, Canada.
⁸ Department of Medicine, University of Toronto, Suite RFE 3-805, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada.
⁹ Department of Family and Community Medicine, The Scarborough Hospital, 3030 Lawrence Avenue East, Suite 414, Scarborough, ON, M1P 2V5, Canada.
¹⁰ Division of Cardiology, St. Michael's Hospital, 30 Bond St, Toronto, ON, M5B 1W8, Canada.
¹¹ Sunnybrook Academic Family Health Team, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada.
¹² Centre for Innovation in Complex Care, University Health Network, 200 Elizabeth Street Rm 13 N 1382, Toronto, ON, M5G 2C4, Canada.
¹³ Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College St, Toronto, ON, M5S 3M2, Canada.
¹⁴ Institute for Better Health, Trillium Health Partners, 2200 Eglinton Avenue West, Mississauga, ON, L5M 2N1, Canada.
¹⁵ Taddle Creek Family Health Team, 790 Bay St #522, Toronto, ON, M5G 1N8, Canada.
¹⁶ Toronto Western Hospital Family Health Team, University Health Network, 399 Bathurst St, Toronto, ON, M5T 2S8, Canada.

Abstract

Background: The prevalence of atrial fibrillation (AF) is growing as the population ages, and at least 15% of ischemic strokes are attributed to AF. However, many high-risk AF patients are not offered guideline-recommended stroke prevention therapy due to a variety of system, provider, and patient-level barriers.

Methods: We will conduct a pragmatic, cluster-randomized controlled trial randomizing primary care clinics to test a "toolkit" of quality improvement interventions in primary care. In keeping with the recommendations of the chronic care model to simultaneously activate patients and facilitate proactive care by providers, the toolkit includes provider-focused strategies (education, audit and feedback, electronic decision support, and reminders) plus patient-directed strategies (educational letters and reminders). The trial will include two feedback cycles at baseline and approximately 6 months and a final data collection at approximately 12 months. The study will be powered to show a difference of 10% in the primary outcome of proportion of patients receiving guideline-recommended stroke prevention therapy. Analysis will follow the intention-to-treat principle and will be blind to treatment allocation. Unit of analysis will be the patient; models will use generalized estimating equations to account for clustering at the clinical level.

Discussion: Stroke prevention therapy using anticoagulation in patients with AF is known to reduce strokes by two thirds or more in clinical trials, but most studies indicate under-use of this treatment in real-world practice. If the toolkit successfully improves care for patients with AF, stakeholders will be engaged to facilitate broader application to maximize the potential to improve patient outcomes. The intervention toolkit tested in this project could also provide a model to improve quality of care for other chronic cardiovascular conditions managed in primary care.

Trial registration: ClinicalTrials.gov ( NCT01927445 ). Registered August 14, 2014 at https://clinicaltrials.gov/ .

Keywords: Atrial fibrillation; Cluster-randomized trial; Multifaceted intervention; Stroke prevention.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Atrial Fibrillation / complications*
Cluster Analysis
Humans
Primary Health Care / methods*
Quality Improvement
Research Design*
Stroke / prevention & control*

Associated data

ClinicalTrials.gov/NCT01927445

Grants and funding

CIHR/Canada