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

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/ .

Evaluating the Usability and Perceived Impact of an Electronic Medical Record Toolkit for Atrial Fibrillation Management in Primary Care: A Mixed-Methods Study Incorporating Human Factors Design.

BACKGROUND: Atrial fibrillation (AF) is a common and preventable cause of stroke. Barriers to reducing stroke risk through appropriate prescribing have been identified at the system, provider, and patient levels. To ensure a multifaceted initiative to address these barriers is effective, it is essential to incorporate user-centered design to ensure all intervention components are optimized for users. OBJECTIVE: To test the usability of an electronic medical record (EMR) toolkit for AF in primary care with the goal of further refining the intervention to meet the needs of primary care clinicians. METHODS: An EMR-based toolkit for AF was created and optimized through usability testing and iterative redesign incorporating a human factors approach. A mixed-methods pilot study consisting of observations, semi-structured interviews, and surveys was conducted to examine usability and perceived impact on patient care and workflow. RESULTS: A total of 14 clinicians (13 family physicians and 1 nurse practitioner) participated in the study. Nine iterations of the toolkit were created in response to feedback from clinicians and the research team; interface-related changes were made, additional AF-related resources were added, and functionality issues were fixed to make the toolkit more effective. After improvements were made, clinicians expressed that the toolkit improved accessibility to AF-related information and resources, served as a reminder for guideline-concordant AF management, and was easy to use. Most clinicians intended to continue using the toolkit for patient care. With respect to impact on care, clinicians believed the toolkit increased the thoroughness of their assessments for patients with AF and improved the quality of AF-related care received by their patients. CONCLUSIONS: The positive feedback surrounding the EMR toolkit for AF and its perceived impact on patient care can be attributed to the adoption of a user-centered design that merged clinically important information about AF management with user needs. This study demonstrates the utility of a human factors approach to piloting and refining an intervention prior to wide-scale implementation.

Atrial fibrillation anticoagulation care in a large urban family medicine practice.

OBJECTIVE: To determine the proportion of patients with atrial fibrillation (AF) in primary care achieving guideline-concordant stroke prevention treatment based on both the previous (2010) and the updated (2012) Canadian guideline recommendations. DESIGN: Retrospective chart review. PARTICIPANTS: Primary care patients (N = 204) with AF. The mean age was 71.3 years and 53.4% were women. SETTING: Large urban community family practice in Toronto, Ont. MAIN OUTCOME MEASURES: Patient demographic characteristics such as sex and age; a list of current cardiac medications including anticoagulants and antiplatelets; the total number of medications; relevant current and past medical history including presence of diabetes, stroke or transient ischemic attack, hypertension, and vascular disease; number of visits to the family physician and cardiologist in the past year and past 5 years, and how many of these were for AF; the number of visits to the emergency department or hospitalizations for AF, congestive heart failure, or stroke; if patients were taking warfarin, how often their international normalized ratios were recorded, and how many times they were in the reference range; CHADS2 (congestive heart failure, hypertension, age ≥ 75, diabetes mellitus, and stroke or transient ischemic attack) score, if recorded; and reason for not taking oral anticoagulants when they should have been, if recorded. RESULTS: Among those who had CHADS2 scores of 0, 64 patients (97.0%) were receiving appropriate stroke prevention in AF (SPAF) treatment according to the 2010 guidelines. When the 2012 guidelines were applied, 39 patients (59.1%) were receiving appropriate SPAF treatment (P < .001). For those with CHADS2 scores of 1, 88.4% of patients had appropriate SPAF treatment according to the 2010 guidelines, but only 55.1% were adequately treated according to the 2012 guidelines (P < .001). Of the patients at the highest risk (CHADS2 score > 1), 68.1% were adequately treated with anticoagulation and an additional 8.7% (6 of 69) had documented reasons why they were not taking anticoagulants. CONCLUSION: When assessed using the 2012 Canadian Cardiovascular Society AF guidelines, the proportion of patients receiving appropriate SPAF therapy in this primary care setting decreased substantially. All patients with CHADS2 scores of 0 or 1 should be reassessed to ensure that they are receiving optimal stroke prevention treatment.

Use of an interdisciplinary, participatory design approach to develop a usable patient self-assessment tool in atrial fibrillation.

After identifying that significant care gaps exist within the management of atrial fibrillation (AF), a patient-focused tool was developed to help patients better assess and manage their AF. This tool aims to provide education and awareness regarding the management of symptoms and stroke risk associated with AF, while engaging patients to identify if their condition is optimally managed and to become involved in their own care. An interdisciplinary group of health care providers and designers worked together in a participatory design approach to develop the tool with input from patients. Usability testing was completed with 22 patients of varying demographics to represent the characteristics of the patient population. The findings from usability testing interviews were used to further improve and develop the tool to improve ease of use. A physician-facing tool was also developed to help to explain the tool and provide a brief summary of the 2012 Canadian Cardiovascular Society atrial fibrillation guidelines. By incorporating patient input and human-centered design with the knowledge, experience, and medical expertise of health care providers, we have used an approach in developing the tool that tries to more effectively meet patients' needs.