Improving Stroke Prevention Therapy for Patients With Atrial Fibrillation in Primary Care: Protocol for a Pragmatic, Cluster-randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Proportion of patients with AF receiving guideline-concordant stroke prevention therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Physicians who do not consent to data sharing
- •Patients who change physicians during the course of the study
研究组 & 干预措施
Usual care
No standardized intervention for management of patients with atrial fibrillation. Instead participants receive interventions for management of chronic kidney disease.
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).
干预措施: quality improvement toolkit (Other)
结局指标
主要结局
Proportion of patients with AF receiving guideline-concordant stroke prevention therapy
时间窗: one year
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.)
次要结局
- 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)