Screening for Atrial Fibrillation in an Ambulatory Clinic Population: The VITAL-AF Study
试验速览
- 阶段
- 不适用
- 入组人数
- 35,308
- 试验地点
- 2
- 主要终点
- Incident AF during the study period
研究概览
简要总结
The overall goal of this study is to assess the effectiveness of screening for undiagnosed atrial fibrillation (AF) using simple, efficient, and portable electronic health and mobile technologies in a healthcare system. The investigators propose to perform population-based screening for undiagnosed AF as part of usual care in patients ≥ 65 years when their vital signs are checked (spot-check) at scheduled outpatient visits in adult Massachusetts General Hospital (MGH) primary care clinics. Patients will receive routine care by their primary care provider (PCP) based upon the results of the screening during the visit.
The investigators hypothesize that rates of AF detection among individuals ≥ 65 years in the MGH primary care network will be greater among patients in clinics assigned to the spot-check arm compared to patients in clinics assigned to the usual care arm of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years or older
- •Presenting for an outpatient clinic appointment at a participating clinic
- •Visit with a physician, nurse practitioner, or physician's assistant
排除标准
- •Have a primary care physician outside of the network
- •Do not visit their primary care practice during the study period
结局指标
主要结局
Incident AF during the study period
时间窗: 12-months
The numerator of the outcome is the number of eligible patients with newly diagnosed AF during the study period. The eligible study population comprising the denominator will be assessed in two ways: (1) the whole population, defined as all patients aged 65 years and older presenting for an outpatient clinic appointment with a participating physician, nurse practitioner, or physician assistant at a study clinic during the enrollment period, and (2) the whole population excluding patients with an AF diagnosis prior to outcome assessment (prevalent AF).
次要结局
- Incident AF associated with a primary care encounter during the study period(12-months)
- New oral anticoagulation prescription during the study period(12-months)
- Continued prescription of anticoagulation at 12 months among those started on anticoagulation during the study period(12-months following initial prescription of anticoagulation (ie, up to 24 months after study start))
- New ischemic stroke within 24-months of the study start(24-months)
- Major hemorrhage within 24-months of the study start(24-months)
研究者
Steven A Lubitz
Cardiac Electrophysiologist, Assistant Professor
Massachusetts General Hospital