Screening for Atrial Fibrillation in an Ambulatory Clinic Population: The VITAL-AF Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 35308
- Locations
- 1
- Primary Endpoint
- Incident AF during the study period
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Steven A Lubitz
Cardiac Electrophysiologist, Assistant Professor
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Have a primary care physician outside of the network
- •Do not visit their primary care practice during the study period
Outcomes
Primary Outcomes
Incident AF during the study period
Time Frame: 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).
Secondary Outcomes
- 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)