Screening for Atrial Fibrillation Among Older Patients in Primary Care Clinics (VITAL-AF)

Mass General Brigham

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Diagnostic Test: Single lead handheld electrocardiogram

Study type: Interventional

Funder types: Other

Identifiers

NCT03515057

CV185-581

Details and patient eligibility

About

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.

Enrollment: 35,308 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35,308 participants in 2 patient groups

Atrial Fibrillation Spot-Check

Experimental group

Description:

For eligible patients from primary care clinics randomly selected for the Atrial Fibrillation Spot-Check arm, practice medical assistants will screen assenting patients for undiagnosed AF during regularly scheduled office visits using a single-lead handheld electrocardiogram (ECG). Single-lead handheld electrocardiogram readings detecting AF will be confirmed during the same office visit with a standard 12-lead ECG at the discretion of the primary care physician. If AF is detected, the patient's PCP will be able to address the condition with them during the clinic visit and initiate appropriate follow-up to manage the AF.

Treatment:

Diagnostic Test: Single lead handheld electrocardiogram

Usual Care

No Intervention group

Description:

For eligible patients from primary care clinics randomly selected for the Usual Care arm, they will receive standard care during outpatient visits without change.