NCT03515057

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35,308

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

April 22, 2018

Last Update Submit

February 22, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Incident AF during the study period

    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).

    12-months

Secondary Outcomes (5)

  • 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

Study Arms (2)

Atrial Fibrillation Spot-Check

EXPERIMENTAL

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.

Diagnostic Test: Single lead handheld electrocardiogram

Usual Care

NO INTERVENTION

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

Interventions

Single lead handheld electrocardiogramDIAGNOSTIC_TEST

Screening for atrial fibrillation during outpatient primary care office visits among patients 65 years and older

Also known as: AliveCor KardiaMobile EKG Monitor
Atrial Fibrillation Spot-Check

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Have a primary care physician outside of the network
  • Do not visit their primary care practice during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

  • Khurshid S, Friedman SF, Al-Alusi MA, Kany S, Sommers T, Anderson CD, Ho JE, McManus DD, Borowsky LH, Ashburner JM, Lubitz SA, Atlas SJ, Maddah M, Singer DE, Ellinor PT. Artificial intelligence-enabled analysis of handheld single-lead electrocardiograms to predict incident atrial fibrillation: an analysis of the VITAL-AF randomized trial. NPJ Digit Med. 2025 Nov 26;8(1):776. doi: 10.1038/s41746-025-02164-2.

    PMID: 41299008DERIVED

  • Atlas SJ, Ashburner JM, Chang Y, Borowsky LH, Ellinor PT, McManus DD, Lubitz SA, Singer DE. Screening for undiagnosed atrial fibrillation using a single-lead electrocardiogram at primary care visits: patient uptake and practitioner perspectives from the VITAL-AF trial. BMC Prim Care. 2023 Jun 30;24(1):135. doi: 10.1186/s12875-023-02087-5.

    PMID: 37391738DERIVED

  • Lubitz SA, Atlas SJ, Ashburner JM, Lipsanopoulos ATT, Borowsky LH, Guan W, Khurshid S, Ellinor PT, Chang Y, McManus DD, Singer DE. Screening for Atrial Fibrillation in Older Adults at Primary Care Visits: VITAL-AF Randomized Controlled Trial. Circulation. 2022 Mar 29;145(13):946-954. doi: 10.1161/CIRCULATIONAHA.121.057014. Epub 2022 Mar 2.

    PMID: 35232217DERIVED

  • Ashburner JM, Atlas SJ, McManus DD, Chang Y, Trisini Lipsanopoulos AT, Borowsky LH, Guan W, He W, Ellinor PT, Singer DE, Lubitz SA. Design and rationale of a pragmatic trial integrating routine screening for atrial fibrillation at primary care visits: The VITAL-AF trial. Am Heart J. 2019 Sep;215:147-156. doi: 10.1016/j.ahj.2019.06.011. Epub 2019 Jun 22.

    PMID: 31326680DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Lubitz, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiac Electrophysiologist, Assistant Professor

Study Record Dates

First Submitted

April 22, 2018

First Posted

May 3, 2018

Study Start

July 31, 2018

Primary Completion

October 8, 2019

Study Completion

October 1, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)