Screening for Atrial Fibrillation Among Older Patients in Primary Care Clinics

NCT ID: NCT03515057

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Atrial Fibrillation Spot-Check

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.

Group Type EXPERIMENTAL

Single lead handheld electrocardiogram

Intervention Type DIAGNOSTIC_TEST

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

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Single lead handheld electrocardiogram

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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AliveCor KardiaMobile EKG Monitor

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Steven A Lubitz

Cardiac Electrophysiologist, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven Lubitz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37391738 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35232217 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31326680 (View on PubMed)

Other Identifiers

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CV185-581

Identifier Type: -

Identifier Source: org_study_id

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