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

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ClinicalTrials.gov Identifier: NCT03515057
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Steven A Lubitz, Massachusetts General Hospital

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Diagnostic Test: Single lead handheld electrocardiogram Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening for Atrial Fibrillation in an Ambulatory Clinic Population: The VITAL-AF Study
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Diagnostic Test: Single lead handheld electrocardiogram
Screening for atrial fibrillation during outpatient primary care office visits among patients 65 years and older
Other Name: AliveCor KardiaMobile EKG Monitor

No Intervention: 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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incident AF associated with a primary care encounter during the study period [ Time Frame: 12-months ]
    The numerator of the outcome will be the number of eligible patients with newly diagnosed AF associated with a primary care visit. Similar to the primary outcome, the denominator will be assessed in two ways: (1) the whole population, and (2) the whole population excluding prevalent AF.

  2. New oral anticoagulation prescription during the study period [ Time Frame: 12-months ]
    The numerator of the outcome will be the number of eligible individuals with a new oral anticoagulation prescription during the study period. The eligible study population comprising the denominator will be assessed in three ways: (1) the whole population, (2) patients with a new AF diagnosis (incident AF), and (3) patients with prevalent AF.

  3. Continued prescription of anticoagulation at 12 months among those started on anticoagulation during the study period [ Time Frame: 12-months following initial prescription of anticoagulation (ie, up to 24 months after study start) ]
    The numerator will be the number of individuals with a refill or prescription of an alternative anticoagulant in the subsequent 12 months after the day of new anticoagulant prescription. The eligible study population comprising the denominator will include individuals who are started on OAC during the study period. The denominator will be assessed in three ways: (1) whole population, (2) incident AF and (3) prevalent AF.

  4. New ischemic stroke within 24-months of the study start [ Time Frame: 24-months ]
    The numerator of the outcome is the number of patients sustaining ischemic stroke within 24 months of the study start. The eligible study population comprising the denominator will be assessed in two ways: (1) whole population, and (2) patients with an AF diagnosis (prevalent AF or incident AF prior to the outcome).

  5. Major hemorrhage within 24-months of the study start [ Time Frame: 24-months ]
    The numerator of the outcome is the number of patients sustaining a major hemorrhagic event within 24 months of the study start. The eligible study population comprising the denominator will be assessed in two ways: (1) whole population, and (2) patients with an AF diagnosis (prevalent AF or incident AF prior to the outcome).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515057


Contacts
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Contact: Steven Lubitz, MD, MPH 617-643-7339 slubitz@mgh.harvard.edu
Contact: Ana Lipsanopoulos 617-726-9618 atlipsanopoulos@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeffrey M Ashburner, MPH    617-724-3828    jashburner@partners.org   
Principal Investigator: Steven A Lubitz, MD, MPH         
Sponsors and Collaborators
Massachusetts General Hospital
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Steven Lubitz, MD, MPH Massachusetts General Hospital

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Responsible Party: Steven A Lubitz, Cardiac Electrophysiologist, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03515057    
Other Study ID Numbers: CV185-581
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes