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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515057
Recruitment Status : Active, not recruiting
First Posted : May 3, 2018
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Steven A Lubitz, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE April 22, 2018
First Posted Date  ICMJE May 3, 2018
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE July 31, 2018
Actual Primary Completion Date October 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2018)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Screening for Atrial Fibrillation Among Older Patients in Primary Care Clinics
Official Title  ICMJE Screening for Atrial Fibrillation in an Ambulatory Clinic Population: The VITAL-AF Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: Single lead handheld electrocardiogram
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 29, 2020)
35308
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2018)
35000
Estimated Study Completion Date  ICMJE October 2021
Actual Primary Completion Date October 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03515057
Other Study ID Numbers  ICMJE CV185-581
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Steven A Lubitz, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE University of Massachusetts, Worcester
Investigators  ICMJE
Principal Investigator: Steven Lubitz, MD, MPH Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP