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

• ClinicalTrials.gov Identifier: NCT03515057
• Recruitment Status: Unknown
• First Posted: May 3, 2018
• Last Update Posted: February 24, 2021
• Sponsor: Massachusetts General Hospital
• Collaborator: University of Massachusetts, Worcester
• Information provided by (Responsible Party): Steven A Lubitz, Massachusetts General Hospital

Tracking Information

• First Submitted Date: April 22, 2018
• First Posted Date: May 3, 2018
• Last Update Posted Date: February 24, 2021
• Actual Study Start Date: July 31, 2018
• Actual Primary Completion Date: October 8, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Screening for Atrial Fibrillation Among Older Patients in Primary Care Clinics
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Screening
• Condition: Atrial Fibrillation

Intervention

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

• 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 *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: January 29, 2020): 35308
• Original Estimated Enrollment (submitted: April 22, 2018): 35000
• Estimated Study Completion Date: October 2021
• Actual Primary Completion Date: October 8, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03515057
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Steven A Lubitz, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: University of Massachusetts, Worcester

Investigators

• Principal Investigator: Steven Lubitz, MD, MPH; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: February 2021