Clinical trial NCT03515057: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
First posted: 2018-05-03
Enrollment: 35308
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Incident AF during the study period
timeFrame: 12-months
Secondary outcomes:
measure: Incident AF associated with a primary care encounter during the study period
timeFrame: 12-months
measure: New oral anticoagulation prescription during the study period
timeFrame: 12-months
measure: Continued prescription of anticoagulation at 12 months among those started on anticoagulation during the study period
timeFrame: 12-months following initial prescription of anticoagulation (ie, up to 24 months after study start)
measure: New ischemic stroke within 24-months of the study start
timeFrame: 24-months
measure: Major hemorrhage within 24-months of the study start
timeFrame: 24-months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven Lubitz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.