Screening for Atrial Fibrillation Among Older Patients in Primary Care Clinics

Atrial Fibrillation Clinical Trial

— VITAL-AF  

Official title:

Screening for Atrial Fibrillation in an Ambulatory Clinic Population: The VITAL-AF Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03515057
• Other study ID #: CV185-581
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 31, 2018
• Est. completion date: October 2021

Study information

• Verified date: February 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35308
• Est. completion date: October 2021
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident AF during the study period	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).	12-months
Secondary	Incident AF associated with a primary care encounter during the study period	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.	12-months
Secondary	New oral anticoagulation prescription during the study period	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.	12-months
Secondary	Continued prescription of anticoagulation at 12 months among those started on anticoagulation during the study period	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.	12-months following initial prescription of anticoagulation (ie, up to 24 months after study start)
Secondary	New ischemic stroke within 24-months of the study start	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).	24-months
Secondary	Major hemorrhage within 24-months of the study start	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).	24-months