Benchmarking an Oral Anticoagulant Treatment Rate in Patients With Nonvalvular Atrial Fibrillation

NCT ID: NCT02919982

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 817 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-09-30

Brief Summary

The purpose of this study is to establish a benchmark for rate of prescription of oral anticoagulants (OA) in patients with non-valvular atrial fibrillation (NVAF) seen in an ambulatory care setting, based on independent medical assessment of clinical data and physician and patient surveys. The study will also assess reasons for not prescribing OA to prevent thromboembolic complications in patients with NVAF seen in ambulatory care, and patients' perspectives of non-use of OA for treatment of NVAF.

Detailed Description

At participating centers within the American College of Cardiology's (ACC) PINNACLE Registry, patients with nonvalvular atrial fibrillation who, according to ACC guidelines, are indicated as having an indication for oral anticoagulants (OA), but who are not receiving them, will be identified. Recruitment of participating physicians will also take place through collaboration with the PINNACLE Registry. Physician and patient participants will be asked to complete clinical surveys characterizing use and perception of OA therapy for each individual patient. The Baim Institute for Clinical Research (Baim Institute) serves as an analytic center for the PINNACLE Registry and will collaboratively lead this project with the ACC. The information collected from the PINNACLE Registry will include patient characteristics, site characteristics (volume, region, etc.) and the treating physician characteristics. Information from the patient and physician surveys will provide the clinical reasons for prior nontreatment as assessed by the treating physicians as well as the patients' perception of OA treatment (overall and according to pre-specified subgroups based on patient and site characteristics). Information will also be gathered from the patients' chart.

The above data will be compiled and reviewed by a committee of cardiologists who will assess whether OA treatment would be appropriate based on all the clinical factors assessed.

The BOAT-AF data will be linked to data from the PINNACLE Registry for the patients for whom surveys have been collected. Linking the two datasets will allow assessment of whether or not the participating physicians prescribed OA treatment and whether those patients started OA treatment within approximately 12 months after completing the questionnaire.

Conditions

Nonvalvular Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Able and willing to complete the survey;
• Diagnosed with nonvalvular atrial fibrillation and CHA2DS2-VASc ≥ 2;
• Not currently treated with oral anticoagulants according to the PINNACLE Registry data;
• Enrolled in the PINNACLE Registry;
• Last physician office visit within the prior 18 months; and
• Age ≥ 18 years.

Exclusion Criteria

• Patient is no longer being followed at the local practice;
• Patient declines participation; and/or
• Patient is unable to speak or read English.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American College of Cardiology

OTHER

Sponsor Role: collaborator

Baim Institute for Clinical Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher P Cannon, MD

Role: PRINCIPAL_INVESTIGATOR

Baim Institute for Clinical Research

Locations

Alaska Heart Institute

Anchorage, Alaska, United States

Orange County Heart Institute and Research Center

Orange, California, United States

Clearwater Cardiovascular & Interventional Consultants MD PA

Clearwater, Florida, United States

Holy Cross Hospital, Inc.

Fort Lauderdale, Florida, United States

Heartwell LLP

Miami, Florida, United States

Cardiac Institute of the Palm Beaches

Palm Beach Gardens, Florida, United States

Adventist Health Partners, Inc. Amita Health

Hinsdale, Illinois, United States

Delmarva Heart LLC

Salisbury, Maryland, United States

Michigan Heart - St. Joseph Mercy Health System

Ann Arbor, Michigan, United States

Munson Medical Group

Traverse City, Michigan, United States

CardioCare, PC

Hillsborough, New Jersey, United States

ProMedica Toledo Hospital

Toledo, Ohio, United States

Southern Oregon Cardiology

Medford, Oregon, United States

Cardiology Consultants of Philadelphia - Lansdale

Lansdale, Pennsylvania, United States

The Heart Institute of East Texas

Lufkin, Texas, United States

Waco Cardiology Associates

Waco, Texas, United States

Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC

St. George, Utah, United States

Centra Health, Inc. dba Stroobants Cardiovascular Center

Lynchburg, Virginia, United States

Virginia Cardiovascular Specialists

Richmond, Virginia, United States

Western Washington Medical Group, Inc.

Everett, Washington, United States

Kootenai Health dba Heart Clinics of the Northwest

Spokane, Washington, United States

Countries

United States

Other Identifiers

AFP14

Identifier Type: -

Identifier Source: org_study_id