Benchmarking an Oral Anticoagulant Treatment Rate in Patients With Nonvalvular Atrial Fibrillation (BOAT-AF)

Benchmarking an Oral Anticoagulant Treatment Rate in Patients With Nonvalvular Atrial Fibrillation: A Study of Clinical Characteristics With Insight From Patient and Physician Perspectives

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.

Study Overview

• Status: Completed
• Conditions: Nonvalvular Atrial Fibrillation

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.

• Study Type: Observational
• Enrollment (Actual): 817

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 95508
      • Alaska Heart Institute
  • California
    • Orange, California, United States, 92868
      • Orange County Heart Institute and Research Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular & Interventional Consultants MD PA
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital, Inc.
    • Miami, Florida, United States, 33173
      • HeartWell LLP
    • Palm Beach Gardens, Florida, United States, 33410
      • Cardiac Institute of the Palm Beaches
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Adventist Health Partners, Inc. Amita Health
  • Maryland
    • Salisbury, Maryland, United States, 21804
      • Delmarva Heart LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48197
      • Michigan Heart - St. Joseph Mercy Health System
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Group
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • CardioCare, PC
  • Ohio
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
  • Oregon
    • Medford, Oregon, United States, 97504
      • Southern Oregon Cardiology
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Cardiology Consultants of Philadelphia - Lansdale
  • Texas
    • Lufkin, Texas, United States, 75904
      • The Heart Institute of East Texas
    • Waco, Texas, United States, 20037
      • Waco Cardiology Associates
  • Utah
    • Saint George, Utah, United States, 84790
      • Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Centra Health, Inc. dba Stroobants Cardiovascular Center
    • Richmond, Virginia, United States, 23229
      • Virginia Cardiovascular Specialists
  • Washington
    • Everett, Washington, United States, 98208
      • Western Washington Medical Group, Inc.
    • Spokane, Washington, United States, 99204
      • Kootenai Health dba Heart Clinics of the Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes, from participating centers within the PINNACLE Registry, patients with nonvalvular atrial fibrillation identified as having an indication for oral anticoagulants, according to guidelines developed by the American College of Cardiology, but not receiving them.

Description

Inclusion Criteria: A patient must meet all of the following criteria to participate in this study:

• 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: A patient will be excluded from participating in the study for any of the following reasons:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A benchmark rate of OA treatment in patients with NVAF	This rate of OA will be based on assessment of appropriateness of OA treatment based on clinical guidelines by cardiologists using clinical data and the physician and patient surveys.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Reason for not prescribing OA; Patient perspectives on non-use of OA	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' charts.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in rate of OA use	Via linking the BOAT-AF data with the PINNACLE Registry data, we will assess if there is a change in the rate of OA one year following the BOAT-AF surveys	1 year

Collaborators and Investigators

• Sponsor: Baim Institute for Clinical Research
• Collaborators: American College of Cardiology
• Investigators: Principal Investigator: Christopher P Cannon, MD, Baim Institute for Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Anticoagulant; Registries; Nonvalvular atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AFP14