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

Nonvalvular Atrial Fibrillation Clinical Trial

— BOAT-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02919982
• Other study ID #: AFP14
• Status: Completed
• Start date: January 2017
• Est. completion date: September 2019

Study information

• Verified date: July 2022
• Source: Baim Institute for Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 817
• Est. completion date: September 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Nonvalvular Atrial Fibrillation

Locations

Country	Name	City	State
United States	Alaska Heart Institute	Anchorage	Alaska
United States	Michigan Heart - St. Joseph Mercy Health System	Ann Arbor	Michigan
United States	Clearwater Cardiovascular & Interventional Consultants MD PA	Clearwater	Florida
United States	Western Washington Medical Group, Inc.	Everett	Washington
United States	Holy Cross Hospital, Inc.	Fort Lauderdale	Florida
United States	CardioCare, PC	Hillsborough	New Jersey
United States	Adventist Health Partners, Inc. Amita Health	Hinsdale	Illinois
United States	Cardiology Consultants of Philadelphia - Lansdale	Lansdale	Pennsylvania
United States	The Heart Institute of East Texas	Lufkin	Texas
United States	Centra Health, Inc. dba Stroobants Cardiovascular Center	Lynchburg	Virginia
United States	Southern Oregon Cardiology	Medford	Oregon
United States	Heartwell LLP	Miami	Florida
United States	Orange County Heart Institute and Research Center	Orange	California
United States	Cardiac Institute of the Palm Beaches	Palm Beach Gardens	Florida
United States	Virginia Cardiovascular Specialists	Richmond	Virginia
United States	Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC	Saint George	Utah
United States	Delmarva Heart LLC	Salisbury	Maryland
United States	Kootenai Health dba Heart Clinics of the Northwest	Spokane	Washington
United States	ProMedica Toledo Hospital	Toledo	Ohio
United States	Munson Medical Group	Traverse City	Michigan
United States	Waco Cardiology Associates	Waco	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baim Institute for Clinical Research	American College of Cardiology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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