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



Status:Active, not recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/27/2018
Start Date:October 2016
End Date:November 2018

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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.

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.

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.
We found this trial at
21
sites
1436 Medical Campus Drive
Traverse City, Michigan 49684
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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Anchorage, Alaska 99508
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Anchorage, AK
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5301 McAuley Drive
Ann Arbor, Michigan 48197
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Ann Arbor, MI
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Clearwater, FL
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Everett, Washington 98208
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Everett, WA
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Hillsborough, New Jersey 08844
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Hillsborough, NJ
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911 North Elm Street
Hinsdale, Illinois 60521
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Hinsdale, IL
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Lansdale, PA
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Lufkin, Texas 75904
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2410 Atherholt Road
Lynchburg, Virginia 24501
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Lynchburg, VA
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Medford, Oregon 97504
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Medford, OR
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7400 Southwest 87th Avenue
Miami, Florida 33173
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Miami, FL
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Orange, CA
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3355 Burns Road
Palm Beach Gardens, Florida 33410
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Palm Beach Gardens, FL
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Richmond, Virginia 23225
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Richmond, VA
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1380 South Medical Center Drive
Saint George, Utah 84790
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Saint George, UT
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Salisbury, Maryland 21804
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Salisbury, MD
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122 West 7th Avenue
Spokane, Washington 99204
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Spokane, WA
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Toledo, Ohio 43606
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Waco, Texas 20037
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Waco, TX
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