Clinical trial NCT02919982: Benchmarking an Oral Anticoagulant Treatment Rate in Patients With Nonvalvular Atrial Fibrillation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonvalvular Atrial Fibrillation
Keywords: Anticoagulant
Nonvalvular atrial fibrillation
Registries
Lead sponsor: Baim Institute for Clinical Research
Sponsor class: OTHER
Collaborators: name: American College of Cardiology
First posted: 2016-09-30
Enrollment: 817
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: A benchmark rate of OA treatment in patients with NVAF
timeFrame: Baseline
Secondary outcomes:
measure: Physician Reason for not prescribing OA; Patient perspectives on non-use of OA
timeFrame: Baseline
Other outcomes:
measure: Change in rate of OA use
timeFrame: 1 year
Locations:
city: Anchorage
country: United States
facility: Alaska Heart Institute
state: Alaska
city: Orange
country: United States
facility: Orange County Heart Institute and Research Center
state: California
city: Clearwater
country: United States
facility: Clearwater Cardiovascular & Interventional Consultants MD PA
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital, Inc.
state: Florida
city: Miami
country: United States
facility: Heartwell LLP
state: Florida
city: Palm Beach Gardens
country: United States
facility: Cardiac Institute of the Palm Beaches
state: Florida
city: Hinsdale
country: United States
facility: Adventist Health Partners, Inc. Amita Health
state: Illinois
city: Salisbury
country: United States
facility: Delmarva Heart LLC
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Heart - St. Joseph Mercy Health System
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Group
state: Michigan
city: Hillsborough
country: United States
facility: CardioCare, PC
state: New Jersey
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Medford
country: United States
facility: Southern Oregon Cardiology
state: Oregon
city: Lansdale
country: United States
facility: Cardiology Consultants of Philadelphia - Lansdale
state: Pennsylvania
city: Lufkin
country: United States
facility: The Heart Institute of East Texas
state: Texas
city: Waco
country: United States
facility: Waco Cardiology Associates
state: Texas
city: Saint George
country: United States
facility: Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC
state: Utah
city: Lynchburg
country: United States
facility: Centra Health, Inc. dba Stroobants Cardiovascular Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists
state: Virginia
city: Everett
country: United States
facility: Western Washington Medical Group, Inc.
state: Washington
city: Spokane
country: United States
facility: Kootenai Health dba Heart Clinics of the Northwest
state: Washington
Study officials:
affiliation: Baim Institute for Clinical Research
name: Christopher P Cannon, MD
role: PRINCIPAL_INVESTIGATOR
References: