- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02919982
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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Alaska
-
Anchorage, Alaska, Estados Unidos, 95508
- Alaska Heart Institute
-
-
California
-
Orange, California, Estados Unidos, 92868
- Orange County Heart Institute and Research Center
-
-
Florida
-
Clearwater, Florida, Estados Unidos, 33756
- Clearwater Cardiovascular & Interventional Consultants MD PA
-
Fort Lauderdale, Florida, Estados Unidos, 33308
- Holy Cross Hospital, Inc.
-
Miami, Florida, Estados Unidos, 33173
- HeartWell LLP
-
Palm Beach Gardens, Florida, Estados Unidos, 33410
- Cardiac Institute of the Palm Beaches
-
-
Illinois
-
Hinsdale, Illinois, Estados Unidos, 60521
- Adventist Health Partners, Inc. Amita Health
-
-
Maryland
-
Salisbury, Maryland, Estados Unidos, 21804
- Delmarva Heart LLC
-
-
Michigan
-
Ann Arbor, Michigan, Estados Unidos, 48197
- Michigan Heart - St. Joseph Mercy Health System
-
Traverse City, Michigan, Estados Unidos, 49684
- Munson Medical Group
-
-
New Jersey
-
Hillsborough, New Jersey, Estados Unidos, 08844
- CardioCare, PC
-
-
Ohio
-
Toledo, Ohio, Estados Unidos, 43606
- ProMedica Toledo Hospital
-
-
Oregon
-
Medford, Oregon, Estados Unidos, 97504
- Southern Oregon Cardiology
-
-
Pennsylvania
-
Lansdale, Pennsylvania, Estados Unidos, 19446
- Cardiology Consultants of Philadelphia - Lansdale
-
-
Texas
-
Lufkin, Texas, Estados Unidos, 75904
- The Heart Institute of East Texas
-
Waco, Texas, Estados Unidos, 20037
- Waco Cardiology Associates
-
-
Utah
-
Saint George, Utah, Estados Unidos, 84790
- Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC
-
-
Virginia
-
Lynchburg, Virginia, Estados Unidos, 24501
- Centra Health, Inc. dba Stroobants Cardiovascular Center
-
Richmond, Virginia, Estados Unidos, 23229
- Virginia Cardiovascular Specialists
-
-
Washington
-
Everett, Washington, Estados Unidos, 98208
- Western Washington Medical Group, Inc.
-
Spokane, Washington, Estados Unidos, 99204
- Kootenai Health dba Heart Clinics of the Northwest
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
A benchmark rate of OA treatment in patients with NVAF
Periodo de tiempo: Baseline
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physician Reason for not prescribing OA; Patient perspectives on non-use of OA
Periodo de tiempo: Baseline
|
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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in rate of OA use
Periodo de tiempo: 1 year
|
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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christopher P Cannon, MD, Baim Institute for Clinical Research
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AFP14
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .