- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Alaska
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Anchorage, Alaska, Stany Zjednoczone, 95508
- Alaska Heart Institute
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California
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Orange, California, Stany Zjednoczone, 92868
- Orange County Heart Institute and Research Center
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Florida
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Clearwater, Florida, Stany Zjednoczone, 33756
- Clearwater Cardiovascular & Interventional Consultants MD PA
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Fort Lauderdale, Florida, Stany Zjednoczone, 33308
- Holy Cross Hospital, Inc.
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Miami, Florida, Stany Zjednoczone, 33173
- HeartWell LLP
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Palm Beach Gardens, Florida, Stany Zjednoczone, 33410
- Cardiac Institute of the Palm Beaches
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Illinois
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Hinsdale, Illinois, Stany Zjednoczone, 60521
- Adventist Health Partners, Inc. Amita Health
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Maryland
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Salisbury, Maryland, Stany Zjednoczone, 21804
- Delmarva Heart LLC
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48197
- Michigan Heart - St. Joseph Mercy Health System
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Traverse City, Michigan, Stany Zjednoczone, 49684
- Munson Medical Group
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New Jersey
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Hillsborough, New Jersey, Stany Zjednoczone, 08844
- CardioCare, PC
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Ohio
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Toledo, Ohio, Stany Zjednoczone, 43606
- ProMedica Toledo Hospital
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Oregon
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Medford, Oregon, Stany Zjednoczone, 97504
- Southern Oregon Cardiology
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Pennsylvania
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Lansdale, Pennsylvania, Stany Zjednoczone, 19446
- Cardiology Consultants of Philadelphia - Lansdale
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Texas
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Lufkin, Texas, Stany Zjednoczone, 75904
- The Heart Institute of East Texas
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Waco, Texas, Stany Zjednoczone, 20037
- Waco Cardiology Associates
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Utah
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Saint George, Utah, Stany Zjednoczone, 84790
- Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC
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Virginia
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Lynchburg, Virginia, Stany Zjednoczone, 24501
- Centra Health, Inc. dba Stroobants Cardiovascular Center
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Richmond, Virginia, Stany Zjednoczone, 23229
- Virginia Cardiovascular Specialists
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Washington
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Everett, Washington, Stany Zjednoczone, 98208
- Western Washington Medical Group, Inc.
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Spokane, Washington, Stany Zjednoczone, 99204
- Kootenai Health dba Heart Clinics of the Northwest
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Kohorta
- Perspektywy czasowe: Spodziewany
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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A benchmark rate of OA treatment in patients with NVAF
Ramy czasowe: Baseline
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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.
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Baseline
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Physician Reason for not prescribing OA; Patient perspectives on non-use of OA
Ramy czasowe: 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
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in rate of OA use
Ramy czasowe: 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
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1 year
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Christopher P Cannon, MD, Baim Institute for Clinical Research
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- AFP14
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