- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Alaska
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Anchorage, Alaska, Stati Uniti, 95508
- Alaska Heart Institute
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California
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Orange, California, Stati Uniti, 92868
- Orange County Heart Institute and Research Center
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Florida
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Clearwater, Florida, Stati Uniti, 33756
- Clearwater Cardiovascular & Interventional Consultants MD PA
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Fort Lauderdale, Florida, Stati Uniti, 33308
- Holy Cross Hospital, Inc.
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Miami, Florida, Stati Uniti, 33173
- HeartWell LLP
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Palm Beach Gardens, Florida, Stati Uniti, 33410
- Cardiac Institute of the Palm Beaches
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Illinois
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Hinsdale, Illinois, Stati Uniti, 60521
- Adventist Health Partners, Inc. Amita Health
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Maryland
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Salisbury, Maryland, Stati Uniti, 21804
- Delmarva Heart LLC
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48197
- Michigan Heart - St. Joseph Mercy Health System
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Traverse City, Michigan, Stati Uniti, 49684
- Munson Medical Group
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New Jersey
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Hillsborough, New Jersey, Stati Uniti, 08844
- CardioCare, PC
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Ohio
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Toledo, Ohio, Stati Uniti, 43606
- Promedica Toledo Hospital
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Oregon
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Medford, Oregon, Stati Uniti, 97504
- Southern Oregon Cardiology
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Pennsylvania
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Lansdale, Pennsylvania, Stati Uniti, 19446
- Cardiology Consultants of Philadelphia - Lansdale
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Texas
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Lufkin, Texas, Stati Uniti, 75904
- The Heart Institute of East Texas
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Waco, Texas, Stati Uniti, 20037
- Waco Cardiology Associates
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Utah
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Saint George, Utah, Stati Uniti, 84790
- Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC
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Virginia
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Lynchburg, Virginia, Stati Uniti, 24501
- Centra Health, Inc. dba Stroobants Cardiovascular Center
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Richmond, Virginia, Stati Uniti, 23229
- Virginia Cardiovascular Specialists
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Washington
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Everett, Washington, Stati Uniti, 98208
- Western Washington Medical Group, Inc.
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Spokane, Washington, Stati Uniti, 99204
- Kootenai Health dba Heart Clinics of the Northwest
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
A benchmark rate of OA treatment in patients with NVAF
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Physician Reason for not prescribing OA; Patient perspectives on non-use of OA
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in rate of OA use
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Christopher P Cannon, MD, Baim Institute for Clinical Research
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AFP14
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .