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Benchmarking an Oral Anticoagulant Treatment Rate in Patients With Nonvalvular Atrial Fibrillation (BOAT-AF)

25. juli 2022 oppdatert av: Baim Institute for Clinical Research

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

817

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alaska
      • Anchorage, Alaska, Forente stater, 95508
        • Alaska Heart Institute
    • California
      • Orange, California, Forente stater, 92868
        • Orange County Heart Institute and Research Center
    • Florida
      • Clearwater, Florida, Forente stater, 33756
        • Clearwater Cardiovascular & Interventional Consultants MD PA
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Holy Cross Hospital, Inc.
      • Miami, Florida, Forente stater, 33173
        • HeartWell LLP
      • Palm Beach Gardens, Florida, Forente stater, 33410
        • Cardiac Institute of the Palm Beaches
    • Illinois
      • Hinsdale, Illinois, Forente stater, 60521
        • Adventist Health Partners, Inc. Amita Health
    • Maryland
      • Salisbury, Maryland, Forente stater, 21804
        • Delmarva Heart LLC
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48197
        • Michigan Heart - St. Joseph Mercy Health System
      • Traverse City, Michigan, Forente stater, 49684
        • Munson Medical Group
    • New Jersey
      • Hillsborough, New Jersey, Forente stater, 08844
        • CardioCare, PC
    • Ohio
      • Toledo, Ohio, Forente stater, 43606
        • ProMedica Toledo Hospital
    • Oregon
      • Medford, Oregon, Forente stater, 97504
        • Southern Oregon Cardiology
    • Pennsylvania
      • Lansdale, Pennsylvania, Forente stater, 19446
        • Cardiology Consultants of Philadelphia - Lansdale
    • Texas
      • Lufkin, Texas, Forente stater, 75904
        • The Heart Institute of East Texas
      • Waco, Texas, Forente stater, 20037
        • Waco Cardiology Associates
    • Utah
      • Saint George, Utah, Forente stater, 84790
        • Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC
    • Virginia
      • Lynchburg, Virginia, Forente stater, 24501
        • Centra Health, Inc. dba Stroobants Cardiovascular Center
      • Richmond, Virginia, Forente stater, 23229
        • Virginia Cardiovascular Specialists
    • Washington
      • Everett, Washington, Forente stater, 98208
        • Western Washington Medical Group, Inc.
      • Spokane, Washington, Forente stater, 99204
        • Kootenai Health dba Heart Clinics of the Northwest

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
A benchmark rate of OA treatment in patients with NVAF
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physician Reason for not prescribing OA; Patient perspectives on non-use of OA
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in rate of OA use
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Baim Institute for Clinical Research

Samarbeidspartnere

American College of Cardiology

Etterforskere

  • Hovedetterforsker: Christopher P Cannon, MD, Baim Institute for Clinical Research

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2017

Primær fullføring (Faktiske)

1. mai 2018

Studiet fullført (Faktiske)

1. september 2019

Datoer for studieregistrering

Først innsendt

26. september 2016

Først innsendt som oppfylte QC-kriteriene

28. september 2016

Først lagt ut (Anslag)

30. september 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juli 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juli 2022

Sist bekreftet

1. juli 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AFP14

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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