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

25. juli 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

817

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Baim Institute for Clinical Research

Samarbejdspartnere

American College of Cardiology

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2017

Primær færdiggørelse (Faktiske)

1. maj 2018

Studieafslutning (Faktiske)

1. september 2019

Datoer for studieregistrering

Først indsendt

26. september 2016

Først indsendt, der opfyldte QC-kriterier

28. september 2016

Først opslået (Skøn)

30. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AFP14

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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