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

25 juli 2022 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

817

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
A benchmark rate of OA treatment in patients with NVAF
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physician Reason for not prescribing OA; Patient perspectives on non-use of OA
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in rate of OA use
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Baim Institute for Clinical Research

Samarbetspartners

American College of Cardiology

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2017

Primärt slutförande (Faktisk)

1 maj 2018

Avslutad studie (Faktisk)

1 september 2019

Studieregistreringsdatum

Först inskickad

26 september 2016

Först inskickad som uppfyllde QC-kriterierna

28 september 2016

Första postat (Uppskatta)

30 september 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 juli 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 juli 2022

Senast verifierad

1 juli 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AFP14

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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