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

2022年7月25日 更新者: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.

研究概览

地位

完全的

详细说明

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.

研究类型

观察性的

注册 (实际的)

817

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
A benchmark rate of OA treatment in patients with NVAF
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Physician Reason for not prescribing OA; Patient perspectives on non-use of OA
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Change in rate of OA use
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Christopher P Cannon, MD、Baim Institute for Clinical Research

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年1月1日

初级完成 (实际的)

2018年5月1日

研究完成 (实际的)

2019年9月1日

研究注册日期

首次提交

2016年9月26日

首先提交符合 QC 标准的

2016年9月28日

首次发布 (估计)

2016年9月30日

研究记录更新

最后更新发布 (实际的)

2022年7月27日

上次提交的符合 QC 标准的更新

2022年7月25日

最后验证

2022年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • AFP14

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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