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
研究概览
地位
条件
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
注册 (实际的)
联系人和位置
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
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
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
调查人员
- 首席研究员:Christopher P Cannon, MD、Baim Institute for Clinical Research
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.