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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Alaska
-
Anchorage、Alaska、アメリカ、95508
- Alaska Heart Institute
-
-
California
-
Orange、California、アメリカ、92868
- Orange County Heart Institute and Research Center
-
-
Florida
-
Clearwater、Florida、アメリカ、33756
- Clearwater Cardiovascular & Interventional Consultants MD PA
-
Fort Lauderdale、Florida、アメリカ、33308
- Holy Cross Hospital, Inc.
-
Miami、Florida、アメリカ、33173
- HeartWell LLP
-
Palm Beach Gardens、Florida、アメリカ、33410
- Cardiac Institute of the Palm Beaches
-
-
Illinois
-
Hinsdale、Illinois、アメリカ、60521
- Adventist Health Partners, Inc. Amita Health
-
-
Maryland
-
Salisbury、Maryland、アメリカ、21804
- Delmarva Heart LLC
-
-
Michigan
-
Ann Arbor、Michigan、アメリカ、48197
- Michigan Heart - St. Joseph Mercy Health System
-
Traverse City、Michigan、アメリカ、49684
- Munson Medical Group
-
-
New Jersey
-
Hillsborough、New Jersey、アメリカ、08844
- CardioCare, PC
-
-
Ohio
-
Toledo、Ohio、アメリカ、43606
- ProMedica Toledo Hospital
-
-
Oregon
-
Medford、Oregon、アメリカ、97504
- Southern Oregon Cardiology
-
-
Pennsylvania
-
Lansdale、Pennsylvania、アメリカ、19446
- Cardiology Consultants of Philadelphia - Lansdale
-
-
Texas
-
Lufkin、Texas、アメリカ、75904
- The Heart Institute of East Texas
-
Waco、Texas、アメリカ、20037
- Waco Cardiology Associates
-
-
Utah
-
Saint George、Utah、アメリカ、84790
- Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC
-
-
Virginia
-
Lynchburg、Virginia、アメリカ、24501
- Centra Health, Inc. dba Stroobants Cardiovascular Center
-
Richmond、Virginia、アメリカ、23229
- Virginia Cardiovascular Specialists
-
-
Washington
-
Everett、Washington、アメリカ、98208
- Western Washington Medical Group, Inc.
-
Spokane、Washington、アメリカ、99204
- Kootenai Health dba Heart Clinics of the Northwest
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
A benchmark rate of OA treatment in patients with NVAF
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physician Reason for not prescribing OA; Patient perspectives on non-use of OA
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in rate of OA use
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Christopher P Cannon, MD、Baim Institute for Clinical Research
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。