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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Alaska
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Anchorage, Alaska, 미국, 95508
- Alaska Heart Institute
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California
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Orange, California, 미국, 92868
- Orange County Heart Institute and Research Center
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Florida
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Clearwater, Florida, 미국, 33756
- Clearwater Cardiovascular & Interventional Consultants MD PA
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Fort Lauderdale, Florida, 미국, 33308
- Holy Cross Hospital, Inc.
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Miami, Florida, 미국, 33173
- HeartWell LLP
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Palm Beach Gardens, Florida, 미국, 33410
- Cardiac Institute of the Palm Beaches
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Illinois
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Hinsdale, Illinois, 미국, 60521
- Adventist Health Partners, Inc. Amita Health
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Maryland
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Salisbury, Maryland, 미국, 21804
- Delmarva Heart LLC
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Michigan
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Ann Arbor, Michigan, 미국, 48197
- Michigan Heart - St. Joseph Mercy Health System
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Traverse City, Michigan, 미국, 49684
- Munson Medical Group
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New Jersey
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Hillsborough, New Jersey, 미국, 08844
- CardioCare, PC
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Ohio
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Toledo, Ohio, 미국, 43606
- ProMedica Toledo Hospital
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Oregon
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Medford, Oregon, 미국, 97504
- Southern Oregon Cardiology
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Pennsylvania
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Lansdale, Pennsylvania, 미국, 19446
- Cardiology Consultants of Philadelphia - Lansdale
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Texas
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Lufkin, Texas, 미국, 75904
- The Heart Institute of East Texas
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Waco, Texas, 미국, 20037
- Waco Cardiology Associates
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Utah
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Saint George, Utah, 미국, 84790
- Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC
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Virginia
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Lynchburg, Virginia, 미국, 24501
- Centra Health, Inc. dba Stroobants Cardiovascular Center
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Richmond, Virginia, 미국, 23229
- Virginia Cardiovascular Specialists
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Washington
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Everett, Washington, 미국, 98208
- Western Washington Medical Group, Inc.
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Spokane, Washington, 미국, 99204
- Kootenai Health dba Heart Clinics of the Northwest
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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A benchmark rate of OA treatment in patients with NVAF
기간: Baseline
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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.
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Baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physician Reason for not prescribing OA; Patient perspectives on non-use of OA
기간: Baseline
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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.
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Baseline
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in rate of OA use
기간: 1 year
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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
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Christopher P Cannon, MD, Baim Institute for Clinical Research
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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