Benchmarking an Oral Anticoagulant Treatment Rate in Patients With Nonvalvular Atrial Fibrillation: A Study of Clinical Characteristics With Insight From Patient and Physician Perspectives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 817
- 试验地点
- 21
- 主要终点
- A benchmark rate of OA treatment in patients with NVAF
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
A benchmark rate of OA treatment in patients with NVAF
时间窗: 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.
次要结局
- Physician Reason for not prescribing OA; Patient perspectives on non-use of OA(Baseline)