Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,001
- 试验地点
- 10
- 主要终点
- Decisional Conflict Scale
研究概览
简要总结
A multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for Atrial Fibrillation Stroke Prevention
详细描述
This study will test to see if a new type of decision-making process tool, called a Shared Decision Making Pathway, can make a difference in decreasing the risk of stroke due to a condition called Atrial Fibrillation (AFib.) This online tool is designed to help doctors and patients decide together on treatment options for AFib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Non-valvular atrial fibrillation or atrial flutter (AFib)
- •CHA2DS2-VASc stroke score of:
- •Men: 1 or more
- •Women: 2 or more
- •Able to consent in English or Spanish (if resources allow) and follow study instructions
排除标准
- •Moderate to severe mitral stenosis
- •Mechanical valve replacement
- •Absolute contraindication to anticoagulation (Based on clinician judgment)
- •Indication for anticoagulation therapy for a condition other than atrial fibrillation
- •Left atrial appendage exclusion (by surgery or device placement)
- •At the clinical discretion of the investigator
结局指标
主要结局
Decisional Conflict Scale
时间窗: Visit 2 (1-month follow-up)
The Decisional Conflict Scale is a 16 Item scale on whether the participants have enough information to make a clear decision. Each item scored from 1-5, where 1 indicates clarity and 5 indicates confusion, with total score ranging from 16-80
次要结局
- Quality of Communication (Based on CAHPS Clinician & Group Survey)(Visit 1 (Post Clinic Visit))
- Utah-Stanford Atrial Fibrillation Knowledge Assessment(Baseline, Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up))
- Atrial Fibrillation Severity Scale (AFSS)(Baseline, Visit 2 (1-month follow up), Visit 3(6-month follow-up))
- Collaborative Agreement on Decision(Visit 1 (Post Clinic Visit))
- Anticoagulant Choice (Patient follow up questions on Anticoagulant use)(Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up))
- Decisional Conflict Scale (16 items)(Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up))
- Decision Regret Scale (5 items)(Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up))
- Weighted composite outcome scale according to patient preference(Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up))
- Preparation for Decision Making Scale (10 items)(Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up))
- Clinician Satisfaction of the Decision Aid: Physician Survey(Visit 1 (Post Clinic Visit))
- Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus(Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled)
- Death(Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled)
- Patient Satisfaction of the Decision Aid: Patient Survey(Visit 1 (Post Clinic Visit))
- Length of Visit at visit 1 (clinician)(Visit 1 (Post Clinic Visit))
- Anticoagulation Persistence and adherence (Patient follow up questions on Anticoagulant use)(Visit 2 (1-month follow up), Visit 3 (6-month follow-up))
研究者
Paul Wang
Professor of Medicine (Cardiovascular Medicine), Stanford University Medical Center
Stanford University