Pilot Randomized Trial of a Patient Decision Aid for Treatment of Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Knowledge score
研究概览
简要总结
This project will evaluate the impact of a patient decision aid created by the American College of Cardiology for patients considering treatment of aortic stenosis. The decision aid describes surgical aortic valve replacement (SAVR) surgery and transcatheter valve replacement surgery (TAVR).
详细描述
The pilot trial will enroll patients who are coming in to see a valve specialist (cardiac surgeon or interventional cardiologist) to discuss treatment options for aortic stenosis. The study will recruit patients at Massachusetts General Hospital or at the University of Colorado Health Heart and Vascular Center, Anschutz Medical in Denver, Colorado and randomly assign them to usual care arm or decision aid arm. The decision aid will be given to the participant in clinic at the time of their appointment. Patient participants in both arms will be asked to complete a short survey after the visit. The survey will assess knowledge, treatment preference, shared decision making (SDM), and decisional conflict. Analyses will compare the two arms on these outcomes to generate preliminary data on impact of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-85 years only
- •English speaking
- •Severe aortic stenosis, defined as an aortic valve area < 1 cm2
- •Never had AVR or who had previous AVR > 6 months previous
- •Patients perceived by the clinician to be at low or intermediate risk for SAVR
排除标准
- •Concomitant disease of another heart valve or the aorta that required either transcatheter or surgical intervention
结局指标
主要结局
Knowledge score
时间窗: About 1 week after receiving the decision aid
Patients will complete 6 multiple choice knowledge items and a total knowledge score (0-100%) will be created by summing the number of correct responses and dividing by the number of items.
次要结局
- Treatment Preference(About 1 week after receiving the decision aid)
- Shared Decision Making Process score(About 1 week after receiving the decision aid)
- Treatment received(12-21 weeks post visit)
研究者
Karen Sepucha
Associate Professor
Massachusetts General Hospital