Evaluating the Impact of Decision Aid Timing on Mandatory Shared Decision Making for Defibrillator Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants
研究概览
简要总结
The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.
详细描述
There are many unanswered questions about how shared decision making should be executed and how decision aids should be employed. The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old and older
- •evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)
排除标准
- 未提供
研究组 & 干预措施
Pre-visit decision aid
Patients receiving the decision aid pre-visit will be given a paper copy of the decision aid in the waiting room and will have a minimum of 15 minutes to review it - either in the waiting room or in the exam room while waiting for the electrophysiologist.
干预措施: Pre-visit timing of receipt of the ICDs implantation decision aid (Behavioral)
Post-visit decision aid
Patients receiving the decision aid after the encounter will meet with the electrophysiologist first and receive the aid afterward.
干预措施: Post-visit timing of receipt of the ICDs implantation decision aid (Behavioral)
结局指标
主要结局
Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants
时间窗: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Patients will receive a survey including 11 questions to gauge decisional knowledge about ICDs. The survey is expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.
次要结局
- Decision Conflict Scale score among pre-visit arm participants compare to post-visit arm participants(Date of ICD implantation (up to 60 days from the date of receiving the decision aid))
- Values-choice ICDs concordance score among pre-visit arm participants compare to post-visit arm participants(Date of ICD implantation (up to 60 days from the date of receiving the decision aid))
研究者
Faisal Merchant MD
Assistant Professor
Emory University