DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 790
- 试验地点
- 2
- 主要终点
- Knowledge About Defibrillation at Baseline
研究概览
简要总结
The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.
详细描述
The investigators propose the DECIDE-ICD trial: a type II effectiveness implementation hybrid trial of the investigators ICD PtDAs. The Investigators will use a 6-site stepped-wedge design, with implementation guided by normalization process theory® and evaluation guided by the RE-AIM framework.
The investigators aim to evaluate reach and effectiveness of the ICD PtDAs using a pragmatic, stepped-wedge design on decision quality (knowledge and value-concordance) and psychosocial outcomes.
- Hypothesis 1a: PtDAs will reach over 50% of eligible patients.
- Hypothesis 1b: ICD PtDAs will be effective in improving decision quality in real-world practice.
- Hypothesis 1c: Better informed patients will have lower anxiety, higher rates of planning for the possibility of deactivation, and increased identification of a surrogate decision maker.
The investigators propose 3 a priori hypotheses:
- The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old);
- The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic);
- The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •18 years or older
- •English-speaking (videos and surveys have only been validated in English)
- •Patients have been offered a primary prevention ICD for initial implant, reimplantation, or CRT with defibrillation
排除标准
- •Prisoners
结局指标
主要结局
Knowledge About Defibrillation at Baseline
时间窗: Baseline
Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
Knowledge About Defibrillation at 1 Month
时间窗: 1 month
Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
Knowledge About Defibrillation at 6 Months
时间窗: 6 months
Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
次要结局
- Reach of Eligible Patients(Baseline)