A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
研究概览
详细说明
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).
Along with these hypotheses, we recognize that other important covariates exist, such as health literacy and education level.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado Denver
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prisoners
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:Participants will fill out surveys
These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
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有源比较器:Educational video and/or handout
These participants will receive an educational video and/or handout about the defibrillator process.
Then they will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
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The intervention includes a video and/or handout (whichever is easier for the participant) that will give information about defibrillators and about other patients' experiences with their decisions about defibrillators.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Knowledge About Defibrillation at Baseline
大体时间:Baseline
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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.
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Baseline
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Knowledge About Defibrillation at 1 Month
大体时间:1 month
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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.
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1 month
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Knowledge About Defibrillation at 6 Months
大体时间:6 months
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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.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Reach of Eligible Patients
大体时间:Baseline
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Measuring how many patients of the eligible patient base are able to view or read the educational materials.
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Baseline
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Differential Effect by Age
大体时间:Baseline, 1 month, 6 months
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The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old)
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Baseline, 1 month, 6 months
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Differential Effect by Heart Failure Type
大体时间:Baseline, 1 month, 6 months
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The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)
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Baseline, 1 month, 6 months
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Differential Effect by Type of Device
大体时间:Baseline, 1 month, 6 months
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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).
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Baseline, 1 month, 6 months
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合作者和调查者
调查人员
- 首席研究员:Daniel D Matlock, MD, MPH、University of Colorado, Denver
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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