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A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators

2022年6月14日 更新者:University of Colorado, Denver

DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators

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.

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

介入性

注册 (实际的)

790

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Denver

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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.
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.
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.

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
Knowledge About Defibrillation at Baseline
大体时间: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.
Baseline
Knowledge About Defibrillation at 1 Month
大体时间: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.
1 month
Knowledge About Defibrillation at 6 Months
大体时间: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.
6 months

次要结果测量

结果测量
措施说明
大体时间
Reach of Eligible Patients
大体时间:Baseline
Measuring how many patients of the eligible patient base are able to view or read the educational materials.
Baseline

其他结果措施

结果测量
措施说明
大体时间
Differential Effect by Age
大体时间:Baseline, 1 month, 6 months
The decision aids will have a differential effect on the decisions of participants by age (>= 70 years old vs <70 years old)
Baseline, 1 month, 6 months
Differential Effect by Heart Failure Type
大体时间:Baseline, 1 month, 6 months
The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)
Baseline, 1 month, 6 months
Differential Effect by Type of Device
大体时间:Baseline, 1 month, 6 months
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).
Baseline, 1 month, 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年5月28日

初级完成 (实际的)

2021年12月31日

研究完成 (实际的)

2021年12月31日

研究注册日期

首次提交

2017年11月29日

首先提交符合 QC 标准的

2017年12月11日

首次发布 (实际的)

2017年12月15日

研究记录更新

最后更新发布 (实际的)

2022年7月8日

上次提交的符合 QC 标准的更新

2022年6月14日

最后验证

2022年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 17-1697
  • 1R01HL136403-01 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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