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An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations (WISDOM)

2016年10月5日 更新者:Icahn School of Medicine at Mount Sinai

An Intervention to Improve ICD Deactivation Conversations (WISDOM - Working to Improve discuSsions About DefibrillatOr Management)

An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest to monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias when necessary. While ICDs reduce sudden cardiac death, patients with ICDs eventually die of heart failure or other diseases. As patients near the end of life, physiologic changes (intrinsic and extrinsic to the heart) may affect the cardiac conduction system, leading to more arrhythmias and increasing the frequency of shocks. Because ICD shocks can cause pain and anxiety and may not prolong a life of acceptable quality, it is appropriate to consider deactivating the shocking function of ICDs as patients' clinical status worsens and death is near. This will be a randomized controlled trial of a physician centered counseling and education intervention to improve clinician-patient communication about the management of ICDs.

研究概览

详细说明

An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest to monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias when necessary. While ICDs reduce sudden cardiac death, patients with these devices do eventually die, either of heart failure or other chronic diseases. As a patient's disease worsens, physiologic changes (intrinsic and extrinsic to the heart) may affect the cardiac conduction system, leading to more arrhythmias and increasing the frequency of shocks. Because ICD shocks can cause pain and anxiety and may not prolong a life of acceptable quality, it is appropriate to consider ICD deactivation as a patient's clinical status worsens and death is near. However, these conversations rarely occur. The investigators propose to conduct a randomized clinical trial of a physician-centered patient counseling and support intervention to improve communication between cardiologists and patients with ICDs. The goals of the study are to determine the effectiveness of the intervention to: 1) increase conversations about ICD deactivation, 2) increase the number of patients who have their devices deactivated, and 3) improve mental health outcomes for bereaved caregivers of deceased patients. The unit of randomization is the hospital, the intervention is aimed at cardiologists, and the unit of analysis is the patient. The investigators have created a network of six academic medical centers across the country. The intervention to be delivered consists of three parts. First, the PI will conduct a workshop on communication specific to ICD-deactivation with cardiologists at the intervention centers. Second, when enrolled patients are admitted to the hospital or seen in the outpatient setting, the cardiologist will receive two reminders (one via email, one in the patient chart) that the patient is appropriate for a conversation about ICD deactivation. Finally, cardiologists will receive aggregated feedback about the number of conversations they have conducted and data on patients' satisfaction with conversations every six months. Physicians at usual care hospitals receive a didactic lecture on advance care planning. All patients and surrogates will be interviewed at baseline and then assessed at regular intervals to determine the outcomes of: 1) the prevalence of conversations about ICD deactivation as reported by the patient/surrogate; and 2) the frequency with which patients have their devices deactivated. Caregivers will continue to be interviewed at regular intervals up to 6 months after the patient dies to determine the relationship of the intervention to caregiver mental health outcomes. Given the exponential increase in the number of patients with ICDs, this intervention has the potential to improve the quality of care for thousands of patients near the end of life and their families.

研究类型

介入性

注册 (实际的)

562

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
      • Denver、Colorado、美国、80045
        • University of Colorado - Denver
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • Yale New-Haven Hospital
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Medical Center
    • New York
      • Bronx、New York、美国、10023
        • Montefiore Medical Center
      • New York、New York、美国、10029
        • Icahn School of Medicine at Mount Sinai
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Hospital of the University of Pennsylvania

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:

Clinicians:

  • At all sites, a core group of approximately 10 heart failure clinicians (physicians, nurses) care exclusively for patients with advanced heart failure in both inpatient and outpatient settings; all of these clinicians are eligible..

Patients:

  • Patient does not currently have a ventricular assist device
  • Age > 18
  • Fluent in English
  • Consistent and reliable access to a phone

For Inpatient:

  • Has had at least 1 other heart failure in the last year, OR
  • Meets all three of the following criteria at time of admission:

    1. BUN > 43
    2. SBP ≤ 115
    3. CR > 2.75 OR
  • Was on inotropes OR intravenous diuretics OR intravenous heart failure treatments in emergency department OR in outpatient setting prior to the current hospital admission

For Outpatient

  • Has had 2 or more heart failure related admissions in the last year OR
  • Has class IV heart failure in the outpatient setting OR
  • Has Class III heart failure in outpatient setting AND 1 heart failure related admission in the last year OR
  • Has Class III heart failure in outpatient setting AND 2 of the following 4 conditions:

    1. Age ≥ 70
    2. BUN ≥ 43
    3. Cr ≥ 2.75
    4. SBP≤115 OR
  • Is on inotropes (e.g., dobutamine, milrinone) OR intravenous diuretics OR intravenous heart failure treatments in emergency department OR in outpatient setting

Caregivers:

  • Age > 18
  • Fluent in English
  • Consistent and reliable access to a phone

Exclusion Criteria for patients:

  • Not having an ICD

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:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Communication training for cardiologists
The intervention consists of an educational workshop for heart failure physicians, a reminder system, and a system providing aggregated feedback on their conversations with patients about ICD deactivation.

Communication training: a 90 minute workshop to discuss ways to improve communication in patients with serious illness.

Reminders to Cardiologists. Cardiologists will receive reminders to prompt them to have conversations relating to ICD management with patients enrolled in the study.

Audit and feedback. Cardiologists will receive feedback on their rates of conversation as well as data on patient/family satisfaction with their communication skills.

安慰剂比较:Control arm
Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.
Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.

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
Prevalence of Conversations about ICD Deactivation
大体时间:after 1st clinical encounter after enrollment for intervention group
Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment
after 1st clinical encounter after enrollment for intervention group
Prevalence of Conversations about ICD Deactivation
大体时间:3rd clinical encounter after enrollment for intervention group
Whether deactivation discussion occurred difference between 1st and 3rd clinical encounters after enrollment
3rd clinical encounter after enrollment for intervention group
Prevalence of Conversations about ICD Deactivation
大体时间:3 months after enrollment for control group
Whether deactivation discussion occurred difference between 3 and 9 months after enrollment
3 months after enrollment for control group
Prevalence of Conversations about ICD Deactivation
大体时间:9 months after enrollment for control group
Whether deactivation discussion occurred difference between 3 and 9 months after enrollment
9 months after enrollment for control group

次要结果测量

结果测量
措施说明
大体时间
Prevalence of ICD Deactivation
大体时间:After 1st encounter after enrollment for intervention group
Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment
After 1st encounter after enrollment for intervention group
Prevalence of ICD Deactivation
大体时间:After 3rd encounter after enrollment for intervention group
Whether ICD deactivation occurred difference between 1st and 3rd clinical encounters after enrollment
After 3rd encounter after enrollment for intervention group
Prevalence of ICD Deactivation
大体时间:After 3 months after enrollment for control group
Whether ICD deactivation occurred difference between 3 and 9 months after enrollment
After 3 months after enrollment for control group
Prevalence of ICD Deactivation
大体时间:After 6 months after enrollment for control group
Whether ICD deactivation occurred difference between 3 and 9 months after enrollment
After 6 months after enrollment for control group
Psychological Outcomes in Bereaved Caregivers
大体时间:4 weeks after patient death
4 weeks after patient death
Psychological Outcomes in Bereaved Caregivers
大体时间:6 months after patient death
6 months after patient death

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。

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。

一般刊物

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

2011年9月1日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2016年9月1日

研究注册日期

首次提交

2011年10月13日

首先提交符合 QC 标准的

2011年10月24日

首次发布 (估计)

2011年10月26日

研究记录更新

最后更新发布 (估计)

2016年10月6日

上次提交的符合 QC 标准的更新

2016年10月5日

最后验证

2016年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GCO 09-0618
  • 1R01HL102084-01A1 (美国 NIH 拨款/合同)

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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