An Intervention to Improve ICD Deactivation Conversations

描述(申请人提供)：植入式心脏复律除颤器(ICD)是一种植入患者胸部的设备，用于监测心率并在必要时提供电击以终止潜在的致命心律失常。虽然ICD可以减少心源性猝死，但使用这些设备的患者最终会死于心力衰竭或其他慢性病。随着患者病情的恶化，生理变化(心脏的内在和外在)可能会影响心脏传导系统，导致更多的心律失常，增加休克的频率。由于ICD电击会导致心理和身体上的痛苦，可能不会延长可接受质量的生命，因此在患者临床状况恶化和死亡临近时，适当地考虑ICD失活。然而，这样的对话很少发生。我们建议进行一项以医生为中心的患者咨询和支持干预的随机临床试验，以改善心脏病医生和ICD患者之间的沟通。大多数以前关于加强医患沟通的工作都是在癌症中完成的，因此这项关于心力衰竭的提案的重点是新颖的，对公共卫生具有很高的重要性。这项研究的目标是确定干预措施的有效性，以：1)增加关于ICD停用的对话，2)增加设备停用的患者数量，3)改善已故患者丧偶照顾者的心理健康结果。随机的单位是医院，干预是针对心脏病医生，分析的单位是患者。我们已经在全国建立了一个由六个学术医疗中心组成的网络。即将实施的干预措施包括三个部分。首先，PI将在干预中心与心脏病专家举办一次关于ICD失活的特定沟通研讨会。其次，当登记的患者进入医院或在门诊环境中被看到时，心脏病专家将收到提醒，该患者适合进行关于ICD停用的对话。最后，心脏病专家将收到关于他们进行的对话次数的季度汇总反馈，以及关于患者对对话的满意度的数据。普通护理医院的医生会接受一堂关于提前护理计划的说教讲座。所有患者和代孕者将在基线上接受采访，然后定期进行评估，以确定关于ICD停用和设备停用频率的对话的流行率。照顾者将在患者死亡后6个月内继续接受访谈，以确定干预措施与照顾者心理健康结果的关系。鉴于ICD患者数量呈指数级增长，这一干预措施有可能改善数千名濒临死亡的患者及其家人的护理质量。我们还相信，利用这项研究的数据，可以创建一个类似的干预结构，以帮助医生讨论在晚期疾病患者中使用其他技术干预措施(例如，为晚期痴呆症患者使用喂养管，或为生命末期心力衰竭患者停止使用左心室辅助装置)。 与公共卫生相关：植入式除颤器的电击会导致身体和心理痛苦，因此，在患者临床状况恶化和死亡临近时，适当考虑ICD停用；研究表明，这种情况很少发生。我们提出了一项干预措施的随机临床试验，以改善心脏科医生和晚期心力衰竭患者之间关于ICD失活的沟通。鉴于ICD患者数量呈指数级增长，这一干预措施有可能改善数千名濒临死亡的患者及其家人的护理质量。

DESCRIPTION (provided by applicant): 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 psychological and physical suffering 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. We 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. Most prior work on strengthening doctor-patient communication has been done in cancer, so the focus of this proposal on heart failure is novel and of high public health importance. 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. We 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 reminders that the patient is appropriate for a conversation about ICD deactivation. Finally, cardiologists will receive quarterly aggregated feedback about the number of conversations they have conducted and data on patients' satisfaction with conversations. 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 prevalence of conversations about ICD deactivation and the frequency of device deactivation. Caregivers will continue to be interviewed 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. We also believe that using the data from this study, a similar intervention structure can be created to help physicians discuss the use of other technologic interventions in patients with advanced disease (e.g. feeding tubes for patients with advanced dementia or discontinuing left ventricular assist devices for patients with heart failure at the end of life). PUBLIC HEALTH RELEVANCE: Shocks from an implantable defibrillator can cause physical and psychological suffering, so it is appropriate to consider ICD deactivation as a patient's clinical status worsens and death is near; studies demonstrate this rarely happens. We propose a randomized clinical trial of an intervention to improve communication between cardiologists and patients with advanced heart failure about deactivation of ICDs. Given the exponential increases 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.