An Intervention to Improve ICD Deactivation Conversations

描述（由申请人提供）：植入式心律转复除颤器（ICD）是一种植入患者胸部的装置，用于监测心律，并在必要时提供电击以终止可能致命的心律失常。虽然icd减少了心源性猝死，但使用这些装置的患者最终还是会死于心力衰竭或其他慢性疾病。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和增加电击频率。由于ICD电击可引起心理和生理上的痛苦，并且可能无法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，考虑停用ICD是合适的。然而，这些对话很少发生。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，以改善心脏病专家与icd患者之间的沟通。先前大多数关于加强医患沟通的工作都是在癌症领域进行的，因此这项建议的重点是心力衰竭，对公共卫生具有很高的重要性。该研究的目的是确定干预的有效性：1)增加关于ICD停用的对话，2)增加设备停用的患者数量，以及3)改善死者家属照顾者的心理健康结果。随机化的单位是医院，干预的目标是心脏病专家，而分析的单位是病人。我们在全国建立了一个由六个学术医疗中心组成的网络。要提供的干预包括三个部分。首先，PI将与干预中心的心脏病专家就icd停用进行专门的交流研讨会。其次，当登记的患者入院或在门诊就诊时，心脏病专家将收到提醒，提醒患者适合讨论ICD停用问题。最后，心脏病专家将每季度收到关于他们进行的谈话数量和患者对谈话满意度的汇总反馈。普通护理医院的医生接受关于预先护理计划的说教讲座。所有患者和替代患者将在基线时接受访谈，然后定期进行评估，以确定ICD停用对话的流行程度和设备停用的频率。护理人员将在患者死亡后6个月内继续接受访谈，以确定干预措施与护理人员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接近生命末期的患者及其家属的护理质量。我们还认为，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（例如，晚期痴呆患者使用饲管或在生命末期心力衰竭患者停止使用左心室辅助装置）。

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).