An Intervention to Improve ICD Deactivation Conversations

改善 ICD 停用对话的干预措施

• 批准号: 8606489
• 负责人: Nathan E Goldstein
• 金额: $ 58.75万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-02-07 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8606489
• 关键词: Academic Medical Centers; Address; Advance Care Planning; Affect; Anxiety; Arrhythmia; Bereavement; Cardiac; Cardiac conduction system; Caregivers; Caring; Cessation of life; Chest; Chronic Disease; Client satisfaction; Clinical; Communication; Counseling; Country; Data; Devices; Disease; Distress; Educational workshop; Effectiveness of Interventions; Elderly; Enrollment; Failure; Family; Feedback; Frequencies; Goals; Grief reaction; Growth; Healthcare; Heart; Heart failure; Hospitals; Implantable Defibrillators; Intervention; Interview; Left; Life; Malignant Neoplasms; Mental Depression; Mental Health; Monitor; Outcome; Outpatients; Pain; Patient Care; Patients; Physical Sufferings; Physicians; Physiological; Post-Traumatic Stress Disorders; Prevalence; Process; Public Health; Quality of Care; Quality of life; Randomized; Randomized Clinical Trials; Registries; Risk; Series; Shock; Stress; Structure; Training; Trauma; Work; advanced dementia; advanced disease; arm; end of life; experience; heart rhythm; implantable device; implantation; improved; individualized feedback; lectures; loved ones; novel; patient oriented; psychologic; public health relevance; sudden cardiac death; treatment as usual; tube feeding; ventricular assist device

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).

描述（由申请人提供）：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 可以减少心源性猝死，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并增加休克的频率。由于 ICD 电击会导致心理和身体痛苦，并且可能无法延长可接受质量的生命，因此当患者临床状况恶化且死亡临近时，考虑停用 ICD 是适当的。然而，这些对话很少发生。我们建议开展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。此前大多数加强医患沟通的工作都是针对癌症进行的，因此这项针对心力衰竭的提案的重点是新颖的，并且具有高度的公共卫生重要性。该研究的目标是确定干预措施的有效性：1）增加有关 ICD 停用的讨论，2）增加停用设备的患者数量，3）改善已故患者家属的护理人员的心理健康结果。随机化单位是医院，干预针对心脏病专家，分析单位是患者。我们在全国创建了一个由六个学术医疗中心组成的网络。所要实施的干预措施由三个部分组成。首先，PI 将与干预中心的心脏病专家举办关于 ICD 停用的具体沟通研讨会。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，告知患者适合就 ICD 停用进行对话。最后，心脏病专家将收到关于他们进行的对话数量的季度汇总反馈以及患者对对话满意度的数据。常规护理医院的医生接受有关预先护理计划的教学讲座。所有患者和代理人都将在基线时接受采访，然后定期进行评估，以确定有关 ICD 停用的对话的流行程度和设备停用的频率。患者死亡后 6 个月内将继续对护理人员进行访谈，以确定干预措施与护理人员心理健康结果的关系。鉴于使用 ICD 的患者数量呈指数级增长，这种干预措施有可能提高数千名临终患者及其家人的护理质量。我们还相信，使用本研究的数据，可以创建类似的干预结构，以帮助医生讨论对晚期疾病患者使用其他技术干预措施（例如，为晚期痴呆患者使用饲管或为患者停用左心室辅助装置）临终时患有心力衰竭）。