An Intervention to Improve ICD Deactivation Conversations

改善 ICD 停用对话的干预措施

• 批准号: 8223199
• 负责人: Nathan E Goldstein
• 金额: $ 59.49万
• 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/8223199
• 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). 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.

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器械，用于监测心律并在必要时提供电击以终止潜在的致命性心律失常。虽然ICD减少了心脏猝死，但使用这些设备的患者最终会死于心力衰竭或其他慢性疾病。随着患者疾病的恶化，生理变化（心脏内在和外在的）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电击可能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，因此将ICD停用视为患者的临床状态恶化且死亡临近是适当的。然而，这种对话很少发生。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，以改善心脏病专家和ICD患者之间的沟通。大多数关于加强医患沟通的先前工作都是在癌症中完成的，因此这项提案对心力衰竭的关注是新颖的，具有高度的公共卫生重要性。该研究的目的是确定干预措施的有效性：1）增加关于ICD停用的对话，2）增加设备停用的患者数量，3）改善已故患者的丧亲护理人员的心理健康结果。随机化的单位是医院，干预针对心脏病专家，分析的单位是患者。我们在全国建立了六个学术医疗中心的网络。要采取的干预措施包括三个部分。首先，PI将与干预中心的心脏病专家就ICD失活的特定沟通举办研讨会。其次，当入组患者入院或在门诊就诊时，心脏病专家将收到患者适合进行ICD停用对话的提醒。最后，心脏病专家将每季度收到关于他们进行的对话数量的汇总反馈，以及关于患者对对话满意度的数据。普通护理医院的医生接受关于预先护理计划的教学讲座。将在基线时对所有患者和代理人进行访谈，然后定期进行评估，以确定关于ICD停用的谈话的流行率和器械停用的频率。在患者死亡后6个月内，护理人员将继续接受采访，以确定干预与护理人员心理健康结果的关系。鉴于植入ICD的患者数量呈指数级增长，这种干预有可能提高数千名接近生命终点的患者及其家人的护理质量。我们还认为，使用本研究的数据，可以创建类似的干预结构，以帮助医生讨论在晚期疾病患者中使用其他技术干预（例如，晚期痴呆患者的饲管或心力衰竭患者在生命结束时停止左心室辅助装置）。 公共卫生关系：植入式除颤器的电击可能会导致身体和心理上的痛苦，因此将ICD停用视为患者的临床状态不佳和死亡临近是适当的;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，以改善心脏病专家和晚期心力衰竭患者之间关于ICD失活的沟通。鉴于植入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接近生命终点的患者及其家人的护理质量。