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）：植入的心脏逆转表纤维（ICD）是一种植入患者胸部的设备，以监测心律并产生冲击，以便在必要时终止潜在的致命性心律不齐。尽管ICD会减少心脏衰竭或其他慢性疾病的心脏死亡，但这些装置的患者最终确实死亡。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，从而导致更多的心律不齐和增加冲击的频率。由于ICD冲击会导致心理和身体上的痛苦，并且可能不会延长可接受的质量寿命，因此将ICD停用为患者的临床状况恶化，死亡差不多。但是，这些对话很少发生。我们建议对以医师为中心的患者咨询和支持干预措施进行随机临床试验，以改善心脏病专家与ICD患者之间的沟通。大多数先前在加强医生沟通方面的工作都是在癌症中进行的，因此该提案对心力衰竭的重点是新颖的，并且具有很高的公共健康重要性。该研究的目标是确定干预措施的有效性：1）增加有关ICD停用的对话，2）增加已停用设备的患者数量，以及3）改善死者丧亲患者的丧亲护理人员的心理健康结果。随机分组是医院，干预措施针对心脏病专家，分析单位是患者。我们在全国各地建立了一个由六个学术医疗中心组成的网络。要提供的干预措施包括三个部分。首先，PI将在干预中心与心脏病专家进行特定于ICD二驱动的通信研讨会。其次，当入学的患者被送往医院或在门诊环境中看到时，心脏病专家将提醒患者，适合关于ICD停用的对话。最后，心脏病专家将收到有关他们进行的对话数量的季度汇总反馈，并获得有关患者对对话满意的数据。常规护理医院的医师接受了有关预先护理计划的教学演讲。所有患者和替代物将在基线时进行访谈，然后定期评估，以确定有关ICD停用的对话的普遍性和设备停用的频率。护理人员将在患者死亡后长达6个月继续接受采访，以确定干预措施与护理人员心理健康成果的关系。鉴于ICD患者人数的指数增加，这种干预措施有可能提高生命及其家人及其家人及其家人及其家人的成千上万患者的护理质量。我们还认为，使用来自这项研究的数据，可以创建类似的干预结构来帮助医生讨论晚期疾病患者中其他技术干预措施的使用（例如，为患有晚期痴呆症患者的喂食管或停止左心室辅助设备的患者为心脏衰竭的患者喂食时患有心脏衰竭时患有心脏衰竭的患者）。