Understanding Patients Decisions About Generator Exchanges for Implantable Defibrillators

了解患者关于更换植入式除颤器发电机的决定

• 批准号: 10314464
• 负责人: Birju Rao
• 金额: $ 7.05万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-27 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10314464
• 关键词: Understanding; Patients; Decisions; About; Generator

Project Summary/Abstract Implantable cardioverter-defibrillators (ICDs) have been shown to improve mortality in selected patients with heart failure. However, they do not improve quality of life and may even impair quality of life due to risks of procedural complications and inappropriate shocks. As a result, clinicians are now required to engage in shared decision-making with patients prior to implanting primary prevention ICDs. Efforts to promote shared decision-making have completely excluded patients undergoing ICD generator exchanges. ICDs have battery that require a surgical generator exchange every 5-7 years. There is evidence that generator exchanges are being performed by default and these decisions are not patient centered. For instance, ICD generator exchanges may not benefit all patients with an active ICD, and some procedural risks of ICD generator exchanges, such as device infections, are higher. In addition, individualized risk stratification using 5-7 years of data stored by the ICD may help identify patients for whom continued ICD therapy may not beneficial. Finally, an ICD generator exchange exposes patients to procedural risk and does not improve quality of life. In the intervening years following the initial ICD implant, patients’ goals of care may have changed and may no longer cohere with ICD therapy. Therefore, as with the initial ICD implantation, ICD generator exchanges are preference sensitive, but studies show that patients are not aware of the choice to not undergo an ICD generator exchange. Given generator exchanges are currently performed without consideration of these important factors, shared decision-making may provide the appropriate framework to ensure the decision is consistent with patients’ expectations and values. To identify areas where shared decision-making can improve decisions for ICD generator exchanges, this proposal will deliver a qualitative assessment of patients’ experience and expectations regarding generator exchange decisions. In addition, clinical tools to predict the individualized risk of needing continued ICD therapy at the time of a generator exchange are being developed. This information is helpful to clinicians, but it is unclear whether presenting patients with individualized risk would impact their generator exchange decisions. Given patients already have already been living with an implanted ICD at the time of battery depletion, they may have strong preferences regarding the GE and additional data may not impact their decision. To determine if providing patients’ individualized risk assessments impact their willingness to undergo an ICD generator exchange, we will conduct a series of iterative discrete choice experiments. This proposal aligns with AHRQ goals and will produce high-impact data to drive intervention development for a prevalent but largely ignored decision with significant resource implications and impact on patients’ lives.

项目总结/摘要 植入式心脏复律除颤器（ICD）已被证明可以改善选定患者的死亡率， 心衰然而，它们并不能改善生活质量，甚至可能由于以下风险而损害生活质量： 手术并发症和不当电击因此，临床医生现在需要从事 在植入一级预防ICD之前与患者共享决策。努力促进共享 决策完全排除了接受ICD发生器更换的患者。ICD有电池 需要每5-7年更换一次手术发生器。有证据表明，发电机交流是 这些决定是默认执行的，并且这些决定不是以患者为中心的。例如，ICD发生器 更换可能不会使所有植入有源ICD的患者受益，ICD发生器的一些手术风险 交换，如设备感染，更高。此外，使用5-7年的个体化风险分层 ICD存储的数据可以帮助识别继续ICD治疗可能无益的患者。 最后，ICD发生器更换会使患者面临手术风险，并且不会改善生活质量。在 在初次植入ICD后的几年里，患者的护理目标可能发生了变化， 与ICD治疗的时间更长。因此，与初始ICD植入一样，ICD发生器更换是 偏好敏感，但研究表明，患者不知道不接受ICD的选择 发电机交换鉴于发电机交换目前执行不考虑这些 重要因素，共同决策可以提供适当的框架，以确保决策是 符合患者的期望和价值观。确定共同决策可以 改进ICD发生器更换决策，本提案将提供以下定性评估： 患者对发生器更换决策的经验和期望。此外，临床工具 预测发生器更换时需要继续ICD治疗的个体化风险， 正在开发中。这些信息对临床医生是有帮助的，但目前还不清楚是否向患者提供 个别风险将影响他们的发电机交换决定。鉴于患者已经 在电池耗尽时与植入的ICD一起生活，他们可能对 GE和其他数据可能不会影响他们的决定。为了确定是否为患者提供个性化的 风险评估影响他们接受ICD发生器更换的意愿，我们将进行 一系列迭代离散选择实验该提案符合AHRQ的目标， 高影响力的数据，以推动一个普遍但在很大程度上被忽视的决定， 对资源的影响和对病人生活的影响。