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.

项目概要/摘要 植入式心律转复除颤器 (ICD) 已被证明可以降低特定患者的死亡率 然而，它们并不能改善生活质量，甚至可能因以下风险而损害生活质量。 结果，士兵们现在被要求参与其中。 在植入一级预防 ICD 之前与患者共同做出决策 努力促进共同决策。 决策完全排除了接受 ICD 发电机更换的患者是否有电池。 需要每 5-7 年更换一次手术发电机 有证据表明发电机更换是必要的。 默认执行，并且这些决定不是以患者为中心的，例如 ICD 发生器。 交换可能不会使所有具有活动 ICD 的患者受益，并且 ICD 发生器的一些程序风险 此外，使用 5-7 年进行个性化风险分层。 ICD 存储的数据可能有助于识别继续 ICD 治疗可能无益的患者。 最后，更换 ICD 发生器会使患者面临手术风险，并且不会改善生活质量。 最初植入 ICD 后的几年里，患者的护理目标可能会发生变化，并且可能不会 与 ICD 治疗更加一致 因此，与最初的 ICD 植入一样，ICD 发生器的更换也需要进行。 偏好敏感，但研究表明患者不知道不接受 ICD 的选择 目前执行发电机交换时不考虑这些。 重要因素，共同决策可以提供适当的框架，以确保决策是 与患者的期望和价值观一致，以确定可以共同决策的领域。 改进 ICD 发电机交换的决策，该提案将提供定性评估 患者对发电机更换决策的经验和期望。此外，临床工具。 预测更换发电机时需要继续 ICD 治疗的个体化风险 这些信息正在开发中，对教区居民有帮助，但尚不清楚是否可以向患者介绍这些信息。 鉴于患者已经经历过，个体化风险将影响他们的发电机更换决策。 在电池耗尽时与植入式 ICD 一起生活，他们可能对以下方面有强烈的偏好： GE 和其他数据可能不会影响他们的决定，以确定是否为患者提供个性化信息。 风险评估会影响他们接受 ICD 发电机更换的意愿，我们将进行一次 该提案与 AHRQ 目标一致，并将产生一系列迭代离散选择实验。 高影响力的数据可推动干预措施的发展，以实现一项普遍但基本上被忽视的重大决策 资源影响和对患者生活的影响。