Patient-centered and efficacious advance care planning in cancer: the PEACe comparative effectiveness trial

摘要概要： 未能在生命末期提供反映患者需求、价值观和偏好的护理， 晚期癌症仍然是我们的癌症护理提供系统的一个关键缺点。国家组织 包括美国国家医学院和美国临床肿瘤学会呼吁， 加强对提前护理计划（ACP）的关注，以改善以患者为中心的临终护理。一个关键 在这一领域取得进展的障碍是缺乏关于最有效和最高效的非加太战略的证据， 改善生命末期的治疗决策，并确保患者的意愿得到尊重。 两种不同的面向患者的ACP干预被广泛使用，并且已知是有效的，但需要相当大的 部署成本和复杂性的差异：（1）与训练有素的主持人进行面对面讨论，（2）网络- 使用交互式视频进行提前护理计划。这些方法从未被直接比较过， 因此，不清楚是否有一种形式的非加太更有潜力，如果是，对谁和根据什么 情节了解面对面、辅助式ACP与基于网络的ACP的相对有效性， 这一点很重要，因为面对面的ACP需要更多的资源。 本提案是一项单盲、患者水平的随机试验，旨在解决这一证据缺口，使用混合 方法在400例患者中比较面对面，方便的ACP与基于网络的ACP的有效性， 晚期癌症患者及其家庭护理人员。目的1比较这些方法对患者的影响， 家庭照顾者结果（参与ACP-主要结果;与家庭照顾者的ACP讨论， 医生;预先指示（AD）完成;以及抑郁和焦虑的照顾者症状）。为 对于研究期间死亡的患者，我们将使用经过验证的、所有人报告的指标进行比较， 临终关怀的感知质量，病人的临终关怀目标的实现，和丧亲照顾者的抑郁症状， 焦虑和创伤后压力目标2评估每项干预措施的执行成本和对 生命末期的医疗保健利用率。目标3确定了影响有效性的背景和机制， 每一种方法。 这项试验将产生很大的影响，因为它将提供新的和急需的经验证据， 面向患者的ACP方法，成功克服了传统书面预先指示的局限性 但是需要非常不同的时间和资源投资。它创新地采用混合方法， 不仅要评估这些方法的相对有效性，还要评估为谁、如何以及在什么方面 在这种情况下，它们是有效的。这是可行的，因为它建立在一个广泛的基础设施， 有经验的研究团队进行行为干预试验和定性研究 ACP和肿瘤学

Abstract Summary: Failure to deliver care near the end of life that reflects the needs, values and preferences of patients with advanced cancer remains a key shortcoming of our cancer care delivery system. National organizations including the National Academy of Medicine and American Society of Clinical Oncology have called for increased attention to advance care planning (ACP) to improve patient-centered care near end of life. A critical barrier to progress in the field is a lack of evidence about the most effective and efficient ACP strategy to improve treatment decisions near end of life and ensure patients' wishes are honored. Two different patient-facing ACP interventions are widely used and known to be effective but entail sizeable differences in costs and complexity to deploy: (1) in-person discussions with trained facilitators and (2) web- based advance care planning using interactive videos. These approaches have never been compared directly; it is therefore unclear whether one form of ACP is more potent—and if so, for whom and under what circumstances. Understanding the relative effectiveness of in-person, facilitated versus web-based ACP is important because in-person ACP requires far more resources. This proposal is a single-blind, patient-level randomized trial to address this evidence gap, using mixed methods to compare the effectiveness of in-person, facilitated ACP vs web-based ACP among 400 patients with advanced cancer and their family caregivers. Aim 1 compares the effect of these approaches on patient and family caregiver outcomes (engagement in ACP—primary outcome; ACP discussions with family caregivers and physicians; advance directive (AD) completion; and caregiver symptoms of depression and anxiety). For patients who die during the study period, we will use validated, caregiver-reported measures to compare perceived quality of EOL care, patients' EOL goal attainment, and bereaved caregiver symptoms of depression, anxiety and post-traumatic stress. Aim 2 assesses implementation costs of each intervention and effects on healthcare utilization at end of life. Aim 3 identifies contexts and mechanisms influencing the effectiveness of each approach. This trial will have a high impact because it will provide new and much-needed empirical evidence about two patient-facing ACP approaches that successfully overcome limitations of traditional written advance directives but entail very different investments of time and resources. It is innovative in using mixed methods to evaluate not only the comparative effectiveness of these approaches, but also for whom, how and in what circumstances they are effective. It is feasible because it builds on extensive infrastructure developed by an accomplished research team with experience conducting behavioral intervention trials and qualitative research in ACP and oncology.