An Effectiveness-Implementation Trial of SPIRIT in ESRD

摘要 尽管在透析方面取得了进展，但只有50%的透析患者在终末期肾病发作后3年内存活。 疾病（ESRD）。虽然退出透析先于1/4的ESRD患者死亡，但退出透析 患者及其代理人很少在足够的时间内讨论透析和积极治疗的影响 考虑其他选择，如临终关怀或在家中死亡。在过去的十年里，我们已经开发和 反复测试的SPIRIT（分享患者的疾病陈述以增加信任），患者和家庭- 以患者教育的代表性方法为基础的集中式高级护理计划干预。 我们已经确定了可行性、患者-替代品可接受性和有效性。SPIRIT是一个6步，2个会话， 面对面的干预，以促进认知和情感准备，为临终决策， 终末期肾病患者及其代理人。在这些在透析诊所进行的解释性试验中，SPIRIT 由训练有素的研究护士提供。SPIRIT中的患者和代理人在以下方面表现出显著改善： 准备结束生命的决策，和代理人在SPIRIT报告显着改善后， 患者死亡后的丧亲心理结果与未治疗的比较 条件合乎逻辑的、关键的下一步是问：SPIRIT作为现实世界中常规护理的一部分是否有效 设置更少的控制？为了解决这个问题，我们将进行一次真实世界的有效性- 执行研究。我们建议进行一项多中心、临床水平的整群随机试验， 透析护理提供者提供SPIRIT作为独立门诊患者常规护理的一部分的有效性 与常规护理加延迟SPIRIT实施相比，透析诊所。同时，我们将评估 执行精神，包括可持续性。我们将招募400对高危患者， 在接下来的一年里，他们从4个州的30个透析诊所中挑选了100名死亡者和他们的代理人，以实现以下目标： 目标1.检查SPIRIT与常规护理相比对临终准备结果的有效性 决策（定义为护理目标的二元一致性、患者决策冲突和替代 干预后2周的决策信心）;目标2。评估SPIRIT的过程结果 实施：可接受性、忠实性、干预成本和初始和延迟期间的可持续性 实现精神;目标3。检查SPIRIT和常规护理对代理人术后的有效性- 丧亲之痛（焦虑，抑郁和创伤后痛苦症状）在3个月后 患者死亡;目标4。次要目的：检查SPIRIT和常规护理在结束时的有效性。 生活治疗强度（住院、ICU住院和强化治疗的患者百分比） 手术和住院时间）。SPIRIT的真实世界试验将 产生新的、有意义的见解，可以推动改善透析护理中ACP的知识前沿。

Abstract Despite advances in dialysis, only 50% of dialysis patients are alive 3 years after the onset of end-stage renal disease (ESRD). Although withdrawal of dialysis precedes 1 in 4 deaths of patients with ESRD, withdrawal from dialysis and aggressive treatment is rarely discussed by patients and their surrogates with sufficient time to consider alternatives such as hospice or dying at home. Over the last decade, we have developed and iteratively tested SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a patient and family- centered advance care planning intervention based on the Representational Approach to Patient Education. We have established feasibility, patient-surrogate acceptability, and efficacy. SPIRIT is a 6-step, 2-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. In these explanatory trials carried out in dialysis clinics, SPIRIT was delivered by trained research nurses. Patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, and surrogates in SPIRIT reported significantly improved post- bereavement psychological outcomes after the patient's death compared to a no treatment comparison condition. The logical, critical next step is to ask: Will SPIRIT be effective as part of routine care in real-world settings with less control? To address this very issue, we will conduct a real-world effectiveness- implementation study. We propose a multicenter, clinic-level cluster randomized trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics compared to usual care plus delayed SPIRIT implementation. Simultaneously, we will evaluate the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in 4 states to accomplish the following aims: Aim 1. Examine the effectiveness of SPIRIT compared to usual care on preparedness outcomes for end-of-life decision making (defined as dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) at 2 weeks post-intervention; Aim 2. Evaluate the process outcomes of SPIRIT implementation: acceptability, fidelity, intervention costs, and sustainability during the initial and delayed implementation of SPIRIT; Aim 3. Examine the effectiveness of SPIRIT and usual care on surrogates' post- bereavement distress (anxiety, depression, and post-traumatic distress symptoms) at 3 months after the patient's death; and Aim 4. Secondary Aim: Examine the effectiveness of SPIRIT and usual care on end-of- life treatment intensity (percentages of patients hospitalized, having ICU admission, and having intensive procedures and length of hospital stay) during the final month of life. This real-world trial of SPIRIT will generate novel, meaningful insights that can push the frontiers of knowledge in improving ACP in dialysis care.