An Effectiveness-Implementation Trial of SPIRIT in ESRD

SPIRIT 在 ESRD 中的有效性实施试验

• 批准号: 9890004
• 负责人: MI-KYUNG SONG
• 金额: $ 68.55万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-06-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9890004
• 关键词: Address; Admission activity; Adult; Advance Care Planning; Affect; Age; Anemia; Anxiety; Belief; Bereavement; Caring; Cessation of life; Charge; Child; Clinic; Clinical; Cluster randomized trial; Cognitive; Conflict (Psychology); Decision Making; Dialysis patients; Dialysis procedure; Disease; Distress; Effectiveness; Effectiveness of Interventions; Emotional; End stage renal failure; Face; Family; Family member; Futile Treatments; Future; Goals; Health; Healthcare Systems; Home environment; Individual; Intervention; Knowledge; Learning; Length of Stay; Life; Measures; Medical; Medicare; Mental Depression; Modeling; Morbidity - disease rate; Nursing Research; Outcome; Outpatients; Patient Education; Patients; Policies; Policy Maker; Preparation; Procedures; Process; Quality Indicator; Readiness; Reporting; Research Training; Role; Services; Societies; Spouses; Symptoms; Testing; Time; Training; Trust; Withdrawal; aggressive therapy; base; care providers; design; effectiveness evaluation; effectiveness implementation study; effectiveness implementation trial; end of life; end of life care; end-of-life decision making; evidence base; experience; frontier; health care service utilization; high risk; hospice environment; improved; infection rate; information gathering; insight; intervention cost; mortality risk; novel; patient oriented; post intervention; psychological outcomes; psychosocial; recruit; routine care; surrogate decision maker; treatment as usual; treatment choice; treatment comparison

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.

抽象的 尽管透析进展，但终末期肾脏发作后3年，只有50％的透析患者还活着 疾病（ESRD）。尽管透析的退出之前有4例ESRD患者的死亡，但戒断 患者及其替代物很少讨论透析和积极治疗 考虑替代品，例如临终关怀或在家死亡。在过去的十年中，我们已经开发了 迭代测试的精神（共享患者的疾病代表以增加信任），患者和家庭 - 基于患者教育的代表性方法，以预先护理计划干预为中心。 我们已经确定了可行性，可接受性和功效。精神是一个6步，2节， 面对面的干预以促进认知和情感准备，以制定生命终止决策 ESRD及其替代患者。在这些在透析诊所进行的解释性试验中，精神是 由训练有素的研究护士提供。精神上的患者和替代物显示出显着改善 准备临终决策的准备和精神替代人报告明显改善 与无治疗比较相比，患者死亡后的丧亲心理结局 健康）状况。逻辑上关键的下一步是要问：精神将在现实世界中作为常规护理的一部分有效 控制较少的设置？为了解决这个问题，我们将发挥现实世界的有效性 - 实施研究。我们提出了一项多中心诊所级别的聚类随机试验，以评估 透析护理提供者提供的精神的有效性，作为独立门诊的常规护理的一部分 透析诊所与通常的护理以及延迟的精神实施相比。同时，我们将评估 精神的实施，包括可持续性。我们将招募400名患者，高风险 第二年的死亡及其在四个州的30个透析诊所的代孕期间死亡，以实现以下目的： 目标1。与通常护理对寿命终止的准备成果相比，检查精神的有效性 决策（定义为二元组的护理目标，患者决定性冲突和代理 决策信心）干预后2周；目标2。评估精神的过程结果 实施：最初和延迟期间的可接受性，忠诚，干预成本和可持续性 精神的实施；目标3。检查精神和通常护理对代理人的有效性 - 丧亲困扰（焦虑，抑郁和创伤后痛苦症状） 病人的死亡；和目标4。次要目标：检查精神和通常护理的有效性 - 生命治疗强度（住院患者百分比，ICU入院和强化 在生命的最后一个月中的程序和住院时间）。这种真实的精神审判意志 产生新颖，有意义的见解，可以推动知识的前沿，以改善透析护理中的ACP。