An Effectiveness-Implementation Trial of SPIRIT in ESRD

SPIRIT 在 ESRD 中的有效性实施试验

• 批准号: 9301866
• 负责人: MI-KYUNG SONG
• 金额: $ 76.53万
• 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/9301866
• 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; Hybrids; Individual; Infection; 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; Provider; Quality Indicator; Readiness; Recruitment Activity; Reporting; Research Training; Role; Services; Societies; Spouses; Symptoms; Testing; Time; Training; Trust; Withdrawal; base; cost; design; end of life; end of life care; end-of-life decision making; evidence base; experience; frontier; health care service utilization; high risk; hospice environment; implementation trial; improved; information gathering; insight; novel; patient oriented; post intervention; psychological outcomes; psychosocial; routine care; surrogate decision maker; treatment as usual; treatment choice

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.

摘要 尽管透析技术取得了进步，但只有50%的透析患者在终末期肾病发作3年后仍能存活。 疾病(ESRD)。尽管ESRD患者四分之一的死亡发生在停止透析之前，但停止透析 患者和他们的代理人很少在有足够时间的情况下讨论透析和积极治疗 考虑其他选择，如临终关怀或在家中死亡。在过去的十年里，我们开发了和 反复测试的精神(分享患者的疾病陈述以增加信任)，患者和家人- 基于患者教育代表性方法的中心超前护理计划干预。 我们已经确定了可行性、患者替代可接受性和有效性。勇气号是6个步骤，2个阶段， 面对面干预，促进临终决策的认知和情感准备 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。患者和代理人在精神方面显示出显著的改善 为临终决策做好准备，精神上的代理人报告说，在 患者死亡后丧亲的心理结局与未接受治疗的比较 条件。合乎逻辑的、关键的下一步是要问：在现实世界中，精神会作为日常护理的一部分而有效吗 控制较少的设置？为了解决这个问题，我们将进行现实世界的有效性- 实施研究。我们提出了一项多中心、临床水平的整群随机试验来评估 透析护理提供者将精神作为独立门诊常规护理的一部分的有效性 与常规护理相比，透析诊所外加延迟的精神实施。同时，我们将评估 落实精神，包括可持续性。我们将招募400名高危患者 来自4个州30个透析诊所的第二年死亡及其代孕，以实现以下目标： 目标1.与常规护理相比，检查精神对临终准备结果的有效性 决策(定义为护理目标、患者决策冲突和代孕者的二元性一致 决策信心)在干预后2周；目标2.评估SPIRIT的过程结果 实施：初始和延迟期间的可接受性、保真度、干预成本和可持续性 贯彻精神；目标3。检查精神和日常关怀对代孕人员岗位的有效性- 丧亲痛苦(焦虑、抑郁和创伤后痛苦症状)在术后3个月 次要目标：检查精神和日常护理在临终时的有效性。 生命治疗强度(住院、入住ICU和重症监护的患者百分比 程序和住院时间)在生命的最后一个月。这是对精神意志的现实考验 产生新的，有意义的见解，可以推动知识的前沿，以改善透析护理的ACP。