Center for Nursing Excellence in Palliative Care, Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.
Rollins School of Public Health, Emory University, Atlanta, Georgia.
JAMA Netw Open. 2024 Jan 2;7(1):e2351511. doi: 10.1001/jamanetworkopen.2023.51511.
Evidence of effectiveness of advance care planning (ACP) strategies for patients receiving dialysis and their families is needed.
To test the effectiveness of an ACP intervention to prepare patients and their surrogates for end-of-life (EOL) decision-making and to improve surrogate bereavement outcomes.
DESIGN, SETTING, AND PARTICIPANTS: This cluster randomized clinical trial, An Effectiveness-Implementation Trial of SPIRIT (Sharing Patients' Illness Representations to Increase Trust) in ESRD, was conducted from December 2017 to March 2023 and included 42 dialysis clinics in 5 US states (Georgia, New Mexico, North Carolina, Pennsylvania, and Virginia) randomized to provide intervention or usual care. Recruitment was from February 15, 2018, to January 31, 2022, and patient-surrogate dyads were followed up for 21 months (until January 17, 2023) or until patient death.
Each clinic selected 1 or 2 health care workers (eg, nurse practitioner, registered nurse, or social worker) to conduct 45- to 60-minute ACP discussions with dyads in the clinic or remotely. After March 13, 2020 (commencement of the COVID-19 emergency declaration), all discussions were conducted remotely. An ACP summary was placed in patients' medical records.
The primary, 2-week preparedness outcomes were dyad congruence on EOL goals of care, patient decisional conflict, surrogate decision-making confidence, and a composite of dyad congruence and surrogate decision-making confidence. Secondary bereavement outcomes were anxiety, depression, and posttraumatic distress 3 months after patient death. To adjust for COVID-19 pandemic effects on bereavement outcomes, a variable to indicate the timing of baseline and 3-month assessment relative to the COVID-19 emergency declaration was created.
Of the 426 dyads enrolled, 231 were in the intervention clinics, and 195 were in the control clinics. Among all dyads, the mean (SD) patient age was 61.9 (12.7) years, and the mean (SD) surrogate age was 53.7 (15.4) years. At 2 weeks, after adjusting for baseline values, dyad congruence (odds ratio [OR], 1.61; 95% CI, 1.12-2.31; P = .001), decisional conflict scores (β, -0.10; 95% CI, -0.13 to -0.07; P < .001), and the composite (OR, 1.57; 95% CI, 1.06-2.34; P = .03) were higher in the intervention group than in the control group. Surrogate decision-making confidence was similar between groups (β, 0.06; 95% CI, -0.01 to 0.13; P = .12). Among 77 bereaved surrogates, after adjusting for baseline values and assessment timing, intervention group anxiety was lower than control group anxiety (β, -1.55; 95% CI, -3.08 to -0.01; P = .05); however, depression (β, -0.18; 95% CI, -2.09 to 1.73; P = .84) and posttraumatic distress (β, -0.96; 95% CI, -7.39 to 5.46; P = .75) were similar.
In this randomized clinical trial, the ACP intervention implemented by health care workers at dialysis centers improved preparation for EOL decision-making but showed mixed effectiveness on bereavement outcomes. The ACP intervention implemented in dialysis centers may be an effective strategy to the dyad preparation for end-of-life care as opposed to the current focus on advance directives.
ClinicalTrials.gov Identifier: NCT03138564.
需要证据来证明针对接受透析治疗的患者及其家属的预先护理计划（ACP）策略的有效性。
测试 ACP 干预措施的有效性，以准备患者及其代理人进行临终决策，并改善代理人的丧亲结局。
设计、设置和参与者：这项名为 SPIRIT（分享患者的疾病表现以增加信任）的有效性-实施试验是一项针对 ESRD 的临床试验，于 2017 年 12 月至 2023 年 3 月进行，包括来自美国 5 个州（佐治亚州、新墨西哥州、北卡罗来纳州、宾夕法尼亚州和弗吉尼亚州）的 42 个透析诊所，随机分为提供干预或常规护理。招募从 2018 年 2 月 15 日持续到 2022 年 1 月 31 日，对患者-代理人对进行为期 21 个月（直到 2023 年 1 月 17 日）或直至患者死亡的随访。
每个诊所选择 1 或 2 名卫生保健工作者（例如，执业护士、注册护士或社会工作者），在诊所或远程与对进行 45-60 分钟的 ACP 讨论。自 2020 年 3 月 13 日（COVID-19 紧急声明开始）以来，所有讨论均通过远程方式进行。将 ACP 总结放入患者的病历中。
主要的 2 周准备结果是代理人在临终关怀目标上的一致性、患者决策冲突、代理人决策信心，以及代理人一致性和代理人决策信心的综合指标。次要丧亲结局包括患者死亡后 3 个月的焦虑、抑郁和创伤后应激障碍。为了调整丧亲结局受 COVID-19 大流行影响，创建了一个变量来指示基线和 3 个月评估相对于 COVID-19 紧急声明的时间。
在 426 对参加者中，231 对参加者来自干预诊所，195 对来自对照组诊所。在所有对中，患者的平均（SD）年龄为 61.9（12.7）岁，代理人的平均（SD）年龄为 53.7（15.4）岁。在 2 周时，调整基线值后，代理人一致性（优势比[OR]，1.61；95%置信区间，1.12-2.31；P = .001）、决策冲突评分（β，-0.10；95%置信区间，-0.13 至 -0.07；P < .001）和综合指标（OR，1.57；95%置信区间，1.06-2.34；P = .03）在干预组中更高。代理人决策信心在两组之间相似（β，0.06；95%置信区间，-0.01 至 0.13；P =.12）。在 77 名丧亲的代理人中，调整基线值和评估时间后，干预组的焦虑低于对照组（β，-1.55；95%置信区间，-3.08 至 -0.01；P = .05）；然而，抑郁（β，-0.18；95%置信区间，-2.09 至 1.73；P =.84）和创伤后应激障碍（β，-0.96；95%置信区间，-7.39 至 5.46；P =.75）相似。
在这项随机临床试验中，由透析中心的卫生保健工作者实施的 ACP 干预措施改善了临终决策的准备，但在丧亲结局方面效果混合。在透析中心实施的 ACP 干预措施可能是一种有效的策略，可以为患者及其代理人提供临终关怀，而不是当前对预先指令的关注。
ClinicalTrials.gov 标识符：NCT03138564。
