From the Program on Ethics and Decision Making in Critical Illness (D.B.W., A.-M.S., P.B.), Clinical Research, Investigation, and Systems Modeling of Acute Illness Center (D.B.W., D.C.A., A.-M.S., P.B., C. Pidro, C.-C.H.C., J.M.K.), Department of Critical Care Medicine (D.B.W., D.C.A., A.-M.S., P.B., C. Pidro, C.-C.H.C., J.M.K., J.M.D.), and the Section of Palliative Care and Medical Ethics, Division of General Internal Medicine (R.M.A.), Department of Medicine (C.-C.H.C., R.M.A.), University of Pittsburgh School of Medicine, and the Intensive Care Unit Service Center (D.B.W., D.C.A., J.M.K.), the Wolff Center (C. Paner, A.K., S.M.), and the Palliative and Supportive Institute (E.C., R.M.A.), UPMC Health System - all in Pittsburgh; Eli Lilly, Indianapolis (F.P.); and the Statistics Collaborative, Washington, DC (L.W.).
N Engl J Med. 2018 Jun 21;378(25):2365-2375. doi: 10.1056/NEJMoa1802637. Epub 2018 May 23.
Surrogate decision makers for incapacitated, critically ill patients often struggle with decisions related to goals of care. Such decisions cause psychological distress in surrogates and may lead to treatment that does not align with patients' preferences.
We conducted a stepped-wedge, cluster-randomized trial involving patients with a high risk of death and their surrogates in five intensive care units (ICUs) to compare a multicomponent family-support intervention delivered by the interprofessional ICU team with usual care. The primary outcome was the surrogates' mean score on the Hospital Anxiety and Depression Scale (HADS) at 6 months (scores range from 0 to 42, with higher scores indicating worse symptoms). Prespecified secondary outcomes were the surrogates' mean scores on the Impact of Event Scale (IES; scores range from 0 to 88, with higher scores indicating worse symptoms), the Quality of Communication (QOC) scale (scores range from 0 to 100, with higher scores indicating better clinician-family communication), and a modified Patient Perception of Patient Centeredness (PPPC) scale (scores range from 1 to 4, with lower scores indicating more patient- and family-centered care), as well as the mean length of ICU stay.
A total of 1420 patients were enrolled in the trial. There was no significant difference between the intervention group and the control group in the surrogates' mean HADS score at 6 months (11.7 and 12.0, respectively; beta coefficient, -0.34; 95% confidence interval [CI], -1.67 to 0.99; P=0.61) or mean IES score (21.2 and 20.3; beta coefficient, 0.90; 95% CI, -1.66 to 3.47; P=0.49). The surrogates' mean QOC score was better in the intervention group than in the control group (69.1 vs. 62.7; beta coefficient, 6.39; 95% CI, 2.57 to 10.20; P=0.001), as was the mean modified PPPC score (1.7 vs. 1.8; beta coefficient, -0.15; 95% CI, -0.26 to -0.04; P=0.006). The mean length of stay in the ICU was shorter in the intervention group than in the control group (6.7 days vs. 7.4 days; incidence rate ratio, 0.90; 95% CI, 0.81 to 1.00; P=0.045), a finding mediated by the shortened mean length of stay in the ICU among patients who died (4.4 days vs. 6.8 days; incidence rate ratio, 0.64; 95% CI, 0.52 to 0.78; P<0.001).
Among critically ill patients and their surrogates, a family-support intervention delivered by the interprofessional ICU team did not significantly affect the surrogates' burden of psychological symptoms, but the surrogates' ratings of the quality of communication and the patient- and family-centeredness of care were better and the length of stay in the ICU was shorter with the intervention than with usual care. (Funded by the UPMC Health System and the Greenwall Foundation; PARTNER ClinicalTrials.gov number, NCT01844492 .).
对于失去能力、病危的患者，其代理决策者在与治疗目标相关的决策上常常感到困难。这些决策会给代理人带来心理困扰，并且可能导致不符合患者偏好的治疗。
我们进行了一项多中心、随机临床试验，涉及五个重症监护病房（ICU）中具有高死亡风险的患者及其代理人，以比较由 ICU 多学科团队提供的多组分家庭支持干预与常规护理。主要结局是代理人在 6 个月时的医院焦虑和抑郁量表（HADS）平均得分（得分范围为 0 到 42，得分越高表示症状越严重）。预设的次要结局是代理人在事件影响量表（IES）上的平均得分（得分范围为 0 到 88，得分越高表示症状越严重）、沟通质量（QOC）量表（得分范围为 0 到 100，得分越高表示临床医生与家属的沟通越好）、改良的患者对以患者为中心的感知（PPPC）量表（得分范围为 1 到 4，得分越低表示以患者和家属为中心的护理越好），以及 ICU 住院时间的平均长度。
共有 1420 名患者参加了试验。干预组和对照组在 6 个月时代理人的 HADS 平均得分（分别为 11.7 和 12.0；β系数为-0.34；95%置信区间[CI]为-1.67 到 0.99；P=0.61）或 IES 平均得分（分别为 21.2 和 20.3；β系数为 0.90；95%CI 为-1.66 到 3.47；P=0.49）均无显著差异。与对照组相比，干预组代理人的 QOC 平均得分（69.1 比 62.7；β系数为 6.39；95%CI 为 2.57 到 10.20；P=0.001）和改良 PPPC 平均得分（1.7 比 1.8；β系数为-0.15；95%CI 为-0.26 到-0.04；P=0.006）更高。与对照组相比，干预组 ICU 住院时间更短（6.7 天比 7.4 天；发病率比，0.90；95%CI 为 0.81 到 1.00；P=0.045），这一结果是通过 ICU 中死亡患者的 ICU 住院时间缩短来介导的（4.4 天比 6.8 天；发病率比，0.64；95%CI 为 0.52 到 0.78；P<0.001）。
在危重病患者及其代理人中，由 ICU 多学科团队提供的家庭支持干预并未显著影响代理人的心理症状负担，但代理人对沟通质量和以患者及家庭为中心的护理的评分更好，且干预组的 ICU 住院时间比常规护理组更短。（由 UPMC 医疗系统和 Greenwall 基金会资助；PARTNER 临床试验.gov 编号，NCT01844492。）
