ORIGINAL ARTICLE

A Randomized Trial of a Family-Support Intervention in Intensive Care Units

Douglas B. White, Derek C. Angus, Anne-Marie Shields, et al

N Engl J Med 2018; 378:2365-2375

DOI: 10.1056/NEJMoa1802637

Abstract

BACKGROUND 背景

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.

无决策能力的危重病患者的决策代理人经常难以作出与治疗目标相关的决策。这些决定可能造成代理人的心理不适，并导致治疗措施与患者的选择不符。

METHODS 方法

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.

我们进行了一项阶梯设计、群组随机试验，纳入5个ICU的死亡高危患者及其代理人，将由多个专科组成的ICU团队实施的多元家庭支持干预措施与常规治疗进行对比。主要预后终点为6个月时代理人的平均医院焦虑和抑郁评分(HADS)（分值范围 0 至 42，分值越高症状越明显）。事先确定的次要终点包括代理人的事件影响量表（IES；分值范围 0 至 88，分值越高症状越明显），沟通质量(QOC)量表（分值范围 0 至 100，分值越高提示医生与家属沟通越好），以及修订的以患者为中心的患者感知 (PPPC) 量表（分值范围 1 至 4，分值越低提示医疗以患者或家属为中心）以及ICU平均住院日。

RESULTS 结果

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).

试验共入选1420名患者。6个月时，干预组与对照组间代理人的平均HADS评分（分别为11.7 和 12.0 分；beta系数，−0.34; 95% 可信限 [CI], −1.67 to 0.99; P=0.61）或平均 IES 评分（分别为21.2 和 20.3 分；beta系数，0.90; 95% CI, −1.66 to 3.47; P=0.49）无显著差异。干预组代理人的平均QOC评分优于对照组（69.1 vs. 62.7; beta系数，6.39; 95% CI, 2.57 to 10.20; P=0.001），平均修订后PPPC评分较低（1.7 vs. 1.8; beta系数，−0.15; 95% CI, −0.26 to −0.04; P=0.006）。干预组患者平均ICU住院日较短（6.7 天 vs. 7.4 天；发生率比值，0.90; 95% CI, 0.81 to 1.00; P=0.045），系由死亡患者ICU住院日较短造成（4.4 天 vs. 6.8 天；发病率比值，0.64; 95% CI, 0.52 to 0.78; P<0.001）。

CONCLUSIONS 结论

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.

对于危重病患者及其代理人而言，与常规治疗相比，由多个专科组成的ICU团队实施的家庭支持干预措施并不显著影响代理人的心理负担，但代理人对沟通质量及患者和家属为中心的医疗服务评价较高，患者ICU住院日较短。

(Funded by the UPMC Health System and the Greenwall Foundation; PARTNER ClinicalTrials.gov number, NCT01844492.)