重症监护病房患者亲属的三步支持策略：一项集群随机试验。

A three-step support strategy for relatives of patients dying in the intensive care unit: a cluster randomised trial.

机构信息

AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France.

Department of Biostatistics and Medical Information, UMR 1153, ECSTRRA Team, INSERM, Paris University, Saint Louis Hospital, AP-HP, Paris, France.

出版信息

Lancet. 2022 Feb 12;399(10325):656-664. doi: 10.1016/S0140-6736(21)02176-0. Epub 2022 Jan 19.

DOI:10.1016/S0140-6736(21)02176-0

PMID:35065008

Abstract

BACKGROUND

In relatives of patients dying in intensive care units (ICUs), inadequate team support can increase the prevalence of prolonged grief and other psychological harm. We aimed to evaluate whether a proactive communication and support intervention would improve relatives' outcomes.

METHODS

We undertook a prospective, multicentre, cluster randomised controlled trial in 34 ICUs in France, to compare standard care with a physician-driven, nurse-aided, three-step support strategy for families throughout the dying process, following a decision to withdraw or withhold life support. Inclusion criteria were relatives of patients older than 18 years with an ICU length of stay 2 days or longer. Participating ICUs were randomly assigned (1:1 ratio) into an intervention cluster and a control cluster. The randomisation scheme was generated centrally by a statistician not otherwise involved in the study, using permutation blocks of non-released size. In the intervention group, three meetings were held with relatives: a family conference to prepare the relatives for the imminent death, an ICU-room visit to provide active support, and a meeting after the patient's death to offer condolences and closure. ICUs randomly assigned to the control group applied their best standard of care in terms of support and communication with relatives of dying patients. The primary endpoint was the proportion of relatives with prolonged grief (measured with PG-13, score ≥30) 6 months after the death. Analysis was by intention to treat, with the bereaved relatives as the unit of observation. The study is registered with ClinicalTrials.gov, NCT02955992.

FINDINGS

Between Feb 23, 2017, and Oct 8, 2019, we enrolled 484 relatives of ICU patients to the intervention group and 391 to the control group. 379 (78%) relatives in the intervention group and 309 (79%) in the control group completed the 6-month interview to measure the primary endpoint. The intervention significantly reduced the number of relatives with prolonged grief symptoms (66 [21%] vs 57 [15%]; p=0·035) and the median PG-13 score was significantly lower in the intervention group than in the control group (19 [IQR 14-26] vs 21 [15-29], mean difference 2·5, 95% CI 1·04-3·95).

INTERPRETATION

Among relatives of patients dying in the ICU, a physician-driven, nurse-aided, three-step support strategy significantly reduced prolonged grief symptoms.

FUNDING

French Ministry of Health.

摘要

背景

在 ICU 中患者死亡的亲属中，团队支持不足会增加长期悲伤和其他心理伤害的发生率。我们旨在评估主动沟通和支持干预是否会改善亲属的结局。

方法

我们在法国 34 个 ICU 中进行了一项前瞻性、多中心、集群随机对照试验，比较了标准护理与一种由医生主导、护士辅助的三步支持策略，该策略适用于在决定撤回或停止生命支持后整个临终过程中的家庭。纳入标准为年龄大于 18 岁、ICU 住院时间大于等于 2 天的 ICU 患者的亲属。参与 ICU 被随机分配（1:1 比例）到干预组和对照组。随机方案由一位不参与研究的统计学家中央生成，使用未发布大小的置换块。在干预组中，与亲属进行了三次会面：一次是为即将到来的死亡做准备的家庭会议，一次是 ICU 病房探访以提供积极的支持，一次是在患者死亡后提供慰问和结束。随机分配到对照组的 ICU 为临终患者的亲属提供了最佳的支持和沟通标准。主要终点是 6 个月后出现长期悲伤（用 PG-13 测量，得分≥30）的亲属比例。分析采用意向治疗，以失去亲人的亲属为观察单位。该研究在 ClinicalTrials.gov 注册，NCT02955992。

结果

2017 年 2 月 23 日至 2019 年 10 月 8 日，我们将 484 名 ICU 患者的亲属纳入干预组，391 名纳入对照组。379 名（78%）干预组的亲属和 309 名（79%）对照组的亲属完成了 6 个月的访谈以测量主要终点。干预组显著减少了出现长期悲伤症状的亲属人数（66 [21%] vs 57 [15%]；p=0·035），干预组的 PG-13 中位数得分明显低于对照组（19 [IQR 14-26] vs 21 [15-29]，平均差异 2·5，95%CI 1·04-3·95）。