Lancet: ICU死亡患者亲属的三步支持策略：整群随机试验

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.

摘要翻译（仅供参考）

背景

       对于在重症监护室（ICU）死亡的病人的亲属来说，团队支持不足会增加长期悲伤和其他心理伤害的发生率。我们旨在评估积极的沟通和支持干预是否会改善亲属的结果。

研究方法

       我们在法国的34个重症监护室进行了一项前瞻性、多中心、分组随机对照试验，以比较标准护理和医生主导、护士辅助的三步支持策略，在决定撤销或扣留生命支持后，为家属提供整个死亡过程的支持。纳入标准是18岁以上、在重症监护室停留2天或以上的病人的亲属。参与的ICU被随机分配（1:1的比例）到一个干预组和一个对照组。随机化方案是由没有参与研究的统计学家集中产生的，使用非释放大小的置换块。在干预组中，与亲属举行了三次会议：一次家庭会议，让亲属为即将到来的死亡做好准备；一次ICU病房访问，以提供积极的支持；以及一次在患者死亡后的会议，以提供哀悼和结束。被随机分配到对照组的ICU在支持和与临终病人的亲属沟通方面采用了他们的最佳护理标准。主要终点是死亡后6个月内有长期悲痛的亲属的比例（用PG-13测量，得分≥30）。分析是通过意向性治疗，以丧亲者为观察单位。该研究已在ClinicalTrials.gov注册，NCT02955992。

研究结果

      在2017年2月23日至2019年10月8日期间，我们将484名ICU患者的亲属纳入干预组，391名纳入对照组。干预组的379名（78%）亲属和对照组的309名（79%）亲属完成了6个月的访谈，以衡量主要终点。干预措施显著减少了有长期悲伤症状的亲属数量（66 [21%] vs 57 [15%]; p=0-035），干预组的PG-13评分中位数显著低于对照组（19 [IQR 14-26] vs 21 [15-29], 平均差异2-5, 95% CI 1-04-3-95）。

解读

       在ICU死亡患者的亲属中，由医生主导、护士辅助的三步支持策略明显减少了长时间的悲伤症状。