Department of Anesthesiology, Nordsjællands Hospital, University of Copenhagen, 3400, Hilleroed, Denmark.
Neurointensive Care Unit, Rigshospitalet, University of Copenhagen and Health & Medical Sciences, University of Copenhagen, 2100, Copenhagen, Denmark.
Intensive Care Med. 2016 Nov;42(11):1733-1743. doi: 10.1007/s00134-016-4522-1. Epub 2016 Sep 30.
The aim of this randomized controlled trial (RCT) was to test the effectiveness of a post-ICU recovery program compared to standard care during the first year after ICU discharge.
A pragmatic, non-blinded, multicenter, parallel-group RCT was conducted between December 2012 and December 2015, at ten intensive care units (ICUs) in Denmark. We randomly assigned 386 adult patients (≥18 years) after receiving mechanical ventilation (≥48 h) to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC). Primary outcome was health-related quality of life (HRQOL) at 12 months. Secondary outcomes were sense of coherence (SOC), anxiety, depression, and post-traumatic stress disorder (PTSD) assessed at 3 and 12 months after ICU discharge including utilization of healthcare services at 12 months.
At 12 months, we found no differences in HRQOL between groups (mean difference in the Physical Component Summary score, 1.41 [95 % CI, -1.53 to 4.35; p = 0.35] (n = 235); and in the Mental Component Summary score, 1.92 [95 % CI, -1.06 to 4.90; p = 0.11] (n = 235). No differences were found on self-reported SOC (p = 0.63), anxiety (p = 0.68), depression (p = 0.67), PTSD (p = 0.27), or the utilization of healthcare services including rehabilitation. We found a difference on anxiety, when a cut-off point ≥11 was applied, in per protocol analysis of complete cases at 3 months favoring the intervention (8.8 % vs. 16.2 %, p = 0.04).
The tested recovery program was not superior to standard care during the first 12 months post-ICU.
The trial is registered at Clinicaltrials.gov, identification no. NCT01721239.
本随机对照试验（RCT）旨在测试 ICU 出院后第一年期间，与标准护理相比， ICU 后恢复计划的效果。
2012 年 12 月至 2015 年 12 月，在丹麦的 10 个重症监护病房（ICU）进行了一项实用、非盲、多中心、平行组 RCT。我们将 386 名成年患者（≥18 岁）随机分为两组：接受机械通气（≥48 小时）后，标准护理（SC）加护士主导的 ICU 康复计划组（190 例）和标准护理组（196 例）。主要结局为 12 个月时的健康相关生活质量（HRQOL）。次要结局为 3 个月和 12 个月时的总体感觉、焦虑、抑郁和创伤后应激障碍（PTSD），并包括 12 个月时的医疗保健服务利用情况。
12 个月时，两组之间的 HRQOL 无差异（物理成分综合评分的平均差异，1.41 [95%CI，-1.53 至 4.35；p=0.35]（n=235）；心理成分综合评分的平均差异，1.92 [95%CI，-1.06 至 4.90；p=0.11]（n=235）。自我报告的总体感觉（p=0.63）、焦虑（p=0.68）、抑郁（p=0.67）、PTSD（p=0.27）或包括康复在内的医疗保健服务利用情况均无差异。我们发现，在 3 个月时的完整病例意向治疗分析中，当采用≥11 的截断点时，干预组的焦虑评分较低（8.8%比 16.2%，p=0.04）。
在 ICU 后 12 个月内，测试的康复计划并不优于标准护理。
该试验在 Clinicaltrials.gov 注册，注册号为 NCT01721239。
