A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study
A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study
复制标题
DOI：
10.1007/s00134-016-4522-1
复制
发表时间：
2016-11-01
影响因子：
38.9
通讯作者：
Overgaard, Dorthe
中科院分区：
文献类型：
--
作者：
Jensen, Janet F.;Egerod, Ingrid;Overgaard, Dorthe
本随机对照试验（RCT）的目的是测试ICU后康复计划与标准护理在ICU出院后第一年的有效性。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、平行组随机对照试验。我们将接受机械通气（48小时）的386名成年患者（18岁）随机分配到标准护理（SC）加护士主导的重症监护康复计划或ICU出院后单独的标准护理（190例干预，196例SC）。主要终点为12个月时健康相关生活质量（HRQOL）。次要结局是在ICU出院后3个月和12个月评估连贯感（SOC）、焦虑、抑郁和创伤后应激障碍（PTSD），包括12个月时医疗保健服务的利用情况。在12个月时，我们发现两组间HRQOL无差异(Physical Component Summary评分的平均差异为1.41 [95% CI, -1.53至4.35;p = 0.35] (n = 235)；在精神成分总结得分中，1.92 [95% CI, -1.06至4.90；P = 0.11] （n = 235）。在自我报告的SOC （p = 0.63）、焦虑（p = 0.68）、抑郁（p = 0.67）、创伤后应激障碍（p = 0.27）或包括康复在内的医疗保健服务的利用方面没有发现差异。在3个月的完整病例的每个方案分析中，我们发现在焦虑方面存在差异，当采用截断点11时，支持干预（8.8%对16.2%,p = 0.04）。在icu后的前12个月，经过测试的恢复方案并不优于标准护理。该试验在Clinicaltrials.gov注册，识别号为：NCT01721239。
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 (aeyen18 years) after receiving mechanical ventilation (aeyen48 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 aeyen11 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.