Original Investigation | February 18, 2019
Effect of a Nurse-Led Preventive Psychological Intervention on Symptoms of Posttraumatic Stress Disorder Among Critically Ill Patients: A Randomized Clinical Trial
Dorothy M. Wade, Paul R. Mouncey, Alvin Richards-Belle, et al
JAMA. 2019;321(7):665-675. doi:10.1001/jama.2019.0073
Abstract
Importance 背景
A meta-analysis of outcomes during the 6 months after intensive care unit (ICU) discharge indicate a prevalence for clinically important posttraumatic stress disorder (PTSD) symptoms of 25%.
对于ICU患者转出后6个月预后的meta分析显示，有临床重要意义的创伤后应激障碍(PTSD)发生率约为25%。
Objective 目的
To determine whether a nurse-led preventive, complex psychological intervention, initiated in the ICU, reduces patient-reported PTSD symptom severity at 6 months.
确定由护士指导的预防性综合心理干预（从ICU开始）能否降低6个月时患者报告的PTSD症状严重程度。
Design, Setting, and Participants 设计，场景及研究人群
A multicenter, parallel-group, cluster-randomized clinical trial with integrated economic and process evaluations conducted in 24 ICUs in the United Kingdom. Participants were critically ill patients who regained mental capacity following receipt of level 3 (intensive) care. A total of 2961 eligible patients were identified from September 2015 to January 2017. A total of 2048 were approached for participation in the ICU, of which 1458 provided informed consent. Follow-up was completed December 2017.
英国24个ICU进行的一项多中心、平行分组、群组随机临床试验，对经济与过程指标进行综合评估。研究人群为接受ICU治疗后意识能力恢复的危重病患者。2015年9月至2017年1月共筛选合格患者2961名。2048名患者在ICU期间就参加临床试验征求意见，其中1458名签署知情同意。2017年12月完成随访。
Interventions 干预措施
Twenty four ICUs were randomized 1:1 to the intervention or control group. Intervention ICUs (n = 12; 669 participants) delivered usual care during a baseline period followed by an intervention period. The preventive, complex psychological intervention comprised promotion of a therapeutic ICU environment plus 3 stress support sessions and a relaxation and recovery program delivered by trained ICU nurses to high-risk (acutely stressed) patients. Control ICUs (n = 12; 789 participants) delivered usual care in both baseline and intervention periods.
24个ICU按照1:1的比例随机分为干预组或对照组。干预组ICU（n = 12；669名患者）在基线阶段进行常规治疗，此后为干预阶段。预防性综合心理干预措施包括改进ICU治疗环境，并由经过培训的ICU护士对高危（急性应激）患者进行3次应激支持培训及1次放松和恢复课程。对照组ICU（n = 12；789名患者）在基线及干预阶段只进行常规治疗。
Main Outcomes and Measures 主要预后终点
The primary clinical outcome was PTSD symptom severity among survivors at 6 months measured using the PTSD Symptom Scale–Self-Report questionnaire (score range, 0-51, with higher scores indicating greater symptom severity; the minimal clinically important difference was considered to be 4.2 points).
主要临床预后终点为6个月存活者PTSD症状的严重程度，采用PTSD症状量表—自我报告问卷进行评估（评分范围0-51，分值越高提示症状越严重；具有临床意义的最小差异为4.2分）。
Results 结果
Among 1458 enrolled patients (mean [SD] age, 58 [16] years; 599 women [41%]), 1353 (93%) completed the study and were included in the final analysis. At 6 months, the mean PTSD Symptom Scale–Self-Report questionnaire score in intervention ICUs was 11.8 (baseline period) compared with 11.5 (intervention period) (difference, −0.40 [95% CI, −2.46 to 1.67]) and in control ICUs, 10.1 (baseline period) compared with 10.2 (intervention period) (difference, 0.06 [95% CI, −1.74 to 1.85]) between periods. There was no significant difference in PTSD symptom severity at 6 months (treatment effect estimate [difference in differences] of −0.03 [95% CI, −2.58 to 2.52]; P = .98).
共入选1458名患者（平均[SD]年龄，58 [16]岁；599名女性[41%]），其中1353 名患者(93%)完成研究，纳入最后分析。6个月时，干预组ICU平均PTSD症状量表–自我报告问卷评分为11.8分（基线阶段）和11.5分（干预阶段）（差异，−0.40 [95% CI, −2.46 to 1.67]），对照组ICU分别为10.1分（基线阶段）和10.2分（干预阶段）（差异，0.06 [95% CI, −1.74 to 1.85]）。6个月时PTSD症状严重程度无显著差异（疗效评估[差异差值] −0.03 [95% CI, −2.58 to 2.52]; P = .98)。
Conclusions and Relevance 结论与意义
Among critically ill patients in the ICU, a nurse-led preventive, complex psychological intervention did not significantly reduce patient-reported PTSD symptom severity at 6 months. These findings do not support the use of this psychological intervention.
对于ICU的危重病患者，由护士指导的预防性综合心理干预措施不能显著降低6个月时患者报告PTSD症状严重程度。这些发现不支持使用这一心理干预措施。
Trial Registration ISRCTN53448131
