Réanimation Polyvalente, Hôpital Louis Pasteur, CH de Chartres, Le Coudray, France.
Unité de Recherche EA3279, Aix-Marseille Université, Marseille, France.
Intensive Care Med. 2017 Dec;43(12):1829-1840. doi: 10.1007/s00134-017-4991-x. Epub 2017 Nov 27.
Critically ill patients are exposed to stressful conditions and experience several discomforts. The primary objective was to assess whether a tailored multicomponent program is effective for reducing self-perceived discomfort.
In a cluster-randomized two-arm parallel trial, 34 French adult intensive care units (ICUs) without planned interventions to reduce discomfort were randomized, 17 to the arm including a 6-month period of program implementation followed by a 6-month period without the program (experimental group), and 17 to the arm with an inversed sequence (control group). The tailored multicomponent program consisted of assessment of ICU-related self-perceived discomforts, immediate and monthly feedback to healthcare teams, and site-specific tailored interventions. The primary outcome was the overall discomfort score derived from the 16-item IPREA questionnaire (0, minimal, 100, maximal overall discomfort) and the secondary outcomes were the discomfort scores of each IPREA item. IPREA was administered on the day of ICU discharge with a considered timeframe from the ICU admission until ICU discharge.
During a 1-month assessment period, 398 and 360 patients were included in the experimental group and the control group, respectively. The difference (experimental minus control) of the overall discomfort score between groups was - 7.00 (95% CI - 9.89 to - 4.11, p < 0.001). After adjustment (age, gender, ICU duration, mechanical ventilation duration, and type of admission), the program effect was still positive for the overall discomfort score (difference - 6.35, SE 1.23, p < 0.001) and for 12 out of 16 items.
This tailored multicomponent program decreased self-perceived discomfort in adult critically ill patients.
Clinicaltrials.gov Identifier NCT02442934.
危重症患者会面临各种应激源，经历多种不适。本研究的主要目的是评估针对个体的多组分方案是否能有效减轻患者的自我感知不适。
在一项 2 组平行的集群随机对照试验中，34 家法国成人重症监护病房（ICU）被随机分为两组，其中 17 家 ICU 无减少不适的干预计划，进入干预组（实验组），接受为期 6 个月的方案实施，之后是 6 个月的无方案期；另外 17 家 ICU 进入对照组（对照组），实施顺序相反。该针对个体的多组分方案包括 ICU 相关自我感知不适的评估、医护团队即时和每月反馈以及特定地点的针对性干预。主要结局指标为 16 项 IPREA 问卷得出的总体不适评分（0 分表示轻微，100 分表示最大总体不适），次要结局指标为每个 IPREA 项目的不适评分。IPREA 问卷在 ICU 出院当天进行评估，评估时间从 ICU 入院到 ICU 出院。
在为期 1 个月的评估期间，实验组和对照组分别纳入了 398 名和 360 名患者。组间总体不适评分的差异（实验组减去对照组）为-7.00（95%CI：-9.89 至-4.11，p<0.001）。调整年龄、性别、ICU 持续时间、机械通气持续时间和入院类型后，方案对总体不适评分仍有积极影响（差异为-6.35，SE 为 1.23，p<0.001），对 16 项中的 12 项也有影响。
该针对个体的多组分方案可降低成年危重症患者的自我感知不适。
Clinicaltrials.gov 标识符：NCT02442934。
