Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial.
Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial.
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DOI：
10.1186/s13063-016-1211-x
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发表时间：
2016-02-16
期刊：
影响因子：
2.5
通讯作者：
Auquier P
中科院分区：
文献类型：
--
作者：
Kalfon P;Mimoz O;Loundou A;Geantot MA;Revel N;Villard I;Amour J;Azoulay E;Garrouste-Orgeas M;Martin C;Sharshar T;Baumstarck K;Auquier P
现在有充分的证据表明，重症患者暴露于压力条件下，并经历来自多种来源的不适。加强对重症监护室（ICU）患者不适的识别可能对管理他们的护理产生影响，包括考虑伦理问题，并可能有助于临床医生选择最合适的干预措施。本研究的主要目的是评估一个多成分的计划，减少危重病人的不适的有效性。次要目标是评估该计划影响的可持续性和潜在的季节性影响。我们进行了一项涉及34名法国成人ICU患者的多中心、随机分组、对照、单（患者）盲研究。实验性干预为期6个月，在此期间在ICU实施多组分计划，包括以下步骤：识别不适，立即反馈给医疗团队，并实施有针对性的干预措施。控制干预是6个月的时间，在此期间实施任何方案。主要终点是法国ICU患者不适问卷（IPREA）中自我报告的每月不适总分。次要终点为IPREA的不适项目评分。样本量为660人，以获得80%的把握度来检测两组之间IPREA总体不适评分的25%差异（设计效应：2.9）。这项随机分组对照研究的结果预计将证实，一个多组分的程序，减少不适可能是一个新的战略，在管理护理危重病人。ClinicalTrials.gov NCT 02442934，2015年5月11日注册。
It is now well documented that critically ill patients are exposed to stressful conditions and experience discomforts from multiple sources. Improved identification of the discomforts of patients in intensive care units (ICUs) may have implications for managing their care, including consideration of ethical issues, and may assist clinicians in choosing the most appropriate interventions. The primary objective of this study was to assess the effectiveness of a multicomponent program of discomfort reduction in critically ill patients. The secondary objectives were to assess the sustainability of the impact of the program and the potential seasonality effect. We conducted a multicenter, cluster-randomized, controlled, single (patient)-blind study involving 34 French adult ICUs. The experimental intervention was a 6-month period during which the multicomponent program was implemented in the ICU and included the following steps: identification of discomforts, immediate feedback to the healthcare team, and implementation of targeted interventions. The control intervention was a 6-month period during which any program was implemented. The primary endpoint was the monthly overall score of self-reported discomfort from the French questionnaire on discomforts in ICU patients (IPREA). The secondary endpoints were the scores of the discomfort items of IPREA. The sample size was 660 individuals to obtain 80 % power to detect a 25 % difference in the overall discomfort score of IPREA between the two groups (design effect: 2.9). The results of this cluster-randomized controlled study are expected to confirm that a multicomponent program of discomfort reduction may be a new strategy in the management of care for critically ill patients. ClinicalTrials.gov NCT02442934 , registered 11 May 2015.