Project and Knowledge Management/Care Development intensive care, Care Directorate, Heart and Diabetes Center NRW, University Hospital of the Ruhr University Bochum, Georgstraße 11, 32345, Bad Oeynhausen, Germany.
Surgical Intensive Care Unit E 0.1, Heart and Diabetes Center NRW, University Hospital of the Ruhr University Bochum, Georgstraße 11, 32345, Bad Oeynhausen, Germany.
Med Klin Intensivmed Notfmed. 2023 May;118(4):257-262. doi: 10.1007/s00063-023-00998-w. Epub 2023 Mar 27.
Since January 2022, a primary nursing system called process-responsible nursing (PP) has substituted the standard room care system in an intensive care unit (ICU) at our institution. The process of the development and implementation of PP is already being evaluated in a separate study as an actual analysis prior to implementation, as well as after 6 and 12 months.
This pilot randomized controlled trial (RCT) aims to test the feasibility of an RCT. For this purpose, the duration of delirium, among other things, will be compared in the project ICU with the results of standard care in another ICU at the university hospital. As secondary aims, the incidence of delirium, anxiety, the satisfaction of relatives, and the effects of PP on nurses will be assessed.
It is planned to recruit about 400-500 patients over a period of one year. They will be allocated to PP or standard care. Delirium will be assessed using the Confusion Assessment Method for Intensive Care Units by specifically trained nurses three times a day. Anxiety in patients, the satisfaction of relatives, and the effects of PP on nurses will be evaluated using the numeric rating scale, a standardized questionnaire, and a focus group interview, respectively.
The primary hypothesis is that compared to usual care PP reduces the duration of delirium by at least 8 h. Additional hypotheses are that PP reduces anxiety in patients and increases the satisfaction of relatives.
自 2022 年 1 月以来，我们机构的重症监护病房（ICU）已将一种名为流程责任制护理（PP）的初级护理系统取代了标准病房护理系统。PP 的开发和实施过程已经在一项单独的研究中进行了评估，作为实施前的实际分析，以及实施后 6 个月和 12 个月。
这项试点随机对照试验（RCT）旨在测试 RCT 的可行性。为此，将比较项目 ICU 中谵妄的持续时间，以及与大学医院另一个 ICU 的标准护理结果。作为次要目标，将评估谵妄、焦虑的发生率、家属的满意度以及 PP 对护士的影响。
计划在一年的时间内招募大约 400-500 名患者。他们将被分配到 PP 或标准护理组。使用专门培训的护士每天三次使用重症监护谵妄评估方法（CAM-ICU）评估谵妄。使用数字评分量表、标准化问卷和焦点小组访谈分别评估患者的焦虑、家属的满意度以及 PP 对护士的影响。
主要假设是与常规护理相比，PP 至少将谵妄持续时间缩短 8 小时。其他假设是 PP 可以降低患者的焦虑程度并提高家属的满意度。
