Randomized feasibility trial for evaluating the impact of primary nursing on delirium duration during intensive care unit stay

IF 4.9 2区 医学 Q1 NURSING Intensive and Critical Care Nursing Pub Date : 2024-06-14 DOI:10.1016/j.iccn.2024.103748
Lars Krüger , Armin Zittermann , Thomas Mannebach , Franziska Wefer , Tobias Becker , Sarah Lohmeier , Anna Lüttermann , Vera von Dossow , Sebastian V. Rojas , Jan Gummert , Gero Langer
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Abstract

Objective

We tested the feasibility of a randomized controlled trial for comparing primary nursing with standard care.

Research Methodology

Elective cardiac surgical patients were eligible for inclusion. Patients with an intensive care unit stay of ≥ 3 days were followed up until intensive care unit discharge. Recruitment period was one year.

Setting

Two intensive care units at a university hospital specialized in cardiovascular and diabetic diseases.

Main Outcome Measures

Primary outcomes were recruitment and delivery rate. Primary clinical outcome was duration of delirium, as assessed by the Confusion Assessment Method for Intensive Care Units. Secondary outcomes included the incidence of delirium, anxiety (10-point Numeric Rating Scale), and the satisfaction of patient relatives (validated questionnaire).

Results

Of 369 patients screened, 269 could be allocated to primary nursing (n = 134) or standard care (n = 135), of whom 46 patients and 48 patients, respectively, underwent an intensive care unit stay ≥ 3 days. Thus, recruitment and delivery rates were 73 and 26 %, respectively. During primary nursing and standard care, 18 and 24 patients developed a delirium, with a median duration of 32 (IQR: 14–96) and 24 (IQR: 8–44) hours (P = 0.10). The risk difference of delirium for primary nursing versus standard care was 11 % and the relative risk was 0.65 (95 % CI: 0.28–1.46; P = 0.29). The extent of anxiety was similar between groups (P = 0.13). Satisfaction could be assessed in 73.5 % of relatives, without substantial differences between groups.

Conclusion

Data demonstrate that a trial for comparing primary nursing with standard care is generally feasible. However, the incidence of delirium may be a better primary outcome parameter than delirium duration, both in terms of long-term patient outcome and robustness of data quality.

Implications for clinical practice

A randomized clinical trial regarding nursing organization during intensive care unit stay requires detailed planning of patient recruitment, data evaluation, and power calculation.

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评估基础护理对重症监护室住院期间谵妄持续时间影响的随机可行性试验。
研究目的我们测试了将基础护理与标准护理进行比较的随机对照试验的可行性:研究方法:择期心脏手术患者均符合纳入条件。对重症监护室住院时间≥3 天的患者进行随访,直至重症监护室出院。招募时间为一年:主要结果指标:主要结果:招募率和分娩率为主要结果。主要临床结果为谵妄持续时间,以重症监护病房意识混乱评估方法进行评估。次要结果包括谵妄发生率、焦虑(10 点数字评分量表)和患者亲属满意度(有效问卷):在筛选出的 369 名患者中,269 人可分配到基础护理(134 人)或标准护理(135 人),其中分别有 46 人和 48 人在重症监护室的住院时间≥ 3 天。因此,招募率和分娩率分别为 73% 和 26%。在基础护理和标准护理期间,分别有 18 名和 24 名患者出现谵妄,中位持续时间分别为 32 小时(IQR:14-96)和 24 小时(IQR:8-44)(P = 0.10)。初级护理与标准护理的谵妄风险差异为 11%,相对风险为 0.65 (95 % CI: 0.28-1.46; P = 0.29)。两组患者的焦虑程度相似(P = 0.13)。73.5%的患者亲属对治疗满意,组间差异不大:数据表明,将基础护理与标准护理进行比较的试验总体上是可行的。结论:数据表明,比较基础护理和标准护理的试验总体上是可行的,但从患者的长期疗效和数据质量的稳健性来看,谵妄发生率可能比谵妄持续时间更适合作为主要结果参数:有关重症监护病房住院期间护理组织的随机临床试验需要对患者招募、数据评估和功率计算进行详细规划。
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来源期刊
CiteScore
6.30
自引率
15.10%
发文量
144
审稿时长
57 days
期刊介绍: The aims of Intensive and Critical Care Nursing are to promote excellence of care of critically ill patients by specialist nurses and their professional colleagues; to provide an international and interdisciplinary forum for the publication, dissemination and exchange of research findings, experience and ideas; to develop and enhance the knowledge, skills, attitudes and creative thinking essential to good critical care nursing practice. The journal publishes reviews, updates and feature articles in addition to original papers and significant preliminary communications. Articles may deal with any part of practice including relevant clinical, research, educational, psychological and technological aspects.
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