在重症监护病房的多组件家庭支持干预:对集群随机对照FICUS试验的统计分析计划
Stefanie von Felten1, Miodrag Filipovic2, Marie-Madlen Jeitziner3
1Department of Biostatistics at Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, Zurich, CH-8001, Switzerland. stefanie.vonfelten@uzh.ch.
Trials
|August 28, 2024
概括
该FICUS试验调查了护士领导的家庭支持干预 (FSI) 对重症患者的家属. 这项研究旨在改善与常规护理相比的护理质量和家庭福祉.
科学领域:
- 关键护理医学 关键护理医学
- 护理研究 护理研究
- 医疗保健服务研究 医疗服务研究
背景情况:
- 危急病患者的家属在护理管理中经历了重大痛苦和挑战.
- 现有的护理模式可能无法充分满足在重症监护室 (ICU) 的家庭的整体需求.
研究的目的:
- 评估护士领导的跨专业家庭支持干预 (FSI) 与通常护理的有效性.
- 评估FSI对家庭护理质量,家庭管理和家庭成员心理健康的影响.
- 为FICUS试验提供详细的统计分析计划.
主要方法:
- 集群随机优势试验与16个ICU随机 1:1 FSI或常规护理.
- 主要结果:在ICU出院时的家庭护理质量 (FS-ICU-24R);在3,6和12个月时评估的次要结果.
- 使用线性混合效应模型 (LMM) 进行分析,包括对共变量调整和子组分析.
主要成果:
- 招聘工作于2024年1月完成;后续工作于2025年初结束.
- 统计分析计划详细介绍了主要和次要结果指标和分析方法.
- 预先规定的子组分析将探讨跨不同特征的干预效应.
结论:
- 该FICUS试验旨在严格评估在重症监护机构的新型家庭支持干预措施.
- 调查结果将为支持重症患者的家属提供最佳实践.
- 这项研究提供了改善ICU患者家庭中心护理的证据.
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