University of Lille, CHU Lille, ULR 2694 - METRICS : Évaluation des technologies de santé et des pratiques médicales, F-59000, Lille, France.
PharmIA, 75017, Paris, France.
Trials. 2024 Nov 18;25(1):779. doi: 10.1186/s13063-024-08569-w.
Clinical decision support systems (CDSSs) enable the automated, real-time detection of situations associated with a risk of adverse drug events (ADEs). However, the effectiveness of CDSS in reducing ADEs has yet to be demonstrated. We have chosen to focus on the detection of ADE such as hyperkalemia and/or acute kidney injury (AKI), which are common among hospitalized older adults. The present study's primary objective is to use a CDSS to reduce the number of ADEs (such as AKI and/or hyperkalemia) that occur in hospitalized older adults.
This is a multicenter, stepped-wedge, cluster-randomized study involving five hospitals. Each hospital will start with a control period (i.e., routine care, during which each center's CDSS is deactivated) and then switch to an intervention period (during which the CDSS is activated). The intervention will be the use of a CDSS and a strategy for managing and transmitting alerts to clinical pharmacists. The rules concerning AKI and hyperkalemia have been drafted and reviewed by a multidisciplinary group. Each rule created in the CDSS is associated with a standardized procedure, based on a review of the literature. Older patients (aged 65 or over) admitted to a participating general medicine ward, a surgical ward, or obstetrics ward will be eligible for inclusion after the provision of verbal informed consent.
This study will assess the effectiveness of the CDSS in reducing the incidence of AKI and hyperkalemia. The implementation of the CDSS can assist clinical pharmacists in their daily work and is expected to prevent ADEs.
ClinicalTrials.gov Identifier: NCT05923983. Registered February 02, 2023.
临床决策支持系统(CDSS)能够实现与药物不良反应(ADE)风险相关情况的自动实时检测。然而,CDSS 在减少 ADE 方面的有效性尚未得到证实。我们选择专注于检测 ADE,如高钾血症和/或急性肾损伤(AKI),这些在住院老年患者中很常见。本研究的主要目的是使用 CDSS 减少住院老年患者发生的 ADE(如 AKI 和/或高钾血症)数量。
这是一项多中心、阶梯式、整群随机研究,涉及五家医院。每家医院将首先进入对照期(即常规护理,在此期间,每个中心的 CDSS 关闭),然后进入干预期(在此期间,CDSS 开启)。干预措施将是使用 CDSS 和管理及向临床药师传输警报的策略。AKI 和高钾血症的规则已经由多学科小组起草和审查。CDSS 中创建的每条规则都与基于文献回顾的标准化程序相关联。参与普通内科病房、外科病房或妇产科病房的 65 岁及以上的老年患者在提供口头知情同意后将有资格入组。
本研究将评估 CDSS 在减少 AKI 和高钾血症发生率方面的有效性。CDSS 的实施可以协助临床药师的日常工作,并有望预防 ADE。
ClinicalTrials.gov 标识符:NCT05923983。注册于 2023 年 2 月 2 日。