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新规则能否整合到临床决策支持系统中以降低住院老年患者急性肾损伤和高钾血症的发生率:一项 stepped-wedge、cluster-randomized 试验(DETECT-IP)的方案。

Can the integration of new rules into a clinical decision support system reduce the incidence of acute kidney injury and hyperkalemia among hospitalized older adults: a protocol for a stepped-wedge, cluster-randomized trial (DETECT-IP).

机构信息

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.

出版信息

Trials. 2024 Nov 18;25(1):779. doi: 10.1186/s13063-024-08569-w.

DOI:10.1186/s13063-024-08569-w
PMID:39558377
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11571581/
Abstract

BACKGROUND

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.

METHODS

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.

DISCUSSION

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.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05923983. Registered February 02, 2023.

摘要

背景

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。

方法

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。

讨论

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。

试验注册

ClinicalTrials.gov 标识符:NCT05923983。注册于 2023 年 2 月 2 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cee9/11571581/09474396cf18/13063_2024_8569_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cee9/11571581/9eab2abc33b8/13063_2024_8569_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cee9/11571581/09474396cf18/13063_2024_8569_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cee9/11571581/9eab2abc33b8/13063_2024_8569_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cee9/11571581/09474396cf18/13063_2024_8569_Fig2_HTML.jpg

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本文引用的文献

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Drugs Aging. 2023 Nov;40(11):965-979. doi: 10.1007/s40266-023-01064-y. Epub 2023 Sep 13.
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Organizational and Human Factors in Green Medical Informatics - A Case Study in Dutch Hospitals.绿色医疗信息学中的组织和人为因素——荷兰医院的案例研究。
Stud Health Technol Inform. 2023 Jun 29;305:537-540. doi: 10.3233/SHTI230552.
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Considering Work Systems and Processes in Assessing the Impact of a CDSS Intervention: Preliminary Results.
考虑工作系统和流程在评估 CDSS 干预影响中的作用:初步结果。
Stud Health Technol Inform. 2023 Jun 22;304:52-56. doi: 10.3233/SHTI230368.
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Detection of Drug-Related Problems through a Clinical Decision Support System Used by a Clinical Pharmacy Team.通过临床药学团队使用的临床决策支持系统检测药物相关问题。
Healthcare (Basel). 2023 Mar 11;11(6):827. doi: 10.3390/healthcare11060827.
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Development and retrospective evaluation of a clinical decision support system for the efficient detection of drug-related problems by clinical pharmacists.开发并回顾性评估一个临床药师高效检测药物相关问题的临床决策支持系统。
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Pharmaceutical algorithms set in a real time clinical decision support targeting high-alert medications applied to pharmaceutical analysis.药物算法设置在实时临床决策支持中,针对高警示药物应用于药物分析。
Int J Med Inform. 2022 Apr;160:104708. doi: 10.1016/j.ijmedinf.2022.104708. Epub 2022 Feb 5.
7
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A systematic review of the evidence for deprescribing interventions among older people living with frailty.衰弱老年人药物重整干预措施的证据的系统评价。
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