ICU 定制药物-药物相互作用警报对药物处方和监测的影响：一项群组随机阶梯式试验方案。
The effect of ICU-tailored drug-drug interaction alerts on medication prescribing and monitoring: protocol for a cluster randomized stepped-wedge trial.
机构信息
Department of Medical Informatics, Amsterdam UMC (location AMC), Amsterdam, The Netherlands.
Pharmaceutical Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
出版信息
BMC Med Inform Decis Mak. 2019 Aug 13;19(1):159. doi: 10.1186/s12911-019-0888-7.
BACKGROUND
Drug-drug interactions (DDIs) can cause patient harm. Between 46 and 90% of patients admitted to the Intensive Care Unit (ICU) are exposed to potential DDIs (pDDIs). This rate is twice as high as patients on general wards. Clinical decision support systems (CDSSs) have shown their potential to prevent pDDIs. However, the literature shows that there is considerable room for improvement of CDSSs, in particular by increasing the clinical relevance of the pDDI alerts they generate and thereby reducing alert fatigue. However, consensus on which pDDIs are clinically relevant in the ICU setting is lacking. The primary aim of this study is to evaluate the effect of alerts based on only clinically relevant interactions for the ICU setting on the prevention of pDDIs among Dutch ICUs.
METHODS
To define the clinically relevant pDDIs, we will follow a rigorous two-step Delphi procedure in which a national expert panel will assess which pDDIs are perceived clinically relevant for the Dutch ICU setting. The intervention is the CDSS that generates alerts based on the clinically relevant pDDIs. The intervention will be evaluated in a stepped-wedge trial. A total of 12 Dutch adult ICUs using the same patient data management system, in which the CDSS will operate, were invited to participate in the trial. Of the 12 ICUs, 9 agreed to participate and will be enrolled in the trial. Our primary outcome measure is the incidence of clinically relevant pDDIs per 1000 medication administrations.
DISCUSSION
This study will identify pDDIs relevant for the ICU setting. It will also enhance our understanding of the effectiveness of alerts confined to clinically relevant pDDIs. Both of these contributions can facilitate the successful implementation of CDSSs in the ICU and in other domains as well.
TRIAL REGISTRATION
Nederlands Trial register Identifier: NL6762 . Registered November 26, 2018.
背景
药物-药物相互作用（DDI）会对患者造成伤害。入住重症监护病房（ICU）的患者中有 46%至 90%存在潜在的药物-药物相互作用（pDDI）。这一比例是普通病房患者的两倍。临床决策支持系统（CDSS）已显示出预防 pDDI 的潜力。然而，文献表明 CDSS 还有很大的改进空间，特别是通过提高其生成的 pDDI 警报的临床相关性，从而减少警报疲劳。然而，在 ICU 环境中，哪些 pDDI 具有临床相关性尚缺乏共识。本研究的主要目的是评估仅基于 ICU 环境下的临床相关相互作用的警报对预防荷兰 ICU 中 pDDI 的效果。
方法
为了确定临床相关的 pDDI，我们将遵循严格的两步德尔菲程序，由一个国家专家小组评估哪些 pDDI 被认为与荷兰 ICU 环境具有临床相关性。干预措施是基于临床相关 pDDI 生成警报的 CDSS。干预措施将在一项逐步楔形试验中进行评估。共有 12 家使用相同患者数据管理系统的荷兰成人 ICU 受邀参加试验。在这 12 家 ICU 中，有 9 家同意参与，并将被纳入试验。我们的主要结局指标是每 1000 次药物管理中出现的临床相关 pDDI 的发生率。
讨论
本研究将确定与 ICU 环境相关的 pDDI。它还将提高我们对仅限于临床相关 pDDI 的警报的有效性的理解。这两个贡献都可以促进 CDSS 在 ICU 以及其他领域的成功实施。
试验注册
荷兰试验注册标识符：NL6762。注册于 2018 年 11 月 26 日。
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