Multi-hospital electronic decision support for drug-associated acute kidney injury (MEnD-AKI): Study protocol for a randomized clinical trial

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-08-22 DOI:10.1016/j.cct.2025.108055

Britney A. Stottlemyer , John A. Kellum , Azra Bihorac , Tezcan Ozrazgat-Baslanti , Raghavan Murugan , Chung-Chou Ho Chang , Nabihah Amatullah , Tiffany L. Tran , Caiden J. Lukan , Michele M. Elder , Esra Adiyeke , Yuanfang Ren , Dan Ricketts , Beth Emanuele , Parisa Rashidi , Sandra L. Kane-Gill

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引用次数: 0

Abstract

Background and objectives

Tools to assist with drug management for both nephrotoxic medications and renally eliminated drugs are urgently needed. “Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury” (MEnD-AKI) aims to examine the effect of a pharmacist-led intervention augmented with predictive analytics in the form of electronic alerts delivered to pharmacists followed by drug management recommendations provided to physicians via telemedicine for the early management of patients at risk of developing AKI or progressing to higher AKI stages.

Design

Prospective, multi-site, cluster-randomized clinical trial.

Setting

Eight hospitals within the UPMC health system.

Patients

Attending physicians belonging to primary services other than intensive care or organ transplant will be eligible for participation in the study. The unit of randomization is physician hospital services (clusters), and outcomes will be assessed for patients cared for by these physicians.

Interventions

Researchers will randomize 38 hospital service clusters to receive: 1) electronic medical record (EMR)-based AKI passive alert, which is standard of care at UPMC; this alert provides the diagnosis and staging of AKI but without recommendations for management; or 2) protocolized, tiered pharmacist-led intervention augmented with near-realtime predictive analytics in the form of automated alerts incorporated into a web application delivered to pharmacists followed by drug management recommendations provided to physicians via telemedicine for consideration and approval.

Outcomes

The primary outcome is major adverse kidney events (MAKE) measured within 30 days of admission. Secondary outcomes include progression of AKI, AKI duration, and nephrotoxic burden.

Clinical trials registration

ClinicalTrials.gov NCT06264752 (v2).

查看原文本刊更多论文

多医院药物相关性急性肾损伤电子决策支持（MEnD-AKI）：一项随机临床试验的研究方案

背景与目的迫切需要辅助肾毒性药物和肾脏消除药物的药物管理的工具。“药物相关急性肾损伤的多医院电子决策支持”（mendaki）旨在检查药剂师主导的干预措施的效果，并以电子警报的形式增强预测分析，然后通过远程医疗向医生提供药物管理建议，以早期管理有发展为AKI风险的患者或进展为更高阶段的AKI。前瞻性、多地点、集群随机临床试验。设置UPMC卫生系统内的八家医院。除重症监护或器官移植以外的初级服务的主治医生将有资格参加研究。随机化的单位是医师医院服务（集群），并将评估由这些医生照顾的患者的结果。研究人员将随机选取38个医院服务集群来接收：1)基于电子病历（EMR）的AKI被动警报，这是UPMC的标准护理；该警报提供AKI的诊断和分期，但不提供管理建议；或者2)协议化的、分层的药剂师主导的干预，辅以近乎实时的预测分析，以自动警报的形式合并到一个web应用程序中，交付给药剂师，然后通过远程医疗向医生提供药物管理建议，供他们考虑和批准。主要终点是入院后30天内测量的主要肾脏不良事件（MAKE）。次要结局包括AKI的进展、AKI持续时间和肾毒性负担。临床试验注册：clinicaltrials .gov NCT06264752 （v2）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.