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

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.govNCT06264752 (v2).