protocolSection identificationModule nctId: NCT06264752, orgStudyIdInfo id: STUDY20120008, secondaryIdInfos id: R01DK121730, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DK121730, briefTitle: Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury, acronym: MEnD-AKI, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, collaborators name: University of Florida, collaborators name: University of Pittsburgh Medical Center, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: This study is a randomized controlled trial at eight hospitals within the University of Pittsburgh Medical Center-UPMC system. The project will assess the efficacy of a clinical surveillance system augmented with real-time predictive analytics to support a pharmacist-led intervention delivered to attending physicians (primary service) to reduce the progression and complications of drug-associated acute kidney injury (D-AKI) in hospitalized (non-ICU) adults., conditionsModule conditions: Acute Kidney Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective, randomized, interventional controlled trial at eight hospitals within the UPMC health-system. Researchers will randomize 39 hospital service clusters to receive either: 1) a Cerner electronic medical record (EMR)-based AKI passive alert which is standard of care at UPMC: this alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management (Usual Care Arm); or 2) protocolized stage-based intervention delivered to the physician by a pharmacist for consideration and approval. Hospital service clusters will be allocated 1:1 to the intervention or usual care with a web-based system to maintain concealment using a randomized block design., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Statisticians performing the analysis will be blinded to the treatment allocation.The investigators will randomize clusters to intervention and control within strata defined hospitals to adjust for inherent subgroup differences. The allocation sequence list will be maintained by the data management team (DMT) using a secure web-based system where assignments will be maintained and accessed by the CDSS. Pharmacists will only receive alerts for patients of physicians randomized to the intervention., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 625, type: ESTIMATED, armsInterventionsModule interventions name: Level A, interventions name: Level B, interventions name: Passive Alert, outcomesModule primaryOutcomes measure: Major Adverse Kidney Events within 30 days of randomization (MAKE30), secondaryOutcomes measure: Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge, secondaryOutcomes measure: AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3, secondaryOutcomes measure: Nephrotoxic burden, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UPMC Altoona, city: Altoona, state: Pennsylvania, zip: 16601, country: United States, geoPoint lat: 40.51868, lon: -78.39474, locations facility: UPMC Horizon, city: Farrell, state: Pennsylvania, zip: 16121, country: United States, geoPoint lat: 41.21228, lon: -80.49674, locations facility: UPMC McKeesport, city: McKeesport, state: Pennsylvania, zip: 15132, country: United States, geoPoint lat: 40.34785, lon: -79.86422, locations facility: UPMC Jameson, city: New Castle, state: Pennsylvania, zip: 16105, country: United States, geoPoint lat: 41.00367, lon: -80.34701, locations facility: UPMC Magee, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: UPMC Presbyterian/Montefiore, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: UPMC Shadyside, city: Pittsburgh, state: Pennsylvania, zip: 15232, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: UPMC Williamsport, city: Williamsport, state: Pennsylvania, zip: 17701, country: United States, geoPoint lat: 41.24119, lon: -77.00108, hasResults: False