Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury (PRECISE-AKI)

Acute kidney injury (AKI) affects up to 20% of hospitalized Veterans and is strongly associated with morbidity and death. AKI is a diverse condition and timely and accurate diagnosis of the type of AKI is critical to begin appropriate therapies, especially those causes that require specific treatments beyond general supportive care. Yet, there are still significant gaps in the initial evaluation of AKI among hospitalized patients. Clinical decision support systems (CDSS) have shown promise to address these barriers, but most consist of simple alerting schemes and general care recommendations provided at a single point in time. The goal of this proposal is to develop and test the feasibility and usability of a rule-based and Artificial Intelligence-assisted precision CDSS tool (PRECISE-AKI) that can provide cognitive support to improve timely initial diagnostic evaluation of AKI.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Kidney Injury (AKI)
• Intervention / Treatment: Other: PRECISE-AKI Clinical Decision Support Tool

Detailed Description

Acute kidney injury (AKI), defined as a sudden loss of kidney function, affects up to 20% of hospitalized Veterans and is strongly associated with chronic kidney disease, poor quality of life, and death. Clinical practice guidelines recommend timely identification of the cause of AKI, but gaps remain in conducting the initial and subsequent diagnostic evaluation. Some causes of AKI also require specific treatments beyond supportive care, can be challenging to diagnose, and can require even more detailed evaluation including kidney biopsies. This clinical trial will evaluate the usability and feasibility of an Artificial Intelligence (AI)-assisted automated and comprehensive precision CDSS tool (PRECISE-AKI) to provide iterative cognitive support of general and nephrology-based providers in the diagnostic evaluation of hospitalized patients experiencing AKI within the Tennessee Valley Health Systems (TVHS). The investigators hypothesize that PRECISE-AKI will be acceptable, appropriate, and feasible to a variety of users and improve the diagnostic evaluation of hospitalized patients AKI.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward D Siew, MD MSc; Phone Number: (615) 343-1279; Email: Edward.siew@va.gov
• Study Contact Backup: Name: Michael E Matheny, MD MS MPH; Phone Number: (615) 936-0090; Email: Michael.Matheny@va.gov

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212-2637
      • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
      • Contact: Michele Lenoue-Newton, PhD; Phone Number: (615) 936-6728; Email: michele.lenoue-newton@va.gov
      • Principal Investigator: Edward D Siew, MD MSc
      • Principal Investigator: Michael E Matheny, MD MS MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible providers will be those that have at least 4 weeks of inpatient ward team or consultation team activity during a 12-month period.
• Case inclusion criteria will consist of hospitalizations that meet criteria for Kidney Disease Improving Global Outcomes Stage 2 injury or persistent Stage 1 injury seen by eligible providers.

Exclusion Criteria:

• Ineligible providers will be those that have < 4 weeks of inpatient ward team of consultative team activity during a 12 month period.
• Hospitalizations with non-persistent (<48 hours) stage 1 injury or less.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (Usual Care); The Control arm will consist of usual care with no additional clinical decision support tool guidance
Experimental: PRECISION AKI Clinical Decision Support; The Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool	Other: PRECISE-AKI Clinical Decision Support Tool; The Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Appropriate Diagnostic Testing	Based on the presenting context, the investigators will compare rates of appropriate diagnostic testing between intervention and control patients among those meeting the AKI case definition	Up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Clinical Outcome: Peak Kidney Disease Improving Global Outcomes (KDIGO) AKI Stage during hospitalization.	For this exploratory clinical outcome, we will compare differences in the peak KDIGO AKI Stage (creatinine-based criteria) during hospitalization after meeting the case definition of AKI between intervention and control cases.	During Index Hospitalization through 30 days
Exploratory Clinical Outcome: Discharge serum creatinine	The investigators will compare differences in the hospital discharge serum creatinine after meeting the case definition of AKI between intervention and control cases.	Last serum creatinine during index hospitalization through 30 days
Exploratory Clinical Outcome: Major Adverse Kidney Events (MAKE) 90	For this exploratory clinical outcome, the investigators will compare the rates of the major adverse kidney events experienced by eligible AKI cases in the intervention compared with the control arm. Major Adverse Kidney Events will be defined as kidney replacement therapy, death, or an increase in baseline serum creatinine of 150% of baseline using the last serum creatinine available up to 90 days.	90 days

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Vanderbilt University Medical Center; VA Tennessee Valley Health Care System
• Investigators: Principal Investigator: Edward D Siew, MD MSc, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN; Principal Investigator: Michael E Matheny, MD MS MPH, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: October 6, 2025
• First Submitted That Met QC Criteria: October 15, 2025
• First Posted (Estimated): October 16, 2025

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Acute Kidney Injury; Decision Support Systems, Clinical
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: HSR3-017-24W

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No