Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • PRECISE-AKI Clinical Decision Support Tool

    Other intervention

    The Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control (Usual Care)No intervention 0 interventions
Group B: PRECISION AKI Clinical Decision SupportExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 30 days

Secondary outcomes

Other outcomes

1

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.

Time frame
During Index Hospitalization through 30 days
2

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.

Time frame
Last serum creatinine during index hospitalization through 30 days
3

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.

Time frame
90 days

Sponsors and contacts

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VA Office of Research and Development

Lead sponsor

VA Tennessee Valley Health Care System

Collaborator

Vanderbilt University Medical Center

Collaborator

This trial is not recruiting at the moment. You can still explore other options: