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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2028-01-01

Study Completion Date

2029-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Kidney Injury (AKI)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Pre-/Post- design

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

It is not possible to blind clinicians. Study data will be extracted by staff blinded to assignment.

Study Groups

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Control (Usual Care)

The Control arm will consist of usual care with no additional clinical decision support tool guidance

Group Type NO_INTERVENTION

No interventions assigned to this group

PRECISION AKI Clinical Decision Support

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

Group Type EXPERIMENTAL

PRECISE-AKI Clinical Decision Support Tool

Intervention Type OTHER

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

Interventions

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PRECISE-AKI Clinical Decision Support Tool

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

Intervention Type OTHER

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No