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| Name | Class |
|---|---|
| VA Tennessee Valley Health Care System | FED |
| Vanderbilt University Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Usual Care) | No Intervention | The Control arm will consist of usual care with no additional clinical decision support tool guidance | |
| PRECISION AKI Clinical Decision Support | Experimental | The Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRECISE-AKI Clinical Decision Support Tool | Other | The Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool |
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| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward D Siew, MD MSc | Contact | (615) 343-1279 | Edward.siew@va.gov | |
| Michael E Matheny, MD MS MPH | Contact | (615) 936-0090 | Michael.Matheny@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Valley Healthcare System Nashville Campus, Nashville, TN | Nashville | Tennessee | 37212-2637 | United States |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Pre-/Post- design
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It is not possible to blind clinicians. Study data will be extracted by staff blinded to assignment.
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |