Effectiveness-Implementation Evaluation of Acute Kidney Injury Decision Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transforming Kidney Care in the Emergency Department: A Prospective Effectiveness-Implementation Evaluation
Overview
Study Purpose: This study is testing an artificial intelligence (AI)-powered clinical decision support (CDS) system designed to help emergency department (ED) doctors detect and manage acute kidney injury (AKI) earlier. The goal is to see whether the tool improves patient care, clinician decision-making, and hospital outcomes when used in real-world ED settings. Study Design: The AI tool will be gradually introduced at three hospital EDs: Johns Hopkins Hospital (JHH) Bayview Medical Center (BMC) Howard County General Hospital (HCGH) Before the tool is activated, it will run in the background to collect baseline data without influencing care. Once implemented, doctors will receive training, and researchers will track how often the tool is used and whether it improves AKI care. What the Study Measures: Process Outcomes: Does the tool help doctors identify AKI sooner, avoid harmful medications, and improve decision-making about hospitalization? Clinical Outcomes: Does the tool reduce the number and severity of AKI cases and improve kidney-related health outcomes? Implementation Outcomes: Do ED doctors find the tool useful? Does it fit into the ED doctor's workflow without slowing the ED doctor's down? Expected Impact: If successful, the AI tool could be expanded to other hospitals and used to improve early detection and treatment of AKI, reducing kidney complications and improving patient care nationwide.
Primary outcome measures
- Number of Patients who receive Guideline-Concordant Kidney Care [Time frame: From time of decision support provision until departure from the ED, approximately 6 hours]
Secondary outcome measures (2)
- New or Progressive Acute Kidney Injury [Time frame: Within 72 hours of first creatinine measurement in the ED]
- Perceived usefulness and usability of AKIDS software as assessed by the System Usability Score [Time frame: Prior to AKIDS implementation, immediately after implementation, and post implementation 6 months]
Eligibility criteria
Inclusion criteria
Participants must meet all of the following conditions to be eligible for the study:
- Emergency Department Visit
Patients presenting to one of the three study site emergency departments (EDs):
Johns Hopkins Hospital (JHH) Bayview Medical Center (BMC) Howard County General Hospital (HCGH) Serum Creatinine Measurement
- At least one serum creatinine (sCr) test performed during the ED visit.
- Age: Adults (≥18 years old) at the time of ED visit.
- Follow-Up Data Available: To be included in analysis for the investigator's secondary effectiveness outcome (new or progressive AKI) patients must have repeat creatinine concentration measurement available within 72 hours
Exclusion criteria
- No ED Serum Creatinine Data: Patients who do not have a measured serum creatinine (sCr) value during the ED visit will not have decision support provided during the ED stay.
- Patients Discharged Without Follow-Up Data: Patients discharged from the ED who do not undergo a follow-up serum creatinine test within 72 hours will be excluded from analysis of new or progressive AKI outcome assessment.
- Age <18 Years
- End-Stage Kidney Disease (ESKD) or Chronic Dialysis: Patients with a documented history of end-stage kidney disease (ESKD), (patients receiving chronic dialysis (hemodialysis or peritoneal dialysis) will will be excluded from analysis of new or progressive AKI outcome assessment).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Johns Hopkins Hospital — Baltimore
Identifiers
NCT: NCT06840210 · IRB00367884 · R01HS027793