Effectiveness-Implementation Evaluation of Acute Kidney Injury Decision Support

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

Total Enrollment

200000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2030-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Injury

Keywords

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Acute Kidney Injury AKI Prediction Machine Learning Emergency Department Clinical Decision Support

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All adult ED patients with creatinine concentration measured during the participant's ED stay

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Participants must meet all of the following conditions to be eligible for the study:

1. 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
2. At least one serum creatinine (sCr) test performed during the ED visit.
3. Age: Adults (≥18 years old) at the time of ED visit.
4. 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

1. 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.
2. 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.
3. Age \<18 Years
4. 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremiah Hinson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Central Contacts

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Jeremiah S Hinson, MD, PhD

Role: CONTACT

Phone: 646-707-1592

Email: [email protected]

Other Identifiers

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R01HS027793

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

IRB00367884

Identifier Type: -

Identifier Source: org_study_id