Personalised recommendations for hospitalised patients with Acute Kidney Injury using a Kidney Action Team (KAT-AKI): protocol and early data of a randomised controlled trial

Abstract

Introduction: Although studies have examined the utility of clinical decision support tools in improving acute kidney injury (AKI) outcomes, no study has evaluated the effect of real-time, personalised AKI recommendations. This study aims to assess the impact of individualised AKI-specific recommendations delivered by trained clinicians and pharmacists immediately after AKI detection in hospitalised patients.

Methods and analysis: KAT-AKI is a multicentre randomised investigator-blinded trial being conducted across eight hospitals at two major US hospital systems planning to enrol 4000 patients over 3 years (between 1 November 2021 and 1 November 2024). A real-time electronic AKI alert system informs a dedicated team composed of a physician and pharmacist who independently review the chart in real time, screen for eligibility and provide combined recommendations across the following domains: diagnostics, volume, potassium, acid-base and medications. Recommendations are delivered to the primary team in the alert arm or logged for future analysis in the usual care arm. The planned primary outcome is a composite of AKI progression, dialysis and mortality within 14 days from randomisation. A key secondary outcome is the percentage of recommendations implemented by the primary team within 24 hours from randomisation. The study has enrolled 500 individuals over 8.5 months. Two-thirds were on a medical floor at the time of the alert and 17.8% were in an intensive care unit. Virtually all participants were recommended for at least one diagnostic intervention. More than half (51.6%) had recommendations to discontinue or dose-adjust a medication. The median time from AKI alert to randomisation was 28 (IQR 15.8-51.5) min.

Ethics and dissemination: The study was approved by the ethics committee of each study site (Yale University and Johns Hopkins institutional review board (IRB) and a central IRB (BRANY, Biomedical Research Alliance of New York). We are committed to open dissemination of the data through clinicaltrials.gov and sharing of data on an open repository as well as publication in a peer-reviewed journal on completion.

Trial registration number: NCT04040296.

Keywords: Acute renal failure; Adult nephrology; INTENSIVE & CRITICAL CARE; Nephrology; Quality in health care.

Figure 1

Trial design of personalised recommendations for AKI care using a KAT trial. The KAT-AKI trial is a 3-year randomised controlled trial that plans to screen and enrol 4000 patients in real time to assess the impact of personalised recommendations for early AKI. The inclusion and exclusion criteria and primary outcomes are shown. AKI, acute kidney injury; CKD, chronic kidney disease; EHR, electronic health record; ESKD, end-stage kidney disease; KAT, Kidney Action Team; KAT-AKI, Acute Kidney Injury Using a Kidney Action Team; KDIGO, Kidney Disease: Improving Global Outcomes; sCr, serum creatinine.

Figure 2

Physician recommendation form structure. Potassium and acid–base recommendations are shown with various options in a checkbox format including options for free text and no recommendation. The note generated is composed of the text associated with checkboxes as well as free texts.

Figure 3

Example of Kidney Action Team recommendation alert. This recommendation alert text is automatically generated within REDCap by combining the physician and pharmacist recommendations for those that randomise to intervention. The note will then be entered into the patient’s electronic health record as a progress note. ABG, arterial blood gas; AKI, acute kidney injury; DVT, deep vein thrombosis; REDCap, Research Electronic Data Capture; VBG, venous blood gas.