NCT04040296

Personalized Recommendations for Acute Kidney Injury (AKI) Care

Personalized Recommendations for Acute Kidney Injury (AKI) Care Using a Kidney Action Team: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,003 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized clinical trial of a "Kidney Action Team", which will provide timely, personalized recommendations for the diagnosis and initial treatment of hospitalized patients with Acute Kidney Injury (AKI).

Detailed description

Acute Kidney Injury (AKI), defined as an abrupt loss in kidney function, is common, occurring in 5-20% of hospitalized patients, and carries a significant and independent risk of inpatient mortality. International guidelines for the treatment of AKI focus on "best practices" that include appropriate management of drug dosing, the avoidance of kidney-toxic exposures, and careful assessment of fluid and electrolyte balance. Early nephrologist involvement may also improve outcomes in AKI. However, AKI, which is often asymptomatic, is frequently overlooked in a variety of hospital settings and many "best practices" occur infrequently and inconsistently. The investigators previously conducted a randomized clinical trial testing the efficacy of electronic alerts for AKI, randomizing patients with AKI to usual care, or to an alert group in which a single alert was sent to the patient's primary provider. The study demonstrated clinical equipoise regarding the effectiveness of such alerting, as there was no improvement in the rates of AKI progression, dialysis or mortality among those in the alert group. Rather than simply making providers aware of AKI, it may be beneficial to provide them with actionable items to increase recognition and rate of best practices. Further, because of the heterogeneous nature of AKI, personalized recommendations tailored to individual patients that are delivered directly to the patient care team may improve AKI outcomes. The aim of this study is to determine, through a single-blind, parallel group, randomized controlled multicenter clinical trial, if personalized recommendations, as delivered by a Kidney Action Team, for the work-up and treatment of AKI will improve patient outcomes. The Kidney Action team will serve as a centralized, remote monitoring service and will consist of a group of highly trained individuals, including an advanced practitioner, a pharmacist and a board-certified nephrologist, dedicated to reviewing enrolled patient's charts and providing recommendations for patient diagnosis and initial work up and care within 60 minutes of AKI onset. Recommendations will span five domains of care, including diagnostic workup, acid/base management, electrolyte management, hemodynamic management, and medication management. Using the Kidney Disease: Improve Global Outcomes creatinine criteria, inpatients in sites of the Yale New Haven Health System and of the John Hopkins University Health System who develop AKI during the course of their hospitalization will be randomized to either receive usual care, or to an active intervention group in which the recommendations of the Kidney Action Team are delivered to the patient's primary care team in the form of a structured note in the electronic health record to be cosigned by the attending of record. The primary clinical outcome will be a composite of AKI progression, dialysis and death at 14 days post-randomization. The primary process outcome will be the percent of recommendations made that are enacted within 24 hours after randomization.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
OTHER	Kidney Action Team Recommendations	Upon review of the patient's medical information, the Kidney Action Team will create personalized recommendations that will be delivered to the patient's primary care team via a specialized note in the electronic medical record system within 2 hours of AKI detection. The attending of record will be identified as a cosigner to ensure that a member of the care team is made aware of the note's presence.

Timeline

• Start date: 2021-10-29
• Primary completion: 2024-02-22
• Completion: 2024-02-22
• First posted: 2019-07-31
• Last updated: 2025-07-17
• Results posted: 2025-07-17

Locations

1 site across 1 country: United States