AKI Management Using Electronic Alerts

Acute Kidney Injury: Integrating E-alerts and Clinical Decision Support System to Improve Outcomes

Acute kidney injury (AKI) is a common clinical event with severe consequences. In the United States alone, greater than one million hospitalized patients per year are diagnosed with AKI. It has been independently associated with prolonged hospital stays, 25-80% risk of in-hospital death, and future progression to chronic kidney disease. While there has been an increase in awareness about the prevalence and significance of AKI, studies have uncovered systematic failure in the management of AKI, largely relating to the failure of clinicians to recognize and manage the condition appropriately. This is where we can use electronic health records (EHRs) and electronic alerts (e-alerts) to our advantage. In this study, the investigators plan to use e-alerts integrated into a clinical decision support (CDS) system to improve the care of and outcomes of patients with AKI. The aims are to study the prevalence of AKI and its progression among hospitalized patients using an 'AKI sniffer' (an EHR based automated system) and to prospectively study if introducing a complex intervention (an e-alert combined with a clinical decision support system) will reduce progression of AKI in children. The investigators have developed an AKI care bundle which provides simple guidelines for management of AKI along with specific discharge instructions to improve follow up care. The primary outcome is AKI progression. Secondary outcomes include morbidity, mortality, length of hospital stay, need for renal replacement therapy, and recovery of renal function by time of hospital discharge. The investigators will also look at documentation of AKI and if these participants get appropriate follow up.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: electronic alert and clinical decision support system

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All patients between 6 months-18 years admitted to the surgical and medical floors of Seattle Children's Hospital

Exclusion Criteria:

1. History of chronic kidney disease stage 4 or worse (i.e., patients on chronic renal replacement therapy or glomerular filtration rate < 30 mL/min/1.73 m2)
2. History of renal transplantation within the last 3 months
3. History of nephrectomy within last 3 months
4. Patients admitted to observation units

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline group; This will be the pre and post alert phase where e-alerts will not be sent to providers
Other: Alert group; This will be the phase when e-alerts will be sent to the provider	Other: electronic alert and clinical decision support system; Providers taking care of patients will receive an electronic alert and will be guided to use a clinical decision support system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AKI documentation	Documentation of AKI in progress notes and discharge summary	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AKI progression	Progression of AKI from Stage 1 to Stage 2/3	7 days

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital

Publications and helpful links

General Publications

• Menon S, Tarrago R, Carlin K, Wu H, Yonekawa K. Impact of integrated clinical decision support systems in the management of pediatric acute kidney injury: a pilot study. Pediatr Res. 2021 Apr;89(5):1164-1170. doi: 10.1038/s41390-020-1046-8. Epub 2020 Jul 3.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): October 16, 2018
• Study Completion (Actual): October 16, 2018

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: STUDY00000811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No