AKI Management Using Electronic Alerts
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electronic alert and clinical decision support system
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
All patients between 6 months-18 years admitted to the surgical and medical floors of Seattle Children's Hospital
Exclusion Criteria:
- 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)
- History of renal transplantation within the last 3 months
- History of nephrectomy within last 3 months
- Patients admitted to observation units
Sites / Locations
- Seattle Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Baseline group
Alert group
Arm Description
This will be the pre and post alert phase where e-alerts will not be sent to providers
This will be the phase when e-alerts will be sent to the provider
Outcomes
Primary Outcome Measures
AKI documentation
Documentation of AKI in progress notes and discharge summary
Secondary Outcome Measures
AKI progression
Progression of AKI from Stage 1 to Stage 2/3
Full Information
NCT ID
NCT03538769
First Posted
May 15, 2018
Last Updated
April 2, 2019
Sponsor
Seattle Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03538769
Brief Title
AKI Management Using Electronic Alerts
Official Title
Acute Kidney Injury: Integrating E-alerts and Clinical Decision Support System to Improve Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
October 16, 2018 (Actual)
Study Completion Date
October 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baseline group
Arm Type
No Intervention
Arm Description
This will be the pre and post alert phase where e-alerts will not be sent to providers
Arm Title
Alert group
Arm Type
Other
Arm Description
This will be the phase when e-alerts will be sent to the provider
Intervention Type
Other
Intervention Name(s)
electronic alert and clinical decision support system
Intervention Description
Providers taking care of patients will receive an electronic alert and will be guided to use a clinical decision support system
Primary Outcome Measure Information:
Title
AKI documentation
Description
Documentation of AKI in progress notes and discharge summary
Time Frame
28 days
Secondary Outcome Measure Information:
Title
AKI progression
Description
Progression of AKI from Stage 1 to Stage 2/3
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients between 6 months-18 years admitted to the surgical and medical floors of Seattle Children's Hospital
Exclusion Criteria:
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)
History of renal transplantation within the last 3 months
History of nephrectomy within last 3 months
Patients admitted to observation units
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32620006
Citation
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.
Results Reference
derived
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AKI Management Using Electronic Alerts
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