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AKI Management Using Electronic Alerts

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ClinicalTrials.gov Identifier: NCT03538769
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Shina Menon, Seattle Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: electronic alert and clinical decision support system Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acute Kidney Injury: Integrating E-alerts and Clinical Decision Support System to Improve Outcomes
Actual Study Start Date : December 18, 2017
Actual Primary Completion Date : October 16, 2018
Actual Study Completion Date : October 16, 2018
Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  1. AKI documentation [ Time Frame: 28 days ]
    Documentation of AKI in progress notes and discharge summary


Secondary Outcome Measures :
  1. AKI progression [ Time Frame: 7 days ]
    Progression of AKI from Stage 1 to Stage 2/3


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538769


Locations
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United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shina Menon, Assistant Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03538769    
Other Study ID Numbers: STUDY00000811
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases