Learning Alerts for Acute Kidney Injury
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|ClinicalTrials.gov Identifier: NCT02786277|
Recruitment Status : Not yet recruiting
First Posted : May 30, 2016
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Other: Alert||Not Applicable|
Acute kidney injury (AKI) carries a significant, independent risk of mortality among hospitalized patients. Recent studies have demonstrated increased mortality among patients with even small increases in serum creatinine concentration. International guidelines for the treatment of AKI focus on appropriate management of drug dosing, avoiding nephrotoxic exposures, and careful attention to fluid and electrolyte balance. Early nephrologist involvement may also improve outcomes in AKI. Without appropriate provider recognition of AKI, however, none of these measures can be taken, and patient outcomes may suffer. AKI is frequently overlooked by clinicians, but carries a substantial cost, morbidity and mortality burden.
The investigators conducted a pilot, randomized trial of electronic alerts for acute kidney injury in 2014. The trial, which randomized 2400 patients with AKI as defined by an increase in creatinine of 0.3mg/dl over 48 hours or 50% over 7 days, found that alerting physicians to the presence of AKI did not improve the course of acute kidney injury, reduce dialysis or death rates. However this study was conducted in a single hospital, and the alert itself did not describe specific actions that a provider could take. In the present proposal, the investigators seek to expand upon their prior study to determine both the modes of alerting that would be most effective and to determine if targeting alerts (such as to patients on medications that may worsen acute kidney injury) will improve effectiveness.
This study will be a randomized, controlled trial of an electronic AKI alert system. Using the Kidney Disease: Improve Global Outcomes creatinine criteria, inpatients at several hospitals will be randomized to usual care versus electronic alerting. Over three separate study intervals, uplift models will be created to identify clusters of patients expected to benefit most from alerting, and randomization will be tailored to that group.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Uplift Modeling to More Narrowly Target Alerts for Acute Kidney Injury|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
No Intervention: Usual Care
No alert will be fired
An alert informing the provider of acute kidney injury will be fired.
An alert informing the provider of the presence of acute kidney injury will be fired.
- Proportion of patients with progression to a higher stage of AKI OR Dialysis OR Death [ Time Frame: 14 days from randomization ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786277
|Contact: Francis P Wilson, MD MSCEfirstname.lastname@example.org|