Clinical trial NCT02753751: Optimizing Electronic Alerts for Acute Kidney Injury
Official title: Optimizing Electronic Alerts for Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-04-28
Enrollment: 6030
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them to usual care versus an electronic alert coupled to a "best practices" order set.

Detailed description: 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. The primary outcome will be a composite of progression of acute kidney injury, dialysis and death.

Eligibility criteria: Inclusion Criteria:

* Adult ≥ 18 years admitted to a participating study hospital
* Acute Kidney Injury as defined by KDIGO consensus creatinine criteria (0.3mg/dl increase in serum creatinine over 48 hours or 50% relative increase over 7 days).

Exclusion Criteria:

* ESKD diagnosis code
* Dialysis order prior to AKI onset
* Initial creatinine \>=4.0mg/dl
* Prior admission in which patient was randomized.
* Admission to hospice service or comfort measures only order
* Kidney transplant within 6 months

Primary outcomes:
measure: Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death
timeFrame: 14 days from randomization
Secondary outcomes:
measure: Mortality
timeFrame: 14 days from randomization
measure: Dialysis
timeFrame: 14 days from randomization
measure: AKI Progression
timeFrame: 14 days from randomization
measure: AKI Duration
timeFrame: 14 days from randomization
measure: Readmission Rate
timeFrame: 30 days from randomization
measure: Index Hospitalization Cost
timeFrame: Index hospitalization through discharge, up to one year
measure: Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
timeFrame: 24 hours from randomization to discharge, up to one year
measure: Number of Subjects With Chart Documentation of AKI
timeFrame: Index hospitalization
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Francis P Wilson, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, Feldman HI, Fernandez H, Gitelman Y, Lin J, Negoianu D, Parikh CR, Reese PP, Urbani R, Fuchs B. Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet. 2015 May 16;385(9981):1966-74. doi: 10.1016/S0140-6736(15)60266-5. Epub 2015 Feb 26.
citation: Wilson FP, Martin M, Yamamoto Y, Partridge C, Moreira E, Arora T, Biswas A, Feldman H, Garg AX, Greenberg JH, Hinchcliff M, Latham S, Li F, Lin H, Mansour SG, Moledina DG, Palevsky PM, Parikh CR, Simonov M, Testani J, Ugwuowo U. Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial. BMJ. 2021 Jan 18;372:m4786. doi: 10.1136/bmj.m4786.
citation: Mutter M, Martin M, Yamamoto Y, Biswas A, Etropolski B, Feldman H, Garg A, Gourlie N, Latham S, Lin H, Palevsky PM, Parikh C, Moreira E, Ugwuowo U, Wilson FP. Electronic Alerts for Acute Kidney Injury Amelioration (ELAIA-1): a completely electronic, multicentre, randomised controlled trial: design and rationale. BMJ Open. 2019 Jun 1;9(5):e025117. doi: 10.1136/bmjopen-2018-025117.