Optimizing Electronic Alerts for Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:

Optimizing Electronic Alerts for Acute Kidney Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753751
• Other study ID #: 1604017596
• Secondary ID: YALEAKIALERT1R01
• Status: Completed
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: January 6, 2020

Study information

• Verified date: January 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6030
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• AKI Alert
Provider's will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death	Progression of AKI is defined by an increase in KDIGO creatinine stage from that present at the time of randomization.; Dialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments (for the purpose of volume removal) will not be included.; Mortality will be determined from hospital administrative records.	14 days from randomization
Secondary	Mortality	14-day or inpatient mortality	14 days from randomization
Secondary	Dialysis	14-day, inpatient, or discharged on dialysis	14 days from randomization
Secondary	AKI Progression	Percent of patients who progress to stage 2 AKI and to stage 3 AKI	14 days from randomization
Secondary	AKI Duration	Number of participants with AKI duration of <2 days, 2-	14 days from randomization
Secondary	Readmission Rate	30 day readmission rate	30 days from randomization
Secondary	Index Hospitalization Cost	Cost of index hospitalization, measured in direct and total costs. Direct costs reflect those associated with direct patient contact involving billable services (for example lab, nursing costs, and supplies). Total costs also include non-billable support services such as medical records, human resources, accounting, support staff, utilities and dietary costs.	Index hospitalization through discharge, up to one year
Secondary	Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization	Best practices assessed include: Avoidance of nephrotoxins (cessation of order or absence of de novo order of IV contrast agent, aminoglycoside, NSAID, or ACE inhibitor within 24 hours of randomization), fluid administration (administration of fluids within 24 hours of randomization), urinalysis order (with or without microscopy within 24 hours of randomization), documentation of AKI (by ICD-9 and ICD-10 codes during index hospitalization), monitoring of creatinine (at least one serum creatinine measurement occurring within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization.; Each metric above is binary. Outcome is reported as a composite best practice outcome representing the proportion of best practices achieved per subject.	24 hours from randomization to discharge, up to one year
Secondary	Number of Subjects With Chart Documentation of AKI	Proportion of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication	Index hospitalization

External Links

•   This link is displayed on the alert and is our clinical trial study website. It contains information about the trial, describes AKI best practices, and provides contact information.