Clinical trial NCT02771977: Drug-Targeted Alerts for Acute Kidney Injury
Official title: Drug-Targeted 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: 2016-05-13
Enrollment: 5060
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this trial, patients with acute kidney injury who have recently received a drug that may affect kidney function will be randomized to having an alert placed in the electronic health record or usual care.

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.

Our research group recently conducted a large-scale multicenter randomized controlled trial of electronic alerts for AKI throughout the Yale New Haven Health System from 2018 to 2020. The trial, which enrolled 6,030 patients with AKI, randomized patients between usual care and an intervention group whereby providers received a general AKI alert informing them to the presence of AKI and the patient's recent creatinine trends, and provided a link to an AKI-specific order set. Our study showed that, overall, alerting physicians to the presence of AKI did not demonstrate a difference in the rate of our primary outcome of progression of AKI, dialysis, or death, nor were there any differences in process measures accessed (i.e. provider actions) between the two groups, however, there was substantial heterogeneity among the study sites. Given the highly heterogenous nature of AKI, a more personalized approach may be warranted. Further, this study enrolled all patients who developed AKI rather than a targeted subset of patients who may benefit, such as those AKI patients receiving potentially harmful kidney-toxic medications. In the present proposal, we seek to expand upon our prior study to determine if the use of medication targeted electronic alerts will modify provider behavior, particularly in regards to nephrotoxic medication use and cessation, in the care of hospitalized patients with AKI and/or reduce the rates of progression to AKI, dialysis, or mortality in hospitalized patients.

The current study is a randomized, controlled trial of a medication-targeted electronic AKI alert system. Using the Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria, inpatients at 4 different teaching hospitals of the Yale New Haven Health System that have had at least one dose of a nephrotoxic agent of interest within 24 hours of AKI onset will be randomized to either usual care or a medication-targeted alert that informs the provider of the presence of AKI and the patient's recent exposures to the targeted classes of medications with an option to discontinue. The primary outcome will be a composite of AKI progression, dialysis, or mortality within 14 days of randomization. Secondary outcomes will focus on the rate of cessation of any medication of interest within 24 hours of randomization and various other best practice metrics.

Eligibility criteria: Inclusion Criteria:

* Acute Kidney Injury based upon the Kidney Disease: Improving Global Outcomes creatinine criteria (a 0.3mg/dl increase over 48 hours or 50% increase over 7 days) and an active order within the past 24 hours to one of the following classes of medications:
* Non-steroidal anti-inflammatory drug
* Renin Angiotensin Aldosterone System Antagonists
* Proton Pump Inhibitors

Exclusion Criteria:

* Dialysis order prior to AKI onset
* Previous randomization
* Admission to a hospice service or CMO
* First hospital creatinine \>=4.0 mg/dl
* ESKD diagnosis code
* Kidney transplant within six months prior to randomization

Primary outcomes:
measure: Percentage of Patients With Progression of AKI OR Dialysis OR Death
timeFrame: 14 days from Randomization
Secondary outcomes:
measure: Percentage of Patients for Whom Any One of the Targeted Medications is Discontinued
timeFrame: Assessed within 24 hours from randomization
measure: 14- Day Mortality Rate
timeFrame: Assessed from date of randomization to date of death from any cause, within 14 days of randomization
measure: Inpatient Mortality Rate
timeFrame: Assessed from point of randomization to the date of death from any cause during the end of current index hospitalization, up to 365 days
measure: Percentage of Patients Who Receive Dialysis Within 14 Days of Randomization
timeFrame: Assessed from point of randomization to date of first documented dialysis order, within 14 days of randomization
measure: Percentage of Patients on Inpatient Dialysis
timeFrame: Assessed from point of randomization to the date of first documented dialysis order during index hospitalization, up to 365 days
measure: Percentage of Patients Discharged on Dialysis
timeFrame: Assessed at the point of discharge from index hospitalization, up to 365 days post randomization
measure: Percentage of Patients With AKI Progression From Stage 1 to Stage 2
timeFrame: Assessed from date of randomization to date of documented AKI progression, within 14 days of randomization
measure: Percentage of Patients With AKI Progression From Stage 2 to Stage 3
timeFrame: Assessed from date of randomization to date of documented AKI progression, within 14 days of randomization
measure: AKI Duration
timeFrame: Assessed from the point of randomization to the point of AKI cessation during index hospitalization, up to 365 days
measure: Readmission Rate
timeFrame: Within 30 days of index hospitalization discharge
measure: Index Hospitalization Cost
timeFrame: Assessed from point of randomization to the date of discharge from index hospitalization, up to 365 days post randomization
measure: Percentage of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
timeFrame: Assessed from 24 hours from randomization up to discharge of index hospitalization
measure: Percentage of Subjects With Chart Documentation of AKI
timeFrame: Assessed from time of randomization through to date of index hospitalization discharge, up to 365 days post randomization
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
References: