Trial Outcomes & Findings for Optimizing Electronic Alerts for Acute Kidney Injury (NCT NCT02753751)

NCT ID: NCT02753751

Last Updated: 2022-02-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6030 participants
• Primary outcome timeframe: 14 days from randomization
• Results posted on: 2022-02-10

Participant Flow

From 3/29/2018 to 12/14/2019, 6,030 individuals met enrollment criteria and were randomized across 6 hospitals of a single healthcare system.

Participant milestones

Measure	Usual Care No alert will be fired.	Electronic AKI Alert A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves. 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.
Overall Study STARTED	2971	3059
Overall Study COMPLETED	2971	3059
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optimizing Electronic Alerts for Acute Kidney Injury

Baseline characteristics by cohort

Measure	Usual Care n=2971 Participants No alert will be fired.	Electronic AKI Alert n=3059 Participants A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves. 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.	Total n=6030 Participants Total of all reporting groups
Age, Continuous	71.3 years n=5 Participants	71 years n=7 Participants	71.2 years n=5 Participants
Sex: Female, Male Female	1440 Participants n=5 Participants	1442 Participants n=7 Participants	2882 Participants n=5 Participants
Sex: Female, Male Male	1531 Participants n=5 Participants	1617 Participants n=7 Participants	3148 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	289 Participants n=5 Participants	331 Participants n=7 Participants	620 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2664 Participants n=5 Participants	2712 Participants n=7 Participants	5376 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Asian	35 Participants n=5 Participants	40 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Black or African American	462 Participants n=5 Participants	484 Participants n=7 Participants	946 Participants n=5 Participants
Race (NIH/OMB) White	2208 Participants n=5 Participants	2234 Participants n=7 Participants	4442 Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment United States	2971 participants n=5 Participants	3059 participants n=7 Participants	6030 participants n=5 Participants
Medical Admission	2280 Participants n=5 Participants	2284 Participants n=7 Participants	4564 Participants n=5 Participants
ICU Patient	961 Participants n=5 Participants	962 Participants n=7 Participants	1923 Participants n=5 Participants
ER Patient	108 Participants n=5 Participants	93 Participants n=7 Participants	201 Participants n=5 Participants
Ward Patient	1902 Participants n=5 Participants	2004 Participants n=7 Participants	3906 Participants n=5 Participants
Hospital 1 (Urban, teaching)	1238 Participants n=5 Participants	1277 Participants n=7 Participants	2515 Participants n=5 Participants
Hospital 2 (Urban, teaching)	599 Participants n=5 Participants	649 Participants n=7 Participants	1248 Participants n=5 Participants
Hospital 3 (Urban, teaching)	456 Participants n=5 Participants	479 Participants n=7 Participants	935 Participants n=5 Participants
Hospital 4 (Suburban, teaching)	292 Participants n=5 Participants	275 Participants n=7 Participants	567 Participants n=5 Participants
Hospital 5 (Suburban, non-teaching)	278 Participants n=5 Participants	276 Participants n=7 Participants	554 Participants n=5 Participants
Hospital 6 (Suburban, non-teaching)	108 Participants n=5 Participants	103 Participants n=7 Participants	211 Participants n=5 Participants
Chronic Kidney Disease	1127 Participants n=5 Participants	1163 Participants n=7 Participants	2290 Participants n=5 Participants
Congestive Heart Failure	1307 Participants n=5 Participants	1351 Participants n=7 Participants	2658 Participants n=5 Participants
COPD	1015 Participants n=5 Participants	1049 Participants n=7 Participants	2064 Participants n=5 Participants
Diabetes Mellitus	1197 Participants n=5 Participants	1287 Participants n=7 Participants	2484 Participants n=5 Participants
Hypertension	2434 Participants n=5 Participants	2510 Participants n=7 Participants	4944 Participants n=5 Participants
Malignancy	471 Participants n=5 Participants	460 Participants n=7 Participants	931 Participants n=5 Participants
Depression	687 Participants n=5 Participants	655 Participants n=7 Participants	1342 Participants n=5 Participants
Liver Disease	397 Participants n=5 Participants	458 Participants n=7 Participants	855 Participants n=5 Participants
eGFR at admission (ml/min/1.73m2)	55.1 ml/min/1.73m2 n=5 Participants	55.8 ml/min/1.73m2 n=7 Participants	55.4 ml/min/1.73m2 n=5 Participants
Creatinine, mg/dL	1.5 mg/dL n=5 Participants	1.5 mg/dL n=7 Participants	1.5 mg/dL n=5 Participants
Nadir creatinine in 48 hrs prior to randomization, mg/dL	1.1 mg/dL n=5 Participants	1.1 mg/dL n=7 Participants	1.1 mg/dL n=5 Participants
Sodium, meq/L	138 meq/L n=5 Participants	138 meq/L n=7 Participants	138 meq/L n=5 Participants
Potassium, meq/L	4.2 meq/L n=5 Participants	4.2 meq/L n=7 Participants	4.2 meq/L n=5 Participants
Chloride, meq/L	102 meq/L n=5 Participants	102 meq/L n=7 Participants	102 meq/L n=5 Participants
Bicarbonate, meq/L	24 meq/L n=5 Participants	24 meq/L n=7 Participants	24 meq/L n=5 Participants
Anion Gap, meq/L	12 meq/L n=5 Participants	12 meq/L n=7 Participants	12 meq/L n=5 Participants
Blood Urea Nitrogen, mg/dL	28 mg/dL n=5 Participants	28 mg/dL n=7 Participants	28 mg/dL n=5 Participants
White Blood Cell Count, (cells*1000/ul)	9.8 cells*1000/uL n=5 Participants	9.8 cells*1000/uL n=7 Participants	9.8 cells*1000/uL n=5 Participants
Hemoglobin, g/dL	10.7 g/dL n=5 Participants	10.5 g/dL n=7 Participants	10.6 g/dL n=5 Participants
Platelet Count, (cells*1000/ul)	202.5 cells*1000/ul n=5 Participants	200 cells*1000/ul n=7 Participants	201 cells*1000/ul n=5 Participants
Contrast in prior 72 hours	586 Participants n=5 Participants	623 Participants n=7 Participants	1209 Participants n=5 Participants
Cardiothoracic surgery in prior 72 hours	110 Participants n=5 Participants	135 Participants n=7 Participants	245 Participants n=5 Participants
ACE inhibitor/ARB in prior 72 hours	626 Participants n=5 Participants	670 Participants n=7 Participants	1296 Participants n=5 Participants
NSAID in prior 72 hours	403 Participants n=5 Participants	388 Participants n=7 Participants	791 Participants n=5 Participants
PPI in prior 72 hours	684 Participants n=5 Participants	677 Participants n=7 Participants	1361 Participants n=5 Participants
Time from admission to randomization, hours	50.7 hours n=5 Participants	50.1 hours n=7 Participants	50.3 hours n=5 Participants
Time from AKI to randomization, hours	0.5 hours n=5 Participants	0.5 hours n=7 Participants	0.5 hours n=5 Participants
Unique providers reached	7 Providers n=5 Participants	7 Providers n=7 Participants	7 Providers n=5 Participants

PRIMARY outcome

Timeframe: 14 days from randomization

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.

Outcome measures

Measure	Usual Care n=2971 Participants No alert will be fired.	Electronic AKI Alert n=3059 Participants A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves. 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.
Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death	622 Participants	653 Participants

SECONDARY outcome

Timeframe: 14 days from randomization

14-day or inpatient mortality

Outcome measures

Measure	Usual Care n=2971 Participants No alert will be fired.	Electronic AKI Alert n=3059 Participants A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves. 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.
Mortality	265 Participants	272 Participants

SECONDARY outcome

Timeframe: 14 days from randomization

14-day, inpatient, or discharged on dialysis

Outcome measures

Measure	Usual Care n=2971 Participants No alert will be fired.	Electronic AKI Alert n=3059 Participants A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves. 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.
Dialysis	93 Participants	106 Participants

SECONDARY outcome

Timeframe: 14 days from randomization

Percent of patients who progress to stage 2 AKI and to stage 3 AKI

Outcome measures

Measure	Usual Care n=2971 Participants No alert will be fired.	Electronic AKI Alert n=3059 Participants A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves. 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.
AKI Progression	461 Participants	487 Participants

SECONDARY outcome

Timeframe: 14 days from randomization

Number of participants with AKI duration of <2 days, 2-<days, and 7+ days (Aki duration defined as time in days between AKI onset and AKI cessation during index hospitalization)

Outcome measures

Measure	Usual Care n=2971 Participants No alert will be fired.	Electronic AKI Alert n=3059 Participants A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves. 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.
AKI Duration <2 days	2108 Participants	2239 Participants
AKI Duration 2-<7 days	722 Participants	700 Participants
AKI Duration 7+ days	141 Participants	120 Participants

SECONDARY outcome

Timeframe: 30 days from randomization

Population: Data have not yet been collected.

30 day readmission rate

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Index hospitalization through discharge, up to one year

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.

Outcome measures

Measure	Usual Care n=2971 Participants No alert will be fired.	Electronic AKI Alert n=3059 Participants A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves. 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.
Index Hospitalization Cost Total Costs	19100 dollars Interval 9900.0 to 42500.0	20100 dollars Interval 10200.0 to 43600.0
Index Hospitalization Cost Direct Costs	10300 dollars Interval 5400.0 to 21900.0	10600 dollars Interval 5400.0 to 22800.0

SECONDARY outcome

Timeframe: 24 hours from randomization to discharge, up to one year

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.

Outcome measures

Measure	Usual Care n=2971 Participants No alert will be fired.	Electronic AKI Alert n=3059 Participants A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves. 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.
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization Aminoglycoside exposure among those already receiving aminoglycoside	8 Participants	5 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization NSAID exposure	166 Participants	144 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization NSAID exposure among those already receiving NSAIDs	129 Participants	103 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization ACE/ARB exposure	425 Participants	424 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization ACE/ARB exposure among those already receiving ACE/ARB	326 Participants	331 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization AKI documentation (at end of encounter)	1871 Participants	2141 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization IV fluid drip order	1034 Participants	1174 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization IV fluid bolus order	339 Participants	397 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization Urinalysis	444 Participants	519 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization Urine Output Measurement	2130 Participants	2242 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization Renal Consult (within 14 days)	517 Participants	541 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization Subsequent Creatinine Measurement (28 hours)	2532 Participants	2666 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization Contrast exposure	102 Participants	115 Participants
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization Aminoglycoside exposure	19 Participants	14 Participants

SECONDARY outcome

Timeframe: Index hospitalization

Population: Chart documentation via ICD-10 codes (code N17) have been collected. Documentation via chart adjudication has not yet been collected.

Proportion of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication

Outcome measures

Measure	Usual Care n=2971 Participants No alert will be fired.	Electronic AKI Alert n=3059 Participants A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves. 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.
Number of Subjects With Chart Documentation of AKI	1871 Participants	2141 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 265 deaths

Electronic AKI Alert

Serious events: 0 serious events

Other events: 0 other events

Deaths: 272 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Francis P. Wilson

Yale University

Phone: 2037376095

Email: francis.p.wilson@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place