search
Back to results

Optimizing Electronic Alerts for Acute Kidney Injury

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AKI Alert
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Electronic AKI Alert

Arm Description

No alert will be fired.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality
14-day or inpatient mortality
Dialysis
14-day, inpatient, or discharged on dialysis
AKI Progression
Percent of patients who progress to stage 2 AKI and to stage 3 AKI
AKI Duration
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)
Readmission Rate
30 day readmission rate
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.
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.
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

Full Information

First Posted
April 25, 2016
Last Updated
January 18, 2022
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT02753751
Brief Title
Optimizing Electronic Alerts for Acute Kidney Injury
Official Title
Optimizing Electronic Alerts for Acute Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
January 6, 2020 (Actual)
Study Completion Date
January 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6030 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No alert will be fired.
Arm Title
Electronic AKI Alert
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
AKI Alert
Intervention Description
Provider's will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.
Primary Outcome Measure Information:
Title
Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death
Description
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.
Time Frame
14 days from randomization
Secondary Outcome Measure Information:
Title
Mortality
Description
14-day or inpatient mortality
Time Frame
14 days from randomization
Title
Dialysis
Description
14-day, inpatient, or discharged on dialysis
Time Frame
14 days from randomization
Title
AKI Progression
Description
Percent of patients who progress to stage 2 AKI and to stage 3 AKI
Time Frame
14 days from randomization
Title
AKI Duration
Description
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)
Time Frame
14 days from randomization
Title
Readmission Rate
Description
30 day readmission rate
Time Frame
30 days from randomization
Title
Index Hospitalization Cost
Description
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.
Time Frame
Index hospitalization through discharge, up to one year
Title
Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization
Description
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.
Time Frame
24 hours from randomization to discharge, up to one year
Title
Number of Subjects With Chart Documentation of AKI
Description
Proportion of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication
Time Frame
Index hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis P Wilson, MD MSCE
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified aggregate data for the primary and secondary outcomes will be made available.
IPD Sharing Time Frame
Data will be available within one year of completion.
Citations:
PubMed Identifier
25726515
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.
Results Reference
background
PubMed Identifier
33461986
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.
Results Reference
derived
PubMed Identifier
31154298
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.
Results Reference
derived
Links:
URL
http://akistudy.org
Description
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.

Learn more about this trial

Optimizing Electronic Alerts for Acute Kidney Injury

We'll reach out to this number within 24 hrs