Clinical trial NCT06264752: Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury
Official title: Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury (MEnD-AKI)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
drug-associated acute kidney injury
adverse drug event
pharmacist
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Florida
name: University of Pittsburgh Medical Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-02-20
Enrollment: 625
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, interventional controlled trial at eight hospitals within the UPMC health-system. Researchers will randomize 38 hospital service clusters to receive either: 1) a Cerner electronic medical record (EMR)-based AKI passive alert which is standard of care at UPMC: this alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management (Usual Care Arm); or 2) protocolized stage-based intervention delivered to the physician by a pharmacist for consideration and approval. Hospital service clusters will be allocated 1:1 to the intervention or usual care with a web-based system to maintain concealment using a randomized block design.
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial at eight hospitals within the University of Pittsburgh Medical Center-UPMC system. The project will assess the efficacy of a clinical surveillance system augmented with near real-time predictive analytics to support a pharmacist-led intervention delivered to attending physicians (primary service) to reduce the progression and complications of drug-associated acute kidney injury (D-AKI) in hospitalized (non-ICU) adults.

Detailed description: Researchers will randomize 38 hospital service clusters to receive either: 1) a Cerner electronic medical record (EMR)-based AKI passive alert which is standard of care at UPMC: this alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management (Usual Care Arm); or 2) protocolized stage-based intervention delivered to the physician by a pharmacist for consideration and approval. The intervention uses an automated alerting system to identify patients: 1) receiving a high-risk drug or drug combination associated with D-AKI and at low-risk for progression to either stage 2 AKI or stage 3 AKI per KDIGO criteria (Level A) and 2) patients without AKI or stage 1 AKI receiving a high-risk drug or drug combination associated with D-AKI and at high risk for progression to either stage 2 AKI or stage 3 AKI per KDIGO criteria, and patients with AKI stage 2 or stage 3 receiving a high-risk drug or drug combination associated with D-AKI or a medication that requires renal dose adjustment (Level B). This patient specific risk-profile will be coupled with recommendations for medication management and delivered to the physician by a pharmacist for consideration and approval. Additionally, the investigators will assess cost-effectiveness and physicians' perception of the pharmacist-led service.

The primary outcome is Major Adverse Kidney Events within 30 days of randomization (MAKE30), defined as defined as a composite of death, new kidney replacement therapy, or final serum creatinine ≥150% of reference at the earliest of hospital discharge or 30 days from study enrollment, whichever occurs first. Key secondary outcomes include: progression of AKI from time of Level B intervention (first alert generated) to hospital discharge, AKI intensity (duration of AKI by all stages, duration of AKI stage 2, and duration of AKI stage 3), and nephrotoxic burden.

Eligibility criteria: Inclusion Criteria:

Physician-subject Inclusion

* Physicians employed at UPMC hospital systems
* Attending physicians of record who care for patients across multiple units outside ICU/ED
* Physician cares for 1 or more patient receiving a system alert identifying high-risk for AKI

Patient-subject Inclusion

* System alert identifying risk for AKI
* Patient has attending physician who is participating in the randomized clusters
* After initial patient inclusion, an individual patient will not be eligible for re-inclusion until after 90 days. Re-inclusion will only be allowed if a separate hospital admission/encounter occurs and only starting on day 91

Exclusion Criteria:

Physician-subject Exclusion

* Physicians of record who only care for ICU or ED patients
* Physicians who primarily provide care for transplant (heart, kidney, liver, etc.) patients
* Physicians who primarily provide consult services only (dermatology, rehabilitation, etc.)

Patient-subject Exclusion

• Patients with end stage renal disease on admission, baseline eGFR \<15, comfort measures only, or died before the intervention could be delivered

Primary outcomes:
measure: Major Adverse Kidney Events within 30 days of randomization (MAKE30)
timeFrame: up to 30 days
Secondary outcomes:
measure: Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge
timeFrame: up to 30 days
measure: AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3
timeFrame: up to 30 days
measure: Nephrotoxic burden
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Altoona
country: United States
facility: UPMC Altoona
state: Pennsylvania
city: Farrell
country: United States
facility: UPMC Horizon
state: Pennsylvania
city: McKeesport
country: United States
facility: UPMC McKeesport
state: Pennsylvania
city: New Castle
country: United States
facility: UPMC Jameson
state: Pennsylvania
city: PIttsburgh
country: United States
facility: UPMC Magee
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian/Montefiore
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside
state: Pennsylvania
city: Williamsport
country: United States
facility: UPMC Williamsport
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sandra L Kane-Gill, PharmD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Azra Bihorac, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: