Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury (MEnD-AKI)
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About
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.
Full 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.
Enrollment
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Volunteers
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
Trial design
Primary purpose
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Interventional model
Masking
698 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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