Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury

University of Pittsburgh698 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

698

Conditions

Acute Kidney Injury

Interventions

Level AOTHER

Pharmacy personnel will generate a general recommendation based on the AKI KDIGO management guidelines to the physician.

Level BOTHER

The pharmacist will make nephrotoxic/renally eliminated medication management recommendations to the attending physician (or designee). Recommendations may include stopping or changing a drug, changing dose or schedule, ordering laboratory tests, taking no action, or other. The pharmacist will record details of the interaction with the physician and whether recommendations were accepted.

Passive AlertOTHER

Passive Cerner alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

UPMC Altoona

Altoona, Pennsylvania, United States

UPMC Horizon

Farrell, Pennsylvania, United States

UPMC McKeesport

McKeesport, Pennsylvania, United States

UPMC Jameson

New Castle, Pennsylvania, United States

Outcomes

Primary Outcomes

Major Adverse Kidney Events within 30 days of randomization (MAKE30)

Composite of death, new kidney replacement therapy, or final serum creatinine greater than or equal to 150 percent of reference at the earliest of hospital discharge or 30 days from study enrollment, whichever occurs first.

Time frame: up to 30 days

Secondary Outcomes

Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge

Percentage of high-risk patients without AKI at the time of a first level B alert who subsequently progress to maximum AKI severity stages 1, 2, or 3 before hospital discharge or 30 days, whichever comes first. Percentage of high-risk patients diagnosed with stage-1 AKI at the time of a level B alert who subsequently progress to maximum severity stages 2 or 3 AKI before hospital discharge or 30 days, whichever comes first. Percentage of high-risk patients diagnosed with stage-2 AKI at the time of a level B alert who subsequently progress to maximum severity stage 3 AKI before hospital discharge or 30 days, whichever comes first.

Time frame: up to 30 days

AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3

AKI intensity rate (per 100 exposed patient-days) calculated as: number of days patients have AKI/ total number of AKI exposed patient-days standardized per 100 exposed days

Time frame: up to 30 days

Nephrotoxic burden

Drug.days\* in both study arms for those drugs considered possible/probable, probable and definitely related to AKI in adult, non-ICU patients. \*Drug.days calculation: each drug and each day of therapy increases the burden by 1 drug.day.

Time frame: up to 30 days

Data from ClinicalTrials.gov

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