Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury (MEnD-AKI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 698
- 试验地点
- 16
- 主要终点
- Major Adverse Kidney Events within 30 days of randomization (MAKE30)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statisticians performing the analysis will be blinded to the treatment allocation.
The investigators will randomize clusters to intervention and control within strata defined hospitals to adjust for inherent subgroup differences. The allocation sequence list will be maintained by the data management team (DMT) using a secure web-based system where assignments will be maintained and accessed by the CDSS. Pharmacists will only receive alerts for patients of physicians randomized to the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Major Adverse Kidney Events within 30 days of randomization (MAKE30)
时间窗: up to 30 days
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.
次要结局
- Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge(up to 30 days)
- Nephrotoxic burden(up to 30 days)
- AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3(up to 30 days)
研究者
Sandra Kane-Gill, PharmD, MSc, FCCP, FCCM
Professor of Pharmacy, Department of Pharmacy and Therapeutics
University of Pittsburgh