Clinical trial NCT01134900: Achieving Medication Safety During Acute Kidney Injury
Official title: Achieving Medication Safety During Acute Kidney Injury: The Impact of Clinical Decision Support and Real-Time Pharmacy Surveillance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Acute
Keywords: Medication Errors
Adverse Drug Events
Decision Support Systems, Clinical
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2010-06-02
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The utilization of clinical decision support (CDS) is increasing among healthcare facilities which have implemented computerized physician order entry or electronic medical records. Formal prospective evaluation of CDS implementations occurs rarely, and misuse or flaws in system design are often unrecognized. Retrospective review can identify failures but is too late to make critical corrections or initiate redesign efforts. A real-time surveillance dashboard for high-alert medications integrates externalized CDS interactions with relevant medication ordering, administration, and therapeutic monitoring data. The surveillance view of the dashboard displays all currently admitted, eligible patients and provides brief demographics with triggering order, laboratory, and CDS failure data to allow prioritization of high-risk scenarios. The patient detail view displays a detailed timeline of orders, order administrations, laboratory values, and CDS interactions for an individual patient and allows users to understand provider actions and patient condition changes occurring in conjunction with CDS failures. Clinical pharmacists' use of the dashboard for patient monitoring and intervention aims to increase the rate and timeliness of intercepted medication errors compared to CPOE-based CDS in the setting of acute kidney injury, which affects patients at various points across all hospital units and services and has numerous opportunities for intervention.


Eligibility criteria: Inclusion Criteria:

* 0.5 mg/dl increase or decrease in serum creatinine within 48 hours
* Active, recurring order for targeted renally cleared or nephrotoxic medication

Exclusion Criteria:

* Chronic dialysis
* Transplant patients

Primary outcomes:
measure: Adverse Drug Events or Potential Adverse Drug Events
timeFrame: Until patient discharge (~2 week average)
Secondary outcomes:
measure: Time to Provider Response
timeFrame: Until patient discharge (~2 week average)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: The University of Texas Health Science Center at Houston (UTHealth)
name: Allison B McCoy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Josh F Peterson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCoy AB, Peterson JF, Gadd CS, Danciu I, Waitman LR. A system to improve medication safety in the setting of acute kidney injury: initial provider response. AMIA Annu Symp Proc. 2008 Nov 6:1051.