Achieving Medication Safety During Acute Kidney Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01134900
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : February 27, 2012
Last Update Posted : February 27, 2012
National Library of Medicine (NLM)
Information provided by (Responsible Party):
Allison McCoy, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Acute Other: Pharmacy Dashboard Review and Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Achieving Medication Safety During Acute Kidney Injury: The Impact of Clinical Decision Support and Real-Time Pharmacy Surveillance
Study Start Date : June 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Dashboard
Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
Other: Pharmacy Dashboard Review and Intervention
Clinical pharmacist reviews patients on dashboard and makes intervention with providing team when necessary.
No Intervention: Control
Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.

Primary Outcome Measures :
  1. Adverse Drug Events or Potential Adverse Drug Events [ Time Frame: Until patient discharge (~2 week average) ]
    Our primary outcome measured the rate of AKI-related ADEs and pADEs. We defined pADEs as incidents with the potential for injury related to a drug, such as use of a non-steroidal anti-inflammatory drug for at least 24 hours, and ADEs as injuries resulting from the administration of a drug, such as a toxic vancomycin trough level or a bleed after administration of enoxaparin. We measured outcomes after completion of the inpatient encounter (either by death or discharge); pADEs or ADEs occurring after patient discharge were not included in the analysis.

Secondary Outcome Measures :
  1. Time to Provider Response [ Time Frame: Until patient discharge (~2 week average) ]
    Time from study event to modification or discontinuation of targeted medication

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01134900

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37235
Sponsors and Collaborators
Vanderbilt University
National Library of Medicine (NLM)
Principal Investigator: Allison B McCoy, PhD The University of Texas Health Science Center at Houston (UTHealth)
Principal Investigator: Josh F Peterson, MD, MPH Vanderbilt University Medical Center

Responsible Party: Allison McCoy, Principle Investigator, Vanderbilt University Identifier: NCT01134900     History of Changes
Other Study ID Numbers: 081002
R01LM009965 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2010    Key Record Dates
Results First Posted: February 27, 2012
Last Update Posted: February 27, 2012
Last Verified: January 2012

Keywords provided by Allison McCoy, Vanderbilt University:
Medication Errors
Adverse Drug Events
Decision Support Systems, Clinical

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases