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OpenTrials
Completed

NCT Number: NCT01134900

Achieving Medication Safety During Acute Kidney Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacy Dashboard Review and Intervention

Other

Clinical pharmacist reviews patients on dashboard and makes intervention with providing team when necessary.

Primary outcomes

  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 outcomes

  1. Time to Provider Response

    Time frame: Until patient discharge (~2 week average)

    Time from study event to modification or discontinuation of targeted medication

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Library of Medicine (NLM)

Registry information

Official study title

Achieving Medication Safety During Acute Kidney Injury: The Impact of Clinical Decision Support and Real-Time Pharmacy Surveillance

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 2, 2010
Registry last updated
Feb 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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