Achieving Medication Safety During Acute Kidney Injury

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Allison McCoy, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01134900
First received: May 27, 2010
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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 Intervention
Kidney Failure, Acute
Other: Pharmacy Dashboard Review and Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Adverse Drug Events or Potential Adverse Drug Events [ Time Frame: Until patient discharge (~2 week average) ] [ Designated as safety issue: Yes ]
    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:
  • Time to Provider Response [ Time Frame: Until patient discharge (~2 week average) ] [ Designated as safety issue: Yes ]
    Time from study event to modification or discontinuation of targeted medication


Enrollment: 540
Study Start Date: June 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134900

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37235
Sponsors and Collaborators
Vanderbilt University
Investigators
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
  More Information

Publications:
Responsible Party: Allison McCoy, Principle Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01134900     History of Changes
Other Study ID Numbers: 081002, R01LM009965
Study First Received: May 27, 2010
Results First Received: January 25, 2012
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014