Achieving Medication Safety During Acute Kidney Injury

• ClinicalTrials.gov Identifier: NCT01134900
• Recruitment Status: Completed
• First Posted: June 2, 2010
• Results First Posted: February 27, 2012
• Last Update Posted: February 27, 2012
• Sponsor: Vanderbilt University
• Collaborator: National Library of Medicine (NLM)
• Information provided by (Responsible Party): Allison McCoy, Vanderbilt University

Study Description

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37235

Sponsors and Collaborators

Vanderbilt University

National Library of Medicine (NLM)

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 Medical Center

More Information

Publications:

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.

• Responsible Party: Allison McCoy, Principle Investigator, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT01134900
• Other Study ID Numbers: 081002; R01LM009965 ( U.S. NIH Grant/Contract )
• First Posted: June 2, 2010
• 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