Achieving Medication Safety During Acute Kidney Injury

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Acute
• Intervention / Treatment: Other: Pharmacy Dashboard Review and Intervention

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37235
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Drug Events or Potential Adverse Drug Events	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.	Until patient discharge (~2 week average)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Provider Response	Time from study event to modification or discontinuation of targeted medication	Until patient discharge (~2 week average)

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: May 27, 2010
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (ESTIMATE): June 2, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 27, 2012
• Last Update Submitted That Met QC Criteria: January 25, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Decision Support Systems, Clinical; Medication Errors; Adverse Drug Events
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 081002; R01LM009965 (NIH)