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Achieving Medication Safety During Acute Kidney Injury

Primary Purpose

Kidney Failure, Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacy Dashboard Review and Intervention
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure, Acute focused on measuring Medication Errors, Adverse Drug Events, Decision Support Systems, Clinical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dashboard

Control

Arm Description

Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.

Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Provider Response
Time from study event to modification or discontinuation of targeted medication

Full Information

First Posted
May 27, 2010
Last Updated
January 25, 2012
Sponsor
Vanderbilt University
Collaborators
National Library of Medicine (NLM)
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1. Study Identification

Unique Protocol Identification Number
NCT01134900
Brief Title
Achieving Medication Safety During Acute Kidney Injury
Official Title
Achieving Medication Safety During Acute Kidney Injury: The Impact of Clinical Decision Support and Real-Time Pharmacy Surveillance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Library of Medicine (NLM)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Acute
Keywords
Medication Errors, Adverse Drug Events, Decision Support Systems, Clinical

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dashboard
Arm Type
Experimental
Arm Description
Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
Intervention Type
Other
Intervention Name(s)
Pharmacy Dashboard Review and Intervention
Intervention Description
Clinical pharmacist reviews patients on dashboard and makes intervention with providing team when necessary.
Primary Outcome Measure Information:
Title
Adverse Drug Events or Potential Adverse Drug Events
Description
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.
Time Frame
Until patient discharge (~2 week average)
Secondary Outcome Measure Information:
Title
Time to Provider Response
Description
Time from study event to modification or discontinuation of targeted medication
Time Frame
Until patient discharge (~2 week average)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison B McCoy, PhD
Organizational Affiliation
The University of Texas Health Science Center at Houston (UTHealth)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josh F Peterson, MD, MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37235
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18999252
Citation
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.
Results Reference
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Achieving Medication Safety During Acute Kidney Injury

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