Achieving Medication Safety During Acute Kidney Injury

Not Applicable

Completed

• Conditions: Kidney Failure, Acute
• Interventions: Other: Pharmacy Dashboard Review and Intervention

• Registration Number: NCT01134900
• Lead Sponsor: Vanderbilt University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-27
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2012-01
• Results First Submitted: 2012-01-25
• Results First Submitted QC: 2012-01-25
• Last Update Submitted: 2012-01-25
• Results First Posted: 2012-02-27
• Last Update Posted: 2012-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dashboard	Pharmacy Dashboard Review and Intervention	Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.

Primary Outcome Measures

Name	Time	Method
Adverse Drug Events or Potential Adverse Drug Events	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

Name	Time	Method
Time to Provider Response	Until patient discharge (~2 week average)	Time from study event to modification or discontinuation of targeted medication

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States