Achieving Medication Safety During Acute Kidney Injury

Kidney Failure, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134900
• Other study ID #: 081002
• Secondary ID: R01LM009965
• Status: Completed
• Phase: N/A
• First received: May 27, 2010
• Last updated: January 25, 2012
• Start date: June 2010
• Est. completion date: August 2010

Study information

• Verified date: January 2012
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Failure, Acute
• Renal Insufficiency

Intervention

Other:
• Pharmacy Dashboard Review and Intervention
Clinical pharmacist reviews patients on dashboard and makes intervention with providing team when necessary.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Library of Medicine (NLM)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Time to Provider Response	Time from study event to modification or discontinuation of targeted medication	Until patient discharge (~2 week average)	Yes