Achieving Medication Safety During Acute Kidney Injury

NCT01134900 | Completed Results DMC

• 2 other identifiers: 081002R01LM009965
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure, Acute

Keywords

Medication Errors; Adverse Drug Events; Decision Support Systems, Clinical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to Provider Response

  Until patient discharge (~2 week average)

Study Arms (2)

Dashboard

EXPERIMENTAL

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

Other: Pharmacy Dashboard Review and Intervention

Control

NO INTERVENTION

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

Interventions

Pharmacy Dashboard Review and Intervention OTHER

Clinical pharmacist reviews patients on dashboard and makes intervention with providing team when necessary.

Dashboard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mg/dl increase or decrease in serum creatinine within 48 hours
• Active, recurring order for targeted renally cleared or nephrotoxic medication

You may not qualify if:

• Chronic dialysis
• Transplant patients

Sponsors & Collaborators

• Vanderbilt University: lead
• National Library of Medicine (NLM): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37235, United States

Location

Related 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.

  PMID: 18999252 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Drug-Related Side Effects and Adverse Reactions

Interventions

Methods

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Allison B. McCoy, PhD
• Organization: The University of Texas Health Science Center at Houston (UTHealth)

allison.b.mccoy@uth.tmc.edu

713-500-6931

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: June 2, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 27, 2012
• Results First Posted: February 27, 2012

Record last verified: 2012-01

Locations

US (1)