Implementation of Real-time ADE Surveillance and Decision Support

Not Applicable

Completed

• Conditions: Adverse Drug Events
• Interventions: Behavioral: ADE alert assistant

• Registration Number: NCT00780572
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The purpose of this study is to determine if an electronic alerting technology improves time to intervention for possible ADEs, identify what factors affect adoption of ADE alerts, and whether there is a cost benefit associated with the alerting technology.

Detailed Description

Inpatient adverse drug events (ADEs) continue to be a major source of morbidity and mortality despite advances in computerized drug safety measures. Reports on the ability of computerized ADE alerts to prevent and mitigate ADEs are lacking. The aims of this project are to 1) Assess organizational, social, and cognitive factors that affect adoption of real-time ADE alerting technology; 2) Analyze the effect of the ADE alerting technology on management and rate of ADEs; and 3) Estimate the cost-benefit of the ADE alerting technology. This study will use a patient randomized design of computerized real-time ADE alerts intended for primary and secondary prevention of ADEs. The ADE alerts promise to reduce mortality, morbidity, and costs due to ADEs. This study will quantify the effect of the alerts in the hands of first-year medical residents and pharmacists. The study will explore the associations of organizational and soci-cognitive barriers and facilitators with the adoption of the ADE alert technology. At the cognitive level, it will explore whether ADE Alerts change user bias in diagnosing ADEs or whether the alerts heighten sensitivity to drug problems.

Study Timeline

• Study First Submitted: 2008-10-24
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Study Start: 2008-12
• Primary Completion: 2010-09
• Study Completion: 2011-03
• Results First Submitted: 2015-10-15
• Results First Submitted QC: 2015-10-15
• Status Verified: 2015-11
• Results First Posted: 2015-11-18
• Last Update Submitted: 2015-11-18
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 595

Inclusion Criteria

• All patients admitted to the SLCVAMC at time of study.

Exclusion Criteria

• There are no exclusions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: ADE Alerts	ADE alert assistant	Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group

Primary Outcome Measures

Name	Time	Method
Time to Intervention Once an ADE Alert Has Fired in CPRS	From the time an ADE alert fires in CPRS until the time action has been taken, i.e. an order placed, up to 24 hours.

Trial Locations

Locations (1)

VA Health Care Salt Lake City; 🇺🇸 Salt Lake City, Utah, United States