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Implementation of Real-time ADE Surveillance and Decision Support (VA ADE)

VA Office of Research and Development logo

VA Office of Research and Development

Status

Completed

Conditions

Adverse Drug Events

Treatments

Behavioral: ADE alert assistant

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00780572
IAB 05-224

Details and patient eligibility

About

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.

Full 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.

Enrollment

595 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • There are no exclusions.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

595 participants in 2 patient groups

Arm 1: ADE Alerts
Experimental group
Description:
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
Treatment:
Behavioral: ADE alert assistant
Arm 2: Control/No Alerts
No Intervention group
Description:
The second arm is the control. Alerts will not be displayed for these patients.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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