Implementation of Real-time ADE Surveillance and Decision Support

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementation of Real-Time ADE Surveillance and Decision Support

Conditions
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Adverse Drug Events

Intervention / Treatment
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* Behavioral: ADE alert assistant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All patients admitted to the SLCVAMC at time of study. Exclusion Criteria: - There are no exclusions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: ADE Alerts<br>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 | Behavioral: ADE alert assistant<br>* A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories.<br>|
| No Intervention: Arm 2: Control/No Alerts<br>The second arm is the control. Alerts will not be displayed for these patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety Management, Risk Management, surveillance, triggers