Implementation of Real-time ADE Surveillance and Decision Support (VA ADE)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Adverse Drug Events |
Behavioral: ADE alert assistant |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Implementation of Real-Time ADE Surveillance and Decision Support |
- Time to intervention once an ADE alert has fired in CPRS [ Time Frame: Once an alert fires, the time frame begins. When action has been taken, ie. an order placed, time frame ends. ] [ Designated as safety issue: Yes ]
| Enrollment: | 425 |
| Study Start Date: | December 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
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
A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories.
|
|
No Intervention: Arm 2
The second arm is the control. Alerts will not be displayed for these patients.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients admitted to the SLCVAMC at time of study.
Exclusion Criteria:
- There are no exclusions.
Contacts and Locations| United States, Utah | |
| VA Health Care Salt Lake City | |
| Salt Lake City, Utah, United States, 84148 | |
| Principal Investigator: | Jonathan R. Nebeker, MD MS | VA Health Care Salt Lake City |
More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00780572 History of Changes |
| Other Study ID Numbers: | IAB 05-224 |
| Study First Received: | October 24, 2008 |
| Last Updated: | April 23, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Safety Management Risk Management surveillance triggers |
Additional relevant MeSH terms:
|
Drug Toxicity Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 21, 2013