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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00780572 |
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 |
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Adverse Drug Events |
Behavioral: ADE alert assistant |
Study Type: | Interventional |
Study Design: | Health Services Research, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Implementation of Real-Time ADE Surveillance and Decision Support |
Estimated Enrollment: | 1750 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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
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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.
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2: No Intervention
The second arm is the control. Alerts will not be displayed for these patients.
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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 both a pre-post and 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 change user bias in diagnosing ADEs or whether the alerts heighten sensitivity to drug problems.
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.
Contact: Brenna Long, BA MS | (801) 582-1565 ext 2470 | brenna.long@pharm.utah.edu |
Contact: Amyanne Wuthrich-Reggio, BS MPH | (801) 582-1565 ext 2419 | amyanne.wuthrich@hsc.utah.edu |
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 |
Responsible Party: | Department of Veterans Affairs ( Nebeker, Jonathan - Principal Investigator ) |
Study ID Numbers: | IAB 05-224, IAB-05-224-2 |
Study First Received: | October 24, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00780572 |
Health Authority: | United States: Federal Government |
Safety Management Risk Management surveillance triggers |
Drug Toxicity Poisoning Disorders of Environmental Origin |