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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780572
Recruitment Status : Completed
First Posted : October 27, 2008
Results First Posted : November 18, 2015
Last Update Posted : December 21, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Adverse Drug Events Behavioral: ADE alert assistant Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 595 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation of Real-Time ADE Surveillance and Decision Support
Study Start Date : December 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: Arm 1: ADE Alerts
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: Control/No Alerts
The second arm is the control. Alerts will not be displayed for these patients.

Primary Outcome Measures :
  1. Time to Intervention Once an ADE Alert Has Fired in CPRS [ Time Frame: 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

- There are no exclusions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00780572

United States, Utah
VA Health Care Salt Lake City
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Jonathan R. Nebeker, MD MS VA Health Care Salt Lake City

Publications of Results:
Other Publications:
Responsible Party: VA Office of Research and Development Identifier: NCT00780572     History of Changes
Other Study ID Numbers: IAB 05-224
First Posted: October 27, 2008    Key Record Dates
Results First Posted: November 18, 2015
Last Update Posted: December 21, 2015
Last Verified: November 2015

Keywords provided by VA Office of Research and Development:
Safety Management
Risk Management

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders