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Implementation of Real-Time ADE Surveillance and Decision Support (VA ADE)
This study is not yet open for participant recruitment.
Verified by Department of Veterans Affairs, November 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00780572
  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

U.S. FDA Resources
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

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

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
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
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.
2: No Intervention
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- There are no exclusions.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780572

Contacts
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

Locations
United States, Utah
VA Health Care Salt Lake City
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
Investigators
Principal Investigator: Jonathan R. Nebeker, MD MS VA Health Care Salt Lake City
  More Information

Publications of Results:
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

Keywords provided by Department of Veterans Affairs:
Safety Management
Risk Management
surveillance
triggers

Study placed in the following topic categories:
Drug Toxicity
Poisoning
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009