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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00780572
First received: October 24, 2008
Last updated: February 6, 2014
Last verified: June 2011
  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

Resource links provided by NLM:


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 ]

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
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

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