Clinical Trials Logo

Clinical Trial Summary

Our 4-year project uses public domain software and content developed by a University of Alabama at Birmingham (UAB) team and updates, refines, and tailors it to the unique clinician populations and electronic educational applications of VAMCs We are testing an innovative, web-based intervention adapted specifically for the VA to increase syndromic recognition, treatment, and post-exposure prophylaxis of biological warfare agents at multiple VA sites via a randomized controlled trial (RCT). Ultimately, we will disseminate the intervention throughout the entire VA system.


Clinical Trial Description

Background:

Because of VA's long history in disaster preparedness, and the crucial role VA providers will play, the VA medical system has the potential to make an enormous difference in outcomes following a bioterror attack or infectious outbreak. A 2002 AHRQ report reviewed 60 studies and found that very few bioterrorism preparedness training programs were rigorously evaluated. Our project was the first effort to formally test and implement a bioterrorism preparedness intervention in the VA healthcare system. Because Internet-delivered interventions have the potential for wide dissemination, we used the Internet to implement the Intervention.

Objectives:

1. To develop, tailor, and continuously update and validate evidence- and scenario-based electronic teaching and testing modules to increase VA clinicians' knowledge of Category A biological warfare agents. We refer to these instruments as Bioterrorism Case Analysis and Skills Enhancement Sessions (BioCASES) and Bioterrorism Skills Test Sessions (BioTESTS).

2. To test the effectiveness of the BioCASES teaching modules by way of a randomized controlled trial of VAMCs using the BioTESTS to evaluate their effectiveness for increasing and sustaining VA clinician knowledge, skills, and ability to respond to bioterrorism events.

3. To continue to develop and adapt BioCASES and BioTESTS for use in VA CME programs. Ultimately, we will disseminate the intervention throughout the entire VA system.

Methods:

Our project team developed or refined and updated a total of 12 educational modules focusing on CDC's Category A agents and other emerging infectious diseases. We developed post-test instruments and case-based scenarios germane to the VA patient population for anthrax and smallpox. Materials were designed specifically for the unique clinician populations and electronic educational applications available in VAMCs. Website functionality and content were refined using the nominal group technique and "thinking aloud" protocols. We tested our innovative, web-based educational intervention at fifteen VA facilities via a randomized controlled trial (RCT).

Status:

The intervention has been completed. Fifteen sites were randomized and completed the study processes. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


NCT number NCT00123396
Study type Interventional
Source VA Office of Research and Development
Contact
Status Completed
Phase N/A
Start date August 2004
Completion date September 2007

See also
  Status Clinical Trial Phase
Completed NCT05976100 - Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years Phase 1
Completed NCT01540929 - Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
Completed NCT00258947 - Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults Phase 2
Completed NCT00189969 - Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects Phase 1
Terminated NCT00053508 - Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination Phase 2
Completed NCT01317238 - Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers Phase 3
Completed NCT01056770 - Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers Phase 3
Terminated NCT00282581 - Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive Phase 1
Withdrawn NCT00389103 - Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD) Phase 1
Completed NCT00998543 - A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain) Phase 2
Completed NCT00133575 - ACAM 3000 MVA at Harvard Medical School Phase 1/Phase 2
Active, not recruiting NCT00103584 - Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers Phase 1/Phase 2
Completed NCT00050505 - Expanded Dryvax Dilution Study in Previously Vaccinated Adults Phase 2
Completed NCT05846243 - Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years Phase 2/Phase 3
Completed NCT05935917 - Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults Phase 1
Completed NCT00082446 - Combination Study With MVA BN and Dryvax Phase 1
Completed NCT00038987 - Vaccinia Virus Vaccine (APSV) in Vaccinia- Naive Subjects: PILOT Phase 1/Phase 2
Completed NCT05762523 - Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years Phase 1
Completed NCT04971109 - Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Day Phase 3
Completed NCT00646152 - Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study Phase 1