VHA Clinicians and Bioterror Events: Interactive Web-based Learning

Smallpox Clinical Trial

Official title:

VHA Clinicians and Bioterror Events: Interactive Web-based Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123396
• Other study ID #: BTI 02-092
• Status: Completed
• Phase: N/A
• First received: July 20, 2005
• Last updated: April 6, 2015
• Start date: August 2004
• Est. completion date: September 2007

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2007
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Clinicians at participating facilities who work in a primary care setting (ED, MOD, general medicine, primary care, or CBOC).

Exclusion Criteria:

Facilities will be excluded from the project that 1)choose not to participate, or 2)do not have the minimum number of clinicians needed.

Study Design

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

Related Conditions & MeSH terms

• Anthrax
• Smallpox

Intervention

Behavioral:
• BioCASES and BioTESTS

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System, Albuquerque, NM	Albuquerque	New Mexico
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA	Bedford	Massachusetts
United States	Birmingham VA Medical Center, Birmingham, AL	Birmingham	Alabama
United States	VA Loma Linda Healthcare System, Loma Linda, CA	Loma Linda	California
United States	Tennessee Valley Healthcare System Nashville Campus, Nashville, TN	Nashville	Tennessee
United States	Phoenix VA Health Care System, Phoenix, AZ	Phoenix	Arizona
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (7)

Abdolrasulnia M, Strasser S, Pryor E, Terndrup T, Weissman NW, Williams M, Heck E, Casebeer L. Spatial Patterns Representing the Geographic Impact of Physician Participation in an Online CME Bioterrorism Course Following the Anthrax Events of 2001. Medinf

Bennett NL, Casebeer LL, Kristofco RE, Strasser SM. Physicians' Internet information-seeking behaviors. J Contin Educ Health Prof. 2004 Winter;24(1):31-8. — View Citation

Casebeer LL, Strasser SM, Spettell CM, Wall TC, Weissman N, Ray MN, Allison JJ. Designing tailored Web-based instruction to improve practicing physicians' preventive practices. J Med Internet Res. 2003 Jul-Sep;5(3):e20. Epub 2003 Sep 25. — View Citation

Filoromo C, Macrina D, Pryor E, Terndrup T, McNutt SD. An innovative approach to training hospital-based clinicians for bioterrorist attacks. Am J Infect Control. 2003 Dec;31(8):511-4. — View Citation

O'Byrne WT, Terndrup TE, Kiefe CI, Weissman NW. A Primer on Biological Weapons for the Clinician, Part I. Johns Hopkins Advanced Studies in Medicine. 2003 Feb 1; 3:75-86.

O'Byrne WT, Terndrup TE, Kiefe CI, Weissman NW. A Primer on Biological Weapons for the Clinician, Part II. Johns Hopkins Advanced Studies in Medicine. 2003 Mar 1; 3:157-167.

Terndrup T, Nafziger S, Weissman N, Casebeer L, Pryor E. Online bioterrorism continuing medical education: development and preliminary testing. Acad Emerg Med. 2005 Jan;12(1):45-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The outcome measure will be performance on post-test administered immediately and at 3 months and 6 months post intervention. Performance on the post-test administered at three months will be considered the main outcome of the study.		3 months	No
Secondary	The 6-month tests will be given to demonstrate the sustainability of the intervention (prevention of decay effect).			No