SmallpoxNCT00123396
VHA Clinicians and Bioterror Events: Interactive Web-based Learning
A study testing BioCASES and BioTESTS in people with Smallpox and Anthrax, run by US Department of Veterans Affairs at 9 sites in United States.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- BioCASES and BioTESTS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2004to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinicians at participating facilities who work in a primary care setting (ED, MOD, general medicine, primary care, or CBOC).
Who cannot join
- Facilities will be excluded from the project that 1)choose not to participate, or 2)do not have the minimum number of clinicians needed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, 92357
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
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.
Read the detailed 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:
- 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).
- 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.
- 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.
- Being tested
- BioCASES and BioTESTS
- Keywords
- Bioterrorism, Education, Medical, Continuing, Internet
- Medical subject headings
- Smallpox, Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioCASES and BioTESTSBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 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. Receives: Behavioral: BioCASES and BioTESTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
The 6-month tests will be given to demonstrate the sustainability of the intervention (prevention of decay effect).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startAug 2004
- Primary completionSep 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SmallpoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Catarina I. Kiefe, PhD MD, Principal investigator, Birmingham VA Medical Center, Birmingham, ALThomas K Houston, MD MPH, Principal investigator, Birmingham VA Medical Center, Birmingham, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123396
- Sponsor's protocol ID
- BTI 02-092
- Status last verified
- Apr 2015
- First submitted
- 20 Jul 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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. Medinfo. 2004 Dec 1; 2004(CD):1498.
Bennett NL, Casebeer LL, Kristofco RE, Strasser SM. Physicians' Internet information-seeking behaviors. J Contin Educ Health Prof. 2004 Winter;24(1):31-8. doi: 10.1002/chp.1340240106.
PubMed 15069910Terndrup 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. doi: 10.1197/j.aem.2004.08.040.
PubMed 15635137O'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.
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. doi: 10.2196/jmir.5.3.e20. Epub 2003 Sep 25.
PubMed 14517111Filoromo 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. doi: 10.1016/s0196-6553(03)00699-0.
PubMed 14647116
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VHA Clinicians and Bioterror Events: Interactive Web-based Learning
- ClinicalTrials.gov ID
- NCT00123396
- Acronym / sponsor ID
- BTI 02-092
- Keywords
- Bioterrorism, Education, Medical, Continuing, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Alabama at Birmingham
- Study start
- Aug 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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).
- 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: BioCASES and BioTESTSTest 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinicians at participating facilities who work in a primary care setting (ED, MOD, general medicine, primary care, or CBOC).
Key exclusion criteria (1 listed)
- Facilities will be excluded from the project that 1)choose not to participate, or 2)do not have the minimum number of clinicians needed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioCASES and BioTESTS | Behavioural | Arm 1 |
Primary outcome
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.
Time frame: 3 months
1 secondary outcome
The 6-month tests will be given to demonstrate the sustainability of the intervention (prevention of decay effect).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publicationAbdolrasulnia 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. Medinfo. 2004 Dec 1; 2004(CD):1498.
- Results publication: PubMed 15069910Bennett NL, Casebeer LL, Kristofco RE, Strasser SM. Physicians' Internet information-seeking behaviors. J Contin Educ Health Prof. 2004 Winter;24(1):31-8. doi: 10.1002/chp.1340240106.
- Results publication: PubMed 15635137Terndrup 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. doi: 10.1197/j.aem.2004.08.040.
- Results publicationO'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.
- Results publicationO'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.
- Results publication: PubMed 14517111Casebeer 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. doi: 10.2196/jmir.5.3.e20. Epub 2003 Sep 25.
- Results publication: PubMed 14647116Filoromo 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. doi: 10.1016/s0196-6553(03)00699-0.
Related trials for Smallpox
Active, not recruitingPhase 2
Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS
Smallpox
Active, not recruitingPhase 4
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Monkeypox
RecruitingPhase 2
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
Mpox (Monkeypox), Smallpox
Enrolling by invitationObservational study
VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
Complication of Smallpox Vaccination
Active, not recruitingPhase 3
Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC
Mpox (Monkeypox), Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catarina I. Kiefe, PhD MD principal investigator
Birmingham VA Medical Center, Birmingham, AL
Thomas K Houston, MD MPH principal investigator
Birmingham VA Medical Center, Birmingham, AL
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioCASES and BioTESTS in people with Smallpox and Anthrax, run by US Department of Veterans Affairs at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123396, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.