- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01270685
2009 H1N1 Pandemic and Seasonal Influenza in SCI/D: Infection Control Strategies
Study Overview
Status
Conditions
Detailed Description
In the United States, H1N1 influenza has been widespread, resulting in many infections, hospitalizations, and deaths. Due to impaired respiratory function following injury, persons with spinal cord injuries and disorders (SCI/D) are at extremely high risk from respiratory complications that occur as a result of contracting influenza.
The overall goal is to understand approaches used to prevent/reduce influenza transmission in the SCI/D System of Care in response to the 2009 H1N1 pandemic, in addition to seasonal influenza. Due to the rapid spread of and uncertainties about the H1N1 virus, one objective is to evaluate patient's beliefs, behaviors, and information seeking strategies (e.g., social media). The other objective is to assess infection control strategies used by SCI staff (and perceptions of) and guidance provided by local infection control units.
Multiple data collection efforts will be used to evaluate strategies used and their impact to address influenza (H1N1 and seasonal) in the VHA SCI/D population. At the facility level, the guidance provided by local infection control units in general and specific to SCI/D will be assessed via a semi-structured interview with infection control Chiefs/liaisons. An anonymous survey will be conducted to assess SCI health care providers' beliefs about and use of infection control strategies (vaccination and non-vaccine methods such as personal protective equipment, hand hygiene practices, appropriate work attendance practices) in addition to their perceptions of strength of evidence for H1N1 prevention measures, resource availability, and outreach by local infection control to facilitate infection prevention strategies. In addition, Veterans with SCI/D will be surveyed about their beliefs and information seeking strategies (e.g., social media) about seasonal and H1N1 influenza during the most recent influenza season, in addition to occurrence of influenza/ILI, receipt of influenza vaccination (H1N1 and/or seasonal) during the current influenza vaccination period, and perceived adverse effects from vaccination. Finally, the use of antiviral medications to treat influenza in Veterans with SCI/D, a two-group retrospective pre-posttest review of all visits and admissions associated with influenza (or related) diagnosis and/or antiviral prescription will be conducted. Charts for Veterans with SCI/D and Veterans who do not have SCI/D will be reviewed and compared for differences in practices in the SCI/D population versus the general veteran population.
This study will provide critical information that can be used to improve compliance with and understanding of influenza vaccination and infection control strategies at the patient, provider, and facility levels. These findings will lend to the understanding of ways to handle emergent issues, such as the H1N1 pandemic, in special populations.
Study Type
Contacts and Locations
Study Locations
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Illinois
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Hines, Illinois, United States, 60141-3030
- Edward Hines, Jr. VA Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Veterans with spinal cord injury
Comparison group of Veterans without SCI/D
Health care providers in the SCI/D System of Care
Infection control chiefs at VA facilities
Description
Inclusion Criteria:
- Health care encounter within prior year (for Veterans).
- Face to face contact with Veterans (for health care providers)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Veterans with spinal cord injuries and disorders
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2
Comparison group: general Veteran population (without spinal cord injuries or disorders)
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3
Health care providers with face-to-face contact with Veterans with SCI/D
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4
Infection control Chiefs/Officers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Influenza vaccination
Time Frame: One year/influenza season
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One year/influenza season
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Influenza non-vaccine infection control strategies
Time Frame: One year/influenza season
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One year/influenza season
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Veterans and health care providers attitudes and beliefs about H1N1
Time Frame: One year/influenza season
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One year/influenza season
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Collaborators and Investigators
Investigators
- Principal Investigator: Sherri L. LaVela, MPH MBA PhD, Edward Hines Jr. VA Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRP 10-046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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