- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01270685
2009 H1N1 Pandemic and Seasonal Influenza in SCI/D: Infection Control Strategies
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Illinois
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Hines, Illinois, Forenede Stater, 60141-3030
- Edward Hines, Jr. VA Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
Beskrivelse
Inclusion Criteria:
- Health care encounter within prior year (for Veterans).
- Face to face contact with Veterans (for health care providers)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
1
Veterans with spinal cord injuries and disorders
|
2
Comparison group: general Veteran population (without spinal cord injuries or disorders)
|
3
Health care providers with face-to-face contact with Veterans with SCI/D
|
4
Infection control Chiefs/Officers
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Influenza vaccination
Tidsramme: One year/influenza season
|
One year/influenza season
|
Influenza non-vaccine infection control strategies
Tidsramme: One year/influenza season
|
One year/influenza season
|
Veterans and health care providers attitudes and beliefs about H1N1
Tidsramme: One year/influenza season
|
One year/influenza season
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Sherri L. LaVela, MPH MBA PhD, Edward Hines Jr. VA Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RRP 10-046
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