- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01270685
2009 H1N1 Pandemic and Seasonal Influenza in SCI/D: Infection Control Strategies
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Hines, Illinois, Estados Unidos, 60141-3030
- Edward Hines, Jr. VA Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
Descripción
Inclusion Criteria:
- Health care encounter within prior year (for Veterans).
- Face to face contact with Veterans (for health care providers)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Influenza vaccination
Periodo de tiempo: One year/influenza season
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One year/influenza season
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Influenza non-vaccine infection control strategies
Periodo de tiempo: 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
Periodo de tiempo: One year/influenza season
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One year/influenza season
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sherri L. LaVela, MPH MBA PhD, Edward Hines Jr. VA Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RRP 10-046
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