2009 H1N1 Pandemic and Seasonal Influenza in SCI/D: Infection Control Strategies

Influenza Clinical Trial

Official title:

2009 H1N1 Pandemic and Seasonal Influenza in SCI/D: Infection Control Strategies

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01270685
• Other study ID #: RRP 10-046
• Status: Withdrawn
• Phase: N/A
• First received: June 3, 2010
• Last updated: June 25, 2015
• Start date: July 2010
• Est. completion date: August 2011

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate specific approaches used to prevent/reduce influenza transmission in the SCI/D System of Care in response to the 2009 H1N1 pandemic, including assessing infection control strategies used by SCI staff and guidance provided by local infection control units. Due to the rapid spread of and uncertainties about the H1N1 virus, we will evaluate patient's beliefs, behaviors, and information seeking strategies (e.g., social media). These findings will lend to the understanding of ways to handle emergent issues, such as the H1N1 pandemic, in special populations.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Health care encounter within prior year (for Veterans).

• Face to face contact with Veterans (for health care providers)

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Locations

Country	Name	City	State
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influenza vaccination		One year/influenza season	No
Primary	Influenza non-vaccine infection control strategies		One year/influenza season	No
Primary	Veterans and health care providers attitudes and beliefs about H1N1		One year/influenza season	No