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

This study has been withdrawn prior to enrollment.
(Not a Clinical Trial requirement per VA HSR&D)
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01270685
First received: June 3, 2010
Last updated: January 4, 2011
Last verified: January 2011
  Purpose

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.


Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 2009 H1N1 Pandemic and Seasonal Influenza in SCI/D: Infection Control Strategies

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Influenza vaccination [ Time Frame: One year/influenza season ] [ Designated as safety issue: No ]
  • Influenza non-vaccine infection control strategies [ Time Frame: One year/influenza season ] [ Designated as safety issue: No ]
  • Veterans and health care providers attitudes and beliefs about H1N1 [ Time Frame: One year/influenza season ] [ Designated as safety issue: No ]

Estimated Enrollment: 3500
Study Start Date: July 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

  • Health care encounter within prior year (for Veterans).
  • Face to face contact with Veterans (for health care providers)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270685

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-3030
Sponsors and Collaborators
Investigators
Principal Investigator: Sherri L. LaVela, MPH MBA PhD Edward Hines Jr. VA Hospital
  More Information

No publications provided

Responsible Party: LaVela, Sherri - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01270685     History of Changes
Other Study ID Numbers: RRP 10-046
Study First Received: June 3, 2010
Last Updated: January 4, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014