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Offering Influenza and Pneumococcal Vaccine to Patients Being Evaluated in the Emergency Department
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Louisiana State University Health Sciences Center in New Orleans.   Recruitment status was  Active, not recruiting

First Received on September 25, 2006.   No Changes Posted
Sponsor: Louisiana State University Health Sciences Center in New Orleans
Collaborator: Centers for Disease Control and Prevention
Information provided by: Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT00380679
  Purpose

According to the Advisory Committee on Immunization Practices (ACIP), all people aged 50 years or older and persons aged less than 50 years who have medical conditions that put them at increased risk for serious influenza disease should receive an annual influenza vaccination. However, since the mid-1990s, vaccination rates and racial disparities have mostly remained static, and there has been limited progress towards the Healthy People 2010 objectives for influenza vaccination coverage.

The purpose of this study is to determine what proportion of previously unvaccinated persons in target groups for whom influenza and pneumococcal vaccine are recommended will accept and receive influenza and/or pneumococcal vaccine in an urban emergency department (ED), and to estimate the potential impact of ED vaccination on population-based vaccination coverage. The intervention will utilize a combination of assessment survey, vaccine information and pre-printed vaccine order sheets.

The target population for influenza vaccinations includes all patients aged 18 years and older for whom influenza vaccine is recommended by the ACIP. This includes all persons aged 50 years and older and persons aged 18 to 49 years who are in one of the following groups: 1) health care workers, 2) pregnant women, 3) residents of long-term care facilities, 4) household contacts and out-of-home caregivers of children aged 0 to 23 months, or 5) persons with underlying chronic medical conditions which increase their risk of influenza-related complications. The target population for pneumococcal vaccination includes all patients aged 65 years or older who have not previously been vaccinated against pneumococcus or have not received the vaccine within 5 years (and were less than 65 years at the time of vaccination).


Condition Intervention Phase
High Risk for Serious Influenza
High Risk for Pneumonia
Biological: Influenza vaccination
Biological: Pneumococcal polysaccharide vaccination
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Offering Influenza and Pneumococcal Vaccine to Patients Being Evaluated in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:

Primary Outcome Measures:
  • Acceptance of vaccinations
  • Receipt of vaccination

Secondary Outcome Measures:
  • Reasons vaccines were refused
  • Reasons vaccines were not administered

Study Start Date: December 2005
Estimated Study Completion Date: March 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Baton Rouge General Medical Center

Inclusion Criteria:

  • Patients aged 18 years and older who are seeking medical care in the ED

Exclusion Criteria:

  • All patients under 18 years of age will be excluded. Any patient with a medically unstable condition, altered mental status, or language barrier will also be excluded. Patients who present with a contraindication to influenza vaccination (acute febrile illness or a history of allergic reaction to eggs) or pneumococcal vaccine will not be eligible for receipt of those vaccines.

Our Lady of the Lake Regional Medical Center

Inclusion Criteria:

  • Patients aged 50 years and older who are seeking medical care in the ED

Exclusion Criteria:

  • All patients under 50 years of age will be excluded. Any patient with a medically unstable condition, altered mental status, or language barrier will also be excluded. Patients who present with a contraindication to influenza vaccination (acute febrile illness or a history of allergic reaction to eggs) or pneumococcal vaccine will not be eligible for receipt of those vaccines
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380679

Locations
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Investigators
Principal Investigator: William M Cassidy, MD Louisiana State University Health Sciences Center
Principal Investigator: Daniel Fishbein, MD Centers for Disease Control and Prevention
  More Information

Publications:
Harper SA, Fukuda K, Uyeki TM, Cox NJ, Bridges CB; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2005 Jul 29;54(RR-8):1-40. Erratum in: MMWR Morb Mortal Wkly Rep. 2005 Aug 5;54(30):750.
Centers for Disease Control and Prevention (CDC). Public health and aging: influenza vaccination coverage among adults aged > or =50 years and pneumococcal vaccination coverage among adults aged > or =65 years--United States, 2002. MMWR Morb Mortal Wkly Rep. 2003 Oct 17;52(41):987-92.
Pleis JR, Gentleman JF. Using the National Health Interview Survey: time trends in influenza vaccinations among targeted adults. Eff Clin Pract. 2002 May-Jun;5(3 Suppl):E3.
Ayanian JZ, Weissman JS, Schneider EC, Ginsburg JA, Zaslavsky AM. Unmet health needs of uninsured adults in the United States. JAMA. 2000 Oct 25;284(16):2061-9.
[No authors listed] U.S. Department of Health and Human Services: Office of Disease Prevention and Health Promotion--Healthy People 2010. Nasnewsletter. 2000 May;15(3):3. No abstract available.
Walls CA, Rhodes KV, Kennedy JJ. The emergency department as usual source of medical care: estimates from the 1998 National Health Interview Survey. Acad Emerg Med. 2002 Nov;9(11):1140-5.
Polis MA, Smith JP, Sainer D, Brenneman MN, Kaslow RA. Prospects for an emergency department-based adult immunization program. Arch Intern Med. 1987 Nov;147(11):1999-2001.
Rodriguez RM, Baraff LJ. Emergency department immunization of the elderly with pneumococcal and influenza vaccines. Ann Emerg Med. 1993 Nov;22(11):1729-32.
Slobodkin D, Zielske PG, Kitlas JL, McDermott MF, Miller S, Rydman R. Demonstration of the feasibility of emergency department immunization against influenza and pneumococcus. Ann Emerg Med. 1998 Nov;32(5):537-43.
Centers for Disease Control (CDC). Adult immunization: knowledge, attitudes, and practices--DeKalb and Fulton Counties, Georgia, 1988. MMWR Morb Mortal Wkly Rep. 1988 Nov 4;37(43):657-61. No abstract available.
Nicoleau A, Nicoleau CA, Balzora JD, Oboh A, Siddiqui N, Rosenberg C. Elderly African-Americans and the influenza vaccine: the impact of the primary care physician. J Am Med Dir Assoc. 2001 Mar-Apr;2(2):56-9.

ClinicalTrials.gov Identifier: NCT00380679     History of Changes
Other Study ID Numbers: 5800
Study First Received: September 25, 2006
Last Updated: September 25, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Emergencies
Influenza, Human
Pneumonia
Disease Attributes
Pathologic Processes
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on February 12, 2012