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Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting

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ClinicalTrials.gov Identifier: NCT00828555
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : October 16, 2012
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Duke University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

PURPOSE To develop, implement, and evaluate the effectiveness of a program designed to assist community Ob/Gyns in vaccinating adolescent and adult women against vaccine-preventable diseases.

SPECIFIC AIMS

  1. Determine the feasibility of implementing a successful vaccination program for adolescent and adult women in Ob/Gyn offices by direct assessment of medical personnel & office staff on their:

    • Attitudes towards vaccination of women against preventable diseases
    • Perceived barriers to implementing a program to vaccinate women in their offices
    • Ideas on how to overcome barriers to successful program implementation
    • Current vaccination practices and office-specific administrative processes
  2. Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis

  3. Determine the effectiveness of the vaccination program based on

    • Pre- and post-program vaccination rates
    • Program satisfaction amongst Ob/Gyn providers and office staff
    • Willingness to continue and possibly extend the program to additional vaccines
  4. Quantify the level of support and resources needed to develop and implement the vaccination program

Condition or disease Intervention/treatment
Influenza Vaccine Papillomavirus Infection Pertussis Other: Vaccination Program

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 3988 participants
Official Title: Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting
Study Start Date : November 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Whooping Cough
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    Other: Vaccination Program
    Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis

Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Implementation and measurement of a health services intervention in community or private Ob/Gyn practices to improve the delivery of standard clinical care to vaccinate women against human papillomavirus, influenza, & pertussis. [ Time Frame: Full-scale program implementation will cover a 12 month period, tentatively planned to begin in April 2009. ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   12 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Population Groups:

Adults

Minors

Patients

Pregnant Women

Fetuses

Criteria

Inclusion Criteria:

  • 4-5 community Ob/Gyn practices
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828555


Locations
United States, North Carolina
Westside OBGYN
Burlington, North Carolina, United States
DWHA
Durham, North Carolina, United States, 27707
Atrium OBGYN
Raleigh, North Carolina, United States
Blue Ridge OBGYN
Raleigh, North Carolina, United States
Sponsors and Collaborators
Duke University
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Geeta Swamy, MD Duke University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00828555     History of Changes
Other Study ID Numbers: Pro00011038
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: October 16, 2012
Last Verified: September 2012

Keywords provided by Duke University:
HPV vaccine
Tdap vaccine

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
 Vaccines
Immunologic Factors
Physiological Effects of Drugs