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

Primary Purpose

Influenza Vaccine, Papillomavirus Infection, Pertussis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Vaccination Program
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Influenza Vaccine focused on measuring HPV vaccine, Tdap vaccine

Eligibility Criteria

12 Years - 26 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 4-5 community Ob/Gyn practices

Sites / Locations

  • Westside OBGYN
  • DWHA
  • Atrium OBGYN
  • Blue Ridge OBGYN

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2009
Last Updated
October 15, 2012
Sponsor
Duke University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00828555
Brief Title
Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting
Official Title
Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting
Study Type
Observational

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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 Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis 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 Quantify the level of support and resources needed to develop and implement the vaccination program

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Vaccine, Papillomavirus Infection, Pertussis
Keywords
HPV vaccine, Tdap vaccine

7. Study Design

Enrollment
3988 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Vaccination Program
Intervention Description
Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 4-5 community Ob/Gyn practices
Study Population Description
Population Groups: Adults Minors Patients Pregnant Women Fetuses
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geeta Swamy, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westside OBGYN
City
Burlington
State/Province
North Carolina
Country
United States
Facility Name
DWHA
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Facility Name
Atrium OBGYN
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Blue Ridge OBGYN
City
Raleigh
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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