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

October 15, 2012 updated by: Duke University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3988

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Burlington, North Carolina, United States
        • Westside OBGYN
      • Durham, North Carolina, United States, 27707
        • DWHA
      • Raleigh, North Carolina, United States
        • Atrium OBGYN
      • Raleigh, North Carolina, United States
        • Blue Ridge OBGYN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 26 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Population Groups:

Adults

Minors

Patients

Pregnant Women

Fetuses

Description

Inclusion Criteria:

  • 4-5 community Ob/Gyn practices

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Full-scale program implementation will cover a 12 month period, tentatively planned to begin in April 2009.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (ESTIMATE)

January 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2012

Last Update Submitted That Met QC Criteria

October 15, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00011038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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