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

Pertussis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828555
• Other study ID #: Pro00011038
• Status: Completed
• Phase: N/A
• First received: January 22, 2009
• Last updated: October 15, 2012
• Start date: November 2008
• Est. completion date: February 2012

Study information

• Verified date: September 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3988
• Est. completion date: February 2012
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 26 Years

Eligibility

Inclusion Criteria:

• 4-5 community Ob/Gyn practices

Study Design

N/A

Related Conditions & MeSH terms

• Influenza Vaccine
• Papillomavirus Infection
• Papillomavirus Infections
• Pertussis

Intervention

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

Locations

Country	Name	City	State
United States	Westside OBGYN	Burlington	North Carolina
United States	DWHA	Durham	North Carolina
United States	Atrium OBGYN	Raleigh	North Carolina
United States	Blue Ridge OBGYN	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Full-scale program implementation will cover a 12 month period, tentatively planned to begin in April 2009.	No