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Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting
This study has been completed.
Sponsor:
Duke University
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00828555
First received: January 22, 2009
Last updated: October 15, 2012
Last verified: September 2012
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Purpose
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
| Condition | Intervention |
|---|---|
| Influenza Vaccine Papillomavirus Infection Pertussis | Other: Vaccination Program |
| Study Type: | Observational |
| Official Title: | Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting |
Resource links provided by NLM:
Further study details as provided by Duke University:
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. [ Time Frame: Full-scale program implementation will cover a 12 month period, tentatively planned to begin in April 2009. ]
| Enrollment: | 3988 |
| Study Start Date: | November 2008 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Other: Vaccination Program
Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00828555
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00828555 History of Changes |
| Other Study ID Numbers: |
Pro00011038 |
| Study First Received: | January 22, 2009 |
| Last Updated: | October 15, 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 |
ClinicalTrials.gov processed this record on June 23, 2017