Effectiveness of a Vaccination Program in the Community O... | NCT00828555

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

NCT00828555

Sponsor

Duke University

Status

Completed

Last Update Posted

Oct 16, 2012Estimated

Enrollment

3,988Actual

Phase

Not provided

Conditions

Influenza Vaccine
Papillomavirus Infection
Pertussis

Interventions

Vaccination Program

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jan 22, 2009

First Submission Date that Met QC Criteria

Jan 23, 2009

First Posted Date

Jan 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2012

Last Update Posted Date

Oct 16, 2012Estimated

Name	Class
Centers for Disease Control and Prevention	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

3,988Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaccination Program	Other	Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

4-5 community Ob/Gyn practices

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

26 Years

Standard Ages

ChildAdult

Study Population

Population Groups:

Adults

Minors

Patients

Pregnant Women

Fetuses

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Geeta Swamy, MD	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Westside OBGYN		Burlington	North Carolina		United States
DWHA

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human
D030361	Papillomavirus Infections
D014917	Whooping Cough

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided