Protecting Pregnant Women From Infectious Diseases

Influenza Clinical Trial

Official title:

Protecting Pregnant Women From Infectious Diseases: a Cluster Randomized Evaluation of the Comprehensive "P3" Intervention Package Within Obstetric Practices in Georgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761799
• Other study ID #: IRB00060292
• Secondary ID: 5P01TP000300-05
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: October 30, 2015
• Start date: December 2012
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis vaccine.

Description:

The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza vaccine and/or Tdap vaccine before delivery. A secondary research aim assesses whether the comprehensive package improves maternal knowledge, attitudes, and beliefs regarding maternal and infant vaccination. The intervention package will include evidence-based components aimed at the practice-level, provider-level, and patient level and will be tested through a cluster-randomized trial design. The primary outcome measure is influenza vaccine receipt during pregnancy. The secondary outcomes include 1) receipt of pertussis (Tdap) vaccination during pregnancy, and 2) changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination. The primary hypothesis is that implementation of a comprehensive vaccine promotion package in the obstetric setting will increase the likelihood that a pregnant woman receives an influenza and/or pertussis vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: August 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18 - 50

• Currently pregnant

• Unvaccinated with 2012 - 2013 seasonal influenza vaccine

• Unvaccinated with Tdap vaccine during current pregnancy

Exclusion Criteria:

• Under 18 years of age or over 50

• Not currently pregnant

• Previous receipt of 2012 - 2013 seasonal influenza vaccine

• Previous receipt of Tdap vaccine during current pregnancy

• Does not speak English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Influenza
• Pertussis

Intervention

Behavioral:
• P3 Vaccine Promotion Package.
"P3" stands for Practice, Provider, and Patient level vaccine promotion package. The 5 obstetric practices randomized to the intervention arm will receive this comprehensive influenza and Tdap vaccine promotion package at the beginning of the study. Physicians and staff will be familiarized with each component, and practices will be instructed to implement each component to the best of their ability. The components include: posters, educational brochures, lapel buttons, provider-to-patient talking points, lists of nearby locations offering flu and/or Tdap vaccines (if not offered by the practice), identification of a "vaccine champion" within the practice, provider and staff training on vaccination during pregnancy, and use of an interactive, tablet-based educational tutorial for patients.

Locations

Country	Name	City	State
United States	Athens OBGYN	Athens	Georgia
United States	Women's Healthcare Associates	Athens	Georgia
United States	Emory Clinic A, Clifton Road Clinic	Atlanta	Georgia
United States	Women's Center of Athens	Bogart	Georgia
United States	North Pointe OB/GYN	Cumming	Georgia
United States	Southern Crescent Women's Health Care	Fayetteville	Georgia
United States	W.T. Anderson Health Center - MCCG	Macon	Georgia
United States	My OB/GYN	Riverdale	Georgia
United States	New Millennium OB/GYN	Riverdale	Georgia
United States	Statesboro OB/GYN Specialists	Statesboro	Georgia
United States	Shaw Center for Women's Health	Thomasville	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortés M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Improving influenza and Tdap vaccination during pregnancy: A cluster-randomized trial of a multi-component antenatal vaccine promotion packa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination	This secondary outcome will be assessed through two surveys: one survey administered at baseline upon enrollment, and another survey administered 2 - 3 months post-partum.	Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.	No
Primary	Receipt of influenza vaccine during pregnancy	Our primary outcome is receipt of a 2012 - 2013 seasonal influenza vaccine during a participant's current pregnancy, before she delivers her child(ren).	Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.	No
Secondary	Receipt of Tdap vaccine during pregnancy	A secondary outcome is receipt of a Tdap vaccine during a participant's current pregnancy, before she delivers her child(ren).	Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.	No