Protecting Pregnant Women From Infectious Diseases

• ClinicalTrials.gov Identifier: NCT01761799
• Recruitment Status: Completed
• First Posted: January 7, 2013
• Last Update Posted: November 1, 2015
• Sponsor: Emory University
• Collaborator: Centers for Disease Control and Prevention
• Information provided by (Responsible Party): Saad B. Omer, PhD, Emory University

Tracking Information

• First Submitted Date: December 18, 2012
• First Posted Date: January 7, 2013
• Last Update Posted Date: November 1, 2015
• Study Start Date: December 2012
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2013)

Receipt of influenza vaccine during pregnancy [ Time Frame: 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. ]

Our primary outcome is receipt of a 2012 - 2013 seasonal influenza vaccine during a participant's current pregnancy, before she delivers her child(ren).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 3, 2013)

Receipt of Tdap vaccine during pregnancy [ Time Frame: 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. ]

A secondary outcome is receipt of a Tdap vaccine during a participant's current pregnancy, before she delivers her child(ren).

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: January 3, 2013)

Changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination [ Time Frame: 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. ]

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Protecting Pregnant Women From Infectious Diseases
• Official Title: Protecting Pregnant Women From Infectious Diseases: a Cluster Randomized Evaluation of the Comprehensive "P3" Intervention Package Within Obstetric Practices in Georgia
• Brief 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.
• Detailed 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• 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.

Study Arms

• Experimental: P3 Vaccine Promotion Package
  The 5 obstetric practices randomized to the intervention arm will receive and implement all components of the evidence-based P3 vaccine promotion package at the beginning of the study.
  Intervention: Behavioral: P3 Vaccine Promotion Package.
• No Intervention: No P3 vaccine promotion package intervention
  The 5 obstetric practices randomized to the control arm will not receive the comprehensive vaccine promotion package at the beginning of the study and will instead be instructed to continue their standard of care regarding influenza and Tdap vaccination of pregnant patients.

Publications *

• 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 package in late influenza season. Vaccine. 2015 Jul 9;33(30):3571-9. doi: 10.1016/j.vaccine.2015.05.048. Epub 2015 Jun 1.
• Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortes M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Impact of a multi-component antenatal vaccine promotion package on improving knowledge, attitudes and beliefs about influenza and Tdap vaccination during pregnancy. Hum Vaccin Immunother. 2016 Aug 2;12(8):2017-2024. Epub 2016 Apr 15.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 23, 2013): 330
• Original Estimated Enrollment (submitted: January 3, 2013): 375
• Actual Study Completion Date: August 2015
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01761799
• Other Study ID Numbers: IRB00060292; 5P01TP000300-05 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Saad B. Omer, PhD, Emory University
• Study Sponsor: Emory University
• Collaborators: Centers for Disease Control and Prevention

Investigators

• Principal Investigator: Saad B Omer, MBBS,MPH,PhD; Emory Unversity

• PRS Account: Emory University
• Verification Date: October 2015