Summary

Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.

Official Title

The VAX-MOM Study: Increasing Influenza and Tdap Vaccination of Pregnant Women

Details

Infants under 6 months of age at increased risk of both influenza (flu) and pertussis disease, and pregnant women risk serious illness and premature labor from flu. The Advisory Committee on Immunization Practices recommends that women receive a flu vaccine in flu season, and tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine during each pregnancy (ideally between 27-36 weeks) to lower the risk for flu and pertussis disease for themselves and their infants. However, only half of pregnant women in the US receive a flu and Tdap vaccine, respectively; only 33% of women receive both vaccines. Lack of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy), provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of standing orders and patient reminders) factors. An effective intervention is needed to improve flu and Tdap vaccination rates for pregnant women. To address these low vaccination rates the investigators plan to use a clustered RCT (randomizing practices), allocating half of the participating practice sites within each health system to the VAX-MOM intervention and the other half to standard of care. The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

Keywords

Immunization; Infection, Pregnancy Related, pertussis, influenza, vaccination, prenatal care, Human Influenza, VAX-MOM Intervention

Eligibility

You can join if…

Patients

  • Sex is female
  • Pregnant
  • identified as being eligible for influenza or Tdap vaccine

Providers

  • any provider, nurse or staff associated with the participating sites

You CAN'T join if...

Patients

  • none

Providers

  • none

Locations

  • Ronald Reagan OB
    Los Angeles California 90095 United States
  • UCLA Faculty Practice. OBGYN at West Medical
    Los Angeles California 90095 United States
  • UCLA OBGYN Nurse-Midwives Clinic
    Santa Monica California 90404 United States
  • Harbor UCLA
    Torrance California 90502 United States
  • Santa Monica Faculty Practice
    Santa Monica California 90404 United States
  • Hudson Comprehensive Health Center
    Los Angeles California 90007 United States
  • Hubert Humphrey Comprehensive Health Center
    Los Angeles California 90003 United States
  • Los Angeles County USC Medical Center
    Los Angeles California 90033 United States
  • MLK Outpatient Center
    Los Angeles California 90059 United States
  • South Bay (Torrance)
    Torrance California 90503 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Rochester
ID
NCT04444518
Study Type
Interventional
Participants
About 9903 people participating
Last Updated