Clinical trial NCT04444518: Increasing Influenza and Tdap Vaccination of Pregnant Women
Official title: The VAX-MOM Study: Increasing Influenza and Tdap Vaccination of Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization; Infection
Pregnancy Related
Keywords: pertussis
influenza
vaccination
prenatal care
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: University of California, Los Angeles
First posted: 2020-06-23
Enrollment: 12760
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Patients

* none

Providers

* none

Primary outcomes:
measure: Rate of Influenza Vaccination
timeFrame: 10/1/2021-6/30/2022 (intervention flu season)
measure: Rate of Tdap Vaccination
timeFrame: 7/1/2021 - 6/30/2022 (intervention period)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center (URMC)
state: New York
Study officials:
References: