Increasing Influenza and Tdap Vaccination of Pregnant Women

University of Rochester

Status: Completed

Conditions: Immunization; Infection; Pregnancy Related

Treatments: Behavioral: Standard of Care; Behavioral: VAX-MOM Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04444518

STUDY00005115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12,760 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12,760 participants in 2 patient groups

VAX-MOM Intervention

Experimental group

Treatment:

Behavioral: VAX-MOM Intervention

Standard of Care

Active Comparator group

Treatment:

Behavioral: Standard of Care