Increasing Influenza and Tdap Vaccination of Pregnant Women

Not Applicable

Completed

• Conditions: Pregnancy Related; Immunization; Infection
• Interventions: Behavioral: Standard of Care; Behavioral: VAX-MOM Intervention

• Registration Number: NCT04444518
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-23
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Results First Submitted: 2024-09-04
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Results First Posted: 2025-01-10
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12760

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	-
VAX-MOM Intervention	VAX-MOM Intervention	-

Primary Outcome Measures

Name	Time	Method
Rate of Influenza Vaccination	10/1/2021-6/30/2022 (intervention flu season)	Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.
Rate of Tdap Vaccination	7/1/2021 - 6/30/2022 (intervention period)	Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.

Trial Locations

Locations (1)

University of Rochester Medical Center (URMC); 🇺🇸 Rochester, New York, United States