VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination

Not Applicable

Completed

• Conditions: Pregnancy Related; Immunization; Infection; COVID-19
• Interventions: Other: Standard of Care; Behavioral: VAX-MOM COVID-19 Intervention

• Registration Number: NCT05570630
• Lead Sponsor: University of Rochester

Brief Summary

COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID vaccination rates for pregnant people overall. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of increasing maternal COVID-19 vaccination rates.

Detailed Description

COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID-19 vaccination rates for pregnant people overall.

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 COVID-19 vaccination rates for pregnant people. To address this, 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 COVID-19 intervention and the other half to standard of care. The multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.

Study Timeline

• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-06
• Study Start: 2022-10-21
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11279

Inclusion Criteria

Patient criteria:

• Sex is female
• Pregnant
• Identified as being eligible for COVID-19 vaccine

Practice personnel criteria:

*Provider, nurse or staff currently affiliated with (employed with) the participating OB/GYN sites

Exclusion Criteria

*None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	-
VAX-MOM COVID-19 Intervention	VAX-MOM COVID-19 Intervention	-

Primary Outcome Measures

Name	Time	Method
Rate of COVID-19 vaccination	6 month baseline compared to 6 month intervention	Average rate of COVID-19 vaccination will be compared between intervention and control arms, for vaccine eligible patients at participating OB/GYN practice sites. 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