VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: VAX-MOM COVID-19 Intervention
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Behavioral: VAX-MOM COVID-19 Intervention
The multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
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Active Comparator: Standard of Care
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Other: Standard of Care
Standard vaccine education and processes provided to patients by obstetric practices.
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Outcome Measures
Primary Outcome Measures
- Change in the rate of COVID-19 vaccination [6 month baseline compared to 6 month intervention]
Average rate of COVID-19 vaccination over 6 months during baseline will be compared with average rate of COVID-19 vaccination over 6 months during intervention, for vaccine eligible patients at participating OB/GYN practice sites. Vaccination status will be obtained from patient electronic health records.
Eligibility Criteria
Criteria
Inclusion Criteria:
Patient criteria:
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Sex is female
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Pregnant
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Ronald Reagan | Los Angeles | California | United States | 90095 |
2 | Pasadena | Pasadena | California | United States | 91105 |
3 | Porter Ranch | Porter Ranch | California | United States | 91326 |
4 | Santa Monica | Santa Monica | California | United States | 90404 |
5 | South Bay: Torrance | Torrance | California | United States | 90503 |
6 | Westlake/Thousand Oaks | Westlake Village | California | United States | 91361 |
7 | Unity OB/GYN at Brockport | Brockport | New York | United States | 14420 |
8 | Clifton Springs Hospital & Clinic | Clifton Springs | New York | United States | 14432 |
9 | Finger Lakes Geneva | Geneva | New York | United States | 14456 |
10 | TWC Newark | Newark | New York | United States | 14513 |
11 | TWC Clinton | Rochester | New York | United States | 14605 |
12 | TWC at Alexander Park | Rochester | New York | United States | 14607 |
13 | Community OB (COB) | Rochester | New York | United States | 14609 |
14 | URMC Midwifery at Culver | Rochester | New York | United States | 14609 |
15 | UMG OBGYN St Marys | Rochester | New York | United States | 14611 |
16 | Parkway OBGYN | Rochester | New York | United States | 14612 |
17 | UMG OBGYN Clinton Crossings | Rochester | New York | United States | 14618 |
18 | Gender Wellness Obstetrics & Gynecology (GOG) | Rochester | New York | United States | 14620 |
19 | Highland Women's Health (HWH) (POB) | Rochester | New York | United States | 14620 |
20 | University OB/GYN (UOG) | Rochester | New York | United States | 14620 |
21 | URMC Midwifery at Lattimore | Rochester | New York | United States | 14620 |
22 | TWC at RGH (Portland) | Rochester | New York | United States | 14621 |
23 | Strong Perinatal Associates (SPA) | Rochester | New York | United States | 14623 |
24 | Park Ridge OBGYN | Rochester | New York | United States | 14626 |
25 | Unity OB/GYN at Ridgeway | Rochester | New York | United States | 14626 |
26 | Bay Creek Midwifery | Webster | New York | United States | 14580 |
Sponsors and Collaborators
- University of Rochester
- Centers for Disease Control and Prevention
- University of California, Los Angeles
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00007624