COVID-19, Immunization; Infection, Pregnancy Related
Conditions
Keywords
COVID-19, Vaccination, Prenatal Care
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.
Interventions
BEHAVIORALVAX-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.
OTHERStandard of Care
Standard vaccine education and processes provided to patients by obstetric practices.
Sponsors
Centers for Disease Control and Prevention
University of California, Los Angeles
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of COVID-19 Vaccination (6 Month) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of COVID-19 Vaccination (9 Month) | 9 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VAX-MOM COVID-19 Intervention 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. | 4,256 |
| Standard of Care Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices. | 2,655 |
| Total | 6,911 |
Baseline characteristics
| Characteristic | VAX-MOM COVID-19 Intervention | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 43 Participants | 39 Participants | 82 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1693 Participants | 1726 Participants | 3419 Participants |
| Race/Ethnicity, Customized Asian | 47 Participants | 69 Participants | 116 Participants |
| Race/Ethnicity, Customized Black | 319 Participants | 367 Participants | 686 Participants |
| Race/Ethnicity, Customized Hispanic | 252 Participants | 265 Participants | 517 Participants |
| Race/Ethnicity, Customized Other/Unknown | 187 Participants | 172 Participants | 359 Participants |
| Race/Ethnicity, Customized White | 931 Participants | 892 Participants | 1823 Participants |
| Region of Enrollment United States | 4256 participants | 2655 participants | 6911 participants |
| Sex: Female, Male Female | 4256 Participants | 2655 Participants | 6911 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Rate of COVID-19 Vaccination (6 Month)
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.
Time frame: 6 months
Population: 6 month cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VAX-MOM COVID-19 Intervention | Rate of COVID-19 Vaccination (6 Month) | 251 Participants |
| Standard of Care | Rate of COVID-19 Vaccination (6 Month) | 130 Participants |
Secondary
Rate of COVID-19 Vaccination (9 Month)
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.
Time frame: 9 months
Population: 9 month cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VAX-MOM COVID-19 Intervention | Rate of COVID-19 Vaccination (9 Month) | 404 Participants |
| Standard of Care | Rate of COVID-19 Vaccination (9 Month) | 180 Participants |