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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| University of California, Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAX-MOM COVID-19 Intervention | Experimental |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAX-MOM COVID-19 Intervention | Behavioral | The multi-component VAX-MOM COVID-19 intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months |
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Inclusion Criteria:
Patient criteria:
Practice personnel criteria:
*Provider, nurse or staff currently affiliated with (employed with) the participating OB/GYN sites
Exclusion Criteria:
*None
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center (URMC) | Rochester | New York | 14642 | United States |
Data will be shared with investigators upon request as part of a collaboration.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard of Care | Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Demographic data was not available for one health system |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 6 month cohort | Posted | Count of Participants | Participants | 6 months |
|
Adverse events were not collected
Adverse events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Rand, PI | University of Rochester | 5852759316 | cynthia_rand@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2025 | Jul 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Standard vaccine education and processes provided to patients by obstetric practices. |
|
Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Data was missing from one health system | Count of Participants | Participants |
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| Region of Enrollment | Number | 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. | 9 month cohort | Posted | Count of Participants | Participants | 9 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard of Care | Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |