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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| University of California, Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAX-MOM Intervention | Experimental |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAX-MOM Intervention | Behavioral | The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Influenza Vaccination | Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records. | 10/1/2021-6/30/2022 (intervention flu season) |
| Rate of Tdap Vaccination | Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records. | 7/1/2021 - 6/30/2022 (intervention period) |
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Inclusion Criteria:
Patients
Providers
Exclusion Criteria:
Patients
Providers
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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 Intervention | VAX-MOM Intervention: The multi-component VAX-MOM 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 Intervention | VAX-MOM Intervention: The multi-component VAX-MOM 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 | Regarding the counts for "Age, Categorical," date of birth (DOB) was unavailable in the EHR for 39 total subjects and thus, age could not be calculated. Due to this, 26 subjects have an unknown age in the "Intervention" group, and 13 subjects have an unknown age in the "Standard of Care" group. |
| 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 Influenza Vaccination | Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records. | Pregnant during flu season | Posted | Number | participants | 10/1/2021-6/30/2022 (intervention flu season) |
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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 Intervention | VAX-MOM Intervention: The multi-component VAX-MOM 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 | Jun 22, 2022 | Sep 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D014917 | Whooping Cough |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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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 | Behavioral | 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 | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Rate of Tdap Vaccination | Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records. | Pregnant individuals during study period | Posted | Number | participants | 7/1/2021 - 6/30/2022 (intervention period) |
|
|
|
| 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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| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |