Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT04444518
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2020-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Increasing Influenza and Tdap Vaccination of Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cynthia_rand@urmc.rochester.edu', 'phone': '5852759316', 'title': 'Cynthia Rand, PI', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were not collected', 'description': 'Adverse events were not collected', 'eventGroups': [{'id': 'EG000', 'title': 'VAX-MOM Intervention', 'description': '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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Influenza Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4609', 'groupId': 'OG000'}, {'value': '5294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VAX-MOM Intervention', 'description': '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.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.'}], 'classes': [{'categories': [{'measurements': [{'value': '2382', 'groupId': 'OG000'}, {'value': '2496', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10/1/2021-6/30/2022 (intervention flu season)', 'description': 'Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pregnant during flu season'}, {'type': 'PRIMARY', 'title': 'Rate of Tdap Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5992', 'groupId': 'OG000'}, {'value': '6768', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VAX-MOM Intervention', 'description': '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.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.'}], 'classes': [{'categories': [{'measurements': [{'value': '4532', 'groupId': 'OG000'}, {'value': '5452', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7/1/2021 - 6/30/2022 (intervention period)', 'description': 'Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pregnant individuals during study period'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VAX-MOM Intervention', 'description': '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.'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '5992'}, {'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '6768'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '5992'}, {'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '6768'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Practices'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5992', 'groupId': 'BG000'}, {'value': '6768', 'groupId': 'BG001'}, {'value': '12760', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'VAX-MOM Intervention', 'description': '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.'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5966', 'groupId': 'BG000'}, {'value': '6755', 'groupId': 'BG001'}, {'value': '12721', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5837', 'groupId': 'BG000'}, {'value': '6637', 'groupId': 'BG001'}, {'value': '12474', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '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.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5992', 'groupId': 'BG000'}, {'value': '6768', 'groupId': 'BG001'}, {'value': '12760', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5992', 'groupId': 'BG000'}, {'value': '6768', 'groupId': 'BG001'}, {'value': '12760', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5992', 'groupId': 'BG000'}, {'value': '6768', 'groupId': 'BG001'}, {'value': '12760', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '430', 'groupId': 'BG000'}, {'value': '526', 'groupId': 'BG001'}, {'value': '956', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5992', 'groupId': 'BG000'}, {'value': '6768', 'groupId': 'BG001'}, {'value': '12760', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '694', 'groupId': 'BG000'}, {'value': '1266', 'groupId': 'BG001'}, {'value': '1960', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5992', 'groupId': 'BG000'}, {'value': '6768', 'groupId': 'BG001'}, {'value': '12760', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '547', 'groupId': 'BG000'}, {'value': '721', 'groupId': 'BG001'}, {'value': '1268', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5992', 'groupId': 'BG000'}, {'value': '6768', 'groupId': 'BG001'}, {'value': '12760', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1831', 'groupId': 'BG000'}, {'value': '2016', 'groupId': 'BG001'}, {'value': '3847', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5992', 'groupId': 'BG000'}, {'value': '6768', 'groupId': 'BG001'}, {'value': '12760', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2490', 'groupId': 'BG000'}, {'value': '2239', 'groupId': 'BG001'}, {'value': '4729', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5992', 'groupId': 'BG000'}, {'value': '6768', 'groupId': 'BG001'}, {'value': '12760', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5992', 'groupId': 'BG000'}, {'value': '6768', 'groupId': 'BG001'}, {'value': '12760', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-22', 'size': 995773, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-03T11:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12760}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2020-06-19', 'resultsFirstSubmitDate': '2024-09-04', 'studyFirstSubmitQcDate': '2020-06-19', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-26', 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Influenza Vaccination', 'timeFrame': '10/1/2021-6/30/2022 (intervention flu season)', 'description': 'Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.'}, {'measure': 'Rate of Tdap Vaccination', 'timeFrame': '7/1/2021 - 6/30/2022 (intervention period)', 'description': 'Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pertussis', 'influenza', 'vaccination', 'prenatal care'], 'conditions': ['Immunization; Infection', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients\n\n* Sex is female\n* Pregnant\n* identified as being eligible for influenza or Tdap vaccine\n\nProviders\n\n* any provider, nurse or staff associated with the participating sites\n\nExclusion Criteria:\n\nPatients\n\n* none\n\nProviders\n\n* none'}, 'identificationModule': {'nctId': 'NCT04444518', 'briefTitle': 'Increasing Influenza and Tdap Vaccination of Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'The VAX-MOM Study: Increasing Influenza and Tdap Vaccination of Pregnant Women', 'orgStudyIdInfo': {'id': 'STUDY00005115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VAX-MOM Intervention', 'interventionNames': ['Behavioral: VAX-MOM Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'interventionNames': ['Behavioral: Standard of Care']}], 'interventions': [{'name': 'VAX-MOM Intervention', 'type': 'BEHAVIORAL', 'description': 'The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.', 'armGroupLabels': ['VAX-MOM Intervention']}, {'name': 'Standard of Care', 'type': 'BEHAVIORAL', 'description': 'Standard vaccine education and processes provided to patients by obstetric practices.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center (URMC)', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be shared with investigators upon request as part of a collaboration.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Cynthia Rand', 'investigatorAffiliation': 'University of Rochester'}}}}