Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT05836818
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2023-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.rodriguez@ucsf.edu', 'phone': '925-457-2145', 'title': 'Robert Rodriguez', 'organization': 'University of California San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days post ED index visit', 'eventGroups': [{'id': 'EG000', 'title': 'Question (Q)', 'description': 'Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine', 'otherNumAtRisk': 244, 'deathsNumAtRisk': 244, 'otherNumAffected': 0, 'seriousNumAtRisk': 244, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Messaging (M)', 'description': 'Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine\n\nMessaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information', 'otherNumAtRisk': 210, 'deathsNumAtRisk': 210, 'otherNumAffected': 0, 'seriousNumAtRisk': 210, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Non Intervention', 'description': 'Usual care', 'otherNumAtRisk': 313, 'deathsNumAtRisk': 313, 'otherNumAffected': 0, 'seriousNumAtRisk': 313, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Messaging (M)', 'description': 'Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine\n\nMessaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information'}, {'id': 'OG001', 'title': 'Non Intervention', 'description': 'Usual care, no intervention given. Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001'], 'paramType': 'Adjusted difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.1', 'ciLowerLimit': '17', 'ciUpperLimit': '33.2', 'groupDescription': 'Adjusted difference 25.1 percentage points', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects logistic regression with a random center effect for within-center characteristics, and terms for calendar time and intervention'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post index ED visit', 'description': 'Participant uptake of the influenza vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways:\n\n1. Receipt in emergency department during index (enrollment) visit\n2. Electronic health record review 30 days after index visit\n3. Follow up phone call to participant at 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vaccine Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Messaging (M)', 'description': 'Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine\n\nMessaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information'}, {'id': 'OG001', 'title': 'Question (Q)', 'description': 'Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during ED visit', 'description': 'Participants who responded they would accept a vaccine of asked in the ED. Comparing Intervention M and Intervention Q groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Question (Q)', 'description': 'Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine'}, {'id': 'OG001', 'title': 'Non Intervention', 'description': 'Usual care, no intervention given. Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post index ED visit', 'description': 'Participant uptake of the influenza vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways:\n\n1. Receipt in emergency department during index (enrollment) visit\n2. Electronic health record review 30 days after index visit\n3. Follow up phone call to participant at 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Intervention Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Messaging (M)', 'description': 'Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine\n\nMessaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information'}, {'id': 'OG001', 'title': 'Question (Q)', 'description': 'Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post index ED visit', 'description': 'Participant uptake of the influenza vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways:\n\n1. Receipt in emergency department during index (enrollment) visit\n2. Electronic health record review 30 days after index visit\n3. Follow up phone call to participant at 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Question (Q)', 'description': 'Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine'}, {'id': 'FG001', 'title': 'Messaging (M)', 'description': 'Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine\n\nMessaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information'}, {'id': 'FG002', 'title': 'Non Intervention', 'description': 'Usual care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '270', 'numSubjects': '245'}, {'groupId': 'FG001', 'numUnits': '270', 'numSubjects': '214'}, {'groupId': 'FG002', 'numUnits': '270', 'numSubjects': '317'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '270', 'numSubjects': '244'}, {'groupId': 'FG001', 'numUnits': '270', 'numSubjects': '210'}, {'groupId': 'FG002', 'numUnits': '270', 'numSubjects': '313'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '4'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Later found to be previously vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Allergic to vaccines', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Recruitment days across all sites'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}, {'value': '767', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Question (Q)', 'description': 'Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine'}, {'id': 'BG001', 'title': 'Messaging (M)', 'description': 'Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine\n\nQuestion (Q): Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine\n\nMessaging (M): Flu vaccine educational materials -videos and flyers containing flu vaccine educational information'}, {'id': 'BG002', 'title': 'Non Intervention', 'description': 'Usual care'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '61'}, {'value': '47', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '59'}, {'value': '44', 'groupId': 'BG002', 'lowerLimit': '32', 'upperLimit': '58'}, {'value': '46', 'groupId': 'BG003', 'lowerLimit': '32', 'upperLimit': '59'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '353', 'groupId': 'BG003'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '274', 'groupId': 'BG003'}]}]}, {'title': 'American Indian/Alaska Native', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}, {'title': 'Latinx', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian/Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Middle Eastern', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'White (Non-Latino)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '286', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants could choose multiple answers and thus may be counted more than once', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}, {'value': '767', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-03', 'size': 399132, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-21T18:36', 'hasProtocol': True}, {'date': '2023-01-10', 'size': 193857, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-01T19:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'outcomes assessor will not know arm assignment'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A three-arm cluster randomized control trial to determine the effect of vaccine messaging and a question about acceptance, a question about acceptance without messaging, and standard care affect vaccine uptake in the ED.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 776}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2023-04-19', 'resultsFirstSubmitDate': '2024-05-01', 'studyFirstSubmitQcDate': '2023-04-19', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-29', 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Intervention Q', 'timeFrame': '30 days post index ED visit', 'description': 'Participant uptake of the influenza vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways:\n\n1. Receipt in emergency department during index (enrollment) visit\n2. Electronic health record review 30 days after index visit\n3. Follow up phone call to participant at 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.'}], 'primaryOutcomes': [{'measure': 'Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention', 'timeFrame': '30 days post index ED visit', 'description': 'Participant uptake of the influenza vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways:\n\n1. Receipt in emergency department during index (enrollment) visit\n2. Electronic health record review 30 days after index visit\n3. Follow up phone call to participant at 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.'}], 'secondaryOutcomes': [{'measure': 'Vaccine Acceptance', 'timeFrame': 'during ED visit', 'description': 'Participants who responded they would accept a vaccine of asked in the ED. Comparing Intervention M and Intervention Q groups'}, {'measure': 'Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group', 'timeFrame': '30 days post index ED visit', 'description': 'Participant uptake of the influenza vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways:\n\n1. Receipt in emergency department during index (enrollment) visit\n2. Electronic health record review 30 days after index visit\n3. Follow up phone call to participant at 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza Vaccination']}, 'referencesModule': {'references': [{'pmid': '38776635', 'type': 'DERIVED', 'citation': "Rodriguez RM, Eucker SA, Rafique Z, Nichol G, Molina MF, Kean E, O'Laughlin KN, Bezek SK, Goicochea K, Ford JS, Morse D, White J, Arreguin MI, Shughart L, Chavez CL, Glidden DV, Rising KL. Promotion of Influenza Vaccination in the Emergency Department. NEJM Evid. 2024 Apr;3(4):EVIDoa2300197. doi: 10.1056/EVIDoa2300197. Epub 2024 Mar 26."}]}, 'descriptionModule': {'briefSummary': 'The goal of this research is to increase influenza vaccine acceptance and uptake in vulnerable populations whose primary (and often only) health care access occurs in emergency departments (ED Usual Source of Care Patients). Toward this goal, the investigators will conduct one on one interviews and focus groups with ED Usual Source of Care Patients and community partners and produce trusted messaging informational platforms (PROmotion of FLU VA(X)ccination in the Emergency Department - PROFLUVAXED) that will address barriers to flu vaccination, especially vaccine hesitancy. The investigators will then conduct a cluster-randomized, controlled trial of PROFLUVAXED platforms in six EDs to determine whether their implementation is associated with greater flu vaccine acceptance and uptake in ED Usual Source of Care Patients.', 'detailedDescription': 'Specific Aim I: To determine whether implementation of influenza vaccine trusted messaging platforms is associated with increased influenza vaccine uptake in unvaccinated ED patients.\n\nAt six EDs (Zuckerberg San Francisco General, UCSF Parnassus Medical Center \\[San Francisco, CA\\], Thomas Jefferson University Hospital \\[Philadelphia, PA\\], Ben Taub Hospital \\[Houston, TX\\], Harborview Medical Center \\[Seattle, WA\\], and Duke University Medical Center \\[Durham, NC\\]), investigators will conduct a cluster-randomized controlled trial of implementation of PROFLUVAXED trusted messaging platforms, with influenza vaccine uptake in the ED as the primary outcome. Hypothesis: Implementation of PROFLUVAXED trusted messaging platforms in EDs will be associated with increased influenza vaccine uptake in unvaccinated ED patients.\n\nSpecific Aim II: To determine whether implementation of influenza vaccine trusted messaging platforms in EDs is associated with increased influenza vaccine acceptance in unvaccinated ED patients. For this specific aim influenza vaccine acceptance in the ED assessed via ED survey will be the primary outcome. Hypothesis: Implementation of PROFLUVAXED trusted messaging platforms in EDs will be associated with increased influenza vaccine acceptance in unvaccinated ED patients.\n\nSpecific Aim III: To determine whether implementation of a protocol in which ED patients are asked whether they will accept an influenza vaccine in the ED (and notifying ED providers when they say they will accept it) is associated with increased influenza vaccine uptake in unvaccinated ED patients. Hypothesis: Implementation of an ED protocol in which patients are asked whether they will accept an influenza vaccine (and notifying ED providers when they say they will accept it) will be associated with increased influenza vaccine uptake in unvaccinated ED patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults\n2. Presenting to ED\n3. Not already vaccinated for influenza in the current year\n4. Able to provide informed consent\n5. Fluent in English or Spanish\n6. Anticipated ability to complete study intervention in ED i.e., able to watch a 3-minute videoclip\n\nExclusion Criteria:\n\n1. Age \\< 18 years\n2. Major trauma such that it will preclude survey\n3. Inability to participate in a survey because of intoxication, altered mental status, or critical illness\n4. Incarceration\n5. Psychiatric hold\n6. We will also exclude patients who state that they have already received an influenza vaccine and patients who are in the ED for suspected acute Covid or influenza illness.'}, 'identificationModule': {'nctId': 'NCT05836818', 'acronym': 'PROFLUVAXED', 'briefTitle': 'PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED', 'orgStudyIdInfo': {'id': '21-34004B'}, 'secondaryIdInfos': [{'id': 'R01AI166967-01', 'link': 'https://reporter.nih.gov/quickSearch/R01AI166967-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Question (Q)', 'description': 'Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine', 'interventionNames': ['Other: Question (Q)']}, {'type': 'EXPERIMENTAL', 'label': 'Messaging (M)', 'description': 'Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine', 'interventionNames': ['Other: Question (Q)', 'Other: Messaging (M)']}, {'type': 'NO_INTERVENTION', 'label': 'Non intervention', 'description': 'Usual care'}], 'interventions': [{'name': 'Question (Q)', 'type': 'OTHER', 'description': 'Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine', 'armGroupLabels': ['Messaging (M)', 'Question (Q)']}, {'name': 'Messaging (M)', 'type': 'OTHER', 'description': 'Flu vaccine educational materials -videos and flyers containing flu vaccine educational information', 'armGroupLabels': ['Messaging (M)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital Emergency Department', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Parnassus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Torresdale Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19148', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Methodist Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington-Harborview Emergency Department', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Robert Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}