Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-25 @ 1:48 PM
Study NCT ID:
NCT04981392
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2021-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trusted Messengers: Intervention to Promote COVID-19 Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000088823', 'term': 'Vaccination Hesitancy'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000072758', 'term': 'Vaccination Refusal'}, {'id': 'D016312', 'term': 'Treatment Refusal'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kimberly.fisher2@umassmed.edu', 'phone': '5088561975', 'title': 'Kimberly Fisher, MD', 'organization': 'UMass Chan Medical School'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Deaths and Adverse Events were not collected', 'description': 'Deaths and Adverse Events were not collected', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Arm', 'description': 'Primary care text message outreach to unvaccinated patients and resources to support PCPs\n\nPrimary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.\n\nProviders: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Patients will receive usual care', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'COVID-19 Vaccination Within 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10996', 'groupId': 'OG000'}, {'value': '10848', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'Primary care text message outreach to unvaccinated patients and resources to support PCPs\n\nPrimary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.\n\nProviders: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Patients will receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0066', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'statisticalMethod': 'Difference in adjusted % vaccinated', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 3 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'COVID-19 Vaccination Within 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10996', 'groupId': 'OG000'}, {'value': '10848', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'Primary care text message outreach to unvaccinated patients and resources to support PCPs\n\nPrimary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.\n\nProviders: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Patients will receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'statisticalMethod': 'Difference in adjusted % vaccinated', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 6 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Arm', 'description': 'Primary care text message outreach to unvaccinated patients and resources to support PCPs\n\nPrimary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.\n\nProviders: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'Patients will receive usual care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '7', 'numSubjects': '10996'}, {'groupId': 'FG001', 'numUnits': '7', 'numSubjects': '10848'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '7', 'numSubjects': '10996'}, {'groupId': 'FG001', 'numUnits': '7', 'numSubjects': '10848'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Clinic Sites', 'recruitmentDetails': '14 primary care clinics from three health systems in Central Massachusetts - a tertiary care academic medical center with community practices and two local Federally Qualified Health Centers were included in the study. The 14 participating clinics were matched according to size, practice setting (academic, community, FQHC), availability of COVID-19 vaccines in-clinic, and baseline COVID-19 vaccination rates and block randomized in 4 blocks.', 'preAssignmentDetails': 'Eligible participants included patients seen at one of the study clinics within 3-years period prior to start of the intervention, age \\>= 18 years, who had not been vaccinated against COVID-19 and were Massachusetts residents.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10,996', 'groupId': 'BG000'}, {'value': '10,848', 'groupId': 'BG001'}, {'value': '21844', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Arm', 'description': 'Primary care text message outreach to unvaccinated patients and resources to support PCPs\n\nPrimary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.\n\nProviders: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Patients will receive usual care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9649', 'groupId': 'BG000'}, {'value': '9720', 'groupId': 'BG001'}, {'value': '19369', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1268', 'groupId': 'BG000'}, {'value': '988', 'groupId': 'BG001'}, {'value': '2256', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '6156', 'groupId': 'BG000'}, {'value': '6134', 'groupId': 'BG001'}, {'value': '12290', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '4839', 'groupId': 'BG000'}, {'value': '4714', 'groupId': 'BG001'}, {'value': '9553', 'groupId': 'BG002'}]}]}, {'title': 'Unknown/Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3937', 'groupId': 'BG000'}, {'value': '4466', 'groupId': 'BG001'}, {'value': '8403', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6676', 'groupId': 'BG000'}, {'value': '6171', 'groupId': 'BG001'}, {'value': '12847', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '383', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '594', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '314', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '467', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1462', 'groupId': 'BG000'}, {'value': '705', 'groupId': 'BG001'}, {'value': '2167', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5913', 'groupId': 'BG000'}, {'value': '6032', 'groupId': 'BG001'}, {'value': '11945', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '875', 'groupId': 'BG000'}, {'value': '2889', 'groupId': 'BG001'}, {'value': '3764', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2290', 'groupId': 'BG000'}, {'value': '985', 'groupId': 'BG001'}, {'value': '3275', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10996', 'groupId': 'BG000'}, {'value': '10848', 'groupId': 'BG001'}, {'value': '21844', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Patients that are ≥18, unvaccinated, visit at study clinic in past 3 years, alive at time of data pull, MA residents.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-01', 'size': 627397, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-16T15:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The intervention will be tested using a pragmatic, cluster randomized clinical trial. Randomization will occur at the clinic level. Clinics will be matched by practice setting (Academic, Community, Federally Qualified Health Center) and other characteristics as possible. Within each pair, clinics will be randomly allocated to either the intervention or usual care Arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21844}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2021-07-26', 'resultsFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-18', 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 Vaccination Within 3 Months', 'timeFrame': '3 months', 'description': 'The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 3 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).'}], 'secondaryOutcomes': [{'measure': 'COVID-19 Vaccination Within 6 Months', 'timeFrame': '6 months', 'description': 'The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 6 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'Vaccine Hesitancy', 'Vaccine Confidence'], 'conditions': ['Covid19', 'Vaccination']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the impact of a multicomponent intervention to support Primary Care Provider (PCP) outreach to promote COVID-19 vaccination among vulnerable patients in and near Worcester, MA via a pragmatic, cluster randomized trial.', 'detailedDescription': 'The goal of this study is to increase uptake of the COVID-19 vaccine among vulnerable populations through systematic primary care (PCP or clinic) text message outreach to unvaccinated patients, information provision via a study website, and resources to support PCPs.\n\nThe clinical trial will randomize 14 primary care clinics from three health systems in the Worcester, Massachusetts area to intervention or control. Eligible patients seen at a study clinic randomized to the intervention will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.\n\nProviders at a study clinic randomized to the intervention will be provided resources to support their conversations with unvaccinated patients during the intervention. Resources will include access to the study website, factsheets to share with vaccine hesitant patients, prescription pads to be used to "prescribe\' the website, and an electronic "smartphrase" that can automatically add information about the study website and how to schedule a COVID-19 vaccination to patients\' After Visit Summary and/or clinic note.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients seen by a PCP at a participating clinic site within 3-years prior to study start\n* Age \\> / = 18 years\n\nExclusion Criteria:\n\n* Patients who have received at least one dose of a COVID-19 vaccine series prior to the start of the intervention\n* Non-Massachusetts residents'}, 'identificationModule': {'nctId': 'NCT04981392', 'briefTitle': 'Trusted Messengers: Intervention to Promote COVID-19 Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Trusted Messengers: Supporting Physicians in Promoting COVID-19 Vaccination', 'orgStudyIdInfo': {'id': 'H00023254'}, 'secondaryIdInfos': [{'id': '1R01MD016883-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01MD016883-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Primary care text message outreach to unvaccinated patients and resources to support PCPs', 'interventionNames': ['Behavioral: Primary care text message outreach to unvaccinated patients and resources to support PCPs']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Patients will receive usual care'}], 'interventions': [{'name': 'Primary care text message outreach to unvaccinated patients and resources to support PCPs', 'type': 'BEHAVIORAL', 'description': 'Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.\n\nProviders: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Chan Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Kimberly A Fisher, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kimberly Fisher', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}