Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-02 @ 4:57 AM
Study NCT ID:
NCT01664793
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
2012-08-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
From Innovation to Solutions: Childhood Influenza Vaccination Planning
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': 'zimmer@pitt.edu', 'phone': '412-383-2355', 'title': 'Richard K. Zimmerman', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '2 offices of 1 practice were randomized to each arm potentially causing carryover of the intervention.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.', 'otherNumAtRisk': 26432, 'otherNumAffected': 0, 'seriousNumAtRisk': 26432, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.', 'otherNumAtRisk': 19352, 'otherNumAffected': 0, 'seriousNumAtRisk': 19352, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49039', 'groupId': 'OG000'}, {'value': '38626', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Children seen in 10 diverse pediatric and family medicine practices between 3/1/2011 and 2/29/2012.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Children with a visit between 3/1/2011 and 2/29/2012 in 10 diverse pediatric and family practices.'}], 'classes': [{'categories': [{'measurements': [{'value': '26432', 'groupId': 'OG000'}, {'value': '19352', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Chi-square tests for comparisons of between-arm changes in vaccination rates from pre to post intervention.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3/1/2011-2/29/2012', 'description': 'Influenza vaccination rates in each arm at the end of year 1', 'unitOfMeasure': 'participants vaccinated out of all', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effectiveness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': '2 respondents in each of 10 diverse pediatric and family medicine practices.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'This group did not rate effectiveness of the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of February 2012', 'description': 'Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the Intervention group; n=49,039.\n\nIntervention sites will use the 4 Pillars toolkit along with early season vaccine to promote increases in childhood influenza vaccination.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the control group; n=38,626. They will receive the 4 Pillars Toolkit and early season vaccine in Year 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49039'}, {'groupId': 'FG001', 'numSubjects': '38626'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49039'}, {'groupId': 'FG001', 'numSubjects': '38626'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43293', 'groupId': 'BG000'}, {'value': '38306', 'groupId': 'BG001'}, {'value': '81599', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'Children in 10 diverse pediatric and family medicine practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Children in 10 diverse pediatric and family practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '7.1', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '7.2', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'To be eligible, the practice must have had a patient population of children under 19 years old.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21560', 'groupId': 'BG000'}, {'value': '18540', 'groupId': 'BG001'}, {'value': '40100', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21733', 'groupId': 'BG000'}, {'value': '19766', 'groupId': 'BG001'}, {'value': '41499', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43293', 'groupId': 'BG000'}, {'value': '38306', 'groupId': 'BG001'}, {'value': '81599', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'children at sites'}], 'populationDescription': 'Children enrolled at family medicine practices and pediatric practices in the year preceding the intervention year for both intervention and control groups who were seen for a visit between 3/1/2010 and 2/28/2011.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87665}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-21', 'studyFirstSubmitDate': '2012-08-02', 'resultsFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2012-08-09', 'lastUpdatePostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-21', 'studyFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome', 'timeFrame': '3/1/2011-2/29/2012', 'description': 'Influenza vaccination rates in each arm at the end of year 1'}], 'secondaryOutcomes': [{'measure': 'Effectiveness Score', 'timeFrame': 'End of February 2012', 'description': 'Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['influenza', 'vaccination', 'strategies', 'children/adolescents'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '25113138', 'type': 'BACKGROUND', 'citation': 'Nowalk MP, Lin CJ, Hannibal K, Reis EC, Gallik G, Moehling KK, Huang HH, Allred NJ, Wolfson DH, Zimmerman RK. Increasing childhood influenza vaccination: a cluster randomized trial. Am J Prev Med. 2014 Oct;47(4):435-43. doi: 10.1016/j.amepre.2014.07.003. Epub 2014 Aug 8.'}, {'pmid': '24793941', 'type': 'BACKGROUND', 'citation': 'Zimmerman RK, Nowalk MP, Lin CJ, Hannibal K, Moehling KK, Huang HH, Matambanadzo A, Troy J, Allred NJ, Gallik G, Reis EC. Cluster randomized trial of a toolkit and early vaccine delivery to improve childhood influenza vaccination rates in primary care. Vaccine. 2014 Jun 17;32(29):3656-63. doi: 10.1016/j.vaccine.2014.04.057. Epub 2014 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to increase childhood influenza vaccination rates using the FDA licensed influenza vaccines according to national guidelines in a randomized cluster trial in which primary care offices are randomized to intervention or control with the control group receiving the intervention in the second year.', 'detailedDescription': 'The investigators will conduct a stratified, randomized cluster trial of 20 diverse primary care practices to compare influenza vaccination rates in intervention and control sites. Intervention sites will use a package of newly developed and evidence-based techniques that will be tailored to their practice structure and culture, called the 4 Pillars Immunization Toolkit, in addition to receiving donated vaccine for early season vaccination. Control practices will not receive such assistance but will receive the intervention in the second year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nFor children: attendance at the selected health care center within the last year and age \\>/=6 months thru 18 years.\n\nExclusion Criteria:\n\nFor children: Severe egg allergy or allergy to influenza vaccine'}, 'identificationModule': {'nctId': 'NCT01664793', 'briefTitle': 'From Innovation to Solutions: Childhood Influenza Vaccination Planning', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'From Innovation to Solutions: Autodialers, Use of Early Autumn Physicals and Vaccination Assessment as a Vital Sign to Increase Childhood Influenza Vaccination in Diverse Settings', 'orgStudyIdInfo': {'id': '1U01IP000321-01', 'link': 'https://reporter.nih.gov/quickSearch/1U01IP000321-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group Year 1', 'description': 'The 4 Pillars Immunization Toolkit along with donated vaccines for early season vaccination, staff education and support.', 'interventionNames': ['Behavioral: 4 Pillars Immunization Toolkit']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group Year 1', 'description': 'Control sites will not receive assistance with increasing influenza vaccination in Year 1, they will follow guidelines for usual care.'}], 'interventions': [{'name': '4 Pillars Immunization Toolkit', 'type': 'BEHAVIORAL', 'description': 'Pillar 1: Convenient Vaccination Services; Pillar 2: Patient notification about the importance of vaccination and availability of convenient services; Pillar 3: Enhanced Office Systems; Pillar 4: Motivation: Office immunization champion tracks progress towards a goal; Early delivery of donated vaccines for disadvantaged children, staff education, support of effort by research staff.', 'armGroupLabels': ['Intervention Group Year 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh, School of Medicine, Deparment of Family Medicine and Clinical Epidemiology', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Richard Zimmerman, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh, School of Medicine, Department of Family Medicine and Clinical Epidemiology'}, {'name': 'Chyongchiou Lin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Richard Zimmerman', 'investigatorAffiliation': 'University of Pittsburgh'}}}}