Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT01159093
Status:
COMPLETED
Last Update Posted:
2015-03-12
First Post:
2010-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Giving Immunizations Through Vaccine Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23675}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-11', 'studyFirstSubmitDate': '2010-07-07', 'studyFirstSubmitQcDate': '2010-07-07', 'lastUpdatePostDateStruct': {'date': '2015-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of HPV vaccination among girls actively cared for at participating sites', 'timeFrame': 'Monthly, up to 1 year', 'description': 'The outcome will be assessed monthly, until study completion (1 year).'}], 'secondaryOutcomes': [{'measure': 'Rates of meningococcal and tetanus, diphtheria, and pertussis vaccines among girls in the study', 'timeFrame': 'Monthly, up to 1 year', 'description': 'The outcome will be assessed monthly, until study completion (1 year).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clinical Decision Support Systems'], 'conditions': ['HPV Vaccines']}, 'referencesModule': {'references': [{'pmid': '25455116', 'type': 'DERIVED', 'citation': 'Mayne SL, duRivage NE, Feemster KA, Localio AR, Grundmeier RW, Fiks AG. Effect of decision support on missed opportunities for human papillomavirus vaccination. Am J Prev Med. 2014 Dec;47(6):734-44. doi: 10.1016/j.amepre.2014.08.010. Epub 2014 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'This study will test the effectiveness of clinician-focused health IT-based decision support, family-focused health IT-based decision support, and a combination of both efforts, in increasing HPV and other adolescent vaccine rates among adolescent girls. We hypothesize that a combination of clinician-focused clinical decision support and family-focused decision support will be most effective.', 'detailedDescription': '* Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.\n* Family-focused intervention includes vaccine reminders and informational telephone calls prompted by the electronic health record.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All clinicians practicing at participating sites\n* Parents with an eligible adolescent girl\n* Adolescent girls\n* Ages 11-17\n* Has a visit at one of the primary care centers within the last 15 months.\n* Has not completed the teen vaccine series\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01159093', 'acronym': 'GIVE', 'briefTitle': 'Giving Immunizations Through Vaccine Education', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Using Health Information Technology to Improve Healthcare Quality in Primary Care Practices and in Transitions Between Care Settings', 'orgStudyIdInfo': {'id': '09-00-7352'}, 'secondaryIdInfos': [{'id': 'AHRQ', 'type': 'OTHER_GRANT', 'domain': 'HHSA29032001T'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family Decision Support', 'description': 'Families will receive informational vaccine reminder telephone calls.', 'interventionNames': ['Behavioral: Family Decision Support']}, {'type': 'EXPERIMENTAL', 'label': 'Clinical Decision Support', 'description': 'In this treatment arm, clinicians receive the decision support at the point of care within an electronic health record.', 'interventionNames': ['Behavioral: Clinician Decision Support']}, {'type': 'EXPERIMENTAL', 'label': 'Family DS+ Clinician DS', 'description': 'Families will receive informational vaccine reminder calls and their clinicians will receive electronic health record-based decision support for immunizations.', 'interventionNames': ['Behavioral: Family Decision Support', 'Behavioral: Clinician Decision Support', 'Other: Family Decision Support and Clinician Decision Support']}, {'type': 'OTHER', 'label': 'Control', 'description': 'This group will receive regular primary care with no decision support.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Family Decision Support', 'type': 'BEHAVIORAL', 'otherNames': ['Clinical Decision Support', 'Family Focused Intervention'], 'description': 'Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.', 'armGroupLabels': ['Family DS+ Clinician DS', 'Family Decision Support']}, {'name': 'Clinician Decision Support', 'type': 'BEHAVIORAL', 'otherNames': ['Clinical Decision Support', 'Clinician Focused Intervention'], 'description': 'Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.', 'armGroupLabels': ['Clinical Decision Support', 'Family DS+ Clinician DS']}, {'name': 'Family Decision Support and Clinician Decision Support', 'type': 'OTHER', 'otherNames': ['Family Decision Support', 'Clinician Decision Support'], 'description': 'This will be a combination of the family-focused decision support (telephone reminder calls) and clinician-focused decision support (clinical alerts).', 'armGroupLabels': ['Family DS+ Clinician DS']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Usual care', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Alexander G Fiks, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}