Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-01-01 @ 1:12 AM
Study NCT ID:
NCT03966300
Status:
TERMINATED
Last Update Posted:
2021-06-29
First Post:
2019-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving the School Vaccination Experience: What CARDs Are You Going to Play?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D000088823', 'term': 'Vaccination Hesitancy'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Students will not be aware of whether they are in the intervention or control group. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are trained in the intervention will not deliver care to participants in the control group and care providers that are not trained will not deliver care to participants in the intervention group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial; schools will be randomized to CARD or usual care and all students attending the schools will receive the allocated treatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1919}}, 'statusModule': {'whyStopped': 'Study was terminated due to inability to: 1) vaccinate at school, 2) control and track vaccinations, 3) continue the intervention as proposed. Data collected during fall 2019 clinics are being transferred to researchers and verified.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-23', 'studyFirstSubmitDate': '2019-05-25', 'studyFirstSubmitQcDate': '2019-05-25', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Student fear', 'timeFrame': 'within 5 minutes after vaccination', 'description': 'student self-reported fear during vaccination, rated on a 0-10 scale'}], 'secondaryOutcomes': [{'measure': 'Student pain', 'timeFrame': 'within 5 minutes after vaccination', 'description': 'student self-reported pain during vaccination, rated on a 0-10 scale'}, {'measure': 'Student dizziness', 'timeFrame': 'within 5 minutes of vaccination', 'description': 'student self-reported dizziness during vaccination, rated on a 0-10 scale'}, {'measure': 'Student fainting', 'timeFrame': 'within 1 hour after vaccination', 'description': 'student fainting during vaccination, yes/no, as assessed by immunizer'}, {'measure': 'Student post-immunization stress-related responses', 'timeFrame': 'within 1 hour after vaccination', 'description': 'student post-immunization stress-related responses, yes/no, as assessed by immunizer using the WHO immunization Stress Responses Criteria'}, {'measure': 'Utilization of coping strategies', 'timeFrame': 'within 5 minutes after vaccination', 'description': 'use of individual coping strategies during vaccination (distraction, topical anesthetic, privacy, support person, deep breathing, muscle tension), yes/no, as assessed by immunizer using Documentation Checklist'}, {'measure': 'Uptake of vaccination', 'timeFrame': 'by end of school year', 'description': 'proportion of students vaccinated (overall and for each vaccine)'}, {'measure': 'Implementation success of CARD', 'timeFrame': 'within 3 months of vaccination clinics', 'description': 'perceptions of implementation success of CARD program delivery as reported by CARD implementers (primary targets) using the CARD Global Impression Checklist, individual questions (5-point likert scale, higher number represents better outcome). This information will be supplemented with information from focus groups with implementers and study notes'}, {'measure': 'Compliance with CARD', 'timeFrame': 'within 3 months of vaccination clinics', 'description': 'percent compliance with CARD implementation as assessed by implementers using a CARD compliance checklist. This information will be supplemented with information from focus groups with implementers and study notes'}, {'measure': 'Knowledge of effective coping strategies', 'timeFrame': 'within 3 months after vaccination clinics', 'description': 'knowledge of effective coping strategies, as assessed using a 10-point investigator-developed knowledge test, administered to implementers'}, {'measure': 'Perceptions about pain and fear', 'timeFrame': 'within 3 months of vaccination clinics', 'description': 'perceptions about pain and fear, as assessed using a 5-point likert scale (higher number represents better outcome) for implementers'}, {'measure': 'Perceptions about vaccination program', 'timeFrame': 'within 3 months of vaccination clinics', 'description': 'perceptions about vaccination program, as assessed using the Vaccination Program Global Impresssion Checklist, individual questions (5-point likert scale, higher number represents better outcome) for implementers'}, {'measure': 'Willingness to be vaccinated', 'timeFrame': 'within 5 minutes after vaccination', 'description': 'student self-reported willingness to be vaccinated, as assessed using a 5-point likert scale (higher number represents better outcome)'}, {'measure': 'Satisfaction with CARD', 'timeFrame': 'within 5 minutes after vaccination', 'description': 'student self-reported satisfaction with CARD, as assessed using Student Feedback Survey, individual questions (5-point likert scale, higher number indicates better outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['school vaccinations', 'pain management', 'vaccination hesitancy', 'knowledge translation'], 'conditions': ['Vaccine Adverse Reaction', 'Vaccination; Complications', 'Fear']}, 'referencesModule': {'references': [{'pmid': '35365344', 'type': 'DERIVED', 'citation': 'Taddio A, Gudzak V, Jantzi M, Logeman C, Bucci LM, MacDonald NE, Moineddin R. Impact of the CARD (Comfort Ask Relax Distract) system on school-based vaccinations: A cluster randomized trial. Vaccine. 2022 Apr 26;40(19):2802-2809. doi: 10.1016/j.vaccine.2022.02.069. Epub 2022 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'Vaccination hesitancy is identified as a threat to global health by the World Health Organization (WHO). For adolescents undergoing vaccination at school, prior studies demonstrate that concerns about pain and/or fear of needles contribute to negative experiences with vaccination and non-compliance with vaccination. The investigators developed an intervention that addresses vaccination hesitancy. In this study, investigators will evaluate the effectiveness of this intervention in a randomized controlled trial.', 'detailedDescription': "Vaccination hesitancy is identified by the World Health Organization (WHO) as one of ten threats to global health. The WHO's 3C model of vaccination hesitancy identifies 3 domains of vaccine hesitancy: 1) Confidence (trust in health care providers), 2) Complacency (perceived importance of vaccine-preventable disease) and 3) Convenience (improving clinic processes). The investigators developed a multifaceted knowledge translation intervention that addresses vaccination hesitancy in school-based vaccinations. The intervention is called The CARD(TM) System (C-Comfort, A-Ask, R-Relax, D-Distract). CARD is a framework for delivering vaccinations that is student-centred and promotes coping. CARD integrates evidence-based interventions related to planning and execution of school vaccination clinics to directly tackle all 3 domains of vaccination hesitancy. It tackles Confidence by improving pain/fear management (it teaches students and public health staff how to reduce student symptoms which improves the vaccination experience and improves student trust in health care providers). It tackles Complacency by educating students about what vaccines are, why they are needed, community immunity, as well as the specific diseases they are being protected against. It tackles Convenience by improving school-based clinic processes by integrating student preferences (e.g., privacy, having a support person present).\n\nIn this randomized controlled trial, the investigators will evaluate the impact of CARD (vs. usual care) on student important outcomes and process outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* grade 7 students eligible for vaccination at school\n* public health staff working in the school vaccination program\n\nExclusion Criteria:\n\n* unable to understand and read English'}, 'identificationModule': {'nctId': 'NCT03966300', 'briefTitle': 'Improving the School Vaccination Experience: What CARDs Are You Going to Play?', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Playing CARDs to Improve the Vaccination Experience at School: a Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '37598'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CARD (multi-faceted knowledge translation intervention)', 'description': 'CARD will be integrated into the school vaccination program. This includes pre-vaccination day preparation (e.g., planning of clinic spaces, student and school staff education about CARD) and vaccination day activities (e.g., clinic set-up, processes for triaging students, implementing pain/fear/fainting mitigation interventions from CARD during vaccination)', 'interventionNames': ['Other: Multi-faceted knowledge translation intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control (standard/usual care)', 'description': 'There are no specific procedures being undertaken to plan or execute clinics. Usual practices will be instituted (i.e., no education specific to CARD, nor clinic set-up or execution to incorporate interventions for pain, fear or fainting)'}], 'interventions': [{'name': 'Multi-faceted knowledge translation intervention', 'type': 'OTHER', 'otherNames': ['CARD'], 'description': 'The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program', 'armGroupLabels': ['CARD (multi-faceted knowledge translation intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L9W 1K3', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Wellington Dufferin Guelph Public Health', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}], 'overallOfficials': [{'name': 'Anna Taddio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anna Taddio', 'investigatorAffiliation': 'University of Toronto'}}}}