[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573388":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":23,"maxAge":23,"enrollmentInfo":70,"targetDuration":23,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":91,"whyStopped":23,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Hospital Israelita Albert Einstein","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Usual Care Group","This arm will continue to follow the routine activities and standard procedures established by the public health system.",[12],"Other: Usual Care",{"label":14,"type":6,"description":15,"interventionNames":16},"Multifaceted Intervention Group","This group will implement a multifaceted quality improvement and process strategy composed of:\n\nVideo-based training on vaccine management. Development of an optimized Cold Chain Manual, streamlining guidelines for vaccine handling.\n\nTechnical documents providing comprehensive guidance on the appropriate management of vaccines and their respective immunization schedules.\n\nTechnical documents addressing the management of errors identified post-vaccination and offering recommendations for public guidance",[17],"Other: Multifaceted intervention",[19,24],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Usual Care","Usual care for immunizations.",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Multifaceted intervention","The multifaceted quality improvement intervention includes: video-based training on vaccine management in SUS, an optimized Cold Chain Manual schema, technical documents on proper vaccine handling and immunization schedules, and checklists for managing post-vaccination errors and corrective procedures. Videos will focus on six key points (right person, vaccine, dose, time, route, and documentation), with each lasting about 2 minutes and accessible on-demand. The Cold Chain schema will cover storage, monitoring, transport, conservation, and handling, with checklists for each category. Standardized technical documents will align with video themes, ensuring protocol adherence. An error identification and management schema will address issues like improper vaccine administration, cold chain violations, and incorrect dosages. This schema will be reviewed by staff and made available in health units.",[14],[29],{"name":30,"affiliation":31,"role":32},"Henrique A Fonseca, ScD, PhD","Hospital Albert Einstein","STUDY_CHAIR",[34],{"name":35,"role":36,"phone":37,"phoneExt":23,"email":38},"Antonio C Mattos, MSc","CONTACT","+55 (11) 2151-1233","antonio.mattos@einstein.br",[40],{"facility":5,"status":23,"city":41,"state":41,"zip":23,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"São Paulo","Brazil","BR",{"type":45,"coordinates":46},"Point",[47,48],-46.63611,-23.5475,{"lat":48,"lon":47},[51],{"name":52,"role":36,"phone":37,"phoneExt":23,"email":53},"Henrique Fonseca","henrique.fonseca@einstein.br",{"type":55,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[57],{"name":58,"class":59},"Ministry of Health, Brazil","OTHER_GOV","100573388","a-multifaceted-intervention-on-reducing-immunization-errors-100573388",false,"NCT06745635","A Multifaceted Intervention on Reducing Immunization Errors","A Multifaceted Intervention on Reducing Immunization Errors: a Pragmatic, Stepped-wedge, Cluster Randomized Trial","THEIA","Cluster Inclusion Criteria\n\n* Health units with vaccination rooms administering at least 2,000 doses of vaccines\u002Fimmunobiologicals per month,\n\nCluster Exclusion Criteria\n\n* Primary health units that do not provide consistent vaccination services to the population.",true,"ALL",{"count":71,"type":72},72,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this trial is to reduce the general error related to vaccines and immunizations (composited on secondary endpoint), after 11 moths of folow-up after cluster randomization and stepped wedge on primary care on brazilian public health.\n\nThe main questions it aims to answer are:\n\n1. To evaluate the effectiveness of a multifaceted intervention in vaccination rooms in reducing vaccination errors.\n2. To describe the rate of adverse events following immunization (AEFI) and the associated factors.",[78,79,80],"Vaccines","Vaccines Adverse Reaction","Vaccine Practice",[82,25,83,84,85,86,87,88,89,90],"Cluster-randomized controlled trial","Quality improvement in immunization","Vaccination errors","Vaccination safety","Primary health care","Vaccination room management","Cold chain management","Public health improvement","Health systems implementation","NOT_YET_RECRUITING","2025-02-07",{"date":94,"type":95},"2025-02-11","ACTUAL",{"date":97,"type":72},"2025-07-03",{"date":99,"type":72},"2026-12-30",{"name":5,"class":6},1]