A Multifaceted Intervention on Reducing Immunization Errors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Usual Care, Multifaceted intervention.
- Who it may be relevant to
- Registry conditions: Vaccines, Vaccines Adverse Reaction, Vaccine Practice. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multifaceted Intervention on Reducing Immunization Errors: a Pragmatic, Stepped-wedge, Cluster Randomized Trial
Overview
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. The main questions it aims to answer are: 1. To evaluate the effectiveness of a multifaceted intervention in vaccination rooms in reducing vaccination errors. 2. To describe the rate of adverse events following immunization (AEFI) and the associated factors.
Detailed description
Researchers will compare two times in a Stepped Wedge design:
1. Usual Care :All sites will follow the standard practices for vaccine management and immunization in health units with vaccination rooms during 1 month.
All sites will be randomized into 11 steps (corresponding to the number of stages required to complete the 12-month study). At each step, 8 clusters (each containing one immunization service within a primary care facility) will receive the intervention." 2. Multifaceted Strategy :\*This time will implement a multifaceted quality improvement and process strategy composed of:
* Video-based training on vaccine management. * Development of an optimized Cold Chain Manual, streamlining guidelines for vaccine handling. * Technical documents providing comprehensive guidance on the appropriate management of vaccines and their respective immunization schedules. * Technical documentsaddressing the management of errors identified post-vaccination and offering recommendations for public guidance.
Interventions
- Other Usual Care
Usual care for immunizations. - Other 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 stor
Primary outcome measures
- Reduction of overall errors attributable to vaccination and immunization processes. [Time frame: From Randomization to the end of Follow-up (12 months)]
Secondary outcome measures (1)
- incidence of the components of the primary outcome [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Cluster Inclusion Criteria
- Health units with vaccination rooms administering at least 2,000 doses of vaccines/immunobiologicals per month,
Cluster Exclusion Criteria
- Primary health units that do not provide consistent vaccination services to the population.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Brazil · 1 center
- Hospital Israelita Albert Einstein — São Paulo
Identifiers
NCT: NCT06745635 · THEIA trial