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NOT YET RECRUITING
NCT06745635
NA

A Multifaceted Intervention on Reducing Immunization Errors

Sponsor: Hospital Israelita Albert Einstein

View on ClinicalTrials.gov

Summary

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.

Official title: A Multifaceted Intervention on Reducing Immunization Errors: a Pragmatic, Stepped-wedge, Cluster Randomized Trial

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2025-07-03

Completion Date

2026-12-30

Last Updated

2025-02-11

Healthy Volunteers

Yes

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 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.

Locations (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil