NCT06745635

A Multifaceted Intervention on Reducing Immunization Errors

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

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.

Conditions

• Vaccines
• Vaccines Adverse Reaction
• Vaccine Practice

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-03
• Primary completion: 2026-07-31
• Completion: 2026-12-30
• First posted: 2024-12-20
• Last updated: 2025-02-11

Locations

1 site across 1 country: Brazil