A Multifaceted Intervention on Reducing Immunization Errors

NCT ID: NCT06745635

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2026-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care Group

This arm will continue to follow the routine activities and standard procedures established by the public health system.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Usual care for immunizations.

Multifaceted Intervention Group

This group 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 documents addressing the management of errors identified post-vaccination and offering recommendations for public guidance

Group Type: OTHER

Multifaceted intervention

Intervention Type: OTHER

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.

Interventions

Usual Care

Usual care for immunizations.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Health units with vaccination rooms administering at least 2,000 doses of vaccines/immunobiologicals per month,

Exclusion Criteria

• Primary health units that do not provide consistent vaccination services to the population.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henrique A Fonseca, ScD, PhD

Role: STUDY_CHAIR

Hospital Albert Einstein

Locations

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Antonio C Mattos, MSc

Role: CONTACT

antonio.mattos@einstein.br

+55 (11) 2151-1233

Facility Contacts

Henrique Fonseca

Role: primary

henrique.fonseca@einstein.br

+55 (11) 2151-1233

Other Identifiers

THEIA trial

Identifier Type: -

Identifier Source: org_study_id