A Multifaceted Intervention on Reducing Immunization Errors (THEIA)

Hospital Israelita Albert Einstein

Status: Not yet enrolling

Conditions: Vaccines Adverse Reaction; Vaccines; Vaccine Practice

Treatments: Other: Usual Care; Other: Multifaceted intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06745635

THEIA trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Usual Care Group

Other group

Description:

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

Treatment:

Other: Usual Care

Multifaceted Intervention Group

Other group

Description:

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

Treatment:

Other: Multifaceted intervention