A Multifaceted Intervention on Reducing Immunization Errors

Not Applicable

Not yet recruiting

• Conditions: Vaccines; Vaccines Adverse Reaction; Vaccine Practice

• Registration Number: NCT06745635
• Lead Sponsor: Hospital Israelita Albert Einstein

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Study Start: 2025-07-03
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Reduction of overall errors attributable to vaccination and immunization processes.	From Randomization to the end of Follow-up (12 months)	The primary composite outcome is defined as the reduction of overall errors attributable to vaccination and immunization processes, including: dilution errors, administration of vaccines outside the recommended age, errors related to inappropriate intervals between doses/vaccines, errors in the use of immunobiologicals, errors related to repeated doses, administration of vaccines not recommended during pregnancy, errors in the storage and handling of vaccines and immunobiologicals, and administration of vaccines via incorrect routes.

Secondary Outcome Measures

Name	Time	Method
incidence of the components of the primary outcome	Through study completion, an average of 1 year	Rate of the components of the primary outcome.

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 Sao Paulo, Brazil