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NCT Number: NCT06745635

A Multifaceted Intervention on Reducing Immunization Errors

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.

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Key information

Conditions

Vaccines Vaccine Practice Vaccines Adverse Reaction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Researchers will compare two times in a Stepped Wedge design:

  • 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."

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Usual Care

Other

Usual care for immunizations.

Multifaceted Intervention

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.

Primary outcomes

  1. Reduction of overall errors attributable to vaccination and immunization processes.

    Time frame: 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 outcomes

  1. incidence of the components of the primary outcome

    Time frame: Through study completion, an average of 1 year

    Rate of the components of the primary outcome.

Other outcomes

  1. Primary Secondary Outcome - Incidence of reported Adverse Events Following Immunization

    Time frame: From Randomization to the end of Follow-up (12 months)

    Incidence of reported Adverse Events Following Immunization (AEFI) in the studied health units-AEFIs recorded either spontaneously or through active surveillance within the health units during the study period.

  2. Exploratory Objective - Economical impact of strategy for reduce the error of immunization

    Time frame: Through study completion, an average of 1 year

    Cost-Effectiveness - Economical impact of strategy for reduce the error of immunization as basis for public vaccination policy justification -

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio C Mattos, MSc

CONTACT

[email protected]

+55 (11) 2151-1233

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

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

Acronym: THEIA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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