A Multifaceted Intervention on Reducing Immunization Errors

NCT06745635 | Not Yet Recruiting

• 1 other identifier: THEIA trial
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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. 1.To evaluate the effectiveness of a multifaceted intervention in vaccination rooms in reducing vaccination errors.
2. 2.To describe the rate of adverse events following immunization (AEFI) and the associated factors.

Conditions

Vaccines; Vaccines Adverse Reaction; Vaccine Practice

Keywords

Cluster-randomized controlled trial; Multifaceted intervention; Quality improvement in immunization; Vaccination errors; Vaccination safety; Primary health care; Vaccination room management; Cold chain management; Public health improvement; Health systems implementation

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (1)

• incidence of the components of the primary outcome

  Through study completion, an average of 1 year

Other Outcomes (2)

• Primary Secondary Outcome - Incidence of reported Adverse Events Following Immunization

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

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

  Through study completion, an average of 1 year

Study Arms (2)

Usual Care Group

OTHER

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

Other: Usual Care

Multifaceted Intervention Group

OTHER

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

Other: Multifaceted intervention

Interventions

Usual Care OTHER

Usual care for immunizations.

Usual Care Group

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.

Multifaceted Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Location

Study Officials

• Henrique A Fonseca, ScD, PhD

  Hospital Albert Einstein

  STUDY CHAIR

Central Study Contacts

Antonio C Mattos, MSc

CONTACT

+55 (11) 2151-1233; antonio.mattos@einstein.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Stepped-Wedge Cluster Randomized Trial (SW-CRT) is a type of clinical trial in which the intervention is progressively implemented across clusters (groups) over time in a staggered and randomized manner. Initially, all clusters start in the control group, and in successive steps, one or more clusters are randomly selected to receive the intervention. This process continues until all clusters have been exposed to the intervention.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 20, 2024
• Study Start: July 3, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)