A Multifaceted Intervention on Reducing Immunization Errors (THEIA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaccines; Vaccine Practice; Vaccines Adverse Reaction
• Intervention / Treatment: Other: Usual Care; Other: Multifaceted intervention

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio C Mattos, MSc; Phone Number: +55 (11) 2151-1233; Email: antonio.mattos@einstein.br

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Hospital Israelita Albert Einstein
    • Contact: Henrique Fonseca; Phone Number: +55 (11) 2151-1233; Email: henrique.fonseca@einstein.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care Group; This arm will continue to follow the routine activities and standard procedures established by the public health system.	Other: Usual Care; Usual care for immunizations.
Other: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of the components of the primary outcome	Rate of the components of the primary outcome.	Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Secondary Outcome - Incidence of reported Adverse Events Following Immunization	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.	From Randomization to the end of Follow-up (12 months)
Exploratory Objective - Economical impact of strategy for reduce the error of immunization	Cost-Effectiveness - Economical impact of strategy for reduce the error of immunization as basis for public vaccination policy justification -	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Ministry of Health, Brazil
• Investigators: Study Chair: Henrique A Fonseca, ScD, PhD, Hospital Albert Einstein

Study record dates

Study Major Dates

• Study Start (Estimated): July 3, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Primary health care; Multifaceted intervention; Cluster-randomized controlled trial; Quality improvement in immunization; Vaccination errors; Vaccination safety; Vaccination room management; Cold chain management; Public health improvement; Health systems implementation
• Other Study ID Numbers: THEIA trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No