Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06745635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-11
First Post:
2024-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multifaceted Intervention on Reducing Immunization Errors
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Study Overview
Official Title:
A Multifaceted Intervention on Reducing Immunization Errors: a Pragmatic, Stepped-wedge, Cluster Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THEIA
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: