Clinical trial NCT06745635: A Multifaceted Intervention on Reducing Immunization Errors
Official title: A Multifaceted Intervention on Reducing Immunization Errors: a Pragmatic, Stepped-wedge, Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2024-12-20
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of overall errors attributable to vaccination and immunization processes.
timeFrame: From Randomization to the end of Follow-up (12 months)
Secondary outcomes:
measure: incidence of the components of the primary outcome
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Primary Secondary Outcome - Incidence of reported Adverse Events Following Immunization
timeFrame: From Randomization to the end of Follow-up (12 months)
measure: Exploratory Objective - Economical impact of strategy for reduce the error of immunization
timeFrame: Through study completion, an average of 1 year
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Hospital Albert Einstein
name: Henrique A Fonseca, ScD, PhD
role: STUDY_CHAIR
References: