A Multifaceted Intervention on Reducing Immunization Errors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHospital Israelita Albert Einstein
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Primary health units that do not provide consistent vaccination services to the population.
Trial design
Design model
Sequential
Treatments tested in this trial
Usual Care
Other interventionUsual care for immunizations.
Multifaceted intervention
Other interventionThe 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Usual Care GroupOther 1 intervention
Group B: Multifaceted Intervention GroupOther 1 intervention
Trial outcomes
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.
Time frame
From Randomization to the end of Follow-up (12 months)Secondary outcomes
1
incidence of the components of the primary outcome
Rate of the components of the primary outcome.
Time frame
Through study completion, an average of 1 yearOther outcomes
1
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.
Time frame
From Randomization to the end of Follow-up (12 months)2
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 -
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Israelita Albert Einstein
Lead sponsor
Ministry of Health, Brazil
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: