A Multifaceted Intervention on Reducing Immunization Errors: a Pragmatic, Stepped-wedge, Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Reduction of overall errors attributable to vaccination and immunization processes.
研究概览
简要总结
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:
- To evaluate the effectiveness of a multifaceted intervention in vaccination rooms in reducing vaccination errors.
- To describe the rate of adverse events following immunization (AEFI) and the associated factors.
详细描述
Researchers will compare two times in a Stepped Wedge design:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cluster Inclusion Criteria
- •Health units with vaccination rooms administering at least 2,000 doses of vaccines/immunobiologicals per month,
排除标准
- •Primary health units that do not provide consistent vaccination services to the population.
研究组 & 干预措施
Usual Care Group
This arm will continue to follow the routine activities and standard procedures established by the public health system.
干预措施: Usual Care (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
干预措施: Multifaceted intervention (Other)
结局指标
主要结局
Reduction of overall errors attributable to vaccination and immunization processes.
时间窗: From Randomization to the end of Follow-up (12 months)
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.
次要结局
- incidence of the components of the primary outcome(Through study completion, an average of 1 year)