The INFLUENTIAL Trial - Inpatient FLU Vaccination Program Effectiveness: National Trial Implementing Best Practices and Learning Collaboratives
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22,000
- 试验地点
- 4
- 主要终点
- Vaccine administration rate
研究概览
简要总结
This study plans to learn more about whether a stakeholder-informed, standardized inpatient vaccination program will increase influenza vaccination rates of hospitalized children across US pediatric health systems. The first part of the study is to form a multidisciplinary team of stakeholders, including parents, providers, nurses, pharmacists, informaticists, data analysts and communication experts across three sites in synthesizing a best practice implementation guide for an inpatient influenza vaccination program, which will then be piloted at these three sites.
详细描述
The overarching goal of this proposal is to determine whether a stakeholder-informed, standardized inpatient influenza vaccination program will increase influenza vaccination rates of hospitalized children across diverse U.S. pediatric health systems. Building upon preliminary data and experience with pediatric inpatient influenza vaccine delivery, the investigators will engage a multidisciplinary team of stakeholders in synthesizing a best practice implementation guide for an inpatient influenza vaccination program across three sites. The next phase of the study, using a novel adaptive trial design, will be to implement and test the program across 12 health systems. Finally, the investigators will evaluate the program's impact using an established dissemination and implementation framework.
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
盲法说明
Sites will be randomized 2:1 by the study statistician to intervention A vs. usual care. The randomization will be stratified by academic or academic plus community setting. This will ensure that the groups are balanced for site variables that may be correlated with the outcomes of interest. After the first intervention season, the 4 usual care sites and 6 lowest performing intervention sites (lowest change in vaccination rates from their baseline data) will be randomized 1:1 to intervention A vs. intervention B.
入排标准
- 年龄范围
- 6 Months 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 6 months of age
- •Admitted to an inpatient unit at a participating health system
- •Admission to critical care sites or hematology-oncology services
排除标准
- •At least 6 months of age
- •Admitted to an inpatient unit at a participating health system
- •Admission to critical care sites or hematology-oncology services
结局指标
主要结局
Vaccine administration rate
时间窗: 1 year
proportion of influenza vaccine administrations to eligible patients during hospitalization.
次要结局
未报告次要终点