Randomized Controlled Trial to Evaluate an Implementation Strategy to Increase Optimal Use of HPV Vaccine in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Initiation of the HPV Vaccine 2-dose Series.
研究概览
简要总结
Washington University will evaluate the effectiveness of a multi-component implementation strategy to increase use of HPV vaccine in primary care practices.
详细描述
The investigators at Washington University will complete a cluster-randomized trial to evaluate the effectiveness of a multi-component implementation strategy (the intervention) to increase use of the HPV vaccine according to CDC guidelines. The unit of randomization is a community-based, primary care pediatric practice. Twenty practices will be randomized into two groups, the intervention group (n=10) or a wait-list control group (n=10). The intervention will be implemented over 2-years and includes: 1) an educational video for providers; 2) audit and feedback of vaccine coverage; 3) a communication strategy; and 4) practice facilitation.
The primary outcome of HPV vaccination by age 13 will be assessed at 24 months, and at 36 months to assess if change is sustained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-based pediatric primary care practices with 2 or more providers.
- •Providers who deliver wellness care to preteens and adolescents.
- •Willingness to participate in the practice facilitator-guided QI process.
- •Providers who deliver wellness care to preteens and adolescents.
- •Willingness to complete study questionnaires.
- •Willingness to participate in the practice facilitator-guided QI process.
排除标准
- •Practices and providers may be excluded at the discretion of the PI.
研究组 & 干预措施
Intervention Group
Practices randomly assigned to this arm will receive the multi-component intervention.
干预措施: Practice Facilitation (Other)
Intervention Group
Practices randomly assigned to this arm will receive the multi-component intervention.
干预措施: Education (Other)
Intervention Group
Practices randomly assigned to this arm will receive the multi-component intervention.
干预措施: Audit and Feedback (Other)
Intervention Group
Practices randomly assigned to this arm will receive the multi-component intervention.
干预措施: Communication Strategy (Other)
Wait list control group
Practices randomly assigned to this arm will be offered the intervention in the last two years of the study.
结局指标
主要结局
Initiation of the HPV Vaccine 2-dose Series.
时间窗: 24 months
The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization
Completion of the HPV Vaccine 2-dose Series.
时间窗: 24 months
The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization.
次要结局
- Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine.(36 months)
- Sustainability of the Intervention Benefit for Completion of the HPV Vaccine.(36 months)