Evaluating the Impact of Optimizing the Use of HPV Vaccine Standing Orders in Primary Care Clinics
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- HPV vaccination (≥1 dose), 9-12 year olds
研究概览
简要总结
This trial will look at the impact of optimizing human papillomavirus (HPV) vaccine standing orders. The research team will work with primary care clinics. Some clinics will receive communication training. Other clinics will receive the same training and tools for increasing the use of their standing orders.
详细描述
The researchers will conduct a cluster randomized clinical trial. The trial will look at the impact of optimizing HPV vaccine standing orders. The recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. The researchers will randomize clinics using simple randomization (1:1). Some clinics will receive a communication training. Other clinics will receive a communication training and tools for optimizing the use of their standing orders. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 24 months. The researchers will also use survey data to compare HPV vaccine communication and implementation of standing orders among clinical staff. The study will engage clinical staff. Researchers will not have direct contact with children or their families.
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
- None
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children and survey data from clinical staff to evaluate intervention effectiveness. We will not enroll children or interact with them directly.
- •Inclusion Criteria
- •Clinics are eligible if they:
- •provide HPV vaccine to children ages 9-12
- •have standing orders for HPV vaccination approved but not routinely used or be willing to adopt them prior to the start of the trial
- •have rates of HPV vaccination (≥1 dose) below 72%, boys and girls combined
- •Children's medical records will be eligible to be included in the dataset if children:
- •are between the ages of 9-12 years at baseline
- •are attributed to a participating clinic at 12- or 24-month follow-up
- •Clinical staff's survey data will be eligible to be included in the dataset if clinical staff complete the follow-up survey.
排除标准
- •Clinics are excluded if they:
- •do not provide HPV vaccine to children ages 9-12
- •do not have standing orders for HPV vaccination or are not willing to adopt them prior to the start of the trial
- •have rates of HPV vaccination (≥1 dose) above 72%, boys and girls combined
- •have hosted an AAT workshop in the previous 3 years or are part of current HPV vaccine communication trainings
- •have quality improvement efforts to change HPV vaccine standing orders during the trial
- •Children's medical records will not be eligible to be included in the dataset if children:
- •are not between the ages of 9-12 years at baseline
- •are not attributed to a participating clinic at 12- or 24-month follow-up
- •are receiving hospice/palliative care, are pregnant, or have a history of HPV vaccine contraindications
- •Clinical staff's survey data will be not eligible to be included in the dataset if clinical staff do not complete the follow-up survey.
研究组 & 干预措施
HPV vaccine communication training and standing orders optimization
Staff in clinics randomized to this arm will receive the AAT and conduct a set of activities to optimize use of HPV vaccine standing orders.
干预措施: Communication training enhanced with standing orders optimization (Behavioral)
HPV vaccine communication training
Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination.
干预措施: Communication training (Behavioral)
结局指标
主要结局
HPV vaccination (≥1 dose), 9-12 year olds
时间窗: from baseline to 12 months
Proportion of unvaccinated children who initiate the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.
次要结局
- Standing orders attitude rating(up to 6 months)
- Standing orders norms rating(up to 6 months)
- Standing orders self-efficacy rating(up to 6 months)
- HPV vaccination (≥1 dose), 9-12 year olds(from 13 months to 24 months)
- HPV vaccination (≥2 doses), 9-12 year olds(from 13 months to 24 months)
- Standing orders appropriateness rating(up to 6 months)
- Recommendation self-efficacy rating(up to 6 months)
- Recommendation intentions rating(up to 6 months)
- Standing orders adoption rating(up to 6 months)
- Standing orders acceptability rating(up to 6 months)
- Standing orders role rating(up to 6 months)
- Standing orders sustainability rating(up to 6 months)
- Estimated time spent on recommendations(up to 6 months)
- Estimated recommendation frequency, 9-10 year olds(up to 6 months)
- Standing orders feasibility rating(up to 6 months)
- Recommendation attitudes rating(up to 6 months)
- Recommendation norms rating(up to 6 months)
- Estimated recommendation frequency, 11-12 year olds(up to 6 months)
- HPV vaccination (≥2 doses), 9-12 year olds(from baseline to 12 months)