HPV ECHO: Increasing the Adoption of Evidence-based Communication Strategies for HPV Vaccination in Rural Primary Care Practices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months
研究概览
简要总结
The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US; only 51% of 13- to 17-year-old girls and boys were up-to-date by 2018. The Announcement Approach Training is effective in increasing HPV vaccine uptake during the clinic visit by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communication like recall notifications also improve vaccination by reducing missed clinical opportunities. Although never tested to support HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) Model is a proven implementation strategy to promote capacity exchange between health care experts at academic centers and primary care providers at the front line of rural community health care. The trial will test the effectiveness of two ECHO-delivered HPV vaccination communication interventions versus control: HPV ECHO will provide Announcement Approach training, and HPV ECHO+ will provide training plus recall notices to communicate with parents who initially decline vaccination.
详细描述
The investigators will recruit 36 primary care clinics (family medicine and pediatric) in Pennsylvania. Eligible clinics will have at least 100 active patients, ages 11-14, in their electronic health record systems. Recruitment will target clinics in Central Pennsylvania, where most counties are designated as rural. Clinics will be randomized to one of three arms: ECHO-delivered HPV vaccine communication training using the Announcement Approach (HPV ECHO); HPV ECHO plus systems follow-up communication for parents who initially decline vaccination (HPV ECHO+); or control. Covariate-constrained randomization will be used to ensure balance among the three arms with respect to clinic size (adolescent patient population), clinic type (academic vs. non-academic), rurality, and historic adolescent HPV vaccination rates.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinics in cluster RCT (main study)
- •Inclusion Criteria:
- •Family medicine or pediatric clinic in Pennsylvania
- •Having at least 100 active patients, ages 11-14.
排除标准
- •Primary care clinic outside Pennsylvania
- •Participated in HPV vaccine communication or quality improvement research either through Penn State or another institution in the last 12 months.
- •Parents in nested study survey
- •Inclusion criteria:
- •Parent or guardian of an adolescent ages 11-17
- •Adolescent has not yet started HPV vaccination
- •Adolescent receive primary care at participating clinic
- •Exclusion criteria:
- •Not the parent or guardian of an adolescent ages 11-17
- •Adolescent already initiated HPV vaccination
- •Adolescent does not receive primary care at participating clinic
研究组 & 干预措施
HPV ECHO
Clinics randomly assigned to this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. The intervention has a curriculum of 10 sessions focused on the evidence-based Announcement Approach. Sessions will be 60 minutes in duration and held every other weekly for 4 months at regularly scheduled times.
干预措施: Project ECHO (Other)
HPV ECHO
Clinics randomly assigned to this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. The intervention has a curriculum of 10 sessions focused on the evidence-based Announcement Approach. Sessions will be 60 minutes in duration and held every other weekly for 4 months at regularly scheduled times.
干预措施: Announcement Approach Training (Other)
HPV ECHO+
Clinics randomly assigned to this arm will receive the HPV ECHO intervention plus a systems communication strategy to deliver recall notices to parents who initially decline HPV vaccination. This arm includes 12 primary care clinics in Pennsylvania.
干预措施: Project ECHO (Other)
HPV ECHO+
Clinics randomly assigned to this arm will receive the HPV ECHO intervention plus a systems communication strategy to deliver recall notices to parents who initially decline HPV vaccination. This arm includes 12 primary care clinics in Pennsylvania.
干预措施: Announcement Approach Training (Other)
HPV ECHO+
Clinics randomly assigned to this arm will receive the HPV ECHO intervention plus a systems communication strategy to deliver recall notices to parents who initially decline HPV vaccination. This arm includes 12 primary care clinics in Pennsylvania.
干预措施: Recall notices (Other)
Control
Clinics randomly assigned to this arm will receive no ECHO interventions. This arm includes 12 primary care clinics in Pennsylvania.
结局指标
主要结局
HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months
时间窗: Twelve months
Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records
次要结局
- HPV Vaccination (≥1 Dose), 11-14 Year Olds at 3 Months(Three months)
- HPV Vaccination (≥1 Dose), 11-14 Year Olds at 6 Months(Six months)
- HPV Vaccination (≥1 Dose), 11-14 Year Olds at 9 Months(Nine months)
- HPV Vaccination (Completion), 11-14 Year Olds at 3 Months(Three months)
- HPV Vaccination (Completion), 11-14 Year Olds at 6 Months(Six months)
- HPV Vaccination (Completion), 11-14 Year Olds at 9 Months(Nine months)
- HPV Vaccination (Completion), 11-14 Year Olds at 12 Months(Twelve months)
- HPV Vaccination (≥1 Dose), 15-17 Year Olds at 3 Months(Three months)
- HPV Vaccination (≥1 Dose), 15-17 Year Olds at 6 Months(Six months)
- HPV Vaccination (≥1 Dose), 15-17 Year Olds at 9 Months(Nine months)
- HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months(Twelve months)
- HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months by Sex(Twelve months)
- HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months by Sex(Twelve months)
研究者
William Calo
Assistant Professor
Milton S. Hershey Medical Center