Impact of AFIX and Physician-to-Physician Engagement on HPV Vaccination in Primary Care: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 6
- 主要终点
- HPV vaccination (≥1 dose), 11-12 year olds at 12 months
研究概览
简要总结
HPV vaccination is at lower levels than the national goals. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescents in primary care clinics.
详细描述
The University of North Carolina will test the effectiveness of the Center for Disease Control and Prevention's AFIX model, physician-to-physician engagement, and both strategies in combination, for increasing HPV vaccination coverage among adolescents in primary care clinics. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. Physician-to-physician (P2P) engagement consists of physician educators providing feedback about clinics' current HPV vaccination coverage and in-depth training about how to make strong and effective HPV vaccination recommendations to primary care providers via remote webinar consultations. Physician educators will also use immunization registry data to provide feedback on clinics' vaccine coverage. The investigators will compare changes in HPV vaccination coverage before and after intervention for high-volume primary care clinics in four study conditions: AFIX consultations delivered in-person by state health department immunization specialists (AFIX group), physician-to-physician consultations delivered remotely by trained physician educators (P2P group), both AFIX and P2P consultations in combination (AFIX + P2P group), or no HPV quality improvement intervention (control group). In each state, 30 clinics will be randomly assigned to each study arm, for a total of 120 clinics per state, or 360 clinics overall. As a secondary endpoint, we proposed to evaluate the impact of intervention "booster" visits delivered at 12-months post-intervention. However, the CDC has recently changed the AFIX program so that the desired comparison is no longer possible. Therefore, we have eliminated booster visits. This change does not affect our primary endpoint. The primary objective of this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 12-month follow-up. Secondarily, the study will compare the change in coverage for other vaccines, age groups and time periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Pediatric or family medicine clinics or practices in New York, Wisconsin, or Arizona with at least 200 active records for patients, ages 11-17, in their states' immunization information systems.
排除标准
- •Less than 200 active records for patients between 11-17
结局指标
主要结局
HPV vaccination (≥1 dose), 11-12 year olds at 12 months
时间窗: Twelve months
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12- year old patients, as measured by states' immunization information system (IIS) records
次要结局
- HPV vaccination (≥1 dose), 11-12 year olds at six months by state(Six months)
- HPV vaccination (≥1 dose), 11-12 year olds at 12 months by state(Twelve months)
- HPV vaccination (≥1 dose), 13-17 year olds at 18 months(Eighteen months)
- HPV vaccination (≥1 dose), 11-12 year olds at 18 months(Eighteen months)
- HPV vaccination (≥1 dose), 11-12 year olds at 6 months(Six months)
- HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at six months by state(Six months)
- HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months(Eighteen months)
- HPV vaccination (≥1 dose), 11-12 year olds at 18 months by state(Eighteen months)
- HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months(Six months)
- HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months(Twelve months)
- HPV vaccination (≥1 dose), 13-17 year olds at 12 months(Twelve months)
- HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 12 months(Twelve months)
- HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 12 months by state(Twelve months)
- HPV vaccination (completion according to ACIP guidelines), 11-12 year olds at 18 months by state(Eighteen months)
- HPV vaccination (≥1 dose), 13-17 year olds at six months(Six months)
- HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at 18 months(Eighteen months)
- HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at six months(Six months)
