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临床试验/NCT06380114
NCT06380114招募中不适用

Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

University of Rochester2 个研究点 分布在 1 个国家目标入组 16,000 人开始时间: 2024年11月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
16,000
试验地点
2
主要终点
Patient-Level Captured Opportunities for HPV Vaccination

研究概览

简要总结

Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time.

Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 9-17 year-olds.

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 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • active patient in AHP practice

排除标准

  • patient belonging to a practice with >80% UTD baseline HPV vaccination rate for ages 13-17
  • patient belonging to a practice with <20 11-12 year-olds eligible for an HPV dose

研究组 & 干预措施

Communication Training

Active Comparator

Practice personnel (providers and nurses) receive training in communication about HPV vaccination.

干预措施: Communication (Behavioral)

Communication Training + Standing Orders Training/Implementation

Experimental

Practice personnel (providers and nurses) receive training in communication about HPV vaccination and training in the implementation of standing orders for HPV vaccination.

干预措施: Communication (Behavioral)

Communication Training + Standing Orders Training/Implementation

Experimental

Practice personnel (providers and nurses) receive training in communication about HPV vaccination and training in the implementation of standing orders for HPV vaccination.

干预措施: Standing Orders (Behavioral)

结局指标

主要结局

Patient-Level Captured Opportunities for HPV Vaccination

时间窗: 12-month baseline compared to 12-month intervention compared to 12-month maintenance (control arm vs intervention arm)

The percentage of HPV vaccine eligible patients, aged 9-17, with a practice visit during the specified timeframe of interest who receive \>=1 HPV vaccination.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia Rand

Professor, Pediatrics

University of Rochester

研究点 (2)

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