权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

RCT to Evaluate an Implementation Strategy to Increase Optimal Use of HPV Vaccine in Primary Care

随机对照试验评估提高 HPV 疫苗在初级保健中最佳使用的实施策略

基本信息

批准号：
10454803
负责人：
Jason Newland
金额：
$ 39.8万
依托单位：
WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-07-02 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10454803
关键词：
17 year old Address Age Belief Centers for Disease Control and Prevention (U.S.)Child Childhood Clinical Cluster randomized trial Collaborations Communication Computerized Medical Record Control Groups Country Data Diphtheria Dose Effectiveness of Interventions Ensure Evaluation Exposure to Feedback Female Future Goals Guidelines Health Care Costs Healthy People 2020 Human Papilloma Virus Vaccination Human Papilloma Virus Vaccine Human Papilloma Virus-Related Malignant Neoplasm Human Papillomavirus Intervention Knowledge Malignant Neoplasms Malignant neoplasm of cervix uteri Measures Mediating Meningococcal vaccine Missouri Morbidity - disease rate Motivation Oncogenic Outcome Parents Patients Pertussis Pilot Projects Primary Health Care Primary Prevention Provider Recommendation Reporting Research Personnel Sampling Schools Self Efficacy Series System Target Populations Testing Tetanus Theoretical Domains framework Time Translating United States Urogenital Cancer Vaccinated Vaccination Vaccines Visit Waiting Lists Work age group base behavior change boys care costs care delivery care providers community based research cost effectiveness evaluation future implementation girls implementation evaluation implementation fidelity implementation strategy improved innovation intervention effect malignant oropharynx neoplasm mortality multi-component intervention pilot test post intervention practice-based research network preadolescence prevent primary care setting primary outcome provider behavior provider intervention satisfaction secondary outcome sexual debut sexually transmitted virus skills study population theories uptake vaccination outcome vaccine delivery

项目摘要

Project Summary Primary prevention of HPV-related urogenital and oropharyngeal cancers could significantly reduce morbidity, mortality, and healthcare costs associated with these commonly occurring cancers. The vaccine targeting oncogenic strains of the human papilloma virus (HPV) can prevent HPV-related cancers if given to girls and boys before exposure to these sexually transmitted viruses. Yet, in the United States (U.S.), more than 10 years after introduction of the vaccine, fewer than half of the target population is vaccinated. The objective of this application is to evaluate the effectiveness of an implementation strategy (the intervention) to improve optimal use of the HPV vaccine. Optimal use requires completion of the 2-dose series before sexual debut. To this end, national recommendations from the Centers for Disease Control and Prevention (CDC) are to complete the 2-dose HPV vaccine series by age 13. The theory-based, multi- component intervention was developed in collaboration with primary care providers and includes: 1) an educational video to increase the provider’s knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13; 2) audit and feedback of vaccine coverage to increase motivation to engage in practice change; 3) a communication strategy to improve the provider’s communication skills and their self-efficacy to address parental hesitation; and 4) practice facilitation to support practice change to develop a sustainable HPV vaccine delivery system. The intervention will be delivered through a series of brief practice visits with the facilitator that occur every 1-4 weeks over 2 years. In a pilot study, the intervention was well-accepted and resulted in a clinically meaningful improvement in vaccine initiation of 19 percentage points over 15-months. This promising intervention will be evaluated in a cluster-randomized trial in 20 primary care pediatric practices in Missouri, a state with low HPV vaccine coverage. Study objectives are to 1) determine if the intervention will increase initiation (primary outcome) and completion (secondary outcome) of the 2-dose HPV vaccine series for preteens before their 13th birthday; 2) determine if provider motivation and improved communication skills mediate the effectiveness of the intervention; and 3) assess factors important for scaling including fidelity, acceptance by primary care providers and parents, and cost. Vaccine use in preteens will be assessed at baseline, at 24 months to assess effectiveness, and at 36 months to assess if change is sustained. For the primary analyses, aggregates of patient-level data will be used to estimate provider behavior, extracting data from the practices’ electronic medical record.

项目概要 HPV 相关泌尿生殖系统癌症和口咽癌的一级预防可显着减少与这些常见癌症相关的发病率、死亡率和医疗费用。疫苗针对人乳头瘤病毒 (HPV) 的致癌菌株，如果给予以下治疗，可以预防 HPV 相关癌症：女孩和男孩在接触这些性传播病毒之前。然而，在美国（U.S.），更多疫苗推出不到 10 年，只有不到一半的目标人群接种了疫苗。该应用程序的目的是评估实施策略的有效性（干预）以改善 HPV 疫苗的最佳使用。最佳使用需要完成 2 剂系列在首次性行为之前。为此，国家疾病控制中心和预防 (CDC) 将在 13 岁时完成 2 剂 HPV 疫苗系列。干预措施是与初级保健提供者合作开发的，包括：1) 教育视频，以增加提供者对指南建议以及患者和患者的了解 13 岁之前练习接种疫苗的好处； 2) 疫苗覆盖率的审核和反馈，以提高疫苗接种的积极性参与实践变革； 3) 提高提供者沟通技巧的沟通策略他们解决父母犹豫问题的自我效能； 4) 实践促进以支持实践改变开发可持续的 HPV 疫苗输送系统。干预措施将通过一系列简短的发言进行练习在 2 年内每 1-4 周拜访一次辅导员。在一项试点研究中，干预措施是得到广泛接受，使疫苗接种率提高了 19 个百分点，具有临床意义超过15个月。这项有希望的干预措施将在 20 个初级保健儿科患者的整群随机试验中进行评估密苏里州的做法，该州 HPV 疫苗覆盖率较低。研究目标是 1) 确定是否干预将增加 2 剂 HPV 的启动（主要结果）和完成（次要结果） 13 岁生日前针对青少年的疫苗系列； 2) 确定提供者的动机是否得到改善沟通技巧调节干预的有效性； 3）评估对扩展很重要的因素包括忠诚度、初级保健提供者和家长的接受度以及成本。青春期前的疫苗使用将在基线时进行评估，在 24 个月时评估有效性，在 36 个月时评估变化是否有效持续。对于初步分析，患者级别数据的汇总将用于估计提供者行为，从诊所的电子病历中提取数据。