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

• 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
• 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

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.

项目摘要 HPV相关的泌尿生殖道和口咽癌的一级预防可以显著减少 发病率、死亡率和与这些常见癌症相关的医疗费用。疫苗 靶向人乳头瘤病毒（HPV）的致癌株可以预防HPV相关的癌症， 在接触这些性传播病毒之前，然而，在美国，更 在引进疫苗后不到10年，不到一半的目标人口接种了疫苗。 该应用程序的目的是评估实施战略的有效性（ 预防HPV疫苗接种的方法有哪些？最佳使用需要完成2剂系列 在初次性行为之前为此，疾病控制中心和 预防中心（CDC）计划在13岁之前完成2剂HPV疫苗系列。理论基础，多 与初级保健提供者合作开发了成分干预，包括：1） 教育视频，以增加提供者关于指南建议和患者的知识， 在13岁之前实践疫苗接种的好处; 2）对疫苗覆盖率进行审计和反馈，以增加 参与实践变革; 3）提高提供者沟通技能的沟通策略， 他们的自我效能，以解决父母的犹豫;和4）实践促进，以支持实践的变化， 开发可持续的HPV疫苗输送系统。干预将通过一系列简短的 在2年内每1-4周与主持人进行一次实践访问。在一项试点研究中， 被广泛接受，导致疫苗启动率提高了19个百分点，具有临床意义 超过15个月。 这项有前途的干预措施将在20名初级保健儿科患者的随机分组试验中进行评估。 密苏里州的做法，一个HPV疫苗覆盖率低的州。研究目的是：1）确定 干预将增加2剂HPV的开始（主要结局）和完成（次要结局） 在13岁生日之前为青少年提供疫苗系列; 2）确定提供者的动机和改善 沟通技巧调解干预的有效性;和3）评估缩放的重要因素 包括忠诚度、初级保健提供者和父母的接受程度以及成本。在青春期前使用疫苗将是 在基线时评估，在24个月时评估有效性，在36个月时评估变化是否 反对有效对于主要分析，将使用患者水平数据的汇总来估计提供者 行为，从实践的电子病历中提取数据。