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：
10669003
负责人：
Jason Newland
金额：
$ 46.76万
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/10669003
关键词：
17 year old Address Age Belief Caring Centers for Disease Control and Prevention (U.S.)Child Childhood Clinical Cluster randomized trial Collaborations Communication Computerized Medical Record Control Groups Country Crying Data Diphtheria Dose Education Effectiveness of Interventions Eligibility Determination 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 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 behavior change boys care delivery 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 provider primary care setting primary outcome provider behavior provider communication 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.

项目摘要一级预防与HPV相关的泌尿生殖器和口咽癌可能会显着降低这些常见发生的癌症相关的发病率，死亡率和医疗保健成本。疫苗靶向人乳头瘤病毒（HPV）的致癌菌株，如果给予HPV相关的癌症在暴露于这些性传播病毒之前的女孩和男孩。但是，在美国（美国），更多引入疫苗后的10年，疫苗的疫苗接种量不到一半。本应用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剂量系列在性别首次亮相之前。为此，疾病控制中心的国家建议和预防（CDC）将在13岁时完成2剂HPV疫苗系列。与初级保健提供者合作开发了组件干预措施，其中包括：1）教育视频，以增加提供者对指导建议和患者的了解以及 13岁时实践疫苗的益处； 2）疫苗覆盖范围的审核和反馈，以增加动力从事实践变革； 3）一种沟通策略，以提高提供商的沟通技巧和他们解决父母犹豫的自我效能； 4）练习设施以支持实践变更为开发可持续的HPV疫苗输送系统。干预将通过一系列简短进行在2年内每1-4周发生一次每1-4周的促进者进行练习访问。在一项试点研究中，干预是经过良好的感受，并在19个百分点的疫苗计划中取得了有意义的改善超过15个月。这一承诺将在20个初级保健小儿的集群随机试验中评估干预措施密苏里州的练习，该州的HPV疫苗覆盖率低。研究目标是1）确定是否是否干预将增加2剂HPV的主动性（主要结果）和完成（次要结果） 13岁生日之前的疫苗系列疫苗系列； 2）确定提供者的动机和改善沟通能力调解干预的有效性； 3）评估对扩展重要的因素包括忠诚，初级保健提供者和父母的接受以及费用。青春期疫苗的使用将是在基线时评估24个月以评估有效性，并在36个月进行评估，以评估变化是否为持续。对于主要分析，将使用患者级数据的汇总来估计提供商行为，从实践的电子病历中提取数据。

项目成果

期刊论文数量（1）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Provider and Practice Factors Associated With On-Time HPV Vaccination in Primary Care.

DOI：
10.1016/j.acap.2022.12.015
发表时间：
2022-12
期刊：
Academic pediatrics
影响因子：
3.1
作者：
J. Garbutt;Ruoyun Wang;Sharon Graham;V. MacKay;D. Haire-Joshu;A. Barker;Lei Liu
通讯作者：
J. Garbutt;Ruoyun Wang;Sharon Graham;V. MacKay;D. Haire-Joshu;A. Barker;Lei Liu