The STOP-HPV Scale-Up Study

STOP-HPV 扩大研究

• 批准号: 10564651
• 负责人: PETER G SZILAGYI
• 金额: $ 64.08万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10564651
• 关键词: 17 year old; Address; Adolescent; Adoption; American; Cessation of life; Childhood; Clinical Nurse Specialists; Communication; Effectiveness; Eligibility Determination; Evaluation; Evidence based practice; Feedback; Goals; Health; Health system; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Learning; Logic; Maintenance; Malignant Neoplasms; Medical; Medical Care Costs; Methods; Modeling; Morbidity - disease rate; Outcome; Parents; Population; Practical Robust Implementation and Sustainability Model; Procedures; Process; Provider; Qualitative Methods; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Readiness; Research; Series; Survey Methodology; System; Techniques; Telephone; Testing; Training; Vaccination; Vaccines; arm; collaborative care; compare effectiveness; cost; cost effective; cost effectiveness; design; effectiveness evaluation; health assessment; health organization; health training; implementation process; implementation science; implementation strategy; improved; interest; organizational readiness; point of care; practice factors; prevent; primary care practice; primary outcome; provider communication; provider factors; recruit; scale up; secondary outcome; treatment as usual; uptake; vaccination outcome; vaccine acceptance; vaccine delivery; vaccine hesitancy; vaccine strategy

Abstract Human papillomavirus (HPV) causes 33,700 US cancer cases per year, 4,000 deaths and $4 billion in cancer- related medical costs. Despite an effective vaccine, in 2020 less than 60% of US adolescents 13-17 years of age completed their HPV vaccine series. Key barriers are suboptimal clinician communication to address parental vaccine hesitancy, and ineffective office systems causing missed opportunities for vaccination. Our research team tested two promising implementation strategies (ISs) in primary care practices to address these barriers: online clinician communication training (“STOP-HPV-Online”) which trains clinicians on communication techniques and addresses parent hesitancy, and a multi-component IS (“STOP-HPV-LC”) that involves both clinician communication training plus office-based changes in workflow learned on monthly learning collaborative group phone calls. Both ISs were deployed by our research team. Widespread scalability requires the ISs to be deployed by health systems since most primary care practices are now part of health systems. For Aim 1 we will adapt the two ISs for deployment by 8 health systems, and also describe baseline strategies used by these systems. We will partner with the American Medical Group Association® (AMGA),the main national organization of health systems. More than 8 health systems have already expressed interest in the study. We will use a mixed-methods approach and the RE-Aim/PRISM framework to evaluate the effectiveness and implementation processes of the health-system deployed implementation strategies. We will assess how health systems deploy core IS functions and how they and practices adapt specific activities (forms) within each IS. Aims 2-3 will use a 3-arm clustered RCT, randomizing 72 practices within the 8 health systems to STOP-HPV- Online, STOP-HPV-LC, or usual care control. Aim 2 will compare the effectiveness and cost-effectiveness of the two ISs to control and to each other over a 12-month IS period and another 12-month maintenance period. The primary outcome for Aim 2 is HPV vaccine initiation; secondary outcomes are vaccine series completion and cost-effectiveness of the IS. Aim 3 will assess provider, practice, and health system factors relevant to implementation of the two ISs. The primary outcome is adoption (uptake of core IS functions such as clinicians completing the online modules); secondary outcomes include reach (e.g., % clinicians participating), practice/provider factors (e.g., organizational readiness) associated with improvement in rates, and maintenance of core IS functions by practices over 12 additional months. We will develop and disseminate online implementation guides for health systems and practices to use, and AMGA will help spread the ISs to their other health systems. By the end of the study, we will have two scalable ISs for AMGA and any health system to improve HPV vaccination rates and reduce HPV-related cancers.

摘要 人类乳头瘤病毒(HPV)每年导致美国33700例癌症病例，4000人死亡，40亿美元癌症-- 相关医疗费用。尽管有一种有效的疫苗，但在2020年，13-17岁的美国青少年中不到60% AGE完成了他们的HPV疫苗系列。关键障碍是需要解决的次优临床医生沟通 父母对疫苗的犹豫不决，以及无效的办公系统导致错过接种疫苗的机会。 我们的研究团队在初级保健实践中测试了两个有前景的实施战略(ISS)，以解决 这些障碍：在线临床医生沟通培训(“Stop-HPV-Online”)，培训临床医生 通信技术和解决父母的犹豫不决，和一个多组件是(“停止-HPV-LC”) 既包括临床医生沟通培训，也包括在每月学习过程中学习的基于办公室的工作流程更改 协作性团体电话。两个国际空间站都是由我们的研究团队部署的。广泛的可扩展性要求 国际空间站将由卫生系统部署，因为大多数初级保健做法现在都是卫生系统的一部分。 对于目标1，我们将调整两个ISS，以供8个卫生系统部署，并描述基线战略 由这些系统使用。我们将与美国医疗集团协会(AMGA)合作，该协会是主要的国家 卫生系统的组织。已有8000多个卫生系统表示对这项研究感兴趣。我们 将使用混合方法和RE-AIM/PRISM框架来评估有效性和 卫生系统部署的实施战略的实施进程。我们将评估健康状况 系统部署核心IS功能，以及它们和实践如何适应每个IS中的特定活动(形式)。 AIMS 2-3将使用三臂群集式随机对照试验，随机选择8个卫生系统内的72种做法来阻止-HPV- 在线、Stop-HPV-LC或常规护理控制。目标2将比较以下各项的有效性和成本效益 这两个国际空间站要控制和相互控制12个月，另一个12个月的维护期。 AIM 2的主要结果是启动HPV疫苗；次要结果是完成疫苗系列 以及信息系统的成本效益。 AIM 3将评估与实施两个ISS相关的提供者、实践和卫生系统因素。这个 主要结果是采用(采用核心信息系统功能，如临床医生完成在线模块)； 次要结果包括覆盖范围(例如，参与的临床医生百分比)、执业/提供者因素(例如， 组织就绪性)与比率的提高和核心信息系统职能的维护相关 练习超过12个月。我们将制定和传播在线健康实施指南 要使用的系统和做法，AMGA将帮助将国际空间站推广到他们的其他卫生系统。 到研究结束时，我们将为AMGA和任何医疗系统提供两个可扩展的ISS，以改善HPV 疫苗接种率和减少人乳头瘤病毒相关癌症。