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 人乳头瘤病毒（HPV）每年导致33,700例美国癌症病例，4,000例死亡和40亿美元的癌症- 相关医疗费用。尽管有有效的疫苗，但到2020年，13-17岁的美国青少年中只有不到60%的人 年龄完成了他们的HPV疫苗系列。关键障碍是有待解决的临床医生沟通欠佳 父母对接种疫苗犹豫不决，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种有希望的实施策略（IS），以解决 这些障碍：在线临床医生沟通培训（“STOP-HPV-Online”） 通信技术和解决父母犹豫，以及多组分IS（“STOP-HPV-LC”）， 涉及临床医生沟通培训以及每月学习中学习的工作流程中基于办公室的变化 协作组电话。这两个IS都是由我们的研究团队部署的。广泛的可扩展性要求 卫生系统将部署信息系统，因为大多数初级保健实践现在是卫生系统的一部分。 对于目标1，我们将调整这两个IS以供8个卫生系统部署，并描述基线策略 使用这些系统。我们将与美国医疗集团协会（AMGA）合作，该协会是美国主要的国家医疗机构。 卫生系统的组织。超过8个卫生系统已经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， 卫生系统的实施进程部署了实施战略。我们将评估健康 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）。 目标2-3将使用3组随机对照试验，在8个卫生系统内随机选择72个实践，以阻止HPV- 在线、STOP-HPV-LC或常规护理控制。目标2将比较以下方法的有效性和成本效益： 两个IS在12个月的IS期和另一个12个月的维护期内相互控制和相互连接。 目标2的主要结局是HPV疫苗的启动;次要结局是疫苗系列的完成 和成本效益。 目标3将评估与两个IS实施相关的提供者、实践和卫生系统因素。的 主要结果是采用（核心IS功能的吸收，例如完成在线模块的临床医生）; 次要结果包括到达（reach）（例如，参与的临床医生百分比），实践/提供者因素（例如， 组织准备）与提高费率有关，并通过以下方式维持核心信息系统职能： 在12个月的额外实践中。我们将制定和传播在线卫生执行指南， AMGA将帮助将IS推广到其他卫生系统。 到研究结束时，我们将为AMGA和任何卫生系统提供两个可扩展的IS，以改善HPV 疫苗接种率和减少HPV相关癌症。