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.

抽象的 人乳头瘤病毒 (HPV) 每年在美国导致 33,700 例癌症病例、4,000 人死亡以及 40 亿美元的癌症损失 - 相关医疗费用。尽管有有效的疫苗，到 2020 年，仍有不到 60% 的 13-17 岁美国青少年接种疫苗 Age 完成了他们的 HPV 疫苗系列。主要障碍是临床医生沟通不够理想，无法解决问题 家长对疫苗接种犹豫不决，办公系统效率低下，导致错过疫苗接种机会。 我们的研究团队在初级保健实践中测试了两种有前景的实施策略（IS），以解决 这些障碍：在线临床医生沟通培训（“STOP-HPV-Online”），对临床医生进行以下方面的培训： 沟通技术并解决父母的犹豫，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到的基于办公室的工作流程变化 协作组电话。两个 IS 均由我们的研究团队部署。广泛的可扩展性需要 由于大多数初级保健实践现已成为卫生系统的一部分，因此卫生系统将部署信息系统。 对于目标 1，我们将调整两个 IS 以供 8 个卫生系统部署，并描述基线策略 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医疗机构 卫生系统的组织。超过 8 个卫生系统已表示对该研究感兴趣。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流程。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 内的特定活动（形式）。 目标 2-3 将使用 3 臂集群随机对照试验，随机分组 8 个卫生系统内的 72 项实践，以阻止 HPV- 在线、STOP-HPV-LC 或常规护理控制。目标 2 将比较以下方案的有效性和成本效益 两个 IS 在 12 个月的 IS 周期和另外 12 个月的维护周期内相互控制和相互连接。 目标 2 的主要成果是启动 HPV 疫苗；次要结果是疫苗系列的完成 以及 IS 的成本效益。 目标 3 将评估与实施两个信息系统相关的提供者、实践和卫生系统因素。这 主要成果是采用（采用核心 IS 功能，例如临床医生完成在线模块）； 次要结果包括覆盖范围（例如，临床医生参与百分比）、实践/提供者因素（例如， 组织准备情况）与率的提高以及核心信息系统功能的维护相关 额外练习 12 个月。我们将制定并传播健康在线实施指南 AMGA 将帮助将 IS 传播到其他卫生系统。 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 疫苗接种率并减少 HPV 相关癌症。