Effectiveness and Mechanisms of Multilevel Implementation Strategies to Improve Provider Recommendation and Advance HPV Vaccination: a Cluster Randomized Trial

项目摘要 数百万美国青少年仍有患人类乳头瘤病毒(HPV)相关癌症的风险，原因是 HPV疫苗接种率不足，尽管在临床指南中得到了强烈支持，并在此之前 干预努力。2018年的一项全国调查显示，HPV疫苗完全覆盖了青少年 13-15年仅为50%，远低于2020年健康人80%的目标。先前的研究已经确定 强烈的提供者推荐是HPV疫苗接种的最有力的促进者。然而，人们对此知之甚少 关于如何利用这个和其他促进者。此外，研究还揭示了多层次的， 改善HPV疫苗接种的多因素障碍包括父母的负面看法和 卫生系统支持。此外，有证据表明，HPV疫苗的障碍可能会因不同而不同 人口分组、社区和诊所。尽管如此，许多先前的干预研究 把重点放在单一层面、单一组成部分的干预上，留下许多障碍没有解决。所有研究都是 多层次和/或多组成部分的干预措施通常是预先选定的，以解决“典型的”障碍，但不是 应对独特的当地障碍和当地环境。为了解决这一关键差距，我们提出了一个三臂集群 随机对照试验(RCT)，用于比较多水平和多成分的实施策略 并在深入了解实践环境中的多层次因素如何修改关键影响的指导下 促进者，如提供者推荐。我们将使用混合方法(调查、访谈、电子 健康记录)；最初，我们将评估患者、提供者和 HPV疫苗接种率和提供者推荐质量的临床水平因素和差异(目的 1)。在目标2中，我们将比较以下两种方案的有效性：1)一种新的“因地制宜”的实施战略，联合 与当地护理团队一起设计，以解决当地的障碍和环境；与2)典型的“规定”战略 在大多数卫生系统中，这涉及解决预先选定的疫苗接种障碍的预先规定的干预措施； 而不是通常的护理。我们将评估这些策略在改进HPV疫苗接种方面的有效性。 (主要结果)和加强提供商建议(次要结果)以及分析成本 有效性。我们还将研究实施战略的影响机制(目标3)。尽管 对本地裁剪的需求似乎是直觉的，还不知道本地裁剪是否会产生更好的结果 抵消所需的额外投资，支持对这一RCT的需求。我们将在Kaiser内部进行研究 南加州Permanente是美国最大的社区儿科护理组织之一。 我们的研究将以执行研究和多层次综合框架为指导。 影响癌症护理连续体框架的因素。完成这些目标将产生重要的 对与提供者推荐和HPV疫苗接种相关的多层次因素的洞察。这 这项研究有很高的潜力为不同的卫生保健环境提供指导，以改进HPV疫苗接种。

Project Abstract Millions of US teens remain at risk of developing human papillomavirus (HPV)-related cancers due to inadequate HPV vaccine uptake, despite strong endorsement in clinical guidelines and substantial prior intervention efforts. A 2018 national survey showed that HPV vaccine complete series coverage for teens age 13-15 years was only 50%, far below the 80% target of Healthy People 2020. Prior research has identified strong provider recommendation as the most powerful facilitator of HPV vaccine uptake. Yet, little is known about how to leverage this and other facilitators. Additionally, studies have also revealed multilevel, multifactorial barriers to improving HPV vaccination including negative parental perceptions and limitations of health system support. Furthermore, evidence suggests that HPV vaccine barriers can vary across demographic subgroups, communities and clinics. Despite this knowledge, many prior intervention studies focus on single-level, single component interventions, leaving many barriers unaddressed. Of studies that are multilevel and/or multi-component, interventions are often pre-selected to address “typical” barriers but are not responsive to unique local barriers and local context. To address this critical gap, we propose a 3-arm cluster randomized controlled trial (RCT) to compare implementation strategies that are multilevel and multicomponent and guided by in-depth understanding of how multilevel factors in the practice settings modify the impact of key facilitators such as provider recommendation. We will use mixed methods (surveys, interviews, electronic health records) throughout; initially we will evaluate baseline associations between patient-, provider-, and clinic-level factors and variations in HPV vaccination rates and the quality of the provider recommendation (Aim 1). In Aim 2, we will compare the effectiveness of: 1) A novel “local-tailored” implementation strategy, co- designed with local care teams to address local barriers and contexts; versus 2) A “prescribed” strategy, typical of most health systems, that involves pre-specified interventions addressing pre-selected vaccination barriers; versus 3) Usual care. We will evaluate the effectiveness of these strategies on improving HPV vaccination (primary outcome) and strengthening provider recommendation (secondary outcome) as well as analyzing cost effectiveness. We will also study mechanisms of effect of the implementation strategies (Aim 3). Although the need of local tailoring seems intuitive, it is unknown if local tailoring will yield superior outcomes that could offset the extra investment required, supporting the need for this RCT. We will conduct the study within Kaiser Permanente Southern California, one of the largest community-based pediatric care organizations in the US. Our study will be guided by the Consolidated Framework for Implementation Research and the Multilevel Factors Across the Cancer Care Continuum framework. Completion of these Aims will generate important insights into the multilevel factors associated with provider recommendation and HPV vaccine uptake. This study has high potential to generate guidance for diverse health care settings to improve HPV vaccination.