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

改善提供者推荐和推进 HPV 疫苗接种的多层次实施策略的有效性和机制：整群随机试验

• 批准号: 10450821
• 负责人: Chun R. Chao
• 金额: $ 64.96万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-15 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10450821
• 关键词: Address; Advisory Committees; Affect; Age; California; Caring; Centers for Disease Control and Prevention (U.S.); Childhood; Clinic; Clinical; Cluster randomized trial; Communication; Communities; Consolidated Framework for Implementation Research; Continuity of Patient Care; Cost Effectiveness Analysis; Data; Education; Effectiveness; Electronic Health Record; Environment; Family; Guidelines; Health Personnel; Health system; Healthy People 2020; Heterogeneity; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Immunization; Intervention; Intervention Studies; Interview; Intuition; Investments; Knowledge; Measures; Mediation; Methods; Nature; Office Visits; Outcome; Parents; Patients; Perception; Provider; Public Health; Randomized Controlled Trials; Recommendation; Research; Resources; Risk; Series; Site; Specific qualifier value; Subgroup; Support System; Surveys; Teenagers; Testing; Thinking; Training; Vaccination; Variant; Work; arm; base; cancer care; community clinic; community setting; compare effectiveness; design; effective intervention; effectiveness evaluation; health care settings; implementation framework; implementation science; implementation strategy; improved; innovation; insight; multi-component intervention; novel; practice setting; primary outcome; process evaluation; programs; response; secondary outcome; success; treatment as usual; vaccine acceptance

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.

项目摘要 数百万美国青少年仍然有患上人乳头瘤病毒（HPV）相关癌症的风险， HPV疫苗接种不足，尽管在临床指南中得到了强烈认可， 干预努力。2018年的一项全国调查显示，HPV疫苗完全覆盖青少年 13 - 15岁仅占50%，远低于2020年健康人80%的目标。先前的研究已经确定 强烈的供应商推荐作为HPV疫苗吸收的最强大的促进剂。然而， 关于如何利用这一点和其他促进者。此外，研究还揭示了多层次， 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疫苗的屏障可能因地区而异。 人口分组、社区和诊所。尽管有这些知识，许多先前的干预研究 侧重于单一层次、单一组成部分的干预措施，使许多障碍得不到解决。得到的研究能够 多层次和/或多组成部分的干预措施往往是预先选定的，以解决"典型"的障碍， 对独特的地方障碍和地方背景作出反应。为了解决这一关键差距，我们提出了一个3臂集群 随机对照试验（RCT），比较多层次和多组分的实施策略 并通过深入了解实践环境中的多层次因素如何修改关键因素的影响， 提供商推荐等。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疫苗接种率的临床水平因素和变化以及提供者推荐的质量（Aim 1）。在目标2中，我们将比较以下措施的有效性：1）一种新的"因地制宜"的实施战略， 与当地护理团队一起设计，以解决当地的障碍和背景;与2）"规定的"战略，典型的 大多数卫生系统的预防接种，包括预先规定的干预措施，解决预先选定的疫苗接种障碍; vs. 3）精神护理。我们将评估这些策略对改善HPV疫苗接种的有效性 （主要结果）和加强提供者建议（次要结果）以及分析成本 有效性我们还将研究实施战略的效果机制（目标3）。虽然 局部定制的需求似乎是直观的，但尚不清楚局部定制是否会产生上级结果， 抵消所需的额外投资，支持本RCT的需求。我们将在Kaiser内部进行研究 Permanente Southern加州，美国最大的社区儿科护理组织之一。 我们的研究将遵循《实施研究综合框架》和《多层次 癌症护理连续框架中的因素。这些目标的实现将产生重要的 深入了解与提供者推荐和HPV疫苗接种相关的多层次因素。这 这项研究很有可能为不同的卫生保健机构提供指导，以改善HPV疫苗接种。