"Less Pain, Less Fuss, Right Now!" and "Make It Count!"- Multilevel Interventions for Patient, Parent, and Practice to Enhance Provider Recommendations for HPV Vaccination

项目摘要 我们广泛的长期目标是通过以下方式大幅提高人乳头瘤病毒（HPV）疫苗接种率： 在美国各地的临床实践中部署有效的人口健康干预措施。作为其中的一部分 我们打算在六个马约评估两种基于证据的干预措施， 临床初级保健实践（PCP），以评估其对HPV感染率的单独和综合影响 为男性和女性患者接种疫苗。目标1，"少痛苦，少大惊小怪，现在!"，将考验 假设，与无干预相比（目前的做法）， 召回的特点是非药物和药物麻醉剂的可用性， 只有护士访问，并使用说服性语言进行早期，按时接种疫苗将改善HPV疫苗 交付率。目标2："让它有价值!"，将测试假设，与没有干预相比，提供者- 利用错失机会评估进行水平干预， 压力（具体的同行业绩比较），并为供应商提供强有力的建议 该工具包将提高HPV疫苗接种率。目标3将检验同时实施 针对个人、人际和组织因素的干预措施将产生协同效应， HPV疫苗接种率。为了实现目标1 - 3，我们将使用一个逐步楔形分组随机试验 一个综合的过程评估。群集方法可防止患者之间的交叉污染， 提供者，因为我们在六个PCP中分配了两个单独的干预措施（目标1和2）。阶梯楔 设计，确保所有的做法最终得到相同的干预，允许单一的 机构审查委员会监督所有六个PCP批准研究，而不需要招募， 个别患者或提供者的同意。阶梯楔的方法也允许我们测试的存在 每个PCP中的每种干预措施，使试验参与更具吸引力，同时也允许每个 实践作为其自身的控制，减少了由于实践中不平衡的风险因素而导致的偏差。的 析因设计允许我们使用一个单一的试验来测试两种干预措施，并单独评估每一种干预措施， 组合.该设计还在保持功效的同时节省了样本量。我们将衡量 分别在女性和男性中，11 - 12岁的人乳头瘤病毒疫苗剂量的接受率。 如果我们要达到健康，经过严格测试的，高度有效的，人口一级的干预措施至关重要。 2020年HPV疫苗接种目标这项研究的严谨性、设计和成功的可能性很高， 提供有关实践和提供者层面干预措施的关键证据，以提高HPV疫苗接种率。 马约诊所的最佳实践不仅为五个州的70种实践提供了信息，也为马约诊所护理提供了信息。 该网络由26个州和波多黎各的近40个医疗保健组织组成。

PROJECT SUMMARY Our broad, long-term objective is to substantially increase human papillomavirus (HPV) vaccination rates by deploying effective population-health interventions in clinical practices across the United States. As part of this effort, we intend to evaluate two evidence-based interventions with innovative enhancements at six Mayo Clinic primary care practices (PCP) to evaluate their individual and combined impact on rates of HPV vaccination among female and male patients. Aim 1, “Less Pain, Less Fuss, Right Now!”, will test the hypothesis that, as compared to no intervention (current practice), a practice-level intervention utilizing reminder-recalls featuring the availability of non-medication and medication anesthetics, the convenience of nurse-only visits, and the use of persuasive language for early, on-time vaccinations will improve HPV vaccine delivery rates. Aim 2, “Make It Count!”, will test the hypothesis that, as compared to no intervention, a provider- level intervention utilizing a missed-opportunities assessment and feedback intervention applying social pressure (specific peer-performance comparisons) and equipping providers with a strong-recommendation toolkit will improve HPV vaccine delivery rates. Aim 3 will test the hypothesis that simultaneous implementation of interventions targeting individual, interpersonal, and organizational factors will have a synergistic effect on HPV vaccine delivery rates. To accomplish Aims 1-3, we will use a stepped-wedge cluster randomized trial with an integrated process evaluation. The cluster approach prevents cross-contamination between patients or providers as we allocate two separate interventions (Aims 1 and 2) in the six PCPs. The stepped-wedge design, which ensures all practices eventually receive the same set of interventions, permits the single institutional review board overseeing all six PCPs to approve the study without requiring recruitment and consent of individual patients or providers. The stepped-wedge approach also permits us to test the presence of each of the interventions in each PCP, making trial participation more attractive, while also allowing each practice to serve as its own control, reducing the bias due to imbalanced risk factors across practices. The factorial design allows us to use a single trial to test two interventions and assess each individually and in combination. The design also conserves sample size while maintaining power. We will measure the impact separately in females and males, 11-12 years of age for the rates of receipt of HPV vaccine doses due. Rigorously tested, highly effective, population-level interventions are essential if we are to reach the Healthy People 2020 goal for HPV vaccination. The rigor, design, and high likelihood of success of this study will provide key evidence regarding practice- and provider-level interventions to improve HPV vaccination rates. Mayo Clinic's best practices inform not only its own 70 practices across five states but its Mayo Clinic Care Network, which consists of nearly 40 health-care organizations across 26 states and Puerto Rico.