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

项目总结 我们广泛而长期的目标是大幅提高人类乳头瘤病毒(HPV)疫苗接种率 在全美的临床实践中部署有效的人口健康干预措施。作为这项工作的一部分 努力，我们打算在Six Mayo评估两种具有创新增强的循证干预措施 临床初级保健实践(PCP)评估其单独和联合对HPV感染率的影响 在女性和男性患者中接种疫苗。目标1，“少一点痛苦，少一点小题大做，现在！”，这将考验 假设，与不干预(当前做法)相比，实践层面的干预利用 提醒-回忆非药物和药物麻醉药的可用性， 只有护士到访，并使用有说服力的语言进行早期、及时的疫苗接种将改进HPV疫苗 快递率。目标2，“让它有价值！”将检验这样的假设，与不干预相比，提供者- 利用错失机会评估的水平干预和应用社交网络的反馈干预 压力(具体的同行业绩比较)，并为提供商提供强有力的建议 工具包将提高HPV疫苗的接种率。目标3将检验同时实施的假设 针对个人、人际和组织因素的干预措施将对 HPV疫苗接种率。为了实现目标1-3，我们将使用阶梯楔形整群随机试验 并进行综合流程评估。集群方法防止患者之间或患者之间的交叉污染 在这六个项目中，我们分配了两个不同的干预措施(目标1和目标2)。阶梯形楔子 设计确保所有实践最终得到相同的一组干预措施，允许单一 监督所有六名初级保健医生的机构审查委员会批准这项研究，而无需招聘和 个别患者或提供者的同意。阶梯式楔形方法还允许我们测试存在 每个初级保健计划中的每一项干预措施，使试验参与更具吸引力，同时也允许 实践作为自己的控制，减少由于实践中不平衡的风险因素造成的偏差。这个 析因设计允许我们使用一项试验来测试两种干预措施，并分别评估每种干预措施 组合。该设计还节省了样本大小，同时保持了功率。我们将衡量其影响 在女性和男性中，11-12岁分别获得HPV疫苗应得剂量的比率。 如果我们要接触到健康的人，经过严格测试的、高效的人口层面的干预是必不可少的 人们2020年的HPV疫苗接种目标。这项研究的严谨性、设计和成功的高可能性将 提供关于提高HPV疫苗接种率的实践和提供者层面干预措施的关键证据。 梅奥诊所的最佳实践不仅为其在五个州的70项实践提供了信息，还为其梅奥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.