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

“减少痛苦，减少烦恼，就现在！”

• 批准号: 9897627
• 负责人: ROBERT M. JACOBSON
• 金额: $ 56.05万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9897627
• 关键词: 12 year old; Address; Adolescent; Anesthetics; Antibiotics; Area; Behavior Therapy; Belief; Caring; Child; Clinic; Clinical Trials; Cluster randomized trial; Communities; Consent; Country; Data; Dose; Effectiveness; Ensure; Evaluation; Evidence based intervention; Feedback; Female; Goals; Healthcare; Healthcare Systems; Healthy People 2020; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Human papilloma virus infection; Human papillomavirus 6; Individual; Institutional Review Boards; Intervention; Language; Malignant Neoplasms; Measures; Minnesota; Modeling; Nurses; Outcome; Pain; Parents; Patients; Performance; Pharmaceutical Preparations; Policies; Politics; Population; Primary Health Care; Process; Provider; Puerto Rico; Recommendation; Reporting; Rest; Risk; Risk Factors; Sample Size; Schools; Series; Testing; Time; United States; Vaccination; Vaccines; Visit; Work; age group; base; clinical practice; contextual factors; design; effective intervention; health care service organization; health service use; immunogenic; improved; individual patient; innovation; insight; male; peer; population health; pressure; prevent; programs; recruit; social; success; tailored messaging; theories; uptake; vaccine delivery

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.

项目摘要 我们广泛的长期目标是通过大大提高人类乳头瘤病毒（HPV）疫苗接种率 在美国各地部署有效的人口健康干预措施。作为其中的一部分 努力，我们打算在六个梅奥（Mayo）上评估两种基于证据的干预措施 诊所初级保健实践（PCP）评估其个体和对HPV率的综合影响 男性和男性患者的疫苗接种。目标1，“减少痛苦，现在减少大惊小怪！”，将测试 假设，与没有干预（当前实践）相比，利用练习级干预 提醒回顾，具有非药物和药物麻醉的可用性，便利性 仅护士的访问，并使用有说服力的语言来早期，即时疫苗接种将改善HPV疫苗接种 交货率。 AIM 2，“使它计算！”将检验以下假设：与没有干预相比，提供商 利用未经企业的评估和反馈干预采用社会的反馈干预措施 压力（特定的同伴表现比较）和为强烈责备的装备提供商 工具包将提高HPV疫苗输送率。 AIM 3将测试简单实施的假设 针对个人，人际关系和组织因素的干预措施将对 HPV疫苗输送率。为了实现目标1-3，我们将使用阶梯式北方群集随机试验 进行集成的流程评估。聚类方法防止患者或 提供者在六个PCP中分配两种单独的干预措施（目标1和2）时。阶梯式街区 确保所有实践最终都会获得相同的干预措施的设计，允许单个 机构审查委员会监督所有六个PCP以批准研究，而无需招募和 单个患者或提供者的同意。阶梯式朝北的方法还允许我们测试存在 每个PCP中的每种干预措施都使试验参与更具吸引力，同时也允许每个人 练习以作为自己的控制，减少了跨实践中风险不平衡的偏见。这 阶乘设计使我们能够使用单个试验来测试两种干预措施，并分别和评估 组合。该设计还可以节省样本量，同时保持动力。我们将衡量影响 在女性和男性中分别为11-12岁，以应得的HPV疫苗剂量收到。 如果我们要达到健康，经过严格测试，高效，人口水平的干预措施至关重要 HPV疫苗接种的2020年人民目标。这项研究成功的严格，设计和很高的可能性将 提供有关实践和提供商级干预措施以提高HPV疫苗接种率的关键证据。 Mayo Clinic的最佳实践不仅为五个州的70种实践提供了信息，还为其Mayo诊所护理提供信息 网络由26个州和波多黎各的近40个医疗组织组成。