"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.

项目概要 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。作为本次活动的一部分 努力，我们打算在梅奥六所大学评估两项具有创新增强功能的循证干预措施 临床初级保健实践 (PCP) 评估其对 HPV 感染率的个体和综合影响 女性和男性患者的疫苗接种。目标 1，“现在就减少痛苦，减少麻烦！”，将测试 假设与无干预（当前实践）相比，利用实践水平的干预 提醒回忆，包括非药物和药物麻醉剂的可用性、使用的便利性 仅由护士就诊，以及使用有说服力的语言进行早期、按时疫苗接种将改善 HPV 疫苗接种 交货率。目标 2“让它发挥作用！”将检验以下假设：与不干预相比，提供者- 利用错失机会评估和反馈干预进行水平干预 压力（具体的同行绩效比较）并为提供商提供强烈推荐 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聚类随机试验 具有综合的过程评估。集群方法可防止患者或患者之间的交叉污染 我们在六个 PCP 中分配了两项单独的干预措施（目标 1 和 2）。阶梯式楔子 设计确保所有实践最终都接受相同的干预措施，允许单一的 机构审查委员会监督所有六个 PCP 批准该研究，无需招募和 个别患者或提供者的同意。阶梯楔形方法还允许我们测试存在性 每个 PCP 中的每项干预措施，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，减少由于实践中风险因素不平衡而导致的偏差。这 因子设计使我们能够使用单个试验来测试两种干预措施并单独评估每种干预措施 组合。该设计还可以在保持功率的同时节省样本量。我们将衡量影响 分别针对女性和男性、11-12 岁的 HPV 疫苗接种率进行了统计。 如果我们要实现健康目标，经过严格测试、高效、人口层面的干预措施至关重要 人们2020年HPV疫苗接种的目标。这项研究的严谨性、设计和成功的可能性将 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。 Mayo Clinic 的最佳实践不仅体现在其遍布 5 个州的 70 家诊所，还体现在 Mayo Clinic 护理服务中 该网络由 26 个州和波多黎各的近 40 个医疗保健组织组成。