RSV I-PREP: Improving Evidence-Based Implementation of RSV Immuno-Prophylaxis Within Ethical and Policy Contexts

1项目概要/摘要 2候选人：Jennifer Kusma，MD，MS是一名儿科医生和初级临床研究员，专注于改善 3有特殊卫生保健需要的儿童的卫生保健政策和获得的证据基础。博士 4 Kusma的长期职业目标是成为一名独立的医生调查员， 5个学科小组，以评价循证保健政策和服务，重点是提供 6.对发病率和死亡率高风险的婴儿进行针对呼吸道合胞病毒（RSV）的免疫预防， 7，重点是患有先天性心脏病（CHD）的婴儿。 8研究背景/目的：RSV感染非常普遍，几乎所有儿童都会在 9、生命的最初两年RSV导致特定人群的显著发病率和死亡率， 10 CSHCN包括CHD、早产儿慢性肺病和早产儿，这是昂贵的，因此， 11免疫预防（IP）治疗可用。然而，只有33%的合格婴儿获得了完整的 12例RSV IP。因此，该奖项的目的是让Kusma博士学习如何评估相关因素 在收到完整的RSV IP后，从道德上评估RSV IP政策中的权衡，并优先考虑障碍， 14名促进者负责实施RSV知识产权政策。 15具体目标：1）确定与接受治疗相关的患者、提供者和机构层面的因素。 根据CFIR模型指导的16例完整RSV IP（6个月RSV季节内5次给药）。2)为了确定道德 潜在RSV IP实践和政策的17个权衡，适用于CHD婴儿的伦理框架， 18与其他符合IP条件的婴儿相比。3)评价RSV IP实施不佳的决定因素 根据CFIR模型制定的19项实践和政策。 20研究计划：Kusma博士将回顾性分析现有的患者，提供者，机构和保险 使用来自PEDSnet（一个学习健康系统）的数据， 22以CFIR模型（目标1）为指导;评估关键利益相关者在RSV知识产权政策方面的道德权衡 23（目标2）;并采用混合方法，优先考虑实施RSV IP的障碍和促进因素（目标3）。 24职业发展计划/环境：通过地方和国家课程、经验学习， 25讲习班，研讨会和专业活动，Kusma博士将获得评估分层的专业知识。 26建模，学习卫生系统，道德评价，混合方法分析和实施科学。 27 Kusma博士将加强她作为一名独立的医生-研究者职业所需的专业技能 28通过由NIH资助的团队导师和顾问组成的经验丰富的互补团队的密切指导。 29西北大学和Lurie儿童医院将提供出色的研究基础设施， 30使一个成功的奖项，并坚定地致力于博士Kusma的过渡到研究独立。

1 PROJECT SUMMARY/ABSTRACT 2 Candidate: Jennifer Kusma, MD, MS is a pediatrician and junior clinical investigator focused on improving the 3 evidence-base for the health care policy and access for children with special health care needs (CSHCN). Dr. 4 Kusma’s long-term career goal is to become an independent physician-investigator who works in cross- 5 disciplinary teams to evaluate evidence-based health care policy and delivery, with a focus on delivery of 6 immunoprophylaxis against respiratory syncytial virus (RSV) for infants at high-risk for morbidity and mortality, 7 with a focus on infants with congenital heart disease (CHD). 8 Research Context/Objective: RSV infection is incredibly prevalent, almost all children will contract RSV within 9 the first two years of life. RSV contributes to significant morbidity and mortality for specific populations of 10 CSHCN including CHD, chronic lung disease of prematurity, and premature infants, which is costly, so an 11 immunoprophylactic (IP) treatment is available. However, only 33% of eligible infants receive their complete 12 RSV IP. Therefore, the objective of this award is for Dr. Kusma to learn how to assess the factors associated 13 with receipt of complete RSV IP, ethically evaluate tradeoffs in RSV IP policy, and prioritize barriers and 14 facilitators to implementation of RSV IP policy. 15 Specific Aims: 1) To identify patient, provider, and institutional level factors associated with receipt of 16 complete RSV IP (5 doses within the 6-month RSV season) guided by the CFIR model. 2) To determine ethical 17 tradeoffs of potential RSV IP practices and policies, applying an ethical framework for infants with CHD as 18 compared with other IP-eligible infants. 3) To evaluate determinants of suboptimal implementation of RSV IP 19 practices and policies informed by the CFIR model. 20 Research Plan: Dr. Kusma will retrospectively analyze existing patient, provider, institution, and insurance 21 level factors associated with complete receipt of RSV IP using data from PEDSnet, a Learning Health System, 22 guided by the CFIR model (Aim 1); evaluate ethical tradeoffs of key stake holders regarding RSV IP policy 23 (Aim 2); and apply mixed methods to prioritize barriers and facilitators of implementation of RSV IP (Aim 3). 24 Career Development Plan/Environment: Through local and national courses, experiential learning, 25 workshops, seminars, and professional activities, Dr. Kusma will acquire expertise in evaluating hierarchical 26 modeling, learning health systems, ethical evaluation, mixed methods analysis, and implementation science. 27 Dr. Kusma will strengthen her professional skills needed for an independent physician-investigator career 28 through close mentorship by an experienced, complementary team of NIH-funded team mentors and advisors. 29 Northwestern University and Lurie Children’s Hospital will provide outstanding research infrastructures to 30 enable a successful award and are strongly committed to Dr. Kusma’s transition to research independence.