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

RSV I-PREP：在伦理和政策背景下改进 RSV 免疫预防的循证实施

• 批准号: 10739713
• 负责人: Jennifer Kusma Saper
• 金额: $ 16.85万
• 依托单位: LURIE CHILDREN'S HOSPITAL OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10739713
• 关键词: 2 year old; Active Learning; Address; Admission activity; Asthma; Award; Black race; Bronchopulmonary Dysplasia; Caring; Cessation of life; Child; Childhood; Clinical Investigator; Clinical Trials; Communication; Consolidated Framework for Implementation Research; Contracts; Cost Effectiveness Analysis; Data; Development; Development Plans; Diagnosis; Dose; Educational workshop; Eligibility Determination; Emergency department visit; Environment; Equity; Ethics; Ethnic Origin; Evaluation; Face; Foundations; Funding; Future; Geography; Goals; Guidelines; Health Policy; Health system; Healthcare; Healthcare Systems; Hispanic; Hospitalization; Hospitals; Improve Access; Infant; Infection; Injections; Inpatients; Institution; Insurance; Insurance Coverage; Knowledge; Learning; Life; Medicaid; Mentors; Mentorship; Methods; Modeling; Monoclonal Antibodies; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Palivizumab; Patients; Pediatric Hospitals; Physicians; Policies; Population; Premature Infant; Prevention; Preventive; Preventive therapy; Preventive treatment; Process; Prophylactic treatment; Provider; Race; Research; Research Infrastructure; Research Personnel; Respiratory Syncytial Virus Infections; Respiratory syncytial virus; Risk; Seasons; Specialist; System; Training; United States; United States National Institutes of Health; Universities; Work; career; career development; congenital heart disorder; cost; cost effective; evidence base; experience; future implementation; health care availability; health inequalities; hemodynamics; high risk; high risk infant; immunoprophylaxis; implementation barriers; implementation facilitators; implementation science; improved; mortality; passive immunoprophylaxis; pediatrician; premature; prevent; preventive intervention; prior authorization; provider factors; public health insurance; skills; tool

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.

1个项目摘要/摘要 2候选人：医学博士Jennifer Kusma是一名儿科医生和初级临床研究者，致力于改善 3有关具有特殊医疗保健需求的儿童（CSHCN）的医疗保健政策的证据基础。博士 4 Kusma的长期职业目标是成为一名独立的物理投资者，在交叉工作中工作 5个纪律团队评估基于证据的医疗保健政策和交付，重点是交付 6针对高危婴儿的呼吸道合胞病毒（RSV）的免疫预防，以表现出发病和死亡率， 7专注于先天性心脏病（CHD）的婴儿。 8研究背景/目标：RSV感染非常普遍，几乎所有儿童都会在其中收缩RSV 9生命的前两年。 RSV有助于对特定人群的显着发病率和死亡率 10 CSHCN，包括CHD，慢性肺早产和早产儿，这是昂贵的，因此 11可以进行免疫原性治疗。但是，只有33％的合格婴儿获得了完整 12 RSV IP。因此，该奖项的目的是让库斯玛博士学习如何评估相关因素 13通过收到完整的RSV IP，可以在道德上评估RSV IP政策中的权衡，并优先考虑障碍和优先级 14促进者实施RSV IP政策。 15特定目标：1）确定与收到的患者，提供者和机构级别的因素 16由CFIR模型引导的16个完整的RSV IP（在6个月的RSV季节内5剂）。 2）确定道德 17个潜在的RSV IP实践和政策的权衡，为患有冠心病的婴儿应用道德框架 18与其他符合IP的婴儿相比。 3）评估RSV IP的次优实施的确定 CFIR模型告知的19条实践和政策。 20研究计划：Kusma博士将回顾性分析现有患者，提供商，机构和保险 21个与完全收到RSV IP相关的级别因素，使用来自学习卫生系统PEDSNET的数据， 22在CFIR模型的指导下（AIM 1）；评估有关RSV IP政策的主要利益持有人的道德权衡 23（目标2）;并应用混合方法来优先考虑RSV IP实施的障碍和促进者（AIM 3）。 24职业发展计划/环境：通过本地和国家课程，专家学习， 25个研讨会，半手和专业活动，Kusma博士将获得评估层次结构的专业知识 26建模，学习卫生系统，道德评估，混合方法分析和实施科学。 27 Kusma博士将增强自己的专业技能 28通过经验丰富，完整的NIH资助团队心态和顾问团队的紧密心态。 29西北大学和Lurie儿童医院将提供出色的研究基础设施 30获得成功的奖励，并强烈致力于Kusma博士对研究独立性的过渡。