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 项目概要/摘要 2 候选人：Jennifer Kusma，医学博士、理学硕士，是一名儿科医生和初级临床研究者，致力于改善 3 有特殊医疗保健需求的儿童的医疗保健政策和可及性的证据基础 (CSHCN)。 4 Kusma 的长期职业目标是成为一名独立的医师研究员，在跨领域工作 5 个纪律小组负责评估基于证据的医疗保健政策和服务，重点是提供 6 对发病和死亡高危婴儿进行呼吸道合胞病毒（RSV）免疫预防， 7 重点关注患有先天性心脏病 (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体内感染 RSV 9 RSV 导致特定人群的发病率和死亡率显着升高。 10 CSHCN 包括冠心病、早产儿慢性肺病和早产儿，费用昂贵，因此 11 可以进行免疫预防 (IP) 治疗，但只有 33% 的符合条件的婴儿接受了完整的治疗。 12 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。 13 收到完整的 RSV IP 后，从道德角度评估 RSV IP 政策的权衡，并优先考虑障碍和风险 14 名 RSV 知识产权政策实施推动者。 15 具体目标： 1) 确定与接收相关的患者、提供者和机构层面的因素 16 次完整的 RSV IP（6 个月 RSV 季节内 5 剂）由 CFIR 模型指导 2) 确定道德。 潜在 RSV IP 实践和政策的 17 项权衡，将道德框架应用于患有 CHD 的婴儿 18 与其他符合 IP 资格的婴儿相比 3) 评估 RSV IP 实施欠佳的决定因素。 CFIR 模型提供的 19 项实践和政策。 20 研究计划：Kusma 博士将回顾性分析现有患者、提供者、机构和保险 使用来自学习健康系统 PEDSnet 的数据，与完全接收 RSV IP 相关的 21 个水平因素， 22 以 CFIR 模型为指导（目标 1）；评估主要利益相关者在 RSV 知识产权政策方面的道德权衡； 23（目标 2）；并应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、体验式学习、 25 场研讨会、研讨会和专业活动，Kusma 博士将获得评估分层结构的专业知识 26 建模、学习健康系统、伦理评估、混合方法分析和实施科学。 27 Kusma 博士将加强独立医师研究员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、互补的团队的密切指导。 29 西北大学和卢里儿童医院将为 30 人使他能够获得成功，并坚定地致力于库斯马博士向独立研究的过渡。