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

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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.