Validation of a pediatric thrombosis risk assessment model and characterization of bleeding in hospitalized children through the Children's Hospital Acquired Thrombosis (CHAT) Consortium

PROJECT SUMMARY/ABSTRACT Venous thromboembolism (VTE), a serious and life-threatening condition, has increased in incidence for hospitalized pediatric patients by 200%. This has led to increased morbidity, mortality and longer hospitalizations, and is thought to be due to more effective care of children with serious and life-threatening disorders. Unfortunately, it is unclear which children are at the highest risk of hospital acquired (HA) VTE and how to prevent these events due to many studies being single center with small case numbers. My parent K23 addresses the critical need to identify children at a high risk of HA-VTE, but a low risk of bleeding, using a risk assessment model (RAM). The study cohort will be used as the target population for trials evaluating the efficacy and safety of prophylactic anticoagulation to progress towards the long-term goal of HA-VTE prevention in children. This Administrative Supplement application focuses on the third research aim, to explore barriers to provider engagement with RAM implementation by conducting focus groups and semi-structured interviews of inpatient medical teams using qualitative thematic analysis strategies. The other objectives of this K23 award are to (1) prospectively validate a pediatric HA-VTE RAM created through my multi-center Children’s Healthcare Advancements in Thrombosis (CHAT) Consortium using a case-control study design and electronic medical record review (EMR) and (2) evaluate the incidence and characterization of bleeding in hospitalized children on and off anticoagulation through EMR review. In order to achieve these research aims, I previously outlined my short-term career goals to obtain new knowledge, skills, and experience that will allow me to (1) analyze data from large datasets from multicenter studies and build and validate risk models through multivariate analysis; (2) develop qualitative research skills to design and analyze focus groups and semi-structured interviews (the focus of this application); and (3) acquire the knowledge to plan and conduct randomized controlled trials. Achieving these career goals will support my long-term career goal of becoming an independently funded, leader in the effort to determine efficacious and safe VTE prevention strategies in children through multicenter randomized controlled trials. I will accomplish my aims with the support of my local mentor, Dr. Aristizabal (qualitative methods expert), who will help lead the team with mentor, Dr. Young (pediatric thrombosis clinical researcher), and co-mentors, Dr. Goldenberg (pediatric clinical trial researcher), Dr. Amankwah (epidemiologist and biostatistician) and Dr. Zakai (adult thrombosis clinical researcher). My plan for career development is enhanced by the outstanding research environment at the University of California, San Diego, Rady Children’s Hospital, which provides junior faculty members with numerous didactic and training opportunities designed specifically to facilitate the transition to research career independence. By completing my research and training aims, I will take the first necessary step in identifying children at high risk of HA- VTE who may safely benefit from prevention strategies and subsequently reduce the incidence of pediatric VTE.