Innovations in treatment adherence in pediatric eosinophilic esophagitis

PROJECT SUMMARY Medication nonadherence leads to increased morbidity, mortality, and costs the US healthcare system hundreds of billions of dollars annually. While there have been decades of research regarding nonadherence, newer research shows that interventions that focus on behavior change, and specifically, habit-building, have

the most potential to result in improvement. Given their higher rates of nonadherence and decreased self- management skills, adolescents with chronic conditions will benefit most from medication adherence interventions. Our prior work shows that adolescents with eosinophilic esophagitis (EoE) – a chronic immune-

mediated inflammatory disease of the esophagus with a rapidly rising incidence – have low medication adherence rates secondary to lack of planning and forgetfulness. Thus, we created a prototype of a clinical tool (a habit-based medication “Action Plan”) and iteratively modified it using stakeholder engagement. The specific

aims of this proposal are to: 1) establish an optimal version of this tool - the “Medication Habit Action Plan (MHAP)” – through usability testing (end-user testing with patients and nurses), 2) conduct a pilot randomized controlled trial of the MHAP to determine feasibility and inform a larger multicenter future hybrid effectiveness-

implementation trial, and 3) measure the effect of dupilumab on adherence and EoE clinical outcomes in nonadherent adolescents using a prospective cohort study design. This career development award is designed to support the transition of Pooja Mehta, MD, MSCS, an Assistant Professor of Pediatrics at the University of

Colorado, into an independent clinician-scientist and to achieve her long-term career goal of improving outcomes in children with chronic gastrointestinal diseases. Guidance from a multidisciplinary mentorship team (Dr. Glenn T. Furuta- renowned EoE clinical researcher, Dr. Bethany Kwan- dissemination and implementation

scientist, and Dr. Sheana Bull- user-centered design and technology expert) will be coupled with training in 1) clinical trial design and conduct, 2) dissemination and implementation science, and 3) healthcare data integration across multiple institutions. Together, these will provide Dr. Mehta with the foundation needed to

successfully create and test adherence-related interventions in large-scale multi-center pragmatic trials. The University of Colorado provides a unique environment to conduct pragmatic research and is supported by collaborative partnerships between The Adult and Child Consortium for Health Outcomes Research and

Delivery Science, The University of Colorado Mobile Health Impact Laboratory, Children's Hospital Colorado Gastrointestinal Eosinophilic Diseases Program, and Denver Health (Denver's safety net hospital). EoE serves as an ideal disease model to study habit-based medication adherence interventions and will have widespread

applicability to a broad range of chronic pediatric gastrointestinal diseases. Ultimately, completion of this research proposal and career development plan will help Dr. Mehta achieve her overall career goal of addressing treatment nonadherence in children with chronic diseases to improve child health outcomes.