Leveraging Advances in Practices and Outcomes in Cleft Care: The LEAP Study

ABSTRACT Currently, there are limited coordinated efforts to rapidly improve care for children born with cleft lip and/or palate directly at the site where care is delivered. This gap perpetuates significant variation in care outcomes for children with cleft, particularly during their first years of life. The field is currently stymied by limited clinical translational research and lags between dissemination of evidence-based interventions and wide-scale implementation in healthcare settings. Many sites where cleft care is delivered do not have the resources or infrastructure to participate in multi-center studies, limiting the generalizability and uptake of this research to diverse settings. Finally, patient and caregiver voices have not been meaningfully integrated into translational studies, despite the significant impacts cleft care outcomes have on their health and well-being across the lifespan. The purpose of the LEAP project is to create an inclusive global collaborative to develop a cleft- focused learning health system. Our efforts will focus on the first 10 years of life, a period during which critical treatments and assessments occur in children with cleft. We will include cleft centers in high and low-resource settings in the USA and internationally and key stakeholders such as patients, providers, caregivers, trainees, and non-profit and advocacy groups. We will select key feedback metrics for 3 domains (nutrition, psychosocial risk identification, and cleft surgery outcomes) and additionally identified priority outcomes based on their ability to inform and facilitate care improvements. The LEAP collaborative will guide the design, build, and reporting of the LEAP learning health system. We will create a LEAP data system with dashboards that include data visualization that show a site’s performance and how they compare to other sites in a format rapidly delivered back to LEAP partner sites. We will facilitate discussions regarding these comparative metrics and create an open and supportive community for learning from inter-center differences. LEAP will create actionable, data-driven insights that will enable cleft team leaders, healthcare providers, patients, and caregivers to better understand cleft centers’ population-level outcomes relative to their peers and foster change and improvements in care. Such an approach has high potential to rapidly improve the health and well- being of children born with cleft.