School-Based Enhanced Hearing Screening and Specialty Telehealth Follow-Up for Hearing Loss Among Children in Rural Alaska: Study Protocol for a Hybrid Effectiveness-Implementation Stepped Wedge, Cluster-Randomized Controlled Trial (North STAR Trial).

Background: Childhood hearing loss has well-known profound implications for language development, school achievement, and future employment opportunities. School-based health programs can provide hearing screening, but access to specialists for follow-up care is limited in rural areas. This is especially problematic for children in rural Alaska who experience a disproportionately high burden of preventable childhood hearing loss. The purpose of this study will be to develop and test the effectiveness and implementation of school-based specialty telehealth follow-up to improve timely access to specialty care after school hearing screening in rural Alaska. Methods: This will be a hybrid type 1 effectiveness-implementation stepped wedge, cluster-randomized trial in three representative regions of Alaska. The trial will evaluate the STAR model, which consists of three core components: 1) enhanced school hearing screening, 2) school-based specialty telehealth follow-up, and 3) streamlined communication between schools, healthcare providers, and parents/caregivers. The trial will begin with a formative phase in the first two years, when qualitative data on community preferences and perspectives will be gathered to systematically adapt the STAR model and develop an implementation plan for participating regions. The adapted STAR model will be evaluated with a stepped wedge, cluster-randomized design in approximately 25 schools in three regions of rural Alaska. The primary effectiveness outcome will be the proportion of referrals resulting in specialty follow-up within 60 days of school hearing screening, measured using queries of electronic health records from the healthcare systems serving each region. Generalized estimating equations (GEE) will be used to model these cluster-period school-level proportions to obtain population-averaged intervention effects that are of public health relevance and therefore of interest in implementation trials. Secondary implementation outcomes will include fidelity, reach, acceptability, feasibility, and appropriateness. Sustainability of the STAR model will be evaluated through iterative meetings with state leaders and policymakers. Discussion: This trial will evaluate school-based specialty telehealth follow-up in diverse regions of Alaska, addressing preventable childhood hearing loss with a model that could be translated to other underserved rural and marginalized groups to bring high-value services into rural schools and alter the paradigm of prevention nationwide. Trial registration: NCT05593484 - https://clinicaltrials.gov/study/NCT05593484.