U01DC021719

Appalachian Star Trial - Health disparities in rural America begin early in life, arising from social determinants of health that start in childhood. School health programs often provide the only access to preventive services for rural children. However, school screening is variably implemented, plagued by loss to follow-up, and limited specialists in rural areas compound barriers to care.

We propose to prospectively implement a novel model of care in Appalachian schools of rural Kentucky to address social determinants at the school, health system, and policy levels that hinder identification and treatment of preventable health disparities for two NIH-designated disparity populations: underserved rural and socioeconomically disadvantaged children. Our goal is to establish a novel, generalizable model of school-based, telehealth-driven preventive care that can be disseminated in underserved populations across rural America.

We will adapt and evaluate our evidence-based approach, "STAR" (Specialty Telemedicine Access for Referrals), that we have found effective in a tribal setting in rural Alaska. Appalachia has some of the poorest counties in the US, making this region ideal for adapting across rural America. The innovative "Appalachian Star Trial" will be the first study to apply school-based telehealth for preventive services, with direct access to specialists.

Hearing screening will be the prototype for STAR due to the high burden of preventable, infection-related hearing loss in underserved children and the profound lifelong implications of childhood hearing loss. Our interdisciplinary team has relationships with underserved communities in Kentucky and partnership with a community advisory board and stakeholder advisory board providing support from the highest levels of state government (see KY Governor letter).

We will begin by adapting the STAR model of care to meet the needs of rural communities and schools through a community- and stakeholder-driven approach. We will evaluate the STAR care model in 66 schools in rural Kentucky through a stepped wedge cluster-randomized hybrid type 1 effectiveness-implementation trial with kindergarten children in 14 counties (N=~3600/year). The STAR intervention includes county-level school screening policy change with enhanced mHealth school hearing screening, followed by virtual specialty care referral.

The stepped-wedge design allows evaluation of the policy/screening and referral components as well as comparison of usual care vs. full intervention (years 2 vs. 5), while meeting community input that the intervention be available to all. Primary outcomes are the percentage of 1) children screened and 2) referrals resulting in specialty care within two months of screening. We conservatively hypothesize the percentage screened will improve by 20% and follow-up will improve by 40%.

During the trial, we will assess multi-level implementation factors and outcomes to inform scale-up into other rural areas. Our STAR model could be both scaled across rural America and applied to other preventable health disparities, combining policy change on school health with digital innovations to radically expand access to care for underserved rural and socioeconomically disadvantaged children nationwide.

University Of Arkansas For Medical Sciences

NOT APPLICABLE

93.173 - Research Related to Deafness and Communication Disorders

National Institute on Deafness and Other Communication Disorders (NIDCD) [HHS - NIH]

Little Rock, Arkansas 722057101 United States

Single Zip Code

Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Allowed) (RFA-RM-21-021)

Amendment Since initial award the End Date has been extended from 04/30/26 to 08/31/26 and the total obligations have increased 326% from $1,077,615 to $4,589,310.