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Accepted for/Published in: JMIR Research Protocols

Date Submitted: May 21, 2025
Open Peer Review Period: May 22, 2025 - Jun 17, 2025
Date Accepted: Jul 3, 2025
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Improving Access to Specialty Care for Rural Children Using Enhanced Hearing Screening and Specialty Telehealth Follow-Up in Rural Kentucky Schools: Protocol for a Hybrid Effectiveness-Implementation Stepped Wedge, Cluster-Randomized Controlled Trial (Appalachian STAR Trial)

Srinivasan T, Kleindienst Robler S, Turner E, Platt A, Arthur D, Prvu Bettger J, Lane H, Schuh Gebert M, Deshpande S, Schoenberg N, Bush M, Emmett SD

Improving Access to Specialty Care for Rural Children Using Enhanced Hearing Screening and Specialty Telehealth Follow-Up in Rural Kentucky Schools: Protocol for a Hybrid Effectiveness-Implementation Stepped Wedge, Cluster-Randomized Controlled Trial (Appalachian STAR Trial)

JMIR Res Protoc 2025;14:e77630

DOI: 10.2196/77630

PMID: 40858294

PMCID: 12421207

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Improving Access to Specialty Care for Rural Children: Protocol for a Hybrid Effectiveness-Implementation Stepped Wedge, Cluster-Randomized Controlled Trial of Enhanced Hearing Screening and Specialty Telehealth Follow-Up in Rural Kentucky Schools (Appalachian STAR Trial)

  • Tarika Srinivasan; 
  • Samantha Kleindienst Robler; 
  • Elizabeth Turner; 
  • Alyssa Platt; 
  • David Arthur; 
  • Janet Prvu Bettger; 
  • Hannah Lane; 
  • Marissa Schuh Gebert; 
  • Shayu Deshpande; 
  • Nancy Schoenberg; 
  • Matthew Bush; 
  • Susan D. Emmett

ABSTRACT

Background:

Rural populations are disproportionately affected by preventable childhood hearing loss, which may lead to speech and language delays, impaired social development, and decreased educational attainment. Rural schools are critical access points for preventive health screenings such as hearing screening, but variable screening implementation, loss to follow-up, and scarcity of specialists in rural areas diminish program effectiveness. We seek to implement a school-based, telehealth intervention to increase access to specialty hearing care for children in rural Kentucky.

Objective:

The Appalachian Specialty Telemedicine Access for Referrals (STAR) trial will assess effectiveness and implementation of the novel, evidence-based STAR model, consisting of three core components: 1) enhanced hearing screening, 2) specialty telehealth follow-up, and 3) streamlined communication between schools, healthcare providers, and parents/caregivers.

Methods:

Adaptation of the STAR model for rural Kentucky will occur in the first two years, followed by a phased rollout of the intervention using a stepped wedge, cluster-randomized design in approximately 63 schools in 14 counties of rural Kentucky. This hybrid type 1 effectiveness-implementation trial will evaluate effectiveness of the STAR model and identify barriers and facilitators to implementation using a mixed methods approach. The primary effectiveness outcomes will be: 1) proportion of children screened and 2) proportion of referred children who receive specialty follow-up within 60 days of screening. Implementation outcomes will include assessment of factors affecting successful integration of the STAR model. Iterative adaptation of the intervention will be performed at prespecified time points to maximize implementation outcomes.

Results:

The trial began in September 2022 and is expected to conclude in May 2026. Final data analysis is planned to be begin in June 2026, and publication of results is expected in 2027.

Conclusions:

The STAR model addresses issues related to identification of hearing loss, loss to follow-up from screening, and access to specialty care in rural Kentucky. Effectiveness outcomes may inform future policy for school hearing screening, including adoption of evidence-based protocols to address preventable childhood hearing loss and integration of school-based specialty telehealth follow-up to improve follow-up. Implementation aims may maximize the adaptability and overall fit of the STAR model. Community input and systematic adaptation will ensure consideration of unique needs and priorities of rural Kentucky counties. If successful, the STAR model could be scaled across rural America and applied to other preventable child health conditions. Clinical Trial: ClinicalTrials.gov, NCT05513833


 Citation

Please cite as:

Srinivasan T, Kleindienst Robler S, Turner E, Platt A, Arthur D, Prvu Bettger J, Lane H, Schuh Gebert M, Deshpande S, Schoenberg N, Bush M, Emmett SD

Improving Access to Specialty Care for Rural Children Using Enhanced Hearing Screening and Specialty Telehealth Follow-Up in Rural Kentucky Schools: Protocol for a Hybrid Effectiveness-Implementation Stepped Wedge, Cluster-Randomized Controlled Trial (Appalachian STAR Trial)

JMIR Res Protoc 2025;14:e77630

DOI: 10.2196/77630

PMID: 40858294

PMCID: 12421207

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