Srinivasan Tarika, Kleindienst Robler Samantha, Turner Elizabeth, Platt Alyssa, Arthur David, Prvu Bettger Janet, Lane Hannah, Schuh Gebert Marissa, Deshpande Shayu, Schoenberg Nancy, Bush Matthew L, Emmett Susan D
Harvard Medical School, Harvard University, Boston, United States.
Center for Hearing Health Access, University of Arkansas for Medical Sciences, Little Rock, AR, United States.
JMIR Res Protoc. 2025 Aug 26;14:e77630. doi: 10.2196/77630.
Rural populations are disproportionately affected by preventable childhood hearing loss, which is associated with 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.
The Appalachian Specialty Telemedicine Access for Referrals (STAR) trial will assess effectiveness and implementation of the novel, evidence-based STAR model, consisting of 3 core components: (1) enhanced hearing screening; (2) specialty telehealth follow-up; and (3) streamlined communication between schools, health care providers, and parents and caregivers.
Adaptation of the STAR model for rural Kentucky will occur in the first 2 years, followed by a phased rollout of the intervention using a stepped wedge, cluster-randomized design among kindergartners enrolled in approximately 63 schools in 14 counties of rural Kentucky. School districts were identified based on scientific and community input, as well as geographic proximity to state-run clinics, which provide audiology evaluation free of charge. School districts were randomized into 2 sequences using constrained randomization to balance baseline covariates, such as kindergarten enrollment and number screened. This hybrid type 1 effectiveness-implementation trial will evaluate effectiveness of the STAR model compared with usual hearing screening and usual follow-up process using an intention-to-treat approach with generalized estimating equations. Barriers and facilitators to implementation of the intervention will be identified using a mixed methods approach. The primary effectiveness outcomes are the (1) proportion of kindergarteners screened and (2) proportion of referred kindergarteners who receive specialty follow-up within 60 days of screening. Implementation outcomes 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.
The trial began in September 2022 and is expected to conclude in May 2026. Final data analysis is planned to begin in June 2026, and publication of results is expected in 2027.
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 STAR model's adaptability and overall fit. 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.
ClinicalTrials.gov NCT05513833; https://clinicaltrials.gov/study/NCT05513833.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77630.
农村人口受可预防的儿童听力损失影响尤为严重，这与言语和语言发育迟缓、社会发展受损以及教育程度降低有关。农村学校是听力筛查等预防性健康筛查的关键接入点，但筛查实施的差异、失访以及农村地区专科医生的短缺降低了项目效果。我们旨在实施一项基于学校的远程医疗干预措施，以增加肯塔基州农村地区儿童获得专科听力护理的机会。
阿巴拉契亚专科远程医疗转诊接入（STAR）试验将评估新型循证STAR模式的有效性和实施情况，该模式由3个核心组成部分：（1）强化听力筛查；（2）专科远程医疗随访；（3）学校、医疗服务提供者以及家长和照顾者之间的简化沟通。
STAR模式在肯塔基州农村地区的适配工作将在前两年进行，随后采用阶梯式楔形整群随机设计分阶段推广该干预措施，对象为肯塔基州农村地区14个县约63所学校的幼儿园儿童。学区是根据科学和社区意见以及与提供免费听力评估的州立诊所的地理距离确定的。学区使用受限随机化方法随机分为2个序列，以平衡基线协变量，如幼儿园入学人数和筛查人数。这项混合型1类有效性-实施试验将采用意向性分析方法和广义估计方程，评估STAR模式与常规听力筛查及常规随访流程相比的有效性。将采用混合方法确定干预措施实施的障碍和促进因素。主要有效性结局为：（1）接受筛查的幼儿园儿童比例；（2）转诊的幼儿园儿童在筛查后60天内接受专科随访的比例。实施结局包括对影响STAR模式成功整合的因素进行评估。将在预定时间点对干预措施进行迭代调整，以实现最佳实施结局。
该试验于2022年9月开始，预计2026年5月结束。最终数据分析计划于2026年6月开始，结果预计于2027年发表。
STAR模式解决了肯塔基州农村地区与听力损失识别、筛查失访以及获得专科护理有关的问题。有效性结局可能为未来学校听力筛查政策提供参考，包括采用循证方案来解决可预防的儿童听力损失问题以及整合基于学校的专科远程医疗随访以改善随访情况。实施目标可能会使STAR模式的适应性和整体契合度最大化。社区意见和系统调整将确保考虑到肯塔基州农村各县的独特需求和优先事项。如果成功，STAR模式可在美国农村地区推广，并应用于其他可预防的儿童健康状况。
ClinicalTrials.gov NCT05513833；https://clinicaltrials.gov/study/NCT05513833。
国际注册报告识别号（IRRID）：DERR1-10.2196/77630。
