School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky
NCT ID: NCT05513833
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
18000 participants
INTERVENTIONAL
2022-09-01
2027-06-30
Brief Summary
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Detailed Description
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To address these key issues, the University of Kentucky has partnered with the University of Arkansas Medical Sciences to lead the Appalachian STAR trial. This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology for specialty care access in rural Kentucky schools. An initial version of the model was used in rural Alaska where telemedicine-based specialty referral improved both proportion of children receiving follow-up and time to follow-up. The refined STAR model will utilize an enhanced mHealth screening protocol that includes tympanometry for the detection of middle ear disease. The STAR model will also include a specialty telemedicine referral process in schools for children who refer school screening.
The Appalachian STAR stepped-wedge cluster randomized trial will be conducted in approximately 64 elementary schools located in 14 counties in rural Kentucky. Approximately 3600 students at school entry will be enrolled annually for 4 years, for a total of approximately 14,400 children. Cluster randomization will occur in two sequences at the county level, with 7 counties (clusters) in each sequence. The 4-year trial will include a control condition period, followed by phased roll-out of the intervention. The enhanced mHealth school hearing screening protocol will be implemented first. The following year, specialty telemedicine referral will be added to the enhanced screening protocol. All 14 counties will receive the STAR model by the end of the trial. An implementation evaluation will be conducted to refine the STAR model throughout the trial. If successful, the STAR model could be applied to address hearing loss and other childhood health conditions that affect underserved rural communities across America.
Timeline update: Based on feedback from community partners, we extended the trial for one year to allow for community-informed adaptations of the enhanced screening. After this additional year of enhanced screening only, specialty telemedicine referral will be added to the enhanced screening protocol. All counties will receive the STAR model by the end of the 5-year trial.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
The enhanced mHealth screening component will be rolled out in Years 2 or 3 (control period in Years 1 and 2) depending on sequence randomization. Specialty telemedicine referral will be rolled out in Years 3 and 4 (control period in Years 2 and 3) depending on sequence randomization.
Timeline update: With the trial extended by one year, rollout of specialty telemedicine referral will be shifted to Years 4 and 5 depending on sequence randomization.
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Sequence 1
Standard School Screening: All counties in Sequence 1 will receive standard hearing screening in the control period, Year 1.
Standard Referral: All counties in Sequence 1 will receive standard referral in control period, Years 1, 2, and 3, based on the updated timeline.
Enhanced mHealth screening component: Counties randomized to Sequence 1 will receive the enhanced mHealth screening in Years 2, 3, 4, and 5, based on the updated timeline.
Specialty telemedicine referral component: Counties randomized to Sequence 1 will receive the specialty telemedicine referral component in addition to the enhanced mHealth screening in Years 4 and 5, based on the updated timeline.
Standard School Screening and Referral
Counties in the control condition will use standard hearing screening and standard referral by school district. Standard referral is typically a letter home from the school to parents/caregivers of children who refer screening.
Enhanced mHealth Screening
The enhanced screening protocol will consist of an mHealth-based hearing screen combined with tympanometry.
Specialty Telemedicine Referral
The specialty telemedicine referral will include a lay-friendly smartphone or tablet that connects to tools necessary for an ear and hearing evaluation. If a child requires referral from hearing screening, a school nurse/teacher will complete the established protocol for the specialty telemedicine referral and send details asynchronously to an audiologist for consultation.
Sequence 2
Standard Hearing Screening: All counties in Sequence 2 will receive standard hearing screening in the control period, Years 1 and 2.
Standard Referral: All counties in Sequence 2 will receive standard referral in control period, Years 1, 2, 3, and 4, based on the updated timeline.
Enhanced mHealth screening component: Counties randomized to Sequence 2 will receive the enhanced mHealth screening in Years 3, 4, and 5, based on the updated timeline.
Specialty telemedicine referral component: Counties randomized to Sequence 2 will receive the specialty telemedicine referral component in addition to the enhanced mHealth screening in Year 5, based on the updated timeline.
Standard School Screening and Referral
Counties in the control condition will use standard hearing screening and standard referral by school district. Standard referral is typically a letter home from the school to parents/caregivers of children who refer screening.
Enhanced mHealth Screening
The enhanced screening protocol will consist of an mHealth-based hearing screen combined with tympanometry.
Specialty Telemedicine Referral
The specialty telemedicine referral will include a lay-friendly smartphone or tablet that connects to tools necessary for an ear and hearing evaluation. If a child requires referral from hearing screening, a school nurse/teacher will complete the established protocol for the specialty telemedicine referral and send details asynchronously to an audiologist for consultation.
Interventions
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Standard School Screening and Referral
Counties in the control condition will use standard hearing screening and standard referral by school district. Standard referral is typically a letter home from the school to parents/caregivers of children who refer screening.
Enhanced mHealth Screening
The enhanced screening protocol will consist of an mHealth-based hearing screen combined with tympanometry.
Specialty Telemedicine Referral
The specialty telemedicine referral will include a lay-friendly smartphone or tablet that connects to tools necessary for an ear and hearing evaluation. If a child requires referral from hearing screening, a school nurse/teacher will complete the established protocol for the specialty telemedicine referral and send details asynchronously to an audiologist for consultation.
Eligibility Criteria
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Inclusion Criteria
* Initial entry into elementary school
* Eligible regardless of age, gender, race, or ethnicity
Exclusion Criteria
3 Years
11 Years
ALL
Yes
Sponsors
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University of Kentucky
OTHER
Duke University
OTHER
National Institutes of Health (NIH)
NIH
University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Matt Bush, MD, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Susan Emmett, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas Medical Sciences
Locations
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University of Kentucky
Lexington, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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Matt Bush, MD, PhD
Role: primary
References
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Srinivasan T, Kleindienst Robler S, Turner E, Platt A, Arthur D, Prvu Bettger J, Lane H, Schuh Gebert M, Deshpande S, Schoenberg N, Bush ML, 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 Aug 26;14:e77630. doi: 10.2196/77630.
Other Identifiers
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274089
Identifier Type: -
Identifier Source: org_study_id
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