Skip to content

School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky

Appalachian Specialty Telemedicine Access for Referrals (STAR) Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05513833
Enrollment
18000
Registered
2022-08-24
Start date
2022-09-01
Completion date
2027-06-30
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

Rural, hearing, loss, telemedicine, telehealth, school, disparities, screening

Brief summary

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.

Detailed description

Childhood hearing loss has substantial lifelong consequences, including speech-language delay, worse academic performance, and limited vocational opportunities. In rural settings, where access to care is limited, school-based preventative screening programs can help in early identification of childhood hearing loss. The state of Kentucky mandates hearing screening for all schools; however, the effectiveness of these programs is unclear. Further, current school programs do not include a middle ear assessment, which is needed to detect infection-related hearing loss common in children in rural and low-income settings. In children referred from school-based hearing screening programs, loss to follow-up also remains a pervasive issue. 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.

Interventions

OTHERStandard 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.

OTHEREnhanced mHealth Screening

The enhanced screening protocol will consist of an mHealth-based hearing screen combined with tympanometry.

OTHERSpecialty 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.

Sponsors

University of Arkansas
Lead SponsorOTHER
University of Kentucky
CollaboratorOTHER
Duke University
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Statisticians will also be masked to group allocation until analysis is complete.

Intervention model description

14 total counties (clusters) are participating in the stepped wedge randomized trial. There are two nested trials within the overall stepped-wedge trial: a complete design to evaluate the enhanced mHealth screening component and an incomplete design to evaluate the specialty telemedicine referral component combined with enhanced screening. Clusters will be randomized to cross over to enhanced mHealth hearing screening and specialty telemedicine referral in a stepwise manner until all clusters receive both the interventions. 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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
Yes

Inclusion criteria

* Enrolled in school in one of the 14 participating counties * Initial entry into elementary school * Eligible regardless of age, gender, race, or ethnicity

Exclusion criteria

• N/A

Design outcomes

Primary

MeasureTime frameDescription
Proportion of children screenedSchool screening occurs once per school year, with timing and practices varying by school.This outcome will be measured at the end of each annual screening period for each school, for 5 years, based on the updated timeline.
Proportion of children who receive follow-upProportion of children who receive follow-up will be measured by the occurrence of an ear/hearing encounter, up to 60 days from the date of screening.This outcome will be measured each school year, for 3 years or 4 years depending on sequence randomization, based on the updated timeline.

Countries

United States

Contacts

CONTACTSusan Emmett, MD, MPH
sdemmett@uams.edu501-603-1212
CONTACTSamantha Robler, AuD,PhD
skrobler@uams.edu907-434-0433
PRINCIPAL_INVESTIGATORMatt Bush, MD, PhD, MBA

University of Kentucky

PRINCIPAL_INVESTIGATORSusan Emmett, MD, MPH

University of Arkansas Medical Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026