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NCT Number: NCT05513833

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

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.

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Key information

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location status: Recruiting

Location contact

Matt Bush, MD, PhD

CONTACT

859-562-3120

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard School Screening and Referral

Other

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

Other

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

Specialty Telemedicine Referral

Other

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.

Primary outcomes

  1. Proportion of children screened

    Time frame: School 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.

  2. Proportion of children who receive follow-up

    Time frame: Proportion 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha Robler, AuD,PhD

CONTACT

[email protected]

907-434-0433

Susan Emmett, MD, MPH

CONTACT

[email protected]

501-603-1212

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Duke University
  • National Institutes of Health (NIH)
  • University of Kentucky

Registry information

Official study title

Appalachian Specialty Telemedicine Access for Referrals (STAR) Trial

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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