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

May 4, 2026 updated by: University of Arkansas

Appalachian Specialty Telemedicine Access for Referrals (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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

18000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University Of Kentucky
        • Contact:
          • Matt Bush, MD, PhD
          • Phone Number: 859-562-3120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.
Other: Enhanced mHealth Screening
The enhanced screening protocol will consist of an mHealth-based hearing screen combined with tympanometry.
Other: 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.
Other: 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.
Other: 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.
Other: Enhanced mHealth Screening
The enhanced screening protocol will consist of an mHealth-based hearing screen combined with tympanometry.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
School screening occurs once per school year, with timing and practices varying by school.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Collaborators

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

Investigators

  • Principal Investigator: Matt Bush, MD, PhD, MBA, University Of Kentucky
  • Principal Investigator: Susan Emmett, MD, MPH, University of Arkansas Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

August 14, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 274089
  • 1U01OD033247 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study focuses on population outcomes. School and health data will remain with local education and healthcare entities, and the study team will receive deidentified information. Data sharing will be considered upon request pending appropriate local approval.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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