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

NCT05513833 | Recruiting

• 2 other identifiers: 2740891U01OD033247
• Study Type: interventional
• Target: 18,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Proportion of children screened

  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

  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.

Study Arms (2)

Sequence 1

OTHER

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; Other: Enhanced mHealth Screening; Other: Specialty Telemedicine Referral

Sequence 2

OTHER

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; Other: Enhanced mHealth Screening; Other: Specialty Telemedicine Referral

Interventions

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.

Sequence 1; Sequence 2

Enhanced mHealth Screening OTHER

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

Sequence 1; Sequence 2

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.

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Arkansas: lead
• University of Kentucky: collaborator
• Duke University: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40858294 DERIVED

MeSH Terms

Conditions

Hearing Loss

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Matt Bush, MD, PhD, MBA

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Susan Emmett, MD, MPH

  University of Arkansas Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Emmett, MD, MPH

CONTACT

501-603-1212; sdemmett@uams.edu

Samantha Robler, AuD,PhD

CONTACT

907-434-0433; skrobler@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statisticians will also be masked to group allocation until analysis is complete.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 24, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)