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

Hearing Loss Clinical Trial

Official title:

Appalachian Specialty Telemedicine Access for Referrals (STAR) Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05513833
• Other study ID #: 274089
• Secondary ID: 1U01OD033247
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 30, 2026

Study information

• Verified date: July 2023
• Source: University of Arkansas
• Contact: Susan Emmett, MD, MPH
• Phone: 501-603-1212
• Email: sdemmett[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14400
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (4)

Lead Sponsor	Collaborator
University of Arkansas	Duke University, National Institutes of Health (NIH), University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children screened	This outcome will be measured at the end of each annual screening period for each school, for 4 years.	School screening occurs once per school year, with timing and practices varying by school.
Primary	Proportion of children who receive follow-up	This outcome will be measured each school year, for 2 years or 3 years depending on sequence randomization.	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.