Telemedicine Referral for Childhood Hearing Loss

Overseen By Susan Emmett, MD, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

8060 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telemedicine approach to help children in rural Alaska with hearing loss receive necessary follow-up care. The researchers aim to determine if using telemedicine directly in schools can improve follow-up rates compared to the usual method of sending a letter to parents. The trial will occur in three regions and involve students from kindergarten to 12th grade. It is ideal for families with children in these areas who have experienced hearing issues but have not always received the follow-up care they need. As an unphased trial, this study offers families the chance to contribute to innovative solutions that could enhance healthcare access for children in rural communities.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the trial focuses on telemedicine for hearing loss, not medication.

What prior data suggests that this telemedicine intervention is safe for childhood hearing loss referrals?

Research shows that telemedicine, including the STAR model, is generally safe and easy to use. Studies on telemedicine in schools have found it improves follow-up care without causing significant problems. The technology, already common in healthcare, is considered safe for patients.

This trial will use mobile health (mHealth) tools for hearing tests in schools. Current evidence suggests these tools are easy to use and safe for children. Previous studies have not found any serious side effects from these technologies.

In summary, past research indicates that this telemedicine approach is well-tolerated, with no major safety concerns. It offers a promising way to improve access to necessary follow-up care in rural areas. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telemedicine Referral for Childhood Hearing Loss trial because it could revolutionize how kids access care for hearing issues. Unlike traditional referral methods that often require multiple in-person visits, the study tests a telemedicine approach. This approach allows for quicker and more convenient access to specialists, especially for families living in remote areas. By leveraging technology, this method aims to streamline the referral process, reduce wait times, and improve overall access to essential hearing health services for children.

What evidence suggests that the STAR intervention is effective for reducing loss to follow-up in childhood hearing loss?

Research has shown that telemedicine can significantly reduce the number of children in rural areas who miss follow-up care for hearing loss. This trial will compare two approaches: the Specialty Telemedicine Access for Referrals (STAR) and Standard Referral. Studies have found that mobile health screenings combined with telemedicine referrals, as in the STAR arm of this trial, increase follow-up rates after initial school hearing tests. In rural Alaska, past trials demonstrated that using telemedicine in schools reduced the number of children missing necessary follow-up care. This method addresses the shortage of specialists and ensures more children receive needed care after being flagged for possible hearing issues. By facilitating virtual visits with specialists, telemedicine can help prevent long-term hearing problems in children. ^{2 3 5 6 7}

Who Is on the Research Team?

Matthew Hirschfeld, MD,PhD

Principal Investigator

Vice President-Specialty Services, Southcentral Foundation, Alaska Native Medical Center

Susan Emmett, MD, MPH

Principal Investigator

University of Arkansas Medical Sciences

Are You a Good Fit for This Trial?

This trial is for children in grades K-12 attending participating schools in rural Alaska regions. It aims to address high rates of childhood hearing loss, which is often preventable and related to infections.

Inclusion Criteria

My eligibility is not limited by my age, gender, race, or ethnicity.

My child is in grades K-12 and can be screened at their school.

Enrolled in one of the participating schools in the 3 regions

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 academic year

School-based screening

Enhanced Screening

Implementation of enhanced mobile health (mHealth) hearing screening in all participating schools

1 academic year

School-based screening

STAR Intervention

Telemedicine referral to specialty care moved from clinic to school, evaluated in a stepped-wedge manner

2 academic years

School-based intervention

Follow-up

Participants are monitored for follow-up after hearing screening and intervention

Up to 60 days from the date of screening

What Are the Treatments Tested in This Trial?

Interventions

• School Screening and Telemedicine Specialty Referral
• Specialty Telemedicine Access for Referrals (STAR)

Trial Overview The study compares two methods: the standard referral process versus a telemedicine intervention called STAR, which brings specialty care directly into schools after mobile health screenings.

How Is the Trial Designed?

Group I: Standard Referral Experimental Treatment 1 Intervention

Group II: Specialty Telemedicine Access for Referrals (STAR) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Southcentral Foundation

Collaborator

Trials

10

Recruited

8,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

The mobile ear-screening service in an Aboriginal community successfully screened 1053 children over three years, achieving an impressive average screening rate of 85%.

More than half of the assessments led to referrals for further evaluation or treatment, demonstrating the effectiveness of telemedicine in connecting local health workers with specialist ENT care for children at risk of hearing impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile telemedicine-enabled ear screening service for Indigenous children in Queensland: activity and outcomes in the first three years. Smith, AC., Armfield, NR., Wu, WI., et al.[2022]

The mobile ear-screening service established in a remote community significantly reduced the number of outpatient appointments for ear, nose, and throat (ENT) issues, dropping from 329 to 105 over three years, indicating improved access to care.

Surgical procedures also decreased at the Royal Children's Hospital from 100 to 43, while local surgeries increased, with 86% of booked procedures completed, demonstrating the effectiveness of the screening program in enhancing local healthcare delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in paediatric hospital ENT service utilisation following the implementation of a mobile, indigenous health screening service. Smith, AC., Armfield, NR., Wu, WI., et al.[2018]

The tele-audiology program successfully diagnosed hearing loss in 59.1% of infants who did not pass their newborn hearing screen, demonstrating its effectiveness in providing necessary evaluations remotely.

The program significantly reduced the loss to follow-up rate from 22% to 0%, indicating that tele-audiology is a feasible and valuable solution for families facing access barriers to traditional audiology services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Loss to Follow-Up with Tele-audiology Diagnostic Evaluations. Dharmar, M., Simon, A., Sadorra, C., et al.[2022]

In a study involving 1481 children from 15 rural Alaskan communities, telemedicine specialty referral significantly reduced the time to follow-up after positive hearing screenings, with an average of 41.5 days compared to 92.0 days for standard primary care referrals.

The telemedicine approach also resulted in a higher follow-up rate, with 68.5% of children receiving follow-up care compared to only 32.1% in the primary care group, demonstrating its effectiveness in improving access to necessary healthcare services for rural children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health school screening and telemedicine referral to improve access to specialty care in rural Alaska: a cluster- randomised controlled trial. Emmett, SD., Platt, A., Turner, EL., et al.[2023]

Telehealth technology can effectively provide hearing screening services to school-age children, as demonstrated by identical results in otoscopy and immittance audiometry between on-site and telehealth screenings for 32 third graders in rural Utah.

While most results were consistent, five children showed different responses to pure-tone stimuli in telehealth screenings compared to on-site, indicating the need for further research to understand these discrepancies and improve telehealth protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote hearing screenings via telehealth in a rural elementary school. Lancaster, P., Krumm, M., Ribera, J., et al.[2022]

In a study involving 153 preschool children across 14 communities in rural Alaska, telemedicine specialty referrals significantly improved the rate of follow-up care for hearing issues, with 76.9% of referred children receiving follow-up compared to 50.0% in standard referrals.

The median time to follow-up was much faster in telemedicine communities (28 days) compared to standard care (85 days), demonstrating that telemedicine can effectively reduce delays in accessing specialty care for early childhood hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine Referral to Improve Access to Specialty Care for Preschool Children in Rural Alaska: A Cluster-Randomized Controlled Trial. Robler, SK., Platt, A., Turner, EL., et al.[2023]

In a study of 179 telemedicine visits, a socioeconomic risk screening tool was completed in 63% of encounters, successfully identifying risks in 5% of cases, leading to a 90% referral rate for those at risk.

Families reported high satisfaction with telemedicine services, but 31% faced challenges in accessing the recommended interventions, highlighting the need for improved connection strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Assessment of a Socioeconomic Risk Screening Tool for Telemedicine Encounters in Pediatric Primary Care: A Pilot Study. Ireson, E., Burkhardt, MC., DeBlasio, D., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11141683

Specialty Telemedicine Access for Referrals in Rural Alaska This study will prospectively evaluate a new virtual specialty triage model in Alaska schools to reduce loss to follow-up from school hearing screening and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05513833

School Screening and Telemedicine Specialty Referral to ... This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08864-0

School-based enhanced hearing screening and specialty ... This trial will evaluate school-based specialty telehealth follow-up in diverse regions of Alaska, addressing preventable childhood hearing loss.

4. trialx.com trialx.com/clinical-trials/listings/236680/school-screening-and-telemedicine-specialty-referral-to-address-childhood-hearing-loss-in-rural-alaska/?&radius=10&place=Seoul,%20etc.&user_country=Korea,%20Republic%20of

School Screening and Telemedicine Specialty Referral to ... The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing ...

5. researchprotocols.org researchprotocols.org/2025/1/e77630

Improving Access to Specialty Care for Rural Children ... Effectiveness outcomes may inform future policy for school hearing screening, including adoption of evidence-based protocols to address ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12107839/

School-based enhanced hearing screening and specialty ... The purpose of this study will be to develop and test the effectiveness and implementation of school-based specialty telehealth follow-up to improve timely ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10642973/

Mobile Health School Screening and Telemedicine ... We hypothesised telemedicine specialty referral would improve time to follow-up for school hearing screening compared with standard primary care referral.