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

Trial Summary

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 data supports the idea that Telemedicine Referral for Childhood Hearing Loss is an effective treatment?

The available research shows that Telemedicine Referral for Childhood Hearing Loss is effective in improving access to specialist care and reducing the number of missed appointments. For example, in a study conducted in a remote community in Queensland, the implementation of a telemedicine-enabled ear screening service led to a significant decrease in missed appointments and increased local surgical procedures. Another study in rural Alaska found that telemedicine referrals improved the time to follow-up for hearing screenings compared to standard primary care referrals. These findings suggest that telemedicine can effectively address hearing loss in children, especially in rural and underserved areas. ^{1 2 3 4 5}

What safety data exists for telemedicine referral for childhood hearing loss?

The studies indicate that telemedicine referral for childhood hearing loss is effective in improving access to specialist care, particularly in rural and underserved areas. The trials conducted in Alaska and Queensland show that telemedicine can enhance follow-up rates and reduce the need for in-person appointments at tertiary centers. The mobile ear-screening services linked to telemedicine have been successful in routine screening and referral processes, with high community satisfaction and improved healthcare access. However, specific safety data regarding adverse effects or risks associated with telemedicine referrals were not detailed in the provided studies. ^{1 3 4 5 6}

Is telemedicine referral a promising treatment for childhood hearing loss?

Yes, telemedicine referral is a promising treatment for childhood hearing loss. It helps improve access to specialists, especially in rural areas, by allowing doctors to assess and treat children remotely. This leads to faster follow-up and more children receiving the care they need. ^{2 3 4 5 7}

What is the purpose of this trial?

The prevalence of childhood hearing loss in rural Alaska is disproportionately high and predominately infection-related. With preventive screenings and access to health care, much of childhood hearing loss is preventable. Although state-mandated school screening helps identify children with hearing loss, loss to follow-up is pervasive and exacerbated by a scarcity of specialists in rural regions. A mixed methods cluster randomized trial conducted in northwest Alaska demonstrated that telemedicine can significantly reduce loss to follow-up. This stepped wedge trial, in partnership with Southcentral Foundation, will build on this existing work to develop a model that can be scaled in diverse environments. We will adapt and implement a new telemedicine intervention called Specialty Telemedicine Access for Referrals (STAR). This trial will be conducted in 3 regions in rural Alaska that represent multiple healthcare systems. Based on stakeholder feedback and evidence generated from the previous trial, an enhanced mobile health (mHealth) hearing screening will be implemented in all participating schools prior to the STAR intervention, and the telemedicine referral to specialty care (STAR intervention) will be moved from the clinic directly into the school. This stepped-wedge cluster randomized trial is part of a larger hybrid type 1 effectiveness-implementation trial. The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing screening in 3 regions of Alaska: Kodiak, Petersburg and Lower Yukon (n=23 schools, \~2,015 K-12 students/year). The STAR Intervention will be compared to the standard referral of a letter home to families. Cluster randomization at the level of school will be performed, with schools (clusters) randomized to one of two sequences. The effectiveness outcome (i.e., proportion of children who receive follow-up) will be evaluated over three academic years (2023-2026), with STAR rolled out in a stepwise manner for each of the two sequences (academic year 2024-2025 for sequence 1 and academic year 2025-2026 for sequence 2). The control periods for each sequence will be academic year 2023-2024 for sequence 1 and academic years 2023-2024 and 2024-2025 for sequence 2. Enhanced screening will be rolled out to both sequences at the same time (i.e., non-randomized) beginning academic year 2023-2024. An implementation evaluation will be conducted to refine and adapt the enhanced hearing screening and STAR intervention throughout the trial. Implementation data will be collected starting academic year 2022-2023 and then annually for each of the subsequent years. 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. Now the STAR intervention will be rolled out in 2025-2026 for sequence 1 and 2026-2027 for sequence 2.

Research Team

Susan Emmett, MD, MPH

Principal Investigator

University of Arkansas Medical Sciences

Matthew Hirschfeld, MD,PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Changes in paediatric hospital ENT service utilisation following the implementation of a mobile, indigenous health screening service. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Remote hearing screenings via telehealth in a rural elementary school. [2022]

3. England 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. [2022]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Telemedicine Referral to Improve Access to Specialty Care for Preschool Children in Rural Alaska: A Cluster-Randomized Controlled Trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

An Assessment of a Socioeconomic Risk Screening Tool for Telemedicine Encounters in Pediatric Primary Care: A Pilot Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Reducing Loss to Follow-Up with Tele-audiology Diagnostic Evaluations. [2022]