Enhanced Hearing Screening + Telemedicine Referral for Childhood Hearing Loss

Overseen By Susan Emmett, MD, MPH

Age: < 18

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

14400 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Enhanced Hearing Screening + Telemedicine Referral for Childhood Hearing Loss?

Research shows that using telemedicine for ear screening in Indigenous communities in Queensland effectively identified children at risk of hearing impairment, leading to timely specialist referrals and improved access to care. Additionally, mobile health screening and telemedicine referrals in rural Alaska improved follow-up times for school hearing screenings, suggesting that similar approaches can enhance access to specialty care for childhood hearing loss. ^{1 2 3 4 5}

Is the Enhanced Hearing Screening + Telemedicine Referral for Childhood Hearing Loss safe for children?

The available research on mobile health and telemedicine-based hearing screening programs, including those using tablets and smartphones, suggests they are generally safe for children. These programs have been effectively used in various communities to screen for hearing issues without reported safety concerns. ^{1 3 6 7 8}

How is the Enhanced mHealth Screening treatment different from other treatments for childhood hearing loss?

The Enhanced mHealth Screening treatment is unique because it uses mobile health technology and telemedicine to screen and refer children for hearing loss, allowing specialists to assess children remotely and improving access to care, especially in rural or underserved areas. This approach is different from traditional methods that require in-person visits and may not be as accessible for all children. ^{1 2 3 9 10}

Research Team

Matt Bush, MD, PhD

Principal Investigator

University of Kentucky

Susan Emmett, MD, MPH

Principal Investigator

University of Arkansas Medical Sciences

Eligibility Criteria

This trial is for children entering elementary school in one of the 14 participating counties in rural Kentucky. It's open to all kids, no matter their age, gender, race, or ethnicity. There are no specific exclusion criteria mentioned.

Inclusion Criteria

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

Enrolled in school in one of the 14 participating counties

Initial entry into elementary school

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 years

Annual school-based screening

Control Period

Standard hearing screening and referral process in place before intervention

1-2 years

Enhanced mHealth Screening

Implementation of enhanced mHealth screening protocol including tympanometry

1-2 years

Specialty Telemedicine Referral

Addition of telemedicine referral process to enhanced screening protocol

1-2 years

Follow-up

Participants are monitored for follow-up after screening and referral

Up to 60 days from the date of screening

Treatment Details

Interventions

• Enhanced mHealth Screening
• Specialty Telemedicine Referral
• Standard School Screening and Referral

Trial Overview The study tests a new approach (STAR model) that uses mobile health tools and telemedicine to improve hearing loss screening and follow-up care in rural schools. It includes an enhanced mHealth screening with tympanometry and a specialty telemedicine referral process.

Participant Groups

Group I: Sequence 2 Experimental Treatment 3 Interventions

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 and 3. Enhanced mHealth screening component: Counties randomized to Sequence 2 will receive the enhanced mHealth screening in Years 3 and 4. 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 4.

Group II: Sequence 1 Experimental Treatment 3 Interventions

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 and 2. Enhanced mHealth screening component: Counties randomized to Sequence 1 will receive the enhanced mHealth screening in Years 2, 3, and 4. 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 3 and 4.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Findings from Research

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 UK has transitioned from using the ineffective infant distraction test for hearing loss screening to implementing a national newborn hearing screening program (NHSP), which is based on more advanced technology and aims for early detection of hearing issues.

The NHSP is expected to improve early identification and intervention for permanent congenital childhood hearing loss, although challenges remain regarding the management of late-onset and temporary hearing losses, as well as the effectiveness of screening for milder cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for hearing loss in childhood: issues, evidence and current approaches in the UK. Bamford, J., Uus, K., Davis, A.[2016]

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]

A mobile ear-screening service established in South Burnett has conducted 5,539 assessments over six years, showing a slight reduction in the proportion of children failing screening tests from 33% in 2009 to 26% in 2014.

Children living in the Cherbourg/Murgon area (postcode 4605) had a higher screening failure rate of 38%, indicating that targeted community-based interventions may be necessary to improve ear and hearing health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring ear health through a telemedicine-supported health screening service in Queensland. Smith, AC., Brown, C., Bradford, N., et al.[2022]

Children with postnatal hearing loss (PNHL) identified through neonatal risk factors were diagnosed earlier (average age of 31 months) and with milder severity compared to those detected through other pathways (average age of 49 months).

Screening programs that focus on children with speech and language delays or significant medical histories are essential, as they identify a higher proportion of more severe cases of PNHL, indicating that current screening practices may need to be adjusted to improve early detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood hearing loss detected beyond the newborn screen. Fitzgibbons, EJ., Keszegi, S., Driscoll, C., et al.[2023]

A community-based hearing screening program using smartphone audiometry showed no significant difference in outcomes between specialist School Health Nurses (SHNs) and non-specialist Community Health Workers (CHWs) when screening 6805 children.

The study found that factors like age, test duration, and noise levels significantly affected screening results, indicating that even minimally trained individuals can effectively conduct hearing screenings using mobile technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mhealth hearing screening for children by non-specialist health workers in communities. Dawood, N., Mahomed Asmail, F., Louw, C., et al.[2021]

A tablet-based hearing screening test was validated in a study with 30 young adult volunteers, showing perfect concordance with conventional audiometry results, indicating it can reliably identify hearing loss.

The tablet method demonstrated excellent sensitivity and specificity, both at 100%, making it a highly accurate tool for hearing screening, especially useful in areas lacking access to audiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tablet-Based Hearing Screening Test. Samelli, AG., Rabelo, CM., Sanches, SGG., et al.[2018]

The tablet-based hearing screening game, Sound Scouts, effectively identified undiagnosed hearing deficits in a study of 1256 primary school children, revealing that 8.84% had middle/outer ear pathologies and 1.67% had hearing loss.

The study highlights the importance of school-based hearing screenings, as it established the prevalence of hearing abnormalities and demonstrated a low false positive rate of 5.01%, indicating that most children who failed the initial screening did not have actual hearing issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a game-based hearing screening program for identifying hearing loss in primary school-aged children. Bowers, P., Graydon, K., Rance, G.[2023]

A two-year study in Cleveland demonstrated that low-cost videoconferencing for speech, language, and hearing screenings in children under six is feasible and reliable, with 100% reliability for hearing and speech-language screenings.

Out of 411 screenings conducted, families expressed high satisfaction with the technology, indicating strong community support for this innovative approach in urban health clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the access of young urban children to speech, language and hearing screening via telehealth. Ciccia, AH., Whitford, B., Krumm, M., et al.[2011]

Tele-audiology services have been shown to be feasible and effective in identifying hearing issues in children, particularly in rural and remote areas, improving access to necessary audiological care.

While the reliability of automated testing in tele-audiology is comparable to conventional methods, challenges such as the need for standardized protocols and staff training remain to be addressed for optimal service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of telehealth services to facilitate audiological management for children: A scoping review and content analysis. Govender, SM., Mars, M.[2018]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Screening for hearing loss in childhood: issues, evidence and current approaches in the UK. [2016]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Monitoring ear health through a telemedicine-supported health screening service in Queensland. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Childhood hearing loss detected beyond the newborn screen. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Mhealth hearing screening for children by non-specialist health workers in communities. [2021]

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

Tablet-Based Hearing Screening Test. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of a game-based hearing screening program for identifying hearing loss in primary school-aged children. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Improving the access of young urban children to speech, language and hearing screening via telehealth. [2011]

10. England pubmed.ncbi.nlm.nih.gov

The use of telehealth services to facilitate audiological management for children: A scoping review and content analysis. [2018]