Telemedicine Referral for Childhood Hearing Loss

Recruiting in Palo Alto (17 mi)

Overseen by Susan Emmett, MD, MPH

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arkansas

No Placebo Group

Trial Summary

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.

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.

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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.

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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.

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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

Trial 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

Participant Groups

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.

Group I: Standard Referral Experimental Treatment 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Southcentral Foundation Anchorage, AK

Who Is Running the Clinical Trial?

University of Arkansas Lead Sponsor

Southcentral Foundation Collaborator

Duke University Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD) Collaborator

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] In 2009, we established a mobile ear-screening service for children in a remote community approximately 350 km north-west of Brisbane. We compared pre-implementation health service utilisation data (2006-2008) with data for the following three years. The study included only children in schools that had participated in screening since the start of the screening programme and for which data for the 6-year study period were available. In the baseline period there were 329 ear, nose and throat (ENT) outpatient appointments at the Royal Children's Hospital (RCH) in Brisbane for children from the selected catchment area. Of these, 166 (51%) were failure-to-attends (FTAs). In the following three years, there were 105 appointments, of which 40 (38%) were FTAs. In the baseline period, 100 children received surgical procedures at the RCH; in the following three years there were 43. In the three years following implementation, 136 children were booked to receive surgical procedures locally at the Cherbourg hospital, and 117 (86%) were completed. Since no other major health service changes occurred in the region during the study period, we conclude that the telemedicine-enabled screening service improved access to specialist care in the community and resulted in fewer outpatient and surgical appointments at the tertiary centre in Brisbane.

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

Remote hearing screenings via telehealth in a rural elementary school. [2022] Telehealth (telepractice) is the provision of health care services using telecommunications. Telehealth technology typically has been employed to increase the level of health care access for consumers living in rural communities. In this way, audiologists can use telehealth to provide services in the rural school systems. This is important because school hearing screening programs are the foundation of educational audiology programs. Therefore, the goal of this study was to determine the feasibility of providing hearing screening services by telehealth technology to school-age children.

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] A mobile ear-screening service was established in an Aboriginal community in central Queensland. Telemedicine allowed ear nose and throat (ENT) specialists at the tertiary children's hospital in Brisbane to assess children at a distance using pre-recorded information comprising video-otoscopic images and the results of tympanometry and audiometry. During the first three years, 1053 children were registered with the service. A total of 2111 screening assessments were carried out at 21 schools in the region. The average screening rate achieved in the community was 85%. More than half of all assessments resulted in a referral to the ENT specialist (for online assessment) or local doctor (for treatment). Twenty specialist ENT online clinics were conducted during which 415 patients were reviewed. Over half of all online review cases (55%) resulted in appointments at the next ENT outreach clinic for further review and/or surgery. The community-based screening service led by local Indigenous health workers, and linked to a tertiary children's hospital by telemedicine, was an effective method for routine screening of children at risk of hearing impairment.

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] School-based programmes, including hearing screening, provide essential preventive services for rural children. However, minimal evidence on screening methodologies, loss to follow-up, and scarcity of specialists for subsequent care compound rural health disparities. We hypothesised telemedicine specialty referral would improve time to follow-up for school hearing screening compared with standard primary care referral.

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] Preschool programs provide essential preventive services, such as hearing screening, but in rural regions, limited access to specialists and loss to follow-up compound rural health disparities. We conducted a parallel-arm cluster-randomized controlled trial to evaluate telemedicine specialty referral for preschool hearing screening. The goal of this trial was to improve timely identification and treatment of early childhood infection-related hearing loss, a preventable condition with lifelong implications. We hypothesized that telemedicine specialty referral would improve time to follow-up and the number of children receiving follow-up compared with the standard primary care referral.

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] Socioeconomic adversity negatively affects child health. Telemedicine use in pediatrics is rapidly expanding. We piloted a socioeconomic risk screening tool within telemedicine visits. Using chart review, our primary aim was to assess the rates of screen completion, risk identification, and referral generation during telemedicine visits. Our secondary aim was to assess family satisfaction and barriers to connecting with referrals/interventions through follow-up telephone interviews. This study included 179 telemedicine encounters. The screening tool was completed in 63% of encounters and was positive in 5% of encounters. Of those who identified socioeconomic risks, 90% received a referral/intervention (social work consultation, food pantry, etc.). During follow-up calls, families expressed satisfaction with telemedicine, though 31% described difficulty connecting with the recommended services. High rates of socioeconomic risk screening resulting in interventions are achievable during telemedicine visits. Further work is needed to identify optimal socioeconomic risk screening questions and opportunities, and to ensure successful interventions.

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

Reducing Loss to Follow-Up with Tele-audiology Diagnostic Evaluations. [2022] Infants who do not pass their newborn hearing screen require diagnostic follow-up visits but often face access barriers such as travel distance and shortage of pediatric audiologists. Telemedicine (tele-audiology) is a potential solution to provide diagnostic hearing evaluations for families of infants facing access barriers. We determined the feasibility and impact of a tele-audiology program that provided comprehensive diagnostic evaluations to a region with a high lost to follow-up rate among newborns who did not pass their newborn hearing screen.