NCT03662256

Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine

Completed NA Last updated 16 June 2020

What this trial tests

NA trial testing Current Primary Care Referral Process in Hearing Loss in 155 participants. Completed in 21 February 2020.

Timeline

7 September 2018

Primary endpoint
21 February 2020

21 February 2020

Quick facts

Lead sponsor	Norton Sound Health Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	155
Start date	7 September 2018
Primary completion	21 February 2020
Estimated completion	21 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Current Primary Care Referral Process
• Telemedicine Referral Process

Conditions studied

• Hearing Loss — all drugs for Hearing Loss →

Sponsor

Norton Sound Health Corporation

Who can join

Adults 2 to 6, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The population in rural Alaska, which is predominately Alaska Native, experiences a disproportionately high burden of hearing loss compared to the general US population. The impact of untreated hearing loss in early childhood is tremendous and has grave implications for school achievement. Preschool children with hearing loss experience speech and language delays and are less likely to be ready for kindergarten than their normal-hearing peers. Early identification and treatment can reverse these ill effects. Importantly, the majority of hearing loss in this age group in rural Alaska is infection-mediated, arising from acute and chronic otitis media that is treatable.

In response, preschool hearing screening is federally mandated at all Head Start centers across the country. In accordance with this mandate, hearing screening is already performed by the three organizations that offer early childhood education in the Norton Sound region: Kawerak Inc, RurAL CAP, and Bering Strait School District.

While the concept of screening in this age group is well established nationally, what is less well understood is the optimal screening protocol for preschool children. There is little evidence evaluating sensitivity and specificity of different screening protocols in this age group. Further, loss to follow up in the referral stage is a problem in preschool hearing screening just as it is in school hearing screening.

Alaska has already developed innovative strategies to address hearing loss. A network of village health clinics staffed by community health aides provide local care, and telemedicine has been adopted in over 250 village clinics statewide. Despite being widely available, telemedicine has not yet been used to speed up the referral process for preventive services such as hearing screening.

Norton Sound Health Corporation has partnered with Duke and Johns Hopkins Universities to evaluate hearing screening and referral processes in early childhood education in the Norton Sound region of northwest Alaska. Preschool children will receive screening from the preschool and a new mHealth screening protocol. These will be compared against a benchmark audiometric assessment to determine sensitivity and specificity. Communities will then be randomized to continue the current primary care referral process or to adopt telemedicine referral. The primary outcome will be time to ICD-10 ear/hearing diagnosis. Secondary outcomes will include sensitivity and specificity of screening protocols and prevalence of hearing loss. The goal of this study is to evaluate the optimal screening and referral strategy for preschool children in rural Alaska.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mobile technologies to support healthcare provider to healthcare provider communication and management of care.
   Gonçalves-Bradley DC, J Maria AR, Ricci-Cabello I, Villanueva G, et al · · 2020 · cited 83× · PMID 32813281 · DOI 10.1002/14651858.cd012927.pub2
2. Prevalence of Childhood Hearing Loss in Rural Alaska.
   Emmett SD, Platt A, Gallo JJ, Labrique AB, et al · · 2023 · cited 8× · PMID 37287104 · DOI 10.1097/aud.0000000000001368
3. Changing the Paradigm for School Hearing Screening Globally: Evaluation of Screening Protocols From Two Randomized Trials in Rural Alaska.
   Robler SK, Platt A, Jenson CD, Meade Inglis S, et al · · 2023 · cited 8× · PMID 36907833 · DOI 10.1097/aud.0000000000001336
4. 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, Gallo JJ, et al · · 2023 · cited 6× · PMID 37226299 · DOI 10.1097/aud.0000000000001372
5. Environmental Factors for Hearing Loss and Middle Ear Disease in Alaska Native Children and Adolescents: A Cross-Sectional Analysis from a Cluster Randomized Trial.
   Hicks KL, Robler SK, Platt A, Morton SN, et al · · 2023 · cited 5× · PMID 35998103 · DOI 10.1097/aud.0000000000001265
6. A Hybrid Deep Learning Approach to Identify Preventable Childhood Hearing Loss.
   Jin FQ, Huang O, Kleindienst Robler S, Morton S, et al · · 2023 · cited 4× · PMID 37318215 · DOI 10.1097/aud.0000000000001380