Hearing Loss Clinical Trial
Official title:
Addressing Early Childhood Hearing Loss in Rural Alaska: A Community Randomized Trial
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.
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