Clinical trial NCT03662256: Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine
Official title: Addressing Early Childhood Hearing Loss in Rural Alaska: A Community Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: hearing loss
deafness
hearing disorders
ear diseases
otorhinolaryngologic diseases
child, preschool
Lead sponsor: Norton Sound Health Corporation
Sponsor class: OTHER
Collaborators: name: Duke University
name: Johns Hopkins University
name: Patient-Centered Outcomes Research Institute
First posted: 2018-09-07
Enrollment: 155
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Early childhood education student of the Bering Strait School District (BSSD), Kawerak Inc, or RurAL CAP in the Norton Sound region of Northwest Alaska
* All preschool-aged children, enrolled in one of the three organizations that provide early childhood education in the region, are eligible to participate
* Parental signed consent to undergo routine hearing screening in the preschool setting
* Child assent from children enrolled in the study

Exclusion Criteria:

* Not an early education student of the Bering Strait School District, Kawerak Inc, or RurAL CAP.
* Parental consent for routine hearing screening not obtained
* Child assent not obtained

Primary outcomes:
measure: Time to diagnosis
timeFrame: From date of screening to date of ICD-10 ear/hearing diagnosis, measured in days, up to 9 months from date of screening
Secondary outcomes:
measure: Sensitivity and specificity of screening protocols
timeFrame: Cross-sectional comparison of concurrent mHealth screening protocol and current preschool hearing screening to audiometric assessment, measured once in the 2018-2019 academic year, all communities combined
measure: Prevalence of hearing loss
timeFrame: Baseline before intervention
Other outcomes:
Locations:
city: Nome
country: United States
facility: Norton Sound Health Corporation
state: Alaska
Study officials:
References: