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

Hearing Loss Clinical Trial

Official title:

Addressing Early Childhood Hearing Loss in Rural Alaska: A Community Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662256
• Other study ID #: AD-1602-34571-S1
• Status: Completed
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: February 21, 2020

Study information

• Verified date: June 2020
• Source: Norton Sound Health Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: February 21, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Other:
• Current Primary Care Referral Process
Children who refer hearing screening will receive the same referral method each preschool had been using previously. This process involves a letter home to the parents, either sent with the child or by mail, requesting that the parent/caregiver bring the child to village health clinic for an evaluation.
• Telemedicine Referral Process
In communities randomized to the expedited telemedicine intervention, parents of children who refer hearing screening will receive a phone call from the school or the clinic on the day of screening notifying them of the day and time of their child's telemedicine consultation appointment. Appointments will be made with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children who refer screening will be transported to clinic for their appointment with adult chaperones. Parent participation will be required unless parents direct otherwise. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process.

Locations

Country	Name	City	State
United States	Norton Sound Health Corporation	Nome	Alaska

Sponsors (4)

Lead Sponsor	Collaborator
Norton Sound Health Corporation	Duke University, Johns Hopkins University, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to diagnosis	Comparing time to International Classification of Disease, Tenth Edition (ICD-10) ear/hearing diagnosis from date of screening between intervention and active comparator	From date of screening to date of ICD-10 ear/hearing diagnosis, measured in days, up to 9 months from date of screening
Secondary	Sensitivity and specificity of screening protocols	School and mobile health (mHealth) screening to audiometric assessment, all measured on the same day in Baseline before intervention	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
Secondary	Prevalence of hearing loss	Estimating baseline prevalence of hearing loss in preschool children using audiometric assessments, all communities combined	Baseline before intervention