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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-07

Study Completion Date

2020-02-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reducing Childhood Hearing Loss in an Alaska Native Population Through a New School Screening and Referral Process That Utilizes Mobile Health and Telemedicine

NCT03309553

Hearing Loss

COMPLETED NA

School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska

NCT05593484

Hearing Loss

RECRUITING NA

Preschool Hearing Screening

NCT06058767

Hearing Loss Hearing Disorders in Children Hearing Loss, Sensorineural +5 more

RECRUITING NA

Addressing Barriers to Adult Hearing Healthcare

NCT02928107

Hearing Loss Geriatric Disorder

COMPLETED NA

Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities at Ages 9 to 11

NCT00365092

Otitis Media Middle Ear Effusion

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

The randomization assignments will be kept confidential within the study team until hearing screening day, when masking the referral process assignment to participants will no longer be possible. All outcome assessors, including audiologists and ear, nose, and throat (ENT) surgeons reading telemedicine consults within the Alaska Native healthcare system and study team members performing medical record abstraction, will be masked to intervention allocation throughout the trial. Study team members who read telemedicine consults as a part of their clinical responsibilities will abstain from reading any study-related consults. The results of the preschool screen, mHealth screen, and audiometric assessments will also be masked, such that study team members performing the mHealth screen or audiometric assessment will be masked to the other results.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Current Primary Care Referral Process

In communities randomized to the current primary care process, families will be notified if their children refer hearing screening in exactly the same 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. Per current practice, most preschools also give the list of referred children to the Norton Sound Audiology Department, whose staff then reaches out to families to schedule appointments during the next available audiology clinic.

Group Type ACTIVE_COMPARATOR

Current Primary Care Referral Process

Intervention Type OTHER

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.

Expedited Telemedicine Referral

In communities randomized to the expedited telemedicine intervention, parents of children who screen positive 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.

Group Type EXPERIMENTAL

Telemedicine Referral Process

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes