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

June 12, 2020 updated by: Norton Sound Health Corporation

Hearing Norton Sound: A Community Randomized Trial to Address Childhood Hearing Loss in Rural Alaska

Hearing loss is a common health problem in Alaska. Up to 75% of children growing up in Alaskan villages experience frequent ear infections, one of the major treatable causes of hearing loss. Children with even mild hearing loss face many challenges. These children often experience speech and language delays and have trouble in school. Teens with hearing loss are more likely to drop out of school, and are at risk for having difficulty finding jobs as adults. Promptly diagnosing and treating hearing loss is important for preventing these consequences. Alaska mandates school-based hearing screening, but many children with hearing loss are not identified by the current screening protocol, and most who are referred never make it into the healthcare system for diagnosis and treatment.

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 in school hearing screenings to speed up the referral process.

Norton Sound Health Corporation has partnered with Duke and Johns Hopkins Universities to explore whether a new school screening and referral process that incorporates mobile, or mHealth, screening and telemedicine referral will reduce childhood hearing loss disparities in the Norton Sound region. Children from kindergarten through 12th grade in 15 Norton Sound villages will receive the current school screening protocol and the new mHealth screen. Villages will then be randomized to continue the current primary care referral process or to adopt telemedicine referral for school screenings. The investigators hypothesize that the new mHealth screening protocol will identify more children with hearing loss, and telemedicine referral will reduce time to diagnosis. By better identifying hearing loss and speeding up diagnosis and treatment, the investigators expect the burden of childhood hearing loss to drop, hearing-related quality of life to improve, and school performance to improve in villages with telemedicine referral compared to current primary care referral villages. If the study shows these positive effects, mHealth screening and the telemedicine referral process could be implemented in school districts across the state of Alaska to reducing childhood hearing loss disparities statewide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1481

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Nome, Alaska, United States, 99762
        • Norton Sound Health Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Student of the Bering Strait School District (BSSD) in Alaska
  • All school-aged children, from Kindergarten through 12th grade in the school district are eligible to participate
  • Parental signed consent to undergo routine hearing screening in the school setting
  • Verbal assent from children enrolled in the study

Exclusion Criteria:

  • Not a student of the Bering Strait School District
  • Parental consent for routine hearing screening not obtained
  • Verbal assent not obtained

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Current Primary Care Referral Process
In villages randomized to the current primary care process, families will be notified if their children screen positive in exactly the same method each school 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. The list of referred children is also given to the Norton Sound Audiology Department, who reaches out to families to schedule appointments during the next available audiology clinic.
Other: Current Primary Care Referral Process
Children who screen positive for hearing loss will receive the same method each school 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.
Experimental: Expedited Telemedicine Referral
In villages 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 same-day or next-day, with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children screening positive will be transported to clinic for their appointment with adult chaperones. Parents are encouraged but not required to attend, except for children grades 2 and younger, for whom parental participation will be required. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process.
Other: Telemedicine Referral Process
In villages 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 same-day or next-day, with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children screening positive will be transported to clinic for their appointment with adult chaperones. Parents are encouraged but not required to attend, except for children grades 2 and younger, for whom parental participation will be required. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to diagnosis
Time Frame: From date of screening to date of ICD-10 ear/hearing diagnosis, measured in days, up to 9 months from date of screening in Year 1 and Year 2
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 in Year 1 and Year 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in prevalence of hearing loss
Time Frame: Annual audiometric assessment at Year 1 and Year 2
Based on audiometric assessment criteria, compared between intervention and active comparator
Annual audiometric assessment at Year 1 and Year 2
Change in hearing-related quality of life
Time Frame: Annual questionnaire assessment at Year 1 and Year 2
Measured using Hearing Environments and Reflection on Quality of Life (HEAR-QL) questionnaire, compared between intervention and active comparator
Annual questionnaire assessment at Year 1 and Year 2
Change in school performance
Time Frame: 3 times annually in Year 1 and Year 2
Measure of math and reading performance using AIMSweb, compared between intervention and active comparator
3 times annually in Year 1 and Year 2

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of screening protocols
Time Frame: Cross-sectional comparison of concurrent mHealth screening protocol and current school hearing screening protocol to audiometric assessment, measured once at Year 1, all communities combined
School and mobile health (mHealth) screening to audiometric assessment, all measured on the same day in Baseline at Year 1 before intervention
Cross-sectional comparison of concurrent mHealth screening protocol and current school hearing screening protocol to audiometric assessment, measured once at Year 1, all communities combined
Prevalence of hearing loss
Time Frame: Baseline at Year 1 before intervention
Estimating baseline prevalence of hearing loss in school-aged children using audiometric assessments, all communities combined
Baseline at Year 1 before intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norton Sound Health Corporation

Collaborators

Patient-Centered Outcomes Research Institute
Johns Hopkins University
Duke University

Investigators

  • Principal Investigator: Samantha Kleindienst Robler, AuD, PhD, Norton Sound Health Corporation
  • Principal Investigator: Susan D Emmett, MD, MPH, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2017

Primary Completion (Actual)

February 21, 2020

Study Completion (Actual)

February 21, 2020

Study Registration Dates

First Submitted

September 29, 2017

First Submitted That Met QC Criteria

October 9, 2017

First Posted (Actual)

October 13, 2017

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-1602-34571
  • AD-1602-34751 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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