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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03309553
• Other study ID #: AD-1602-34571
• Secondary ID: AD-1602-34751
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1481
• Est. completion date: February 21, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.
• 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.

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
Other	Sensitivity and specificity of screening protocols	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
Other	Prevalence of hearing loss	Estimating baseline prevalence of hearing loss in school-aged children using audiometric assessments, all communities combined	Baseline at Year 1 before intervention
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 in Year 1 and Year 2
Secondary	Change in prevalence of hearing loss	Based on audiometric assessment criteria, compared between intervention and active comparator	Annual audiometric assessment at Year 1 and Year 2
Secondary	Change in hearing-related quality of life	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
Secondary	Change in school performance	Measure of math and reading performance using AIMSweb, compared between intervention and active comparator	3 times annually in Year 1 and Year 2