Clinical trial NCT03309553: Reducing Childhood Hearing Loss in an Alaska Native Population Through a New School Screening and Referral Process That Utilizes Mobile Health and Telemedicine
Official title: Hearing Norton Sound: A Community Randomized Trial to Address Childhood Hearing Loss in Rural Alaska
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
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: 2017-10-13
Enrollment: 1481
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

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 in Year 1 and Year 2
Secondary outcomes:
measure: Change in prevalence of hearing loss
timeFrame: Annual audiometric assessment at Year 1 and Year 2
measure: Change in hearing-related quality of life
timeFrame: Annual questionnaire assessment at Year 1 and Year 2
measure: Change in school performance
timeFrame: 3 times annually in Year 1 and Year 2
Other outcomes:
measure: Sensitivity and specificity of screening protocols
timeFrame: 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
measure: Prevalence of hearing loss
timeFrame: Baseline at Year 1 before intervention
Locations:
city: Nome
country: United States
facility: Norton Sound Health Corporation
state: Alaska
Study officials:
affiliation: Norton Sound Health Corporation
name: Samantha Kleindienst Robler, AuD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Susan D Emmett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.
citation: Emmett SD, Platt A, Turner EL, Gallo JJ, Labrique AB, Inglis SM, Jenson CD, Parnell HE, Wang NY, Hicks KL, Egger JR, Halpin PF, Yong M, Ballreich J, Robler SK. Mobile health school screening and telemedicine referral to improve access to specialty care in rural Alaska: a cluster- randomised controlled trial. Lancet Glob Health. 2022 Jul;10(7):e1023-e1033. doi: 10.1016/S2214-109X(22)00184-X.
citation: Robler SK, Inglis SM, Gallo JJ, Parnell HE, Ivanoff P, Ryan S, Jenson CD, Ross A, Labrique A, Wang NY, Emmett SD. Hearing Norton Sound: community involvement in the design of a mixed methods community randomized trial in 15 Alaska Native communities. Res Involv Engagem. 2020 Nov 3;6(1):67. doi: 10.1186/s40900-020-00235-0.
citation: Emmett SD, Robler SK, Wang NY, Labrique A, Gallo JJ, Hofstetter P. Hearing Norton Sound: a community randomised trial protocol to address childhood hearing loss in rural Alaska. BMJ Open. 2019 Jan 15;9(1):e023078. doi: 10.1136/bmjopen-2018-023078.
citation: Emmett SD, Robler SK, Gallo JJ, Wang NY, Labrique A, Hofstetter P. Hearing Norton Sound: mixed methods protocol of a community randomised trial to address childhood hearing loss in rural Alaska. BMJ Open. 2019 Jan 22;9(1):e023081. doi: 10.1136/bmjopen-2018-023081.