Hearing Norton Sound: a community randomised trial protocol to address childhood hearing loss in rural Alaska

BMJ Open - Tập 9 Số 1 - Trang e023078 - 2019
Susan D. Emmett1,2, Samantha Kleindienst Robler3, Nae‐Yuh Wang4,5, Alain Labrique6, Joseph J. Gallo7, Philip Hofstetter8
1Department of Surgery Duke University School of Medicine Durham, North Carolina USA
2Duke Global Health Institute, Durham, North Carolina, USA
3Department of Audiology, Norton Sound Health Corporation, Nome, Alaska, USA
4Department of Medicine, Johns Hopkins University, School of Medicine, Baltimore, Maryland USA
5Departments of Biostatistics and Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
6Departments of International Health and Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA
7Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
8Norton Sound Health Corporation, Nome, Alaska, USA

Tóm tắt

IntroductionThe population in rural Alaska experiences a disproprionately high burden of infection-mediated hearing loss. While the state mandates school hearing screening, many children with hearing loss are not identified or are lost to follow-up before ever receiving treatment. A robust, tribally owned healthcare system exists in Alaska, but children with hearing loss must first be identified and referred for existing infrastructure to be used. This trial will evaluate a new school hearing screening and referral process in rural Alaska, with the goal of improving timely identification and treatment of childhood hearing loss.Methods and analysisComparative effectiveness community randomised trial testing digital innovations to improve school hearing screening and referral in 15 communities in the Norton Sound region of northwest Alaska, with data collection from October 2017 to February 2020. All children (K-12) attending school in Bering Strait School District with parental informed consent and child assent will be eligible (target recruitment n=1500). Participating children will undergo both the current school hearing screen and new mobile health (mHealth) screen, with screening test validity evaluated against an audiometric assessment. Communities will be cluster randomised to continue the current primary care referral process or receive telemedicine referral for follow-up diagnosis and treatment. The primary outcome will be time to International Statistical Classification of Diseases, 10th Revision, ear/hearing diagnosis from screening date, measured in days. Secondary outcomes will include: sensitivity and specificity of current school and mHealth screening protocols measured against a benchmark audiometric assessment (air and bone conduction audiometry, tympanometry and digital otoscopy); hearing loss prevalence; hearing-related quality of life; and school performance (AIMSweb). Intention-to-treat analysis will be used.Ethics and disseminationThis study has been approved by the Institutional Review Boards of Alaska Area, Norton Sound and Duke University and is registered on clinicaltrials.gov. Results will be distributed with equal emphasis on scientific and community dissemination.Trial registration numberNCT03309553; Pre-results.

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BMJ Open

Tập 9 Số 1

e023078

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