TY - JOUR
T1 - Hearing Norton Sound
T2 - A community randomised trial protocol to address childhood hearing loss in rural Alaska
AU - Emmett, Susan D.
AU - Robler, Samantha Kleindienst
AU - Wang, Nae Yuh
AU - Labrique, Alain
AU - Gallo, Joseph J.
AU - Hofstetter, Philip
N1 - Funding Information:
The objective of the Hearing Norton Sound study is to 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. The study is funded by the Patient-Centered Outcomes Research Institute, a non-governmental organisation that supports patient-centred comparative effectiveness research and represents a collaboration between Norton Sound Health Corporation, Duke University and Johns Hopkins University. Stakeholder and community involvement are integral to this mixed methods community randomised trial and are described in depth in the companion protocol.34 This protocol focuses specifically on the community randomised trial, with the specific aim of:
Publisher Copyright:
© Author(s) (or their employer(s)) 2019.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - Introduction: The 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 analysis: Comparative 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: dissemination This 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.
AB - Introduction: The 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 analysis: Comparative 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: dissemination This 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.
KW - Alaska native
KW - children
KW - community-based research
KW - health disparities
KW - hearing loss
KW - randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85060061863&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85060061863&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2018-023078
DO - 10.1136/bmjopen-2018-023078
M3 - Article
C2 - 30782695
AN - SCOPUS:85060061863
SN - 2044-6055
VL - 9
JO - BMJ open
JF - BMJ open
IS - 1
M1 - e023078
ER -