Hearing Norton Sound: A Community Randomized Trial to Address Childhood Hearing Loss in Rural Alaska
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,481
- 试验地点
- 1
- 主要终点
- Time to diagnosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The randomization assignments will be kept confidential within the study team until hearing screening day, when masking the referral process assignment will no longer be possible. All outcome assessors, including audiologists and ear, nose, and throat (ENT) surgeons reading telemedicine consults within the Alaska Native healthcare system and study team members performing medical record abstraction, will be masked to intervention allocation. Study team members who read telemedicine consults as a part of their clinical responsibilities will abstain from reading any study-related consults. The results of the school screen, mHealth screen, and audiometric assessments will also be masked, such that study team members performing the mHealth screen or audiometric assessment will be masked to the other results.
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Not a student of the Bering Strait School District
- •Parental consent for routine hearing screening not obtained
- •Verbal assent not obtained
研究组 & 干预措施
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.
干预措施: Current Primary Care Referral Process (Other)
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.
干预措施: Telemedicine Referral Process (Other)
结局指标
主要结局
Time to diagnosis
时间窗: 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
次要结局
- Change in prevalence of hearing loss(Annual audiometric assessment at Year 1 and Year 2)
- Change in hearing-related quality of life(Annual questionnaire assessment at Year 1 and Year 2)
- Change in school performance(3 times annually in Year 1 and Year 2)