An interventional study of Current Primary Care Referral Process and Telemedicine Referral Process in Hearing Loss, sponsored by Norton Sound Health Corporation. Completed at 1 site in United States. Open to participants aged 2 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-16.
Sponsored by Norton Sound Health Corporation · Not applicable, Interventional, and Health services research
The population in rural Alaska, which is predominately Alaska Native, experiences a disproportionately high burden of hearing loss compared to the general US population. The impact of untreated hearing loss in early childhood is tremendous and has grave implications for school achievement. Preschool children with hearing loss experience speech and language delays and are less likely to be ready for kindergarten than their normal-hearing peers. Early identification and treatment can reverse these ill effects. Importantly, the majority of hearing loss in this age group in rural Alaska is infection-mediated, arising from acute and chronic otitis media that is treatable.
In response, preschool hearing screening is federally mandated at all Head Start centers across the country. In accordance with this mandate, hearing screening is already performed by the three organizations that offer early childhood education in the Norton Sound region: Kawerak Inc, RurAL CAP, and Bering Strait School District.
While the concept of screening in this age group is well established nationally, what is less well understood is the optimal screening protocol for preschool children. There is little evidence evaluating sensitivity and specificity of different screening protocols in this age group. Further, loss to follow up in the referral stage is a problem in preschool hearing screening just as it is in school hearing screening.
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 to speed up the referral process for preventive services such as hearing screening.
Norton Sound Health Corporation has partnered with Duke and Johns Hopkins Universities to evaluate hearing screening and referral processes in early childhood education in the Norton Sound region of northwest Alaska. Preschool children will receive screening from the preschool and a new mHealth screening protocol. These will be compared against a benchmark audiometric assessment to determine sensitivity and specificity. Communities will then be randomized to continue the current primary care referral process or to adopt telemedicine referral. The primary outcome will be time to ICD-10 ear/hearing diagnosis. Secondary outcomes will include sensitivity and specificity of screening protocols and prevalence of hearing loss. The goal of this study is to evaluate the optimal screening and referral strategy for preschool children in rural Alaska.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's enrollment of 155 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Norton Sound Health Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
In communities randomized to the current primary care process, families will be notified if their children refer hearing screening in exactly the same method each preschool 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. Per current practice, most preschools also give the list of referred children to the Norton Sound Audiology Department, whose staff then reaches out to families to schedule appointments during the next available audiology clinic.
Other: Current Primary Care Referral Process
In communities 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 with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children who refer screening will be transported to clinic for their appointment with adult chaperones. Parent participation will be required unless parents direct otherwise. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process.
Other: Telemedicine Referral Process
Children who refer hearing screening will receive the same referral method each preschool 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.
In communities randomized to the expedited telemedicine intervention, parents of children who refer hearing screening 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 with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children who refer screening will be transported to clinic for their appointment with adult chaperones. Parent participation will be required unless parents direct otherwise. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process.
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
Time frame: From date of screening to date of ICD-10 ear/hearing diagnosis, measured in days, up to 9 months from date of screening
Sensitivity and specificity of screening protocols
School and mobile health (mHealth) screening to audiometric assessment, all measured on the same day in Baseline before intervention
Time frame: Cross-sectional comparison of concurrent mHealth screening protocol and current preschool hearing screening to audiometric assessment, measured once in the 2018-2019 academic year, all communities combined
Prevalence of hearing loss
Estimating baseline prevalence of hearing loss in preschool children using audiometric assessments, all communities combined
Time frame: Baseline before intervention
Ran from Sep 2018 to primary completion in Feb 2020, 17 months.
Of 196 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's 17 months is below that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Norton Sound Health Corporation