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Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Current Primary Care Referral Process
Telemedicine Referral Process
Sponsored by
Norton Sound Health Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hearing Loss focused on measuring hearing loss, deafness, hearing disorders, ear diseases, otorhinolaryngologic diseases, child, preschool

Eligibility Criteria

2 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Early childhood education student of the Bering Strait School District (BSSD), Kawerak Inc, or RurAL CAP in the Norton Sound region of Northwest Alaska
  • All preschool-aged children, enrolled in one of the three organizations that provide early childhood education in the region, are eligible to participate
  • Parental signed consent to undergo routine hearing screening in the preschool setting
  • Child assent from children enrolled in the study

Exclusion Criteria:

  • Not an early education student of the Bering Strait School District, Kawerak Inc, or RurAL CAP.
  • Parental consent for routine hearing screening not obtained
  • Child assent not obtained

Sites / Locations

  • Norton Sound Health Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Current Primary Care Referral Process

Expedited Telemedicine Referral

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Prevalence of hearing loss
Estimating baseline prevalence of hearing loss in preschool children using audiometric assessments, all communities combined

Full Information

First Posted
September 5, 2018
Last Updated
June 12, 2020
Sponsor
Norton Sound Health Corporation
Collaborators
Duke University, Johns Hopkins University, Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03662256
Brief Title
Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine
Official Title
Addressing Early Childhood Hearing Loss in Rural Alaska: A Community Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 7, 2018 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
February 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norton Sound Health Corporation
Collaborators
Duke University, Johns Hopkins University, Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
hearing loss, deafness, hearing disorders, ear diseases, otorhinolaryngologic diseases, child, preschool

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The randomization assignments will be kept confidential within the study team until hearing screening day, when masking the referral process assignment to participants 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 throughout the trial. 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 preschool 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.
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Current Primary Care Referral Process
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Expedited Telemedicine Referral
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Current Primary Care Referral Process
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Telemedicine Referral Process
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to diagnosis
Description
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
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of screening protocols
Description
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
Title
Prevalence of hearing loss
Description
Estimating baseline prevalence of hearing loss in preschool children using audiometric assessments, all communities combined
Time Frame
Baseline before intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Early childhood education student of the Bering Strait School District (BSSD), Kawerak Inc, or RurAL CAP in the Norton Sound region of Northwest Alaska All preschool-aged children, enrolled in one of the three organizations that provide early childhood education in the region, are eligible to participate Parental signed consent to undergo routine hearing screening in the preschool setting Child assent from children enrolled in the study Exclusion Criteria: Not an early education student of the Bering Strait School District, Kawerak Inc, or RurAL CAP. Parental consent for routine hearing screening not obtained Child assent not obtained
Facility Information:
Facility Name
Norton Sound Health Corporation
City
Nome
State/Province
Alaska
ZIP/Postal Code
99762
Country
United States

12. IPD Sharing Statement

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Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine

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