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Reducing Childhood Hearing Loss in an Alaska Native Population Through a New School Screening and Referral Process That Utilizes 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

Eligibility Criteria

4 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not a student of the Bering Strait School District
  • Parental consent for routine hearing screening not obtained
  • Verbal 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 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.

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.

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

Change in prevalence of hearing loss
Based on audiometric assessment criteria, compared between intervention and active comparator
Change in hearing-related quality of life
Measured using Hearing Environments and Reflection on Quality of Life (HEAR-QL) questionnaire, compared between intervention and active comparator
Change in school performance
Measure of math and reading performance using AIMSweb, compared between intervention and active comparator

Full Information

First Posted
September 29, 2017
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
NCT03309553
Brief Title
Reducing Childhood Hearing Loss in an Alaska Native Population Through a New School Screening and Referral Process That Utilizes Mobile Health and Telemedicine
Official Title
Hearing Norton Sound: A Community Randomized Trial to Address Childhood Hearing Loss in Rural Alaska
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

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 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.
Allocation
Randomized
Enrollment
1481 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Current Primary Care Referral Process
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Expedited Telemedicine Referral
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Current Primary Care Referral Process
Intervention Description
Children who screen positive for hearing loss will receive 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.
Intervention Type
Other
Intervention Name(s)
Telemedicine Referral Process
Intervention Description
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.
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 in Year 1 and Year 2
Secondary Outcome Measure Information:
Title
Change in prevalence of hearing loss
Description
Based on audiometric assessment criteria, compared between intervention and active comparator
Time Frame
Annual audiometric assessment at Year 1 and Year 2
Title
Change in hearing-related quality of life
Description
Measured using Hearing Environments and Reflection on Quality of Life (HEAR-QL) questionnaire, compared between intervention and active comparator
Time Frame
Annual questionnaire assessment at Year 1 and Year 2
Title
Change in school performance
Description
Measure of math and reading performance using AIMSweb, compared between intervention and active comparator
Time Frame
3 times annually in Year 1 and Year 2
Other Pre-specified Outcome Measures:
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 at Year 1 before intervention
Time Frame
Cross-sectional comparison of concurrent mHealth screening protocol and current school hearing screening protocol to audiometric assessment, measured once at Year 1, all communities combined
Title
Prevalence of hearing loss
Description
Estimating baseline prevalence of hearing loss in school-aged children using audiometric assessments, all communities combined
Time Frame
Baseline at Year 1 before intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Not a student of the Bering Strait School District Parental consent for routine hearing screening not obtained Verbal assent not obtained
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha Kleindienst Robler, AuD, PhD
Organizational Affiliation
Norton Sound Health Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan D Emmett, MD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norton Sound Health Corporation
City
Nome
State/Province
Alaska
ZIP/Postal Code
99762
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35724253
Citation
Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.
Results Reference
derived
PubMed Identifier
35714630
Citation
Emmett SD, Platt A, Turner EL, Gallo JJ, Labrique AB, Inglis SM, Jenson CD, Parnell HE, Wang NY, Hicks KL, Egger JR, Halpin PF, Yong M, Ballreich J, Robler SK. Mobile health school screening and telemedicine referral to improve access to specialty care in rural Alaska: a cluster- randomised controlled trial. Lancet Glob Health. 2022 Jul;10(7):e1023-e1033. doi: 10.1016/S2214-109X(22)00184-X.
Results Reference
derived
PubMed Identifier
33292651
Citation
Robler SK, Inglis SM, Gallo JJ, Parnell HE, Ivanoff P, Ryan S, Jenson CD, Ross A, Labrique A, Wang NY, Emmett SD. Hearing Norton Sound: community involvement in the design of a mixed methods community randomized trial in 15 Alaska Native communities. Res Involv Engagem. 2020 Nov 3;6(1):67. doi: 10.1186/s40900-020-00235-0.
Results Reference
derived
PubMed Identifier
30782695
Citation
Emmett SD, Robler SK, Wang NY, Labrique A, Gallo JJ, Hofstetter P. Hearing Norton Sound: a community randomised trial protocol to address childhood hearing loss in rural Alaska. BMJ Open. 2019 Jan 15;9(1):e023078. doi: 10.1136/bmjopen-2018-023078.
Results Reference
derived
PubMed Identifier
30674486
Citation
Emmett SD, Robler SK, Gallo JJ, Wang NY, Labrique A, Hofstetter P. Hearing Norton Sound: mixed methods protocol of a community randomised trial to address childhood hearing loss in rural Alaska. BMJ Open. 2019 Jan 22;9(1):e023081. doi: 10.1136/bmjopen-2018-023081.
Results Reference
derived

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Reducing Childhood Hearing Loss in an Alaska Native Population Through a New School Screening and Referral Process That Utilizes Mobile Health and Telemedicine

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