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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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ClinicalTrials.gov Identifier: NCT03309553
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
Duke University
Johns Hopkins University
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Norton Sound Health Corporation

Tracking Information
First Submitted Date  ICMJE September 29, 2017
First Posted Date  ICMJE October 13, 2017
Last Update Posted Date March 4, 2019
Actual Study Start Date  ICMJE October 10, 2017
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
Time to diagnosis [ 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 ]
Comparing time to International Classification of Disease, Tenth Edition (ICD-10) ear/hearing diagnosis from date of screening between intervention and active comparator
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03309553 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
  • Change in prevalence of hearing loss [ Time Frame: Annual audiometric assessment at Year 1 and Year 2 ]
    Based on audiometric assessment criteria, compared between intervention and active comparator
  • Change in hearing-related quality of life [ Time Frame: Annual questionnaire assessment at Year 1 and Year 2 ]
    Measured using Hearing Environments and Reflection on Quality of Life (HEAR-QL) questionnaire, compared between intervention and active comparator
  • Change in school performance [ Time Frame: 3 times annually in Year 1 and Year 2 ]
    Measure of math and reading performance using AIMSweb, compared between intervention and active comparator
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 9, 2017)
  • Sensitivity and specificity of screening protocols [ 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 ]
    School and mobile health (mHealth) screening to audiometric assessment, all measured on the same day in Baseline at Year 1 before intervention
  • Prevalence of hearing loss [ Time Frame: Baseline at Year 1 before intervention ]
    Estimating baseline prevalence of hearing loss in school-aged children using audiometric assessments, all communities combined
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Hearing Norton Sound: A Community Randomized Trial to Address Childhood Hearing Loss in Rural Alaska
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Health Services Research
Condition  ICMJE Hearing Loss
Intervention  ICMJE
  • Other: Current Primary Care Referral Process
    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.
  • Other: Telemedicine Referral Process
    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.
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Other: Current Primary Care Referral Process
  • Experimental: 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.
    Intervention: Other: Telemedicine Referral Process
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2017)
1900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Samantha Kleindienst Robler, AuD, PhD 907-434-0433 skleindienst@nshcorp.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03309553
Other Study ID Numbers  ICMJE AD-1602-34571
AD-1602-34751 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norton Sound Health Corporation
Study Sponsor  ICMJE Norton Sound Health Corporation
Collaborators  ICMJE
  • Duke University
  • Johns Hopkins University
  • Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Samantha Kleindienst Robler, AuD, PhD Norton Sound Health Corporation
Principal Investigator: Susan D Emmett, MD, MPH Duke University
PRS Account Norton Sound Health Corporation
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP