School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska
NCT ID: NCT05593484
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
8060 participants
INTERVENTIONAL
2023-09-01
2027-06-30
Brief Summary
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We will adapt and implement a new telemedicine intervention called Specialty Telemedicine Access for Referrals (STAR). This trial will be conducted in 3 regions in rural Alaska that represent multiple healthcare systems. Based on stakeholder feedback and evidence generated from the previous trial, an enhanced mobile health (mHealth) hearing screening will be implemented in all participating schools prior to the STAR intervention, and the telemedicine referral to specialty care (STAR intervention) will be moved from the clinic directly into the school.
This stepped-wedge cluster randomized trial is part of a larger hybrid type 1 effectiveness-implementation trial. The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing screening in 3 regions of Alaska: Kodiak, Petersburg and Lower Yukon (n=23 schools, \~2,015 K-12 students/year). The STAR Intervention will be compared to the standard referral of a letter home to families. Cluster randomization at the level of school will be performed, with schools (clusters) randomized to one of two sequences. The effectiveness outcome (i.e., proportion of children who receive follow-up) will be evaluated over three academic years (2023-2026), with STAR rolled out in a stepwise manner for each of the two sequences (academic year 2024-2025 for sequence 1 and academic year 2025-2026 for sequence 2). The control periods for each sequence will be academic year 2023-2024 for sequence 1 and academic years 2023-2024 and 2024-2025 for sequence 2. Enhanced screening will be rolled out to both sequences at the same time (i.e., non-randomized) beginning academic year 2023-2024. An implementation evaluation will be conducted to refine and adapt the enhanced hearing screening and STAR intervention throughout the trial. Implementation data will be collected starting academic year 2022-2023 and then annually for each of the subsequent years.
Timeline update: Based on feedback from community partners, we extended the trial for one year to allow for community-informed adaptations of the enhanced screening. Now the STAR intervention will be rolled out in 2025-2026 for sequence 1 and 2026-2027 for sequence 2.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Timeline update: Due to feedback from community partners, we extended the trial for one year. In academic year 2024-2025 all schools received the adapted enhanced screening. The STAR intervention will be rolled out in 2025-2026 and 2026-2027 depending on sequence randomization.
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Standard Referral
Standard Referral
Schools in the control condition will use standard referral, as determined by the school district. Standard referral is typically a letter home from the school to parents/caregivers of children who refer screening.
Specialty Telemedicine Access for Referrals (STAR)
Specialty Telemedicine Access for Referrals (STAR)
The STAR intervention will include a lay-friendly smartphone or tablet that connects to tools necessary for an ear and hearing evaluation. If a child requires referral from hearing screening, a school nurse/teacher will complete the established protocol for the STAR intervention and send the information asynchronously to an audiologist for review.
Interventions
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Standard Referral
Schools in the control condition will use standard referral, as determined by the school district. Standard referral is typically a letter home from the school to parents/caregivers of children who refer screening.
Specialty Telemedicine Access for Referrals (STAR)
The STAR intervention will include a lay-friendly smartphone or tablet that connects to tools necessary for an ear and hearing evaluation. If a child requires referral from hearing screening, a school nurse/teacher will complete the established protocol for the STAR intervention and send the information asynchronously to an audiologist for review.
Eligibility Criteria
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Inclusion Criteria
* Children from grades (K-12) that are typically screened within participating schools
* Eligible regardless of age, gender, race, or ethnicity
Exclusion Criteria
3 Years
21 Years
ALL
Yes
Sponsors
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Southcentral Foundation
OTHER
Duke University
OTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Matthew Hirschfeld, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Vice President-Specialty Services, Southcentral Foundation, Alaska Native Medical Center
Susan Emmett, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas Medical Sciences
Locations
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Southcentral Foundation
Anchorage, Alaska, United States
Countries
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Central Contacts
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Facility Contacts
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Matthew Hirschfeld, MD
Role: primary
References
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Robler SK, Bettger JP, Turner E, Platt A, Arthur D, Hofstetter P, Lane H, Srinivasan T, Deshpande S, Hirschfeld M, Emmett SD. School-based enhanced hearing screening and specialty telehealth follow-up for hearing loss among children in rural Alaska: study protocol for a hybrid effectiveness-implementation stepped wedge, cluster-randomized controlled trial (North STAR trial). Trials. 2025 May 27;26(1):175. doi: 10.1186/s13063-025-08864-0.
Robler SK, Bettger JP, Turner E, Platt A, Arthur D, Hofstetter P, Lane H, Srinivasan T, Deshpande S, Hirschfeld M, Emmett SD. School-Based Enhanced Hearing Screening and Specialty Telehealth Follow-Up for Hearing Loss Among Children in Rural Alaska: Study Protocol for a Hybrid Effectiveness-Implementation Stepped Wedge, Cluster-Randomized Controlled Trial (North STAR Trial). Res Sq [Preprint]. 2025 Apr 1:rs.3.rs-5252346. doi: 10.21203/rs.3.rs-5252346/v1.
Other Identifiers
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274168
Identifier Type: -
Identifier Source: org_study_id
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