School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska
North STAR Trial: Specialty Telemedicine Access for Referrals (STAR) in Rural Alaska
2 other identifiers
interventional
8,060
1 country
1
Brief Summary
The prevalence of childhood hearing loss in rural Alaska is disproportionately high and predominately infection-related. With preventive screenings and access to health care, much of childhood hearing loss is preventable. Although state-mandated school screening helps identify children with hearing loss, loss to follow-up is pervasive and exacerbated by a scarcity of specialists in rural regions. A mixed methods cluster randomized trial conducted in northwest Alaska demonstrated that telemedicine can significantly reduce loss to follow-up. This stepped wedge trial, in partnership with Southcentral Foundation, will build on this existing work to develop a model that can be scaled in diverse environments. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2022
CompletedFirst Posted
Study publicly available on registry
October 25, 2022
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
May 6, 2026
May 1, 2026
3.8 years
October 20, 2022
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of children who receive follow-up
This outcome will be measured each school year, for 4 years, based on the updated timeline.
Proportion of children who receive follow-up will be measured by the occurrence of an ear/hearing encounter, up to 60 days from the date of screening.
Study Arms (2)
Standard Referral
OTHERSpecialty Telemedicine Access for Referrals (STAR)
OTHERInterventions
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.
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
You may qualify if:
- Enrolled in one of the participating schools in the 3 regions
- Children from grades (K-12) that are typically screened within participating schools
- Eligible regardless of age, gender, race, or ethnicity
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arkansaslead
- Southcentral Foundationcollaborator
- Duke Universitycollaborator
- National Institute on Deafness and Other Communication Disorders (NIDCD)collaborator
Study Sites (1)
Southcentral Foundation
Anchorage, Alaska, 99508, United States
Related Publications (2)
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.
PMID: 40426213DERIVEDRobler 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.
PMID: 40235498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Hirschfeld, MD,PhD
Vice President-Specialty Services, Southcentral Foundation, Alaska Native Medical Center
- PRINCIPAL INVESTIGATOR
Susan Emmett, MD, MPH
University of Arkansas Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Statisticians will also be masked to group allocation until analysis is complete.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2022
First Posted
October 25, 2022
Study Start
September 1, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
This study focusses on population outcomes. School and health data will remain with local education and healthcare entities, and the study team will receive deidentified information. Data sharing will be considered upon request pending appropriate local approval.