School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska

Last updated: August 29, 2024
Sponsor: University of Arkansas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Hearing Impairment

Deafness

Treatment

Specialty Telemedicine Access for Referrals (STAR)

Standard Referral

Clinical Study ID

NCT05593484
274168
R01DC020026
  • Ages 3-21
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

N/A

Study Design

Total Participants: 6045
Treatment Group(s): 2
Primary Treatment: Specialty Telemedicine Access for Referrals (STAR)
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
May 30, 2026

Connect with a study center

  • Southcentral Foundation

    Anchorage, Alaska 99508
    United States

    Site Not Available

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