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

Hearing Loss Clinical Trial

Official title:

North STAR Trial: Specialty Telemedicine Access for Referrals (STAR) in Rural Alaska

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05593484
• Other study ID #: 274168
• Secondary ID: R01DC020026
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 30, 2026

Study information

• Verified date: July 2023
• Source: University of Arkansas
• Contact: Susan Emmett, MD, MPH
• Phone: 5016031212
• Email: sdemmett[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6045
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 21 Years

Eligibility

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 Criteria:

N/A

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Southcentral Foundation	Anchorage	Alaska

Sponsors (4)

Lead Sponsor	Collaborator
University of Arkansas	Duke University, National Institute on Deafness and Other Communication Disorders (NIDCD), Southcentral Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children who receive follow-up	This outcome will be measured each school year, for 1 year or 2 years depending on sequence randomization.	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.