Clinical trial NCT05593484: School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska
Official title: North STAR Trial: Specialty Telemedicine Access for Referrals (STAR) in Rural Alaska
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Keywords: Rural
Hearing loss
Telemedicine
Telehealth
School
Disparities
Screening
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Southcentral Foundation
name: Duke University
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2022-10-25
Enrollment: 8060
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Approximately 23 schools from 3 regions are participating in the effectiveness trial. Clusters (\~23 schools) will be randomized to one of two sequences. In academic year 2023-2024, all schools will receive enhanced screening (with standard referral). The Specialty Telemedicine Access for Referrals (STAR) intervention will be rolled out in a stepwise manner in academic years 2024-2025 and 2025-2026 depending on sequence randomization.

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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of children who receive follow-up
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Southcentral Foundation
state: Alaska
Study officials:
affiliation: Vice President-Specialty Services, Southcentral Foundation, Alaska Native Medical Center
name: Matthew Hirschfeld, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas Medical Sciences
name: Susan Emmett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: