Hearing LossNCT05593484
School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska
A study testing Standard Referral and Specialty Telemedicine Access for Referrals (STAR) in people with Hearing Loss, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Standard Referral and Specialty Telemedicine Access for Referrals (STAR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,060 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Southcentral Foundation
Anchorage, Alaska, 99508
Matthew Hirschfeld, MD, 907-729-1084
About this study
Official title: North STAR Trial: Specialty Telemedicine Access for Referrals (STAR) in Rural Alaska
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.
Read more
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.
- Conditions
- Hearing Loss
- Being tested
- Standard Referral, Specialty Telemedicine Access for Referrals (STAR)
- Keywords
- Rural, Hearing loss, Telemedicine, Telehealth, School, Disparities, Screening
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ReferralOther
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Referral | Other | Not described Receives: Other: Standard Referral |
| Specialty Telemedicine Access for Referrals (STAR) | Other | Not described Receives: Other: Specialty Telemedicine Access for Referrals (STAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children who receive follow-up
This outcome will be measured each school year, for 4 years, based on the updated timeline.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Sep 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Southcentral Foundation, Duke University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Matthew Hirschfeld, MD,PhD, Principal investigator, Vice President-Specialty Services, Southcentral Foundation, Alaska Native Medical CenterSusan Emmett, MD, MPH, Principal investigator, University of Arkansas Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593484
- Sponsor's protocol ID
- 274168
- Other IDs
- R01DC020026
- Status last verified
- May 2026
- First submitted
- 20 Oct 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40426213Robler 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.
PubMed 40235498
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- North STAR Trial: Specialty Telemedicine Access for Referrals (STAR) in Rural Alaska
- ClinicalTrials.gov ID
- NCT05593484
- Acronym / sponsor ID
- 274168
- Conditions
- Hearing Loss
- Keywords
- Rural, Hearing loss, Telemedicine, Telehealth, School, Disparities, Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,060 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Southcentral Foundation, Duke University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Referral | Other | Other: Standard Referral |
| Specialty Telemedicine Access for Referrals (STAR) | Other | Other: Specialty Telemedicine Access for Referrals (STAR) |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ReferralSchools 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. | Other | Standard Referral |
| 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. | Other | Specialty Telemedicine Access for Referrals (STAR) |
Primary outcome
Proportion of children who receive follow-up
Time frame: 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.
This outcome will be measured each school year, for 4 years, based on the updated timeline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 40426213Robler 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.
- Derived from this study: PubMed 40235498Robler 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Hirschfeld, MD,PhD principal investigator
Vice President-Specialty Services, Southcentral Foundation, Alaska Native Medical Center
Susan Emmett, MD, MPH principal investigator
University of Arkansas Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Referral and Specialty Telemedicine Access for Referrals (STAR) in people with Hearing Loss, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Emmett, MD, MPH (5016031212, sdemmett@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children who receive follow-up (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593484, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.