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

Primary Purpose

Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Referral
Specialty Telemedicine Access for Referrals (STAR)
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hearing Loss focused on measuring Rural, Hearing loss, Telemedicine, Telehealth, School, Disparities, Screening

Eligibility Criteria

3 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Southcentral FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Standard Referral

Specialty Telemedicine Access for Referrals (STAR)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2022
Last Updated
October 24, 2023
Sponsor
University of Arkansas
Collaborators
Southcentral Foundation, Duke University, National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT05593484
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
May 30, 2026 (Anticipated)
Study Completion Date
May 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
Southcentral Foundation, Duke University, National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Rural, Hearing loss, Telemedicine, Telehealth, School, Disparities, Screening

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Outcomes Assessor
Masking Description
Statisticians will also be masked to group allocation until analysis is complete.
Allocation
Randomized
Enrollment
6045 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Referral
Arm Type
Other
Arm Title
Specialty Telemedicine Access for Referrals (STAR)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Standard Referral
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Specialty Telemedicine Access for Referrals (STAR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of children who receive follow-up
Description
This outcome will be measured each school year, for 1 year or 2 years depending on sequence randomization.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Emmett, MD, MPH
Phone
5016031212
Email
sdemmett@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Robler, Aud, PhD
Phone
907-434-0433
Email
skrobler@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Hirschfeld, MD,PhD
Organizational Affiliation
Vice President-Specialty Services, Southcentral Foundation, Alaska Native Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Emmett, MD, MPH
Organizational Affiliation
University of Arkansas Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southcentral Foundation
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Hirschfeld, MD
Phone
907-729-1084

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.

Learn more about this trial

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

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