Appalachian Specialty Telemedicine Access for Referrals (STAR) Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology for specialty care access in rural Kentucky schools. An initial version of the model was used in rural Alaska where telemedicine-based specialty referral improved both proportion of children receiving follow-up and time to follow-up. The refined STAR model will utilize an enhanced mHealth screening protocol that includes tympanometry for the detection of middle ear disease. The STAR model will also include a specialty telemedicine referral process in schools for children who refer school screening.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 11
Healthy Volunteers: t
View:

• Enrolled in school in one of the 14 participating counties

• Initial entry into elementary school

• Eligible regardless of age, gender, race, or ethnicity

Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Susan Emmett, MD, MPH
sdemmett@uams.edu
501-603-1212
Backup
Samantha Robler, AuD,PhD
skrobler@uams.edu
907-434-0433
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 18000
Treatments
Other: Sequence 1
Standard School Screening: All counties in Sequence 1 will receive standard hearing screening in the control period, Year 1.~Standard Referral: All counties in Sequence 1 will receive standard referral in control period, Years 1, 2, and 3, based on the updated timeline.~Enhanced mHealth screening component: Counties randomized to Sequence 1 will receive the enhanced mHealth screening in Years 2, 3, 4, and 5, based on the updated timeline.~Specialty telemedicine referral component: Counties randomized to Sequence 1 will receive the specialty telemedicine referral component in addition to the enhanced mHealth screening in Years 4 and 5, based on the updated timeline.
Other: Sequence 2
Standard Hearing Screening: All counties in Sequence 2 will receive standard hearing screening in the control period, Years 1 and 2.~Standard Referral: All counties in Sequence 2 will receive standard referral in control period, Years 1, 2, 3, and 4, based on the updated timeline.~Enhanced mHealth screening component: Counties randomized to Sequence 2 will receive the enhanced mHealth screening in Years 3, 4, and 5, based on the updated timeline.~Specialty telemedicine referral component: Counties randomized to Sequence 2 will receive the specialty telemedicine referral component in addition to the enhanced mHealth screening in Year 5, based on the updated timeline.
Related Therapeutic Areas
Sponsors
Leads: University of Arkansas
Collaborators: University of Kentucky, National Institutes of Health (NIH), Duke University

This content was sourced from clinicaltrials.gov