Clinical trial NCT05513833: School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky
Official title: Appalachian Specialty Telemedicine Access for Referrals (STAR) Trial
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: University of Kentucky
name: Duke University
name: National Institutes of Health (NIH)
First posted: 2022-08-24
Enrollment: 14400
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 14 total counties (clusters) are participating in the stepped wedge randomized trial. There are two nested trials within the overall stepped-wedge trial: a complete design to evaluate the enhanced mHealth screening component and an incomplete design to evaluate the specialty telemedicine referral component combined with enhanced screening. Clusters will be randomized to cross over to enhanced mHealth hearing screening and specialty telemedicine referral in a stepwise manner until all clusters receive both the interventions.

The enhanced mHealth screening component will be rolled out in Years 2 or 3 (control period in Years 1 and 2) depending on sequence randomization. Specialty telemedicine referral will be rolled out in Years 3 and 4 (control period in Years 2 and 3) depending on sequence randomization.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Childhood hearing loss has substantial lifelong consequences, including speech-language delay, worse academic performance, and limited vocational opportunities. In rural settings, where access to care is limited, school-based preventative screening programs can help in early identification of childhood hearing loss. The state of Kentucky mandates hearing screening for all schools; however, the effectiveness of these programs is unclear. Further, current school programs do not include a middle ear assessment, which is needed to detect infection-related hearing loss common in children in rural and low-income settings. In children referred from school-based hearing screening programs, loss to follow-up also remains a pervasive issue.

To address these key issues, the University of Kentucky has partnered with the University of Arkansas Medical Sciences to lead the Appalachian STAR trial. 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.

The Appalachian STAR stepped-wedge cluster randomized trial will be conducted in approximately 64 elementary schools located in 14 counties in rural Kentucky. Approximately 3600 students at school entry will be enrolled annually for 4 years, for a total of approximately 14,400 children. Cluster randomization will occur in two sequences at the county level, with 7 counties (clusters) in each sequence. The 4-year trial will include a control condition period, followed by phased roll-out of the intervention. The enhanced mHealth school hearing screening protocol will be implemented first. The following year, specialty telemedicine referral will be added to the enhanced screening protocol. All 14 counties will receive the STAR model by the end of the trial. An implementation evaluation will be conducted to refine the STAR model throughout the trial. If successful, the STAR model could be applied to address hearing loss and other childhood health conditions that affect underserved rural communities across America.

Eligibility criteria: Inclusion Criteria:

* Enrolled in school in one of the 14 participating counties
* Initial entry into elementary school
* Eligible regardless of age, gender, race, or ethnicity

Exclusion Criteria:

• N/A

Primary outcomes:
measure: Proportion of children screened
timeFrame: School screening occurs once per school year, with timing and practices varying by school.
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: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Matt Bush, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas Medical Sciences
name: Susan Emmett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: