Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies

Part of paid clinical trials in Tuscaloosa, Alabama.

Sponsor
University of Alabama, Tuscaloosa
Study ID
NCT06864273
Status
Recruiting
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Conditions

  • Bilateral Hearing Loss
  • Health Services Research

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Pharmacy Technician Educational Training — BEHAVIORAL
    Pharmacy Technicians will participate in a stepped-wedge educational training program. The first step will be a control condition where they will receive no training, the second step will include viewing online modules, the third step will include online discussions, and the fourth step will include practical experiences with adults with bilateral hearing loss. Pre-training quizzes and surveys will be completed before and after each step.

Study Details

Hearing loss is a major public health concern due to its negative association with emotional well-being, cognition, and physical ailments, such as diabetes. Access to audiologists and otolaryngologists in many regions across the US is poor or extremely limited. Rural populations are older, less educated, and have lower household incomes compared to populations in metropolitan areas. Also, with increasing age adults experience greater rates of hearing loss. Fortunately, the 2022 FDA Final Rule for Over-the-Counter Hearing Aids (OTC HAs) could revolutionize assess to hearing aids and hearing healthcare by allowing adults with perceived mild-to-moderate hearing loss to purchase these devices over the counter, without medical clearance or care from an audiologist. Pharmacies located in rural areas now have the option to provide OTC HAs, something previously not possible. Currently, however, there are no established guidelines for effective provision of these devices in pharmacies located in rural communities. Educating pharmacy technicians to provide basic hearing healthcare related to OTC HAs use could address a critical need and create a new care delivery model to ensure sustainable, long-term access to hearing healthcare. The long-term goal of this study is to create a sustainable interprofessional collaborative between audiologists and pharmacists for the development of a hearing healthcare model that improves access and affordability of care in rural regions across the country. The specific aims are to 1) Determine an effective approach for educating pharmacy technicians for the provision of OTC HAs in rural community pharmacies, and 2) Identify satisfaction of care provided by pharmacy technicians and initial performance with OTC HAs in adults with hearing loss living in rural communities. A stepped wedged clinical trial design will be used to study the effectiveness of a comprehensive educational training program for pharmacy technicians. Technicians from rural Alabama and Mississippi, placed within four different clusters, will participate in a multimodal training program for the purpose of developing basic clinical skills to assist adults with perceived mild-to-moderate hearing loss. Additionally, adults with hearing loss who receive clinical services from trained pharmacy technicians will be asked to report on the care they received and benefit from their OTC HAs. The central hypotheses are a) that pharmacy technician training will result in greater understanding of hearing healthcare concepts compared to no training, and b) the training will lead to successful provision of basic hearing healthcare to adults with hearing loss in rural communities. The expected outcome of this project will be the establishment of a multimodal education program, leveraging the increased access of OTC HAs, to support those with hearing loss in rural pharmacies across the county. The ability of pharmacy technicians to provide this support will dramatically increase the availability of hearing services in rural communities, which will positively impact the quality of life for those with hearing loss.

Key Dates

Start date
Jul 25, 2025
Status verified
Jul 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
144 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Alabama and Mississippi Pharmacy Technicians
    Pharmacy technicians from Alabama and Mississippi will progress through four different steps of educational training for the purpose of assisting with the provision of over-the-counter hearing aids in rural Alabama and Mississippi counties. The types of training include four weeks of no training (control condition), four weeks of viewing online modules, four weeks of participating in online discussions, and four weeks of practical experiences. The practicum will include using hearing screening equipment to help assess hearing loss in adults, and setting over-the-counter hearing aid controls for adults with mild-to-moderate hearing bilateral hearing loss.

Primary Outcome Measure

Pre- and Post-training Quiz [ Time Frame: From enrollment to the end of the educational training at 16 weeks. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Department of Communicative DisordersTuscaloosaAlabama35487-0242
Marcia J Hay-McCutcheon, PhD
[email protected]
205-348-4572
Abigail Hubbard, AuD
[email protected]
205-348-2585
Marcia J Hay-McCutcheon, PhD (PRINCIPAL_INVESTIGATOR)
Lucas Berenbrok, PharmD (PRINCIPAL_INVESTIGATOR)
The Department of Communicative Disorders, Box 870242TuscaloosaAlabama35487-0242-

Find similar trials in Tuscaloosa, AL

By research site
The Department of Communicative Disorders· Tuscaloosa, ALThe Department of Communicative Disorders, Box 870242· Tuscaloosa, AL

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