NCT06864273 · University of Alabama, Tuscaloosa
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Pharmacy Technician Educational Training
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.
Primary outcome measures
Pre- and Post-training Quiz
Time frame: From enrollment to the end of the educational training at 16 weeks.
This quiz will assess knowledge and skills that are provided in during the 16-weeks of educational training that pharmacy technicians will receive. It will be administered before and after each training step.
Pre- and Post-training Confidence in Skills
Time frame: From enrollment to the end of the educational training at 16 weeks.
The questions in this survey will assess confidence levels of pharmacy technicians in assisting adults with hearing loss who receive over-the-counter hearing aids in their community pharmacy. It will be administered before and after each training step.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Pharmacy technicians licensed to practice in the state of Alabama or Mississippi.
- Pharmacy technicians who practice in rural communities of Alabama and Mississippi.
- Adults 18 years of age with mild to moderate hearing loss and who live in rural communities of Alabama or Mississippi.
Exclusion criteria
- Pharmacy technicians with hearing loss who could have prior understanding of care for those with hearing loss will not be included in the study.
- Adults 18 years of age or older with typical hearing will not be included in the study.
- Adults with hearing loss who live in urban areas of Alabama and Mississippi will not be included in the study.
- Participants will be excluded if they have any medical condition resulting in cognitive impairment that results in an inability to complete the study tasks (e.g., mental health condition, stroke, head injury, dementia, or Alzheimer's disease)
Where
- Tuscaloosa, Alabama
Collaborators
National Institutes of Health (NIH), University of Pittsburgh, National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2025 · Source of record for eligibility and locations