About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Sequential
Treatments tested in this trial
Pharmacy Technician Educational Training
BehavioralPharmacy 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.
Treatment groups
Trial outcomes
Primary outcomes
Pre- and Post-training Quiz
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
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.
Secondary outcomes
Training Satisfaction Survey
This survey will be completed by pharmacy technicians. Questions will assess how satisfied these participants are with the educational training they receive. It will be completed before and after each of the four training steps.
Satisfaction of Care Survey
This survey will assess how satisfied adults with hearing loss are with the care provided to them by a pharmacy technician.
Use and Care for Hearing Aids Survey
This survey will be completed by adults with hearing loss who receive over-the-counter hearing aids from pharmacy technicians. It will assess how frequently they use their hearing aids and how they care for them.
Revised Hearing Handicap Inventory (RHHI)
This 18-question survey measures emotional and social/situational consequences of hearing loss. It will be completed by adults before they receive over-the-counter hearing aids from pharmacy technicians. It will be repeated at the end of 4-weeks of hearing aid use.
Sponsors and contacts
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University of Alabama, Tuscaloosa
Lead sponsor
National Institutes of Health (NIH)
Collaborator
University of Pittsburgh
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator