Recruiting

Pharmacy Technicians & OTC HAs

Sponsor:

University of Alabama, Tuscaloosa

Code:

NCT06864273

Conditions

Bilateral Hearing Loss

Health Services Research

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pharmacy Technician Educational Training

Study Details

Brief summary:

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.

Conditions

Bilateral Hearing Loss

Health Services Research

Study ID

NCT06864273

Start date

Jul 25, 2025

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Pharmacy technicians licensed to practice in the state of Alabama or Mississippi.
2. Pharmacy technicians who practice in rural communities of Alabama and Mississippi.
3. Adults 18 years of age with mild to moderate hearing loss and who live in rural communities of Alabama or Mississippi.

Exclusion Criteria:

1. Pharmacy technicians with hearing loss who could have prior understanding of care for those with hearing loss will not be included in the study.
2. Adults 18 years of age or older with typical hearing will not be included in the study.
3. Adults with hearing loss who live in urban areas of Alabama and Mississippi will not be included in the study.
4. 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)

Study Design

Enrollment

144 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Marcia J Hay-McCutcheon, PhD

205-348-4572mhaymccu@ua.edu

Abigail Hubbard, AuD

205-348-2585aflesley@ua.edu

Locations

The Department of Communicative Disorders, Box 870242

Recruiting

Tuscaloosa, Alabama, United States, 35487-0242

The Department of Communicative Disorders

Recruiting

Tuscaloosa, Alabama, United States, 35487-0242

Contacts

Marcia J Hay-McCutcheon, PhD

205-348-4572mhaymccu@ua.edu

Abigail Hubbard, AuD

205-348-2585aflesley@ua.edu

Principal Investigator:

Marcia J Hay-McCutcheon, PhD

More Information

Sponsor

University of Alabama, Tuscaloosa

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • pharmacy education
  • rural health
  • Aids, Hearing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama, Tuscaloosa on 2026-08-07.