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

NCT06864273 | Recruiting

• 2 other identifiers: A24-0556R21DC022070
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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

Keywords

pharmacy education; rural health; Aids, Hearing

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to the end of the educational training at 16 weeks.

• 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.

  From enrollment to the end of the educational training at 16 weeks.

Secondary Outcomes (6)

• Training Satisfaction Survey

  From enrollment to the end of the educational training at 16 weeks.

• Satisfaction of Care Survey

  This survey will be completed by adults with hearing loss at the end of the 4 weeks of the pharmacy technician practicum.

• Use and Care for Hearing Aids Survey

  This survey will be completed by adults with hearing loss at the end of the 4 weeks of pharmacy technician practicum.

• Revised Hearing Handicap Inventory (RHHI)

  This survey will be completed by adults with hearing loss at enrollment and at the end of the 4 weeks of hearing aid use.

• International Outcome Inventory for Hearing Aids (IOI-HA)

  This survey will be completed by adults with hearing loss prior to receiving hearingthe end of the 4 weeks of hearing aid use.

Study Arms (1)

Alabama and Mississippi Pharmacy Technicians

EXPERIMENTAL

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.

Behavioral: Pharmacy Technician Educational Training

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.

Alabama and Mississippi Pharmacy Technicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• National Institutes of Health (NIH): collaborator
• University of Pittsburgh: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

The Department of Communicative Disorders, Box 870242

Tuscaloosa, Alabama, 35487-0242, United States

RECRUITING

The Department of Communicative Disorders

Tuscaloosa, Alabama, 35487-0242, United States

RECRUITING

Related Publications (1)

• Brothers EB, Hay-McCutcheon MJ, Hughes PJ, Friend ML. Audiology, Medicine, and Pharmacy Interprofessional Preliminary Interviews and Discussions: Improving Hearing Health Care in Rural Alabama. Am J Audiol. 2022 Sep;31(3):656-668. doi: 10.1044/2022_AJA-21-00272. Epub 2022 Jun 23.

  PMID: 35737896 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Bilateral; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Marcia J Hay-McCutcheon, PhD

  The University of Alabama

  PRINCIPAL INVESTIGATOR

• Lucas Berenbrok, PharmD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcia J Hay-McCutcheon, PhD

CONTACT

205-348-4572; mhaymccu@ua.edu

Abigail Hubbard, AuD

CONTACT

205-348-2585; aflesley@ua.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The educational pharmacy technician training includes four sequential stages. Each technician will receive stepped interventions of "No Training", followed by "Online Modules," then "Online Discussions and Assigned Readings," and finish with "Practicum." The practicum experience will involve providing over-the-counter hearing aids to adults with bilateral mild-to-moderate hearing loss. Once completed, pharmacy technicians will have experienced a multimodal form of educational training that is considered best practices by the American Society of Health System Pharmacists and the Accreditation Council for Pharmacy Education for training pharmacy technicians, which must include didactic, simulated and experiential training.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: Release of a complete data set will to the Inter-university Consortium for Political and Social Research (ICPSR) occur within 12 months of the end of project data collection. Data used for the generation of manuscripts will be shared prior to publication. Data stored with the Data Sharing for Demographic Research (DSDR) repository through ICPSR will be available to the research community in perpetuity.
• Access Criteria: For Public Use Data, all deidentified data that is not designated as restricted use data will be made publicly available via DSDR. To use these data, researchers must register with ICPSR and agree to the terms of use, which are designed to protect study participants. The sharing or redistribution of data downloads is not allowed. Datasets in DSDR are identified using a study digital object identifier (DOI), created by ICPSR. The DOI will allow researchers to find and identify data.

Locations

US (2)