RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Increasing Access to Hearing Healthcare: An Assessment of Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies

Quick Facts

Study Start:2025-08-01
Study Completion:2026-09-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06864273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Pharmacy technicians licensed to practice in the state of Alabama or Mississippi.
  2. 2. Pharmacy technicians who practice in rural communities of Alabama and Mississippi.
  3. 3. Adults 18 years of age with mild to moderate hearing loss and who live in rural communities of Alabama or Mississippi.
  1. 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. 2. Adults 18 years of age or older with typical hearing will not be included in the study.
  3. 3. Adults with hearing loss who live in urban areas of Alabama and Mississippi will not be included in the study.
  4. 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)

Contacts and Locations

Study Contact

Marcia J Hay-McCutcheon, PhD
CONTACT
205-348-4572
mhaymccu@ua.edu
Abigail Hubbard, AuD
CONTACT
205-348-2585
aflesley@ua.edu

Principal Investigator

Marcia J Hay-McCutcheon, PhD
PRINCIPAL_INVESTIGATOR
The University of Alabama
Lucas Berenbrok, PharmD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

The Department of Communicative Disorders, Box 870242
Tuscaloosa, Alabama, 35487-0242
United States
The Department of Communicative Disorders
Tuscaloosa, Alabama, 35487-0242
United States

Collaborators and Investigators

Sponsor: University of Alabama, Tuscaloosa

  • Marcia J Hay-McCutcheon, PhD, PRINCIPAL_INVESTIGATOR, The University of Alabama
  • Lucas Berenbrok, PharmD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01
Study Completion Date2026-09-05

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2026-09-05

Terms related to this study

Keywords Provided by Researchers

  • pharmacy education
  • rural health
  • Aids, Hearing

Additional Relevant MeSH Terms

  • Bilateral Hearing Loss