Addressing Barriers to Adult Hearing Healthcare
Condition: Hearing Loss; Geriatric Disorder
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      The aim of this project is to develop evidence that can inform hearing health care best
      practices for adults between the ages of 65-75, and determine what level of involvement by
      the primary care practitioner (PCP) is required to inform and encourage adults age 65-75 to
      follow through with routine hearing screening.

      This study also aims to evaluate the accuracy of assessment of medical conditions for which
      the FDA requires physician evaluation and management prior to hearing aid fitting, and
      determine which medical conditions should require medical evaluation prior to hearing aid
      fitting.

      The results of this study should provide information to implement changes in health care
      policy to facilitate accessible and affordable hearing health care.
    

Detailed description: 
      Age-related hearing loss is the third-most common chronic condition affecting older adults in
      the US (data from Healthy People 2020 US Dept of Health and Human Services). This study aims
      to improve the understanding of attitudes, barriers and facilitators needed to improve
      hearing health care delivery. Two study cohorts of study participants between the ages of 65
      - 75 are proposed.

      The first cohort of participants include healthy adults being seen by a primary care provider
      (PCP) for a routine appointment. Each participating primary care practice is assigned to one
      of three different telephone hearing screening strategies that include progressive levels of
      PCP time and guidance to complete telephone-based hearing screening. Those who fail a
      telephone hearing screening go on to a medical referral study and receive (1) diagnostic
      audiological testing and (2) determination of the reliability and validity of identification
      of conditions that should require medical referral prior to hearing aid provision (called FDA
      'Red Flag' conditions, including conditions such as sudden hearing loss, cerumen impaction,
      conductive hearing loss, dizziness, external deformity, ear drainage). We will evaluate the
      proportion of subjects in Groups 1 and 2 who dial the phone number and complete the telephone
      hearing test at or within two months of their PCP visit, relative to Group 3, and the
      proportion of subjects in all groups who: a) schedule and b) complete the visit for
      diagnostic audiological testing, and subsequently, c) complete a plan for appropriate hearing
      loss intervention, if indicated, within four months of initial hearing screening. Enrollment
      in this cohort is complete. 955 subjects were screened for eligibility. Of those, 660
      patients were enrolled.

      The second cohort includes adults who are being seen for a routine appointment for a
      complaint of hearing loss at one of several participating Ear, Nose, and Throat (ENT)
      practices in the CHEER network. Information about Red Flag conditions will be obtained from
      the patient, audiologist, and ENT provider. This information, along with Red Flag data from
      the PCP Cohort, will be used to evaluate the accuracy of assessment of medical conditions for
      which the FDA requires physician evaluation and management prior to hearing aid fitting, and
      determine which medical conditions should require medical evaluation prior to hearing aid
      fitting. Enrollment in this cohort is ongoing. The anticipated enrollment goal is 500
      subjects.
    

Intervention name(s): Tele-HS; PCP encouragement
Intervention type(s): Other; Other
Intervention description(s): Patients will be given information on the Tele-HS and given access to take the screening at home or in-office, depending on arm.; Patients will or will not either receive PCP encouragement to do the Tele-HS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening