Hard of Hearing Clinical Trial
Official title:
Audiology Visits After Screening for Hearing Loss: An RCT
Hearing impairment is one of the most common disabilities in veterans. The decreased ability to communicate is troubling in itself, but the strong association of hearing loss with functional decline and depression adds further to the burden on the hearing-impaired. Although hearing amplification improves quality of life, hearing evaluations are offered infrequently to older patients. Only 25 percent of patients with aidable hearing loss receive treatment. Up to 30 percent of patients who receive hearing aids do not use them. We contend that an effective formal screening program should identify hearing-impaired patients who are motivated to seek evaluation and who derive benefit from treatment.
Background:
Hearing impairment is one of the most common disabilities in veterans. The decreased ability
to communicate is troubling in itself, but the strong association of hearing loss with
functional decline and depression adds further to the burden on the hearing-impaired.
Although hearing amplification improves quality of life, hearing evaluations are offered
infrequently to older patients. Only 25 percent of patients with aidable hearing loss
receive treatment. Up to 30 percent of patients who receive hearing aids do not use them. We
contend that an effective formal screening program should identify hearing-impaired patients
who are motivated to seek evaluation and who derive benefit from treatment.
Objectives:
The first specific aim is to determine if formal screening programs for hearing loss can
increase visits to audiologists. The second specific aim is to determine which specific
screening strategy leads to the most frequent audiology visits.
Methods:
Our four-armed randomized clinical trial compares three screening strategies (physiologic
testing, a self-report questionnaire, and combined use of both physiologic and self-report
testing), against a control arm (usual care). Physiologic testing was done with the
Audioscope, a portable otoscope that emits tones from selected frequencies at a variety of
loudness levels. The self-report questionnaire was the screening version of the Hearing
Handicap Inventory of the Elderly questionnaire (HHIE-S), which quantifies the social and
emotional handicap from hearing loss. Patients aged 50 and older who did not wear hearing
aids were recruited from the outpatient clinics at the VA Puget Sound Health Care System.
Only patients who were eligible for VA-issued hearing aids were enrolled in this trial.
Patients randomized to the control arm were not screened. Patients screened with both the
Audioscope and HHIE-S were referred to the audiology service for evaluation if either of the
tests was positive. All patients, regardless of screening status, were followed to determine
how many patients in each arm subsequently visit an audiologist.
The primary outcome is the percentage of patients who contact the audiology service within 6
months of the date of screening. Secondary outcomes include: 1) the number of cases of
hearing loss detected; 2) the number of dispensed hearing aids; 3) self-rated communication
ability; 4) hearing-related quality of life; and 5) rates of hearing aid adherence. Costs of
screening and subsequent treatment were collected. The study is not powered to determine
cost-effectiveness, but to pilot calculations of the costs to implement the screening
program will be made. An intention-to-screen analysis will be used to minimize bias due to
subject self-selection.
Status:
Enrollment and follow-up is complete. Outcomes data are currently being analyzed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02369718 -
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N/A |