高齢の恵まれない成人向けのプライマリケアにおける聴覚プログラムの実現可能性に関する研究プロトコル

Age-related hearing loss is highly prevalent, underrecognized, and consequently, undertreated. Hearing loss can have a substantial negative impact on communication and biopsychosocial health. We hypothesize that offering validated hearing assessments and a point-of-care counseling program in an older, underserved population will be more accessible and acceptable than the traditional pathway for audiology care, particularly in marginalized communities.

This convergent mixed methods feasibility study will assess the implementation of a hearing program embedded in a quality improvement initiative within the Geriatric Clinic of New York City Health and Hospital's Bellevue Hospital Center and the feasibility of recruiting for a future efficacy trial to test the intervention. Adult patients ≥ 60 years who are proficient in English or Spanish and not currently using hearing rehabilitation are eligible for initial screening. Hearing level, including individual ear severity, is identified using a validated tablet-based measure of pure tone audiometry and a self-report measure of hearing disability. We define hearing loss subjectively based on a score of 8 or greater on the Hearing Handicap Inventory-Screen (HHI-S) or using a four-frequency pure tone average > 25 dB hearing level in the better ear, representing at least a mild hearing loss. Patients who are determined to have measurable hearing loss and provide informed consent will be invited to participate in a pilot study and randomized to one of two approaches: (1) a counseling on alternative rehabilitation strategies intervention arm or (2) usual care with referral to the audiology pathway. Primary feasibility outcomes include recruitment and retention rates, intervention adherence, acceptability, and the ability to collect outcome measurements. We will also explore changes in HHI-S scores over 3 months and assess subsequent audiology service utilization in both groups. In addition to the quantitative data, we will include key participant interviews with staff and patients to assess feasibility from participant attitudes.

This study will provide insights into the feasibility of offering hearing screening/assessments and counseling in primary care and its potential to improve access to hearing care for underserved older adults. Findings will inform the design of future trials evaluating the impact of primary care-based tailored hearing interventions on patient health and quality of life.

ClinicalTrials.gov NCT05943509, Trial registration date: July 13, 2023, Protocol Version: 1.