University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT02037139
Hearing loss screening rates in for older persons in primary care clinics are very low even though hearing loss is relatively common for older persons. When diagnosed with hearing loss older persons are often reluctant to follow through. This study involves a prospective controlled trial comparing the effectiveness of three primary care based protocols for older adults ≥ 60 who screen positive for possible hearing loss in promoting subsequent access to and use of hearing health care services. The protocols will compare: 1) screening only (standard care control); 2) screening plus an illustrated educational brochure; and 3) screening plus an in-person educational intervention and an illustrated educational brochure. Screening will be done by primary care personnel. Participants will be tracked for 8 months to assess outcomes.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
The purpose of this study is to evaluate the extent to which hearing health outcomes are improved when patients are screened for hearing loss and provided an educational brochure or screened and provided the brochure plus an educational segment emphasizing points in the brochure versus a standard screening only protocol. These procedures are non-invasive. Hearing loss screening is part of basic health evaluations for older persons, brochures are commonly handed out for a variety of health conditions, and providing patient education is common practice.
At all sites our study research nurse will train clinic staff, contact patients who have indicated they are interested in taking part, obtain informed consent, administer baseline and follow-up questionnaires, and ensure that those completing the two follow-ups receive their gift cards. No information from clinic medical records will be obtained.
Aims:
The three primary outcomes involve comparing the differential impacts of adding an illustrated educational brochure or adding both a brochure and a brief educational segment over screening only. These three outcomes are whether the participant went to see a hearing specialist for an evaluation, whether a hearing or other assistive listening device was obtained if recommended, and whether the device if obtained was being used. Other outcomes include the number of hours a day participants who received assistive devices actually wear them, the number of changes participants have made to improve communication other than obtaining an assistive device, and the extent to which their hearing related quality of life improves.
The primary care clinics taking part in our study already do some screening for hearing loss but often screening is not perceived as leading to better outcomes. The clinics are interested in the opportunity to participate in a project that will assess how effective screening is when combined with additional educational material. All consenting and data collection will be done by our study's Research Nurse.
Specific procedures are:
One of three protocols will then occur for those indicating an interest in the study:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard care screening
Participants are given an illustrated educational brochure
Participants undergo a in-person educational intervention
Time frame: 8 months after initial screening
Proportion of those who screened positive for possible hearing loss who follow through on clinic recommendations for referrals or who elect a referral on their own
Time frame: 8 months after initial screening
Other than adopting hearing aids, how many changes did participants make to improve their hearing since screened. Education segment lists 6 possible changes.
Time frame: 8 months following initial screening
Improvement in hearing over the course of the study as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S) and Inner Ear scales
University of California, San Francisco
Other
Primary Care Intervention Promoting Hearing Health Care Service Access and Use
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