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临床试验/NCT02037139
NCT02037139已完成不适用

Primary Care Intervention Promoting Hearing Health Care Service Access and Use

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
155
试验地点
2
主要终点
Referral rates for hearing evaluation

研究概览

简要总结

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.

详细描述

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:

  1. 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..
  2. Examine hearing health outcomes by patient and clinic characteristics.
  3. Compare any observed gains in outcomes against the estimated staff time to administer either the brochure or the brochure plus the educational segment.

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60 or older
  • Not currently wearing a hearing aid
  • Cognitively capable of giving informed consent
  • Able to speak and understand English
  • No concurrent health problem that would limit participation
  • Screen positive for hearing loss using single question and/or finger rub

排除标准

  • Age 59 or less
  • Currently wearing a hearing aid
  • Cognitively impaired or not cognitively capable of giving informed consent
  • Unable to speak and understand English
  • Has a concurrent health condition that limits participation
  • Does not screen positive for hearing loss

结局指标

主要结局

Referral rates for hearing evaluation

时间窗: 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

次要结局

  • Number of changes made to improve hearing(8 months after initial screening)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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