Multi-Site Evaluation of Progressive Tinnitus Management

描述（由申请人提供）： 项目概要/摘要：耳鸣患病率随着年龄的增长而增加，暴露于高水平的噪音是耳鸣最常见的原因。退伍军人特别容易患耳鸣他们往往比一般人年长，而且他们的军事经历经常涉及危险的噪音暴露。虽然耳鸣是一个重要的和不断升级的问题，退伍军人和退伍军人管理局医疗保健系统，退伍军人管理局还没有实施耳鸣管理的标准化方法。我们的努力集中在为退伍军人开发耳鸣管理方法，最终在目前的研究“耳鸣管理的渐进式干预计划”（RR&D C4488 R）.作为这项试点研究的结果，我们已经制定了一个定义的方法，称为渐进式耳鸣管理（PTM）。本研究的目的是（a）确定该计划对退伍军人的益处，（B）进行定性计划评估，以确定PTM作为VA医疗中心标准耳鸣管理计划的适当性。 在迄今为止取得的成就的基础上，拟议的研究将：完善PTM，确保方案可以在各种VA环境中引入和维持，在方案中添加心理管理组件，并评估修改后方案的患者结局。研究设计为两组多中心随机临床试验。其中一组将接受“常规护理”治疗耳鸣。第二组将接受PTM。耳鸣治疗是根据VA听力学诊所提供的耳鸣服务的主要方法来定义的。这些服务包括听力评估，助听器（如果需要），最小的耳鸣咨询，耳鸣教育材料，并在适当的情况下转诊（通常是耳鼻喉科或心理健康）。PTM是一个分层（五个级别）的计划，旨在提供耳鸣服务，只有每个患者所需的水平。这五个级别包括1级分诊，2级听力评估，3级小组教育，4级跨学科评估和5级个性化支持。研究的前6个月将涉及修改PTM方案（主要是通过添加认知行为治疗的组成部分）并准备实施试验，该试验将在两个VA医疗中心（West Haven，CT和孟菲斯，TN）进行，剩余的21/2年。在基线和基线后6个月和12个月，将使用Tinker残疾量表评估结局。在研究结束时，将记录标准化PTM在多个VA诊所实施的疗效和效率。

DESCRIPTION (provided by applicant): Project Summary/Abstract: Tinnitus prevalence increases with age, and exposure to high levels of noise is the most commonly reported cause of tinnitus. Veterans are especially at risk for incurring tinnitus-they tend to be older than the general population, and their military experience often involves hazardous-noise exposure. Although tinnitus is a significant and escalating problem for Veterans and for the VA healthcare system, the VA has not implemented a standardized method of tinnitus management. Our efforts have focused on developing tinnitus management methodologies for Veterans, culminating in the current study "Progressive Intervention Program for Tinnitus Management" (RR&D C4488R). As a result of this pilot study we have developed a defined methodology referred to as Progressive Tinnitus Management (PTM). The goals of this study are to (a) determine the program's benefit to Veterans and (b) perform a qualitative program evaluation to determine the appropriateness of PTM for utilization as a standard tinnitus management program for VA medical centers. Building on accomplishments thus far, the proposed study will: refine PTM, assure the protocol can be introduced and maintained in various VA settings, add psychological management components to the protocol, and evaluate patient outcomes for the modified protocol. The design of the study is a two-group multi-site randomized clinical trial. One group will receive "usual care" for their tinnitus. The second group will receive PTM. Usual care is defined according to the predominant method of tinnitus services provided at VA audiology clinics. These services include an audiologic assessment, hearing aids (if needed), minimal tinnitus counseling, tinnitus educational materials, and referral if appropriate (typically to Otolaryngology or Mental Health). PTM is a hierarchical (five levels) program designed to provide tinnitus services only to the level needed by each patient. The five levels include Level 1 Triage, Level 2 Audiologic Evaluation, Level 3 Group Education, Level 4 Interdisciplinary Evaluation, and Level 5 Individualized Support. The first 6 months of the study will involve modifying the PTM protocol (mostly by adding components of Cognitive-Behavioral Therapy) and preparing to implement the trial, which will take place at two VA medical centers (West Haven, CT and Memphis, TN) for the remaining 21/2 years. Outcomes will be assessed using the Tinnitus Handicap Inventory at baseline and at 6 and 12 months post-baseline. By the end of the study, standardized PTM will be documented for its efficacy and efficiency as implemented in multiple VA clinics.