Multi-Site Evaluation of Progressive Tinnitus Management

描述(由申请人提供)： 项目摘要/摘要：耳鸣的患病率随着年龄的增长而增加，暴露在高水平的噪音中是最常见的耳鸣原因。退伍军人尤其有患耳鸣的风险--他们往往比一般人年龄大，而且他们的军事经历往往涉及危险的噪音暴露。尽管耳鸣对退伍军人和退伍军人医疗保健系统来说是一个严重且不断升级的问题，但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，最终形成了目前的研究“耳鸣管理渐进式干预计划”(RR&D C4488R)。作为这项初步研究的结果，我们开发了一种被称为进行性耳鸣管理(PTM)的明确方法。这项研究的目标是(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是否适合用作退伍军人医学中心的标准耳鸣管理计划。在迄今取得的成就的基础上，拟议的研究将：完善PTM，确保该方案可以在各种退伍军人管理局环境中引入和维护，在该方案中增加心理管理组件，并评估修改后方案的患者结果。本研究设计为两组多部位随机临床试验。其中一组患者将接受耳鸣的“常规治疗”。第二组将接受PTM。通常的护理是根据退伍军人管理局听力学诊所提供的耳鸣服务的主要方法来定义的。这些服务包括听力学评估、助听器(如果需要)、最低限度的耳鸣咨询、耳鸣教育材料，以及适当的转介(通常是耳鼻喉科或精神健康)。PTM是一种分级(五级)计划，旨在仅为每个患者所需的级别提供耳鸣服务。这五个级别包括第一级分诊、第二级听力学评估、第三级团体教育、第四级跨学科评估和第五级个性化支持。研究的前6个月将包括修改PTM方案(主要通过增加认知-行为疗法的组件)并准备实施试验，试验将在退伍军人管理局的两个医疗中心(康涅狄格州西黑文和田纳西州孟菲斯)进行，持续21年半。结果将在基线时、基线后6个月和12个月时使用耳鸣残疾调查表进行评估。在研究结束时，标准化PTM的有效性和效率将被记录下来，并在多个退伍军人管理局诊所实施。 公共卫生相关性： 项目简介：虽然耳鸣长期以来一直是退伍军人的问题，但在过去的十年里，它已经大大升级为一个问题。这一增长在很大程度上是因为暴露在军队的高水平噪音中，但也因为耳鸣经常与创伤性脑损伤和创伤后应激障碍有关--这是伊拉克和阿富汗冲突的“标志性伤害”。虽然耳鸣在退伍军人中很常见，但退伍军人医学中心还没有统一的耳鸣管理方法。拟议的研究将继续努力改进和记录进行性耳鸣管理(PTM)的方法。PTM涉及为耳鸣提供临床服务。这种方法是“循序渐进的”，因为服务只提供给个别病人所需的程度。PTM有可能使耳鸣的VA护理标准化。

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. PUBLIC HEALTH RELEVANCE: Project Narrative: Although tinnitus has long been a problem for Veterans, it has greatly escalated as a problem during the last decade. This increase is due largely because of exposure to high levels of noise in the military, but also because tinnitus often is associated with traumatic brain injury and post- traumatic stress disorder-"signature injuries" of the Iraq and Afghanistan conflicts. Although tinnitus is so common with Veterans, VA Medical Centers have not had a uniform method of tinnitus management. The proposed study will continue our efforts to refine and document the method of Progressive Tinnitus Management (PTM). PTM involves the provision of clinical services for tinnitus. The method is "progressive" because services are provided only to the degree needed by individual patients. PTM has the potential to standardize VA care for tinnitus.