Multi-Site Evaluation of Progressive Tinnitus Management

渐进性耳鸣管理的多站点评估

• 批准号: 8898725
• 负责人: JAMES A HENRY
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-01 至 2012-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8898725
• 关键词: Accounting; Acoustics; Address; Afghanistan; Age; Anxiety; Audiology; Auditory; Caring; Clinic; Clinical; Clinical Protocols; Clinical Services; Cognitive Therapy; Conflict (Psychology); Controlled Clinical Trials; Counseling; Data; Data Analyses; Disabled Persons; Discipline; Distress; Educational Background; Educational Materials; Enrollment; Environment; Equipment and supply inventories; Evaluation; Exposure to; Freedom; General Population; Goals; Healthcare Systems; Hearing; Hearing Aids; Individual; Injury; Intervention; Iraq; Learning; Measures; Medical center; Mental Depression; Mental Health; Methodology; Methods; Military Personnel; Modification; Nature; Nervous system structure; Noise; Otolaryngology; Outcome; Patients; Perception; Pilot Projects; Post-Traumatic Stress Disorders; Prevalence; Program Evaluation; Protocols documentation; Psychologist; Psychology; Randomized; Randomized Clinical Trials; Reaction; Relative (related person); Reporting; Research Design; Risk; Self Efficacy; Services; Site; Sleep Disorders; Speech Pathology; Testing; Tinnitus; Traumatic Brain Injury; Triage; Veterans; Veterans Hospitals; Work; abstracting; design; disability; disability payment; evidence base; experience; handicapping condition; interdisciplinary approach; intervention program; operation; programs; psychologic; skills; treatment as usual

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.

描述（由申请人提供）： 项目摘要/摘要：耳鸣患病率随着年龄的增长而增加，而暴露于高水平的噪音是最常见的耳鸣原因。退伍军人尤其容易出现耳鸣——他们的年龄往往比一般人群要大，而且他们的军事经验往往涉及危险噪音暴露。尽管耳鸣对于退伍军人和退伍军人管理局医疗保健系统来说是一个严重且不断升级的问题，但退伍军人管理局尚未实施标准化的耳鸣管理方法。我们的工作重点是为退伍军人开发耳鸣管理方法，最终形成了当前的研究“耳鸣管理渐进干预计划”(RR&D C4488R)。作为这项试点研究的结果，我们开发了一种称为渐进性耳鸣管理 (PTM) 的明确方法。本研究的目标是 (a) 确定该计划对退伍军人的益处，以及 (b) 进行定性计划评估，以确定 PTM 是否适合用作 VA 医疗中心的标准耳鸣管理计划。 在迄今为止取得的成就的基础上，拟议的研究将：完善 PTM，确保该方案可以在各种 VA 环境中引入和维护，在方案中添加心理管理组件，并评估修改方案的患者结果。该研究的设计是一项两组多中心随机临床试验。一组将接受针对耳鸣的“常规护理”。第二组将接受 PTM。常规护理是根据 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）、轻度耳鸣咨询、耳鸣教育材料以及转诊（如果适用）（通常转诊至耳鼻喉科或心理健康科）。 PTM 是一个分层（五个级别）计划，旨在仅根据每位患者所需的级别提供耳鸣服务。这五个级别包括 1 级分诊、2 级听力评估、3 级团体教育、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（主要是添加认知行为疗法的组成部分）并准备实施试验，该试验将在两个 VA 医疗中心（康涅狄格州西黑文和田纳西州孟菲斯）进行剩下的 21/2 年。将使用基线时以及基线后 6 个月和 12 个月时的耳鸣障碍清单来评估结果。在研究结束时，将记录在多个 VA 诊所实施的标准化 PTM 的功效和效率。