Multi-Site Evaluation of Progressive Tinnitus Management

Portland Va Medical Center, Portland OR

Investigators

Abstract

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.