Multi-Site Evaluation of Progressive Tinnitus Management
This multi-site study will evaluate the implementation of Progressive Tinnitus Management (PTM), which combines both Audiology and Psychology approaches to Tinnitus Management. Those Veterans who require intervention for tinnitus have different levels of need, and this progressive approach gives them the appropriate level of intervention.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multi-Site Evaluation of Progressive Tinnitus Management|
- Tinnitus Handicap Inventory [ Time Frame: Baseline, 6 months (from Baseline), 12 months (from Baseline) ] [ Designated as safety issue: No ]
- Tinnitus & Hearing Survey [ Time Frame: Baseline, 6 months (from Baseline), 12 months (from Baseline) ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Progressive Tinnitus Management
Procedure: Progressive Tinnitus Management
The program follows a five-level "progressive intervention" model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support
Other Name: PTM
Procedure: Usual Care
VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Usual care subjects also can be referred for other clinical services as deemed appropriate.
Objectives. We currently are completing a single-site pilot project to develop and evaluate Progressive Tinnitus Management (PTM). PTM takes into account the fact that most Veterans who complain of tinnitus do not require extensive intervention. The method thus is "progressive" in that a hierarchical approach is used to provide clinical services only to the degree needed by individual patients. Preliminary analyses of our pilot data provide evidence that PTM is an effective and efficient means of providing tinnitus management services to Veterans. Importantly, The Veterans Affairs (VA) Audiology and Speech Pathology Program Office has tentatively identified PTM as a standardized method of tinnitus management for use at all VA medical centers. It is essential to more definitively evaluate PTM for routine application at VA medical centers. Accordingly, the specific aim of this study is to conduct a randomized clinical trial at multiple VA medical centers to evaluate the effectiveness and clinical utility of PTM as compared to usual care.
Plan. The 3-year study will be based at the VA National Center for Rehabilitative Auditory Research (NCRAR), and PTM will be implemented and evaluated in a randomized clinical trial at the Memphis VA Medical Center and at the VA Connecticut Healthcare System (West Haven). During months 0-6: (a) All clinical materials for conducting PTM will be modified (especially with the addition of Cognitive-Behavioral Therapy - CBT); (b) training materials will be developed (the web-based PTM training program for VA audiologists will be updated; PTM training will be developed for VA psychologists); (c) by random selection, five audiologists (two in Memphis, three in West Haven) will be identified to conduct PTM and five (two in Memphis, three in West Haven) will be identified to conduct usual care; (d) the five PTM audiologists and the West Haven psychologist will receive PTM training (the West Haven study psychologist will develop the training). By month 7, the randomized clinical trial will be implemented at the two VA sites and will continue through year 3.
Methods. Prior to conducting the clinical trial, PTM will be modified to incorporate critical components of CBT at all levels of intervention so as to address the psychological effects of tinnitus. Qualifying Veteran subjects (n=150 at each site) will be randomized into either PTM or usual care. Self-perceived tinnitus handicap will be evaluated pre- and post-intervention for each subject using the Tinnitus Handicap Inventory. The five audiologists and two psychologists who participate in this study will be interviewed to determine their level of satisfaction with the PTM protocol to which they are assigned. Evaluation of the program will determine its efficacy, and will identify areas of needed improvement.
Although quantitative efficacy data are not yet complete, a great deal has been learned from the study for which the current proposed study would be a continuation. A preliminary process evaluation has revealed mostly positive results of implementing the PTM protocol at the James A. Haley (Tampa) Veterans' Hospital. The process evaluation has already indicated a number of changes that need to be made to the protocol, and those changes will be made for the continuation study.
Relevance to VA's Mission. Although tinnitus is the second most common service-connected disability, most VA medical centers do not provide comprehensive clinical services for Veterans suffering from tinnitus. This study will extend our current work, which has focused on the development of a comprehensive tinnitus management protocol that can be implemented efficiently in VA hospitals. Further development of PTM has the potential of providing needed tinnitus services to Veterans across the country for a relatively small cost and with minimal impact on individual VA hospitals.
|United States, Connecticut|
|VA Connecticut Health Care System (West Haven)|
|West Haven, Connecticut, United States, 06516|
|United States, Oregon|
|VA Medical Center, Portland|
|Portland, Oregon, United States, 97201|
|United States, Tennessee|
|VA Medical Center, Memphis|
|Memphis, Tennessee, United States, 38104|
|Principal Investigator:||James Henry, PhD||VA Medical Center, Portland|