Hearing Loss Clinical Trial
Official title:
Progressive Intervention Program for Tinnitus Management
The purpose of this multi-site randomized clinical study is to test a model treatment program in a VA Audiology clinic, to evaluate its efficacy, ease of implementation, and acceptability to audiologists.
The 2004 VA Annual Benefits Report reveals that tinnitus is the third most common individual
service-connected disability in veterans. As of September 30, 2005, there were 339,573
veterans who had been awarded a service connection for their tinnitus, with annual
compensation amounting to over $418,000,000 (Office of Policy and Planning, VA Central
Office). In addition to being a major expense for VHA, tinnitus is a health care problem
that is inadequately addressed at most VA medical centers. We have developed a
research-based model of tinnitus clinical management that is designed for efficient
implementation in VA Audiology clinics. The objective of this study is to establish the
model program at a VA Audiology clinic, and to evaluate its efficacy with veteran patients
and its acceptability to audiologists.
The study is based at the NCRAR, and a prototype tinnitus management program will be
established in the Audiology Clinic at the James A. Haley (Tampa) VA Medical Center. 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. It is hypothesized that progressive intervention
will result in a significant reduction in self-perceived tinnitus handicap relative to usual
care.
A comprehensive web-based tinnitus training course for audiologists has been developed, as
well as a patient tinnitus-information book that uses principles of low health literacy. Six
audiologists at the Tampa VA are participating in the study, of which three were randomly
selected to complete the training course as preparation to conduct each of five levels of
progressive intervention: (1) triage; (2) audiologic evaluation; (3) group education; (4)
tinnitus evaluation; and (5) individualized management. The other three audiologists have
not received the training, and these "usual care" audiologists provide intervention that
more closely typifies what is done at some VA medical centers.
Patients will be randomized to one of the two groups. All patients will complete outcomes
questionnaires (Tinnitus Handicap Inventory [THI] and Veterans Short Form-36 health survey
[SF-36V]) at baseline, immediately post-treatment and 6 months post treatment. Outcomes of
the THI will be compared between the two groups of patients to test the hypothesis. Data
from the SF-36V will be used in secondary outcomes analyses. Each of the six audiologists
will be interviewed informally to determine their satisfaction with the tinnitus services
that they provide, and how they feel they are meeting the needs of their patients. The three
web-based-trained audiologists will provide formative data to the Co-PI on an ongoing basis
to monitor and adjust the program to achieve the best possible outcomes.
Development and evaluation of this prototype program will establish its practical utility
for addressing the tinnitus needs of veterans in a comprehensive, yet efficient, fashion. If
the study shows that the program is effective, then the program could establish the standard
for tinnitus management at all VA medical centers-meeting the needs of all veterans who have
access to VA services.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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