Hearing Loss, Tinnitus
Conditions
Keywords
Counseling, Education, Evaluation studies, Quality of health care, Rehabilitation of hearing impaired, Triage
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREProgressive Audiologic Tinnitus Management
The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management.
PROCEDUREUsual Care
Typical audiologic care that would be received in a VA Audiology Clinic.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Veterans who: * Are outpatients at VA clinics in the vicinity of the James A. Haley VA Medical Center in Tampa, FL * Have clinically significant tinnitus * Have no significant language barrier * Are capable of and willing to fulfill all study requirements
Exclusion criteria
* Subjects must be free from any medical conditions that would interfere with study participation, e.g. medically or surgically treatable otologic disease; end-stage renal, pulmonary, or cardiovascular disease * Patients undergoing chemotherapy or radiation treatment * Patients with severe psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| THI (Tinnitus Handicap Inventory) | Baseline, 6 months | The THI (Tinnitus Handicap Inventory) is a statistically validated tinnitus questionnaire that provides an index score, ranging from 0 to 100, with higher scores reflecting greater self-perceived tinnitus handicap. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tinnitus Progressive Management Tinnitus Progressive 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) tinnitus evaluation; and (5) individual management. | 92 |
| Usual Care Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic. | 89 |
| Total | 181 |
Baseline characteristics
| Characteristic | Tinnitus Progressive Management | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 56.0 years STANDARD_DEVIATION 11.2 | 59.0 years STANDARD_DEVIATION 10.5 | 57.5 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 92 participants | 89 participants | 181 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 89 Participants | 87 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
THI (Tinnitus Handicap Inventory)
The THI (Tinnitus Handicap Inventory) is a statistically validated tinnitus questionnaire that provides an index score, ranging from 0 to 100, with higher scores reflecting greater self-perceived tinnitus handicap.
Time frame: Baseline, 6 months
Population: The THI was completed by 58 of the 92 PATM patients at both baseline and 6 months. The THI was completed by 68 of the 89 Usual Care patients at both baseline and 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | THI (Tinnitus Handicap Inventory) | Baseline | 37.0 scores on a scale | Standard Deviation 24.3 |
| Arm 1 | THI (Tinnitus Handicap Inventory) | 6 months | 33.0 scores on a scale | Standard Deviation 26.4 |
| Arm 2 | THI (Tinnitus Handicap Inventory) | Baseline | 43.0 scores on a scale | Standard Deviation 25.4 |
| Arm 2 | THI (Tinnitus Handicap Inventory) | 6 months | 40.0 scores on a scale | Standard Deviation 27.6 |