Tinnitus
Conditions
Keywords
Tinnitus, Counseling, Education, Rehabilitation of hearing impaired, Triage, Evaluation studies, Quality of health care
Brief summary
This multi-site study evaluated 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.
Detailed description
Objectives. We completed 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 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 was to conduct a randomized clinical trial at multiple VA medical centers to evaluate the effectiveness and clinical utility of PTM as compared to Wait List Control. Plan. The 3-year study was based at the VA National Center for Rehabilitative Auditory Research (NCRAR), and PTM was 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 were modified (especially with the addition of Cognitive-Behavioral Therapy - CBT); (b) training materials were developed (the web-based PTM training program for VA audiologists was updated; PTM training will be developed for VA psychologists); (c) by random selection, five audiologists (two in Memphis, three in West Haven) were identified to conduct PTM and five (two in Memphis, three in West Haven) were identified to conduct usual care; (d) the five PTM audiologists (the West Haven study psychologist developed the training). By month 7, the randomized clinical trial was implemented at the two VA sites and continued through year 3. Methods. Prior to conducting the clinical trial, PTM was 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) were randomized into either PTM or Wait List Control. Self-perceived tinnitus handicap was evaluated pre- and post-intervention for each subject using the Tinnitus Handicap Inventory. The five audiologists and two psychologists who participate in this study were 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. 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 extends 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.
Interventions
PROCEDUREProgressive 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
PROCEDUREWait List Control
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.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* are eligible for audiology services at their respective VAMC; * report the chronic presence of tinnitus (i.e., they have tinnitus that they can usually hear when they listen for it in a quiet room); * report that their tinnitus is at least a small problem; and * are willing to give verbal consent.
Exclusion criteria
* are not Veterans; * have received previous tinnitus services at their VAMC; * report that their tinnitus is no problem; * are unable (for any reason) to fulfill all of the requirements of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Functional Index Change Score | Baseline, 6 months (from Baseline) | The Tinnitus Functional Index (TFI) is a tinnitus outcome measure that has been validated for responsiveness (Meikle et al., 2012). Prior to the TFI, no tinnitus questionnaire had been specifically designed and tested to maximize responsiveness to treatment-related change. Completion of the 25-item TFI results in an index score that can range from 0 to 100, with higher scores reflecting greater problems associated with tinnitus. The following is a general guide to facilitate interpretation of TFI scores: * \<25 = relatively mild tinnitus (little or no need for intervention) * 25-50 = significant problems with tinnitus (possible need for intervention) •\>50 = tinnitus severe enough to qualify for more aggressive intervention Data from the TFI development study (Meikle et al., 2012) suggest that a reduction in the TFI score of at least 13 points would indicate a clinical improvement that a patient would consider important or meaningful. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Care 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 | 150 |
| Wait List Control 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. Wait List Control subjects also can be referred for other clinical services as deemed appropriate. | 150 |
| Total | 300 |
Baseline characteristics
| Characteristic | Immediate Care | Wait List Control | Total |
|---|---|---|---|
| Age, Continuous | 57.72 years STANDARD_DEVIATION 13.92 | 58.05 years STANDARD_DEVIATION 12.05 | 57.89 years STANDARD_DEVIATION 12.99 |
| Region of Enrollment United States | 150 participants | 150 participants | 300 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 145 Participants | 141 Participants | 286 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
Tinnitus Functional Index Change Score
The Tinnitus Functional Index (TFI) is a tinnitus outcome measure that has been validated for responsiveness (Meikle et al., 2012). Prior to the TFI, no tinnitus questionnaire had been specifically designed and tested to maximize responsiveness to treatment-related change. Completion of the 25-item TFI results in an index score that can range from 0 to 100, with higher scores reflecting greater problems associated with tinnitus. The following is a general guide to facilitate interpretation of TFI scores: * \<25 = relatively mild tinnitus (little or no need for intervention) * 25-50 = significant problems with tinnitus (possible need for intervention) •\>50 = tinnitus severe enough to qualify for more aggressive intervention Data from the TFI development study (Meikle et al., 2012) suggest that a reduction in the TFI score of at least 13 points would indicate a clinical improvement that a patient would consider important or meaningful.
Time frame: Baseline, 6 months (from Baseline)
Population: The analysis was intention to treat (ITT). Includes all subjects from whom both baseline and 6 month data were collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Care | Tinnitus Functional Index Change Score | -5.71 units on a scale | Standard Deviation 18.77 |
| Wait List Control | Tinnitus Functional Index Change Score | .8 units on a scale | Standard Deviation 17.47 |