Progressive Tinnitus Management: Counseling Guide is designed for conducting one-on-one counseling. While the PTM counseling involves both audiologic and psychologic counseling, this book focuses on the audiologic counseling. However, it can be used for any patient who requires individual counseling to learn how to manage reactions to tinnitus. The Counseling Guide is used like a flip chart, but laid flat on a table between clinician and patient.
James Henry, Ph. His research focuses on the development of standardized protocols for clinical assessment and management of tinnitus, and conducting randomized clinical trials to assess outcomes of different methods of tinnitus intervention. Through her involvement in tinnitus clinical trials over the last 10 years at the NCRAR, she has developed considerable expertise in tinnitus assessment and management, and in the training of audiologists to perform tinnitus management. Paula Myers, Ph.
Haley VA Hospital. Her research focuses on the development of patient health education programs and materials, standardized protocols for clinical assessment and management of tinnitus, and blast injury and auditory dysfunction. Caroline J. In , the team began a series of clinical trials to evaluate different methods of tinnitus management [9]. This work not only provided efficacy data but also identified procedures that were most efficient for clinical application.
The first three of these studies [9—11] supported the need for a stepped-care "progressive" approach to tinnitus management. PATM was developed as a hierarchical model of providing clinical services for Veteran patients who complain of tinnitus [12]. The hierarchy of services involved in the protocol includes five stepped levels of care. The objective of this study was to define and test a tinnitus-management protocol that could be administered in VA Audiology clinics with minimal impact on routine clinical activities.
The work required two phases. For phase 1, a model of care was defined and the necessary materials to administer the protocol were developed.
Phase 2 involved conducting a pilot study to examine the feasibility and potential efficacy of the new program. A thorough literature review was conducted with particular attention to the prior tinnitus clinical services offered for Veterans.
Weekly conferences were held with the study team as the model was developed, drawing on VA and external experts as needed. The proposed tinnitus-management program was based on a "progressive intervention" approach that we had previously conceptualized [13].
The program took into account the fact that most individuals with tinnitus do not require extensive intervention [2] Figure 1. Most of them require education, which can be administered efficiently and consistently through a structured group education process [10,14—15]. A triaging protocol was also required to ensure that the tinnitus does not indicate the presence of a medical problem requiring surgery a rarity or some other serious medical condition.
The relatively few patients requiring further services could progress to receive an in-depth tinnitus evaluation level 4 and individualized intervention as needed level 5. Appendix 1 available online only provides details of the PATM protocol and the clinical materials that were developed. Tinnitus pyramid [2]. Concept depicted here is that pyramid contains entire population of people who experience chronic tinnitus.
Majority of these people lower part of pyramid are not particularly bothered by their tinnitus. Many only want assurance that their tinnitus does not reflect some serious medical condition middle of pyramid. Relatively few have tinnitus that requires some degree of clinical intervention toward top of pyramid. Click Image to Enlarge. View as PowerPoint Slide. Tinnitus pyramid represents population of all people who experience chronic tinnitus see Figure 1. Typical progression for patients beyond level 1 Triage is level 2 Audio-logic Evaluation , level 3 Group Education , level 4 Tinnitus Evaluation , and level 5 Individualized Management.
Decreasing numbers of patients require the higher levels of services. In fact, the great majority of patients who complain of tinnitus have their needs met at levels 2 and 3.
The American Speech-Language-Hearing Association includes tinnitus management in its scope of practice for audiologists [16], which is justified for many reasons [17—18]. Audiologists were therefore the primary providers of the intervention for this study.
The training Web site incorporated a modular design i. Plans were made to secure continuing education credits for providers who completed the modules. Details of the online training course are provided in Appendix 2 available online only. Approximately 2 yr were spent developing the PATM clinical materials and online training modules described in Appendixes 1 and 2 , respectively; available online only. This work was guided by the modified PATM model, educational research, and VA guidelines about appropriate language levels and formatting.
The materials were repeatedly reviewed and modified by the team of study audiologists. All these audiologists had prior experience providing clinical tinnitus services, involving hearing aids, combination instruments hearing aid and sound generator combined , and basic audiologic counseling education about tinnitus and various problem-solving and coping strategies.
The audiologists were randomized by the study biostatistician to provide either PATM or usual care UC for tinnitus management. Of note, the audiologists randomized to UC all had considerably more tinnitus-management training and experience than the audiologists randomized to PATM.
They had to report that their tinnitus was at least a "small problem" see "Screening and Randomization" section. The providers received copies of referral guidelines that were developed for the pilot study Tinnitus Triage Guidelines; see Appendix 1 , available online only.
None of these providers was required to participate. These three sources of recruitment were sufficient, and no recruitment advertisements were posted. Patients who expressed interest in study participation were asked up to four questions by the RA to determine candidacy: 1 "Do you have ringing, humming, buzzing, or other sounds in your ears or head? The RA mailed the baseline questionnaires see "Questionnaires" section to eligible patients to complete before their initial visit.
These patients were not required to sign an informed consent form. A Waiver of Documentation of Informed Consent was approved by the IRB because the clinical services provided in conjunction with the study were considered routine and customary care.
After audiologic testing, patients randomized to UC received a frequently asked questions handout on tinnitus education and brief counseling about the use of sound to manage tinnitus. Individualized tinnitus counseling was offered as an option to those patients requesting further services. These patients also had the option of receiving sound therapy devices, including ear-level sound generators and combination instruments, and tabletop sound conditioners.
They were told that if they desired further services after reading the workbook, they were welcome to attend two group workshops, separated by 2 wk and conducted by one of the three PATM audiologists. The workshops and workbook are described in Appendix 1 , available online only. Following the workshops, patients were offered further intervention, if needed.
These questionnaires were mailed to all eligible patients following the telephone screening and again 6 mo later. Screening versions of the HHI are also available.
The HHIE-S was chosen because it is short and contains no questions about employment, making it applicable to all patients regardless of employment status and age. The THI is a statistically validated tinnitus questionnaire that provides an index score, ranging from 0 to , with higher scores reflecting greater self-perceived tinnitus handicap. A change in the index score of at least 20 points is reported to indicate a clinically significant improvement for individuals at the 95 percent confidence level [26].
A shortcoming of the THI and of all statistically validated tinnitus questionnaires is that it is vulnerable to influence from hearing problems; i. Therefore, a high score on the THI could indicate the need for intervention for a hearing problem rather than for a tinnitus problem. For this reason, the THI could not be relied upon alone to determine the need for intervention specifically for tinnitus and was thus supplemented by the THS.
The THS was developed to distinguish between self-perceived tinnitus problems and hearing problems, making it an efficient tool to determine whether intervention specific to tinnitus is needed [23].
Discussion of the THS results with the study subjects was the primary means of determining whether intervention for tinnitus should be offered. Data were also analyzed to determine whether patients in each group were similar with respect to demographics, health status, and tinnitus severity at baseline. To compare groups, a Student t -test was used for continuous variables and a chi-square test for categorical data. Due to multiple comparisons, Bonferroni corrections were applied.
Due to the exploratory nature of this project, formative data collection was planned. A formative evaluation has been defined as "a rigorous assessment process designed to identify potential and actual influences on the progress and effectiveness of implementation efforts" [28, p. Formative data included semistructured surveys for the audiologists about the online training experience, four interviews with the study audiologists as a group during the study, individual discussions between audiologists and the Chief of Audiology Section PJM on site throughout the study, and weekly conference calls with the study team for which detailed minutes were taken.
Records were kept and data were collated and analyzed by the team implementation specialist MWL and reported to the team to identify barriers to care and issues encountered when using the new materials. Themes were noted and changes effected due to this information were recorded. A clinical handbook was completed that consisted of detailed procedures, checklists, handouts, forms, and questionnaires needed to conduct each of the five hierarchical levels of PATM.
The five levels of care and the materials developed for each level are described in Appendix 1 available online only , and a description of the online training program is provided in Appendix 2 available online only. After completing the online training course, audiologists responded anonymously to brief semistructured surveys about the training modules.
Questions addressed time to complete, utility of information conveyed, confidence of learner to perform the described practices, and perceived barriers to completing the described practices. Responses were tallied and shared with the study team. The results of this survey indicated that time to complete each varied by learner and by content from less than 30 min to more than 2 h usually 31—60 min. All three PATM audiologists endorsed the course as useful to their practice and that the module content met their stated objectives.
Their level of confidence in the ability to perform practices as described was divided between 51—75 percent and 76— percent. No one reported seeing significant barriers to performing the work. Each module, or chapter, stated objectives and then presented learning content that also contained comprehension questions throughout. Responses were analyzed and a detailed report was written by the implementation research specialist MWL. The responses are summarized below [along with lessons we have drawn from them].
Of these patients, 20 randomized to UC and 20 randomized to PATM were excluded from participation because they did not show up, called to be removed, or had a serious health concern that might have interfered with participation. The randomization was successful in that patients in the PATM and UC groups were not significantly different in demographics age, sex, race, education or health variables perceived health, mental health diagnoses, or tinnitus handicap Table.
The patients randomized to PATM varied widely by age, averaging 56 yr. They were predominantly male and half reported education beyond grade Approximately one-quarter of the PATM patients were nonwhite. Their self-reported health ranged from poor to excellent, with Their baseline mean THI index score was Of the 92 PATM patients, 28 Following level 3, 4 4. Of the 89 UC patients, 37 attended a tinnitus-evaluation appointment and 52 attended a second appointment to receive hearing aids.
The mean baseline THI index score for these 58 patients was The mean baseline and 6 mo THI index scores for these 68 patients was However, because only 8 of the 92 PATM patients attended both sessions of the level 3 intervention, a statistical comparison of patients between groups would not have yielded meaningful data.
The three PATM audiologists were interviewed as a group four times during the study about using the PATM model and about the materials provided for this purpose including implementation, acceptance by patients and staff, and clinical effectiveness.
They were also asked about satisfaction and the perceived clinical effectiveness of the interventions. Participants on these calls included the implementation consultant, study team members, and the PATM audiologists.
A semistructured discussion was conducted on each call, with detailed minutes transcribed for analysis. The following issues were identified and addressed. Notes were kept about issues discussed and decisions reached. Of primary interest was identifying changes that may be necessary or barriers to performing the work as described. PATM audiologists provided formative data to the co-principal investigator PJM on an ongoing basis, which focused on improving fidelity to the protocol.
Themes that appeared from the data included the importance of working with administrators at sites planning to use PATM concerning the requirements of audiologists and patients: release time for audiologists for educational course, to establish a smooth referral system in and out of the audiology clinic, to clarify the kinds and amounts of ear-level devices that may be needed, and to establish the importance of providing a location and time for level 3 classes.
This project was designed to develop all materials necessary to implement the PATM protocol and then to introduce the PATM clinical model at one VA site, obtaining pilot data to evaluate its clinical utility relative to UC i. A major goal of this project was to learn about the process of putting the PATM protocol into clinical practice.
To do so, we conducted several formative evaluations. Development of the PATM implementation materials was a substantial undertaking requiring 2 yr of continuous effort by the study team. Insights gained from our previous controlled studies were applied to the new PATM protocol. Five hierarchical levels of PATM were defined, and detailed clinical procedures were developed for each level.
A completely new counseling protocol was developed that incorporated principles of patient education and health literacy to ensure that the materials were accessible to as many Veterans as possible [29]. An online, module training course was developed for audiologists see Appendix 2 , available online only , and numerous clinical materials were developed for audiologists and patients see Appendix 1 , available online only.
Major educational materials were developed to implement the protocol at the different levels, including 1 a self-help workbook 94 pages given to patients at level 2 Audiologic Evaluation [19], 2 PowerPoint presentations for use during the two classes comprising level 3 Group Education, 3 DVD video presentations for use during the two classes comprising level 3 Group Education, and 4 a counseling guide to facilitate one-on-one counseling during level 5.
Following development of the PATM program, a pilot clinical trial of the new method was implemented. The pilot trial did not result in useful outcome data because too few of the patients progressed to receive the intervention they mostly received an audiologic assessment, and many required amplification.
The most notable finding gleaned from this pilot study was how little tinnitus-specific intervention was required for the majority of patients.
This finding supports the rationale for progressively providing only as much intervention as needed. Some comments are necessary to provide the proper perspective to interpret the findings of the pilot study. If an intervention is offered, then it would be essential to include only subjects who have a condition warranting receipt of the intervention. The "condition" of tinnitus does not necessarily require intervention.
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Instructions: 1. Follow along with the video, hosted by James A.
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