Voices From the Field: A Quality Improvement Project for Progressive Tinnitus Management 2.0.

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Published in final edited form as: Am J Audiol. 2024 Oct 8;33(4):1077–1091. doi: 10.1044/2024_AJA-23-00167 Voices From the Field: A Quality Improvement Project for Progressive Tinnitus Management 2.0 Khaya Clark a, b, c , Suheily Lovelace d, e , John C Moring f , Emily J Thielman a , Kassander A Thompson g , James A Henry a, h , Tara Zaugg i Author information Article notes Copyright and License information a National Center for Rehabilitative Auditory Research (NCRAR), VA Portland Health Care System, OR b Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland c Center to Improve Veteran Involvement in Care (CIVIC), VA Portland Health Care System, OR d zCore Business Solutions, Inc., Round Rock, TX e The Hearing Center of Excellence, Dearborn, MI f Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio g Department of Speech, Language, and Hearing Sciences, University of Connecticut, Storrs h Department of Otolaryngology—Head & Neck Surgery, School of Medicine, Oregon Health & Science University, Portland i Veterans Integrated Service Network 20, VA Boise Health Care, ID ✉ Correspondence to Khaya Clark: Khaya.Clark@va.gov . Issue date 2024 Dec 2. PMC Copyright notice PMCID: PMC13235278  NIHMSID: NIHMS2167634  PMID: 39377661 The publisher's version of this article is available at Am J Audiol Abstract Purpose: Tinnitus is a common health condition in the general population, with increased prevalence among military Veterans. Tinnitus is, in fact, the most prevalent military service–connected disability. There is no cure for tinnitus, but interventions are available to help patients manage their reactions to tinnitus and reduce its functional impact. Progressive tinnitus management (PTM) is a stepped-care protocol that involves coordinated audiological and behavioral health clinical services. PTM was endorsed by national Veterans Affairs (VA) audiology leadership in 2009. Given new clinical insights and research findings since the initial rollout of PTM, it remains necessary to improve and update the protocol in response to feedback from clinicians and patients. Method: This two-phase quality improvement project captured quantitative and qualitative feedback from VA and Department of Defense (DOD) clinicians and patients concerning PTM materials. A convergent parallel mixed-methods design was used to integrate the quantitative and qualitative data, and a consensus method was used to adjudicate any discrepant findings. Results: In Phase 1, 21 VAs and DOD clinicians and patients completed semi-structured interviews and quantitative measures on the PTM handbook and workbook revisions. Phase 1 findings were recommendations to modify content, format, and adaptations of content (e.g., electronic formats with a clickable index). In Phase 2, six non-Veteran patients assisted in pilot testing PTM PowerPoint slides used by clinicians for PTM skills education sessions. Phase 2 findings indicated that the revised PTM PowerPoint slides were useful and clinically acceptable. Conclusions: Findings from this study are being used to revise and update materials in the PTM skills education sessions. More generally, the study demonstrates the necessity of end-user input to inform and implement clinical updates. Supplemental Material: https://doi.org/10.23641/asha.27057691 Chronic tinnitus is a common but frequently misunderstood condition experienced by 10%–15% of adults ( Henry et al., 2020 ; Trevis et al., 2018 ). Approximately 80% of individuals affected by tinnitus do not pursue tinnitus-specific clinical services ( Henry et al., 2020 ; Hoffman & Reed, 2004 ; Jarach et al., 2022 ; Tunkel et al., 2014 ). Adverse effects of tinnitus motivate the remaining 20% of those who suffer with it to seek clinical care. Difficulties associated with tinnitus include, but are not limited to, sleep disturbances ( Folmer & Griest, 2000 ; Li et al., 2022 ), impaired concentration ( Trevis et al., 2018 ), and negative emotional reactions ( Aazh & Moore, 2018 ). Military personnel have a much higher risk of developing tinnitus by proximity to hazardous noise sources, including military aircraft ( Smalt et al., 2017 ) and weapons fire ( Beach et al., 2013 ; Brungart et al., 2019 ; Jokel et al., 2019 ), and by exposure to other known risk factors for acoustic trauma such as car bombs, improvised explosive devices, incoming mortar attacks, and rocket-propelled grenades ( Moring et al., 2018 ). Those who experience blast-related traumatic brain injury (TBI) have an increased likelihood of developing tinnitus during and after deployment ( Moring et al., 2018 ; Yurgil et al., 2016 ). Additionally, Veterans and active-duty Service members are regularly exposed to ototoxic levels of occupational noise and solvents ( Gordon et al., 2017 ; Henry et al., 2017 ), which are further associated with an increased risk for developing tinnitus. As of fiscal year 2022, tinnitus was the most prevalent service-connected disability (over 2.7 million Veterans; Veterans Benefits Administration, 2023 ). Veterans have a relatively high prevalence of mental health conditions ( Fagelson, 2007 ; Oster et al., 2017 ; Trevis et al., 2018 ), and approximately half of Veterans who seek intervention for bothersome tinnitus also live with one or more mental health conditions ( Carlson et al., 2019 ). Comorbidities common to tinnitus include posttraumatic stress disorder (PTSD; Fagelson, 2007 ; Moring et al., 2018 ; Oster et al., 2017 ); TBI ( Carlson et al., 2019 ; Oster et al., 2017 ; Yurgil et al., 2016 ); anxiety, depression ( Trevis et al., 2018 ); and suicidal ideation ( Aazh & Moore, 2018 ; Han et al., 2018 ; Oster et al., 2017 ). Given the higher prevalence of both tinnitus and mental health conditions in Veterans, in some cases, comorbidity may be simple co-incidence ( Carlson et al., 2019 ; Folmer et al., 2011 ; Schmidt et al., 2018 ). It is also possible that mental health symptoms may be worsened by bothersome tinnitus or that poor mental health may make tinnitus more difficult to tolerate. Progressive tinnitus management (PTM) is a steppedcare program designed to facilitate the development of an individualized approach to tinnitus care. Coordinated by audiology and behavioral health, the program teaches coping strategies to improve functional status and quality of life with tinnitus. Delivered in clinical settings or by telephone, PTM has been demonstrated effective in reducing the negative impact of tinnitus and improving quality of life ( Beck et al., 2019 ; Henry et al., 2017 ; Henry, Thielman, et al., 2019 ; Schmidt et al., 2017 ; Sherlock et al., 2019 ). Self-management skills acquired through PTM are reported to remain effective 5 and 10 years after completion of PTM, indicating its sustained benefit ( Edmonds et al., 2017 , 2022 ). Due to these findings, VA’s central office and audiology leaders continue to endorse PTM. However, the most recent versions of the PTM clinician handbook ( Henry et al., 2010a ) and patient workbook ( Henry et al., 2010b ) are now 14 years old. These resources remain in current clinical use, but they should be updated to maintain their relevance and clinical currency. In 2018, the Veterans Affairs (VA) enacted a Whole Health (WH) initiative to advocate for a more proactive and patient-centered approach to care ( Haun et al., 2021 ). The WH model takes a holistic view of patients’ goals, values, and preferences to drive care delivery. Its objective is to provide resources and self-care tools that support patient well-being through a biopsychosocial (vs. diseasebased) model of care ( Bokhour et al., 2020 ; Edmonds et al., 2017 ). The WH program is being implemented into a variety of VA clinical programs for chronic conditions, including tinnitus. Because tinnitus is a chronic condition with no cure, the WH model offers an opportunity to focus on patient wellness, goals, values, and living life to its fullest. This approach is also consistent with PTM strategies to improve quality of life and functional status through coping strategies (e.g., sound and relaxation techniques) and proactive engagement in enjoyable activities. Teaching these strategies may also help Veterans to manage other difficulties (e.g., PTSD, pain, sleep apnea, anxiety, depression, relationship problems). PTM has always included goal setting to support activities of daily living that may be disrupted by tinnitus (sleep, relaxation, concentration, etc.). The WH-updated version of PTM (PTM 2.0) maintains original tinnitusspecific goal setting. In addition, the content includes additional WH-related goals focused on values and living life to its fullest. A WH implementation specialist was included as part of the PTM 2.0 quality improvement (QI) project to support the updates that integrate concepts of WH into PTM. QI initiatives can identify and mitigate barriers that would otherwise reduce access to clinical care ( Green et al., 2010 ). This approach has been used to standardize and streamline Veteran health care, increase overall population health, enhance patient safety standards, and improve patient outcomes ( Gawron et al., 2018 ; Newins et al., 2019 ). Here, we report a QI project to revise PTM 2.0 program materials based on collaboration and feedback from stakeholders from audiology, psychology, WH, implementation science, and patients familiar with PTM. Including patients’ experiences and perspectives is widely acknowledged as an integral component to quality care ( Committee on Quality of Health Care in America, 2001 ) and for informing clinical improvements ( Locock et al., 2020 ). Our aim is to improve Veteran health outcomes by breaking down barriers to utilization (for clinicians) and barriers to care (for patients with bothersome tinnitus). The main objective of this QI project was to determine how to update PTM 2.0 materials while maintaining the core PTM clinical goals of reducing tinnitus-related distress and increasing patient functional status. This objective was achieved by soliciting end-user (i.e., clinical and patient partners) feedback concerning the need to add or remove specific elements, condense materials, update graphics, and/or reorganize the structure or format of PTM 2.0 materials to ensure their usability. We also explored the integration of PTM 2.0 materials in the context of the VA’s WH initiative to ensure the intelligibility and usability of all PTM 2.0 program content and material. The Standards for Quality Improvement Reporting Excellence in Education 2.0 ( Ogrinc et al., 2016 ) guided our reporting of the findings from this project. Method Ethical Issues The VA Portland Health Care System (VAPORHCS) institutional review board designated this project as a QI activity (i.e., not research). Although we were not required to obtain informed consent, all participants were aware they were participating in a QI project. To ensure participants’ privacy, interviews from Phase 1 were de-identified. Qualitative data collected from Phase 2 and notes taken during the pilot test were also de-identified. In addition, one of the developers of PTM (T.Z.) served as a facilitator in Phase 2 and declared her status as part of the PTM 2.0 development team. Recruitment Phase 1 Researchers recruited VA and Department of Defense (DOD) clinicians using VA and DOD electronic mailing lists. VA and DOD clinicians informed patients of the project by sharing project flyers. Those interested in completing interviews contacted the project team to schedule their interviews. Phase 2 Since the inception of PTM, the National Center for Rehabilitative Auditory Research (NCRAR) has maintained a contact list of Veterans interested in PTM and other tinnitus support services. Using this extensive contact list, researchers recruited individuals via postcards to participate as members of a patient panel. Interested participants contacted the project team facilitators to join the project. The only inclusion criterion was interest in learning coping strategies for tinnitus via online, video-based participation. Participants Phase 1 One VA clinician and three DOD clinicians completed interviews on the PTM handbook for audiologists ( n = 4). Seven VA clinicians and four DOD clinicians completed interviews on the PTM workbook ( n = 11), while four VA patients and two active-duty DOD patients completed interviews on the PTM workbook ( n = 6). Phase 2 Individuals with bothersome tinnitus ( n = 6) were recruited for a virtual pilot PTM course under the facilitation of a VA research audiologist (an original PTM developer; T.Z.) and a VA clinical psychologist. The pilot test was conducted virtually due to COVID-19–related restrictions on in-person care. Several members of the VA–DOD Tinnitus Working Group (TWG; i.e., audiologists, psychologist, implementation researcher) observed the pilot test, took notes, participated in a question-and-answer session with the facilitators and participants after each pilot session, and then participated in a team debrief without the participants after each pilot session. The patient panel was split into two groups based on their availability. Researchers did not collect demographic information during Phase 2; however, one participant self-reported as a Veteran. PTM Materials PTM was developed by Dr. James Henry and colleagues at the NCRAR at the VAPORHCS ( Henry et al., 2010a ). PTM is patient-centric stepped-care program used in the VA and DOD. Grounded in evidenced-based practices, it aims to help patients with tinnitus to effectively improve their quality of life and functional status. It involves collaboration between audiology and behavioral health practitioners to ensure comprehensive and coordinated care. PTM support materials include a published patient workbook, titled How to Manage Your Tinnitus: A Step-by-Step Workbook ( Henry et al., 2010b ); a clinician handbook, titled Progressive Tinnitus Management: Clinical Handbook for Audiologists ( Henry et al., 2010a ); and a series of PowerPoint presentations that clinicians can use to implement PTM in clinical settings. The third edition of the patient workbook, published in 2010, consists of four chapters and 10 appendices: (a) Introduction to Tinnitus , (b) Using Sound to Manage Tinnitus , (c) Changing Thoughts and Feelings to Manage Reactions to Tinnitus , (d) Protect Your Ears , and (e) Appendices A–J. The clinician handbook consists of nine chapters and 15 appendices, outlining tinnitus management at five different levels (referral, audiologic evaluation, skills education, interdisciplinary evaluation, and individualized support). As its name implies, PTM is progressive, meaning that the intensity and duration of therapeutic support depend on the severity of tinnitus and each patient’s individual needs. The VA and DOD have adopted PTM as their preferred approach for the clinical management of tinnitus. Procedures Phase 1 Phase 1 was composed of semistructured interviews with VA and DOD patients and clinicians who were already familiar with the PTM course and support materials. All patients had participated in a PTM workshop within 2 years of the interview, and all clinical audiologists and psychologists had used the PTM materials as part of their tinnitus management practice. The team developed six interview guides to streamline interactions with participants, effectively organizing the interviews to ensure the team gathered all pertinent information. These six interview guides included (a) VA Clinician Handbook Interview Guide, (b) VA Clinician Workbook Interview Guide, (c) VA Patient Workbook Interview Guide, (d) DOD Clinician Handbook Interview Guide, (e) DOD Clinician Workbook Interview Guide, and (f) DOD Patient Workbook Interview Guide. Each interview guide was specific to participant type (clinician or patient), setting (VA or DOD), and which PTM materials were being reviewed. VA and DOD clinicians completed interviews regarding either the handbook for audiologists ( Henry et al., 2010a ) or the patient workbook ( Henry et al., 2010b ). VA and DOD patients completed interviews about the patient workbook only. At the beginning of each interview, participants were asked to provide their demographic information. Each interview included Likert-type rating scales and open-ended questions to solicit interviewees’ ratings and opinions about PTM 2.0 content, format, organization, and accessibility. Interviewees indicated which chapters, sections, and appendices they used most frequently, how helpful those portions were, and how to increase the usability of the less helpful portions. Researchers also collected interviewees’ opinions about the real-life use of each guide, advice the interviewees would share with others about PTM 2.0 and tinnitus, and any personal modifications they had made that proved clinically beneficial. Using one of the six interview guides, 21 interviews were conducted between September 2020 and May 2021, using a virtual platform (Microsoft Teams) or by phone. Each interview lasted approximately 90 min. Participants scored individual sections of the patient workbook and/or clinician handbook using a Likert rating scale from very helpful, neither helpful or unhelpful, not so helpful , to not helpful at all , or I don’t know . Each rating scale response was followed by a series of open-ended questions to assess why the participant chose a particular rating and to identify which workbook and/or handbook section(s) could be presented in different formats or organized differently. After completing the ratings of individual workbook or handbook sections, five open-ended questions requested feedback about patient experiences with tinnitus, the impact of tinnitus on their quality of life, and clinicians’ experiences with providing care for tinnitus. Interviews were digitally recorded and professionally transcribed. Data collected from the interviews were analyzed using the qualitative software program Atlas TI. Results from this phase guided the multidisciplinary work group and the TWG to identify necessary and preferred updates to the patient workbook, the clinician handbook, and the clinician PowerPoints. Using the data collected from Phase 1, a multidisciplinary work group composed of clinical audiologists and clinical psychologists, two of the original developers of PTM, and a VA WH Implementation Specialist updated the PTM 2.0 PowerPoint slides and associated patient worksheets that VA clinicians use in PTM sessions with their patients. These updates to PTM 2.0 are further being incorporated by DOD clinicians who provide PTM to their patients. Phase 2 Phase 2 included the implementation of a pilot PTM 2.0 course using materials as revised from Phase 1, as well as the assessment of (a) revised PTM 2.0 PowerPoint and patient worksheets, (b) format of the presentation and worksheets, and (c) overall usability and accessibility of revised PTM 2.0 course materials. The facilitation materials used by audiologists and mental health clinicians for formal PTM 2.0 administration included revised PowerPoint presentations and patient handouts. Each group of participants completed the pilot PTM 2.0 course between June and August of 2022. The course was separated into eight 90-min sessions, including five mandatory and three optional sessions. The session topics and their order of delivery are presented in Table 1 . Table 1. Progressive tinnitus management PowerPoint Sessions 2.0. Session # Content description Mandatory/optional 1 Introductory Mandatory 2 Sound 1 Mandatory 3 Planning Pleasant Activities Mandatory 4 Relaxation Techniques Mandatory 5 Sound 2 & Homework Review Mandatory 6 Changing Thoughts & Feelings 1 Optional 7 Changing Thoughts & Feelings 2 Optional 8 Communication Strategies & Relaxation Review Optional Open in a new tab Session facilitators presented each PowerPoint as they would in a typical clinical PTM workshop setting, with the exception that they met virtually via Zoom due to COVID-19 restrictions. Any documents or worksheets to be used by patients during the PTM 2.0 sessions were e-mailed to participants in advance. Facilitators encouraged participants to print the documents and worksheets for ease of access, so they could fill them out during the session. Session presentations covered various methods to reduce stress and cope with tinnitus, including the use of sound, relaxation techniques, planning and engaging in pleasant activities, and cognitive restructuring. WH concepts were also integrated throughout the PTM 2.0 sessions. Participants were introduced to eight WH self-care practices from the WH Circle of Health ( U.S. Department of Veterans Affairs, 2022 ), that is, moving the body, surroundings, recharge, and so forth (see Figure 1 ). For each of the eight practice areas, participants were asked to rate themselves on a scale of 1 ( low ) to 5 ( high ) to reflect where they are now, and where they want to be. After rating themselves in each area, they were invited to choose one area of self-care and write down one simple self-care action in that area they could complete over the next week. At the beginning of each subsequent session, facilitators asked participants to review which techniques had been successful or unsuccessful from previous sessions. As they moved through the course, facilitators instructed participants to document the most effective methods for improving their quality of life and function with tinnitus, thus building a personalized list of strategies to refer to when feeling particularly bothered by tinnitus. Each session ended with group discussion concerning presentation format, content, and worksheets. Facilitators asked participants whether they found any sections confusing, how they perceived the flow of the presentation, and whether they found the supplemental worksheets and graphics to be useful. Throughout each session, participants were encouraged to share how the course affected their tinnitus experience and overall quality of life. Following each PTM 2.0 session, PTM facilitators and members of the clinical advisory panel remained to discuss how the content was presented; ways to improve wording and flow of any difficult sections; and quality of interactions between the patient panelists, facilitators, and the session content itself. Figure 1. Open in a new tab Diagram of Veterans Affairs Whole Health Circle of Health. The eight areas of self-care are depicted in the inner circles. The figure is reprinted from the U.S. Department of Veterans Affairs’ (2022) “Circle of Health Overview.” Analysis Phase 1 Quantitative data (Likert-type rating scales) were extracted from interview transcripts and tallied for each chapter in the PTM patient workbook (see Supplemental Materials S1 and S2 ). Missing data occurred when a participant failed to provide a rating for a particular workbook component during the interview. Percentages were calculated based on the total number of observed responses for each item. Several participants gave a rating between two categories (e.g., 1.5 is between very helpful and somewhat helpful ). The lower rating was recorded in these cases. In a few cases, although the participant did not explicitly choose a rating, their response could be gleaned from their feedback on the workbook chapter. These gleaned responses were included in the data set. If more than one response could have fit, the lowest rating was used. One participant had never read the workbook appendices; their response was counted as “I don’t use” for each appendix. A convergent parallel mixed-methods design was utilized through the collection of quantitative data (described above), followed by the collection of qualitative data (answers to questions about ratings given). All measures were integrated to guide the interpretation of the results ( Creswell, 2014 ). Approximately 424 pages of interview transcripts were compiled, integrated, and analyzed by six multidisciplinary work group members, guided by the lead analyst. The quantitative data are depicted in Supplemental Materials S1 and S2 , and qualitative data are presented in Tables 2 and 3 . A clinical audiologist with experience in qualitative data analysis reviewed the findings and inserted annotations about how the workbook and handbook content should be revised (or not) based on the feedback. The clinical audiologist presented the data tables and annotated feedback to the TWG during a series of eight 1-hr meetings. We used a consensus-based method to adjudicate any discrepant findings, namely, specific recommendations for changes to PTM 2.0 materials. We used principles from a Nominal Group Technique (NGT; McMillan et al., 2016 ) in which we reviewed the qualitative data over the course of six 1-hr, virtual meetings and discussed the data in a round-robin fashion ( Tully & Cantrill, 1997 ). The NGT was selected because it is a structured method that encourages participants to express their opinions about how to determine which feedback to prioritize ( Black et al., 1999 ; McMillan et al., 2016 ). After each round-robin, we instructed the TWG Delphi panel to submit their vote on proposed patient workbook and clinician handbook changes via e-mail to the lead qualitative analyst. The lead qualitative analyst was responsible for reporting back to the panel on any discrepant opinions regarding these changes. Table 2. Qualitative feedback on progressive tinnitus management patient workbook. Section Participant type Feedback Chapters: Parts 1–4 DOD clinicians Add information for tinnitus counseling for ENTs (Part 1. Introduction) Revise section on pharmaceuticals in “Tinnitus at a Glance” so that it is less likely to cause patient concern (Part 1. Introduction, Tinnitus at a Glance) Provide more guidance on the use of the tinnitus handicap inventory (THI) for sound tolerance after a positive screen (Part 2. Step-by-Step Guide: Using Sound to Manage Tinnitus, Tinnitus and Hearing Survey) Modify or delete sound grids as they cause confusion (Part 2. Step-by-Step Guide: Using Sound to Manage Tinnitus, Sound Grid) Revise sections on relaxation exercises and deep breathing to make them more understandable for clinicians not familiar with behavioral health (Part 3. Step-by-Step Guide: Changing Thoughts and Feelings to Manage Reactions to Tinnitus, Relaxation Exercises) Update information on hearing protection and associated graphics (Part 4. Protect Your Ears) Chapters: Parts 1–4 VA clinicians Create PTM materials for those uninterested in joining a formal PTM program (all chapters) Revise the wording in “Should I See a Physician” section to cause less worry in patients (Part 1. Introduction, Should I See a Physician) Revise section on pharmaceuticals in “Tinnitus at a Glance” so that it is less likely to cause patient concern (Part 1. Introduction, Tinnitus at a Glance) Change wording of “managing reactions to tinnitus” to make it easier to understand (Part 1. Introduction, Tinnitus at a Glance) Modify or delete sound grids as they cause confusion (Part 2. Step-by-Step Guide: Using Sound to Manage Tinnitus, Sound Grid) Eliminate the “changing thoughts” worksheet as it is not often used (Part 3. Step-by-Step Guide: Changing Thoughts and Feelings to Manage Reactions to Tinnitus, Changing Thoughts) Change “tinnitus relief” to “soothing scale” (Part 2. Step-by-Step Guide: Using Sound to Manage Tinnitus, Soothing Sound) Add audio tracks in “interesting sounds” or provide guidance on alternative ways to find sounds (Appendix C) Modify the “changing thoughts” section to clarify who is and isn’t qualified to teach that section (Part 3. Step-by-Step Guide: Changing Thoughts and Feelings to Manage Reactions to Tinnitus, Changing Thoughts) Revise wording of “thought errors” to have a less negative connotation (Part 3. Step-by-Step Guide: Changing Thoughts and Feelings to Manage Reactions to Tinnitus, Changing Thoughts) Chapters: Parts 1–4 VA and DOD patients Add information about anatomy and physiology in “what is tinnitus chapter” (Part 1. Introduction, What is Tinnitus) Combine redundant portions of “what is tinnitus” and “tinnitus at a glance” chapters (Part 1. Introduction, What is Tinnitus and Tinnitus at a Glance) Revise the wording in “Should I See a Physician” section to cause less worry in patients (Part 1. Introduction, Should I see a Physician) Add recommendation to providers to create an appropriate and up-to-date list of resources for patients (appendices) Revise “Goals of Tinnitus Management” to remove references regarding feeling less stressed as this is not realistic for many Veterans with co-occurring stress-related conditions (Part 1. Introduction, Goals of Tinnitus Management) Add information about common comorbidities and their impact on tinnitus in the “Goals of Tinnitus Management” chapter (Part 1. Introduction, Goals of Tinnitus Management) Modify or delete sound grids as they cause confusion (Part 2. Step-by-Step Guide: Using Sound to Manage Tinnitus, Sound Grid) Remove “Ongoing Use of a Sound Plan” (Part 2. Step-by-Step Guide: Using Sound to Manage Tinnitus, Develop a Personal “Sound Plan”) Expand “Relaxation Exercises” to include how tinnitus and other comorbidities impact tension, anxiety, deep-breathing exercises, and imagery exercises (Part 3. Step-by-Step Guide: Changing Thoughts and Feelings to Manage Reactions to Tinnitus, Relaxation Exercises) Streamline content in the “Pleasant Activities” section (Part 3. Step-by-Step Guide: Changing Thoughts and Feelings to Manage Reactions to Tinnitus, Pleasant Activity Scheduling) Eliminate the “changing thoughts” worksheet as it is not often used (Part 3. Step-by-Step Guide: Changing Thoughts and Feelings to Manage Reactions to Tinnitus, Changing Thoughts) Update information on hearing protection and associated graphics (Part 4. Protect Your Ears) Appendices DOD clinicians Move the description of tinnitus from Appendix A to the beginning of the workbook (Appendix A) Simplify “What Causes Tinnitus” section to increase understanding (Appendix B) Revise section on pharmaceuticals in “Tinnitus at a Glance” so that it is less likely to cause patient concern (Part 1. Introduction, What is Tinnitus and Tinnitus at a Glance) Update “How to Choose Devices” section to include current technologies or modify it so it doesn’t become outdated so easily (Appendix H) Update Resources section so it is less vulnerable to becoming outdated or remove it and encourage clinicians to generate their own locally relevant and up-to-date sets of resources for patients (Appendix J) Appendices VA clinicians Provide more information on navigating sleep issues (Appendix I) Add information regarding the various pronunciations of ‘tinnitus’ in the “Descriptions of Tinnitus” section (Appendix A) Include more anatomy and physiology in the front end of the workbook Remove section regarding pharmaceuticals from the “ Methods of Tinnitus” section (Appendix C) Add information regarding sound tolerance issues and develop materials to support clinicians addressing these issues (Appendix D) Remove “How to Choose Devices” or find a way to update this section that makes it easy to update over time as recommendations change (Appendix H) Update “Tips for Getting Better Sleep” (Appendix I) Remove “Resources” section (Appendix J) Add information about research surrounding the use of coping strategies in the “ Methods of Tinnitus Management” section (Appendix C) Change “relief scale” to “soothing scale” (Part 2. Step-by-Step Guide: Using Sound to Manage Tinnitus, Soothing Sound) Move information on the effects of tinnitus to front-end of workbook Appendices VA and DOD patients Move “Description of Tinnitus” to the front-end of the workbook (Appendix A) Clarify content related to the causes of tinnitus (e.g., text states that there are causes of tinnitus and then goes on to say that “no one knows what causes tinnitus” (Appendix B) Revise “ Methods of Tinnitus Management” to be more succinct (Appendix C) Remove “Effects of Tinnitus” due to content redundancy (Appendix E) Remove “Effects of Hearing Loss,” as it is not perceived as helpful (Appendix F) Remove Appendix G, “How People Use Sound to Manage Reactions to Tinnitus,” due to content redundancy (Appendix G) Update Resources section so it is less vulnerable to becoming outdated or remove it and encourage clinicians to generate their own locally relevant and up-to-date sets of resources for patients (Appendix J) Move information regarding sleep issues to the front of the workbook (Appendix I) Update or eliminate “Resources” section (Appendix J) Create electronic forms of the workbook and worksheets (appendices) Eliminate some appendices to minimize redundancy in the workbook (appendices) Alternative formats & other considerations DOD clinicians Revise the wording in “Should I See a Physician” section to cause less worry in patients (Part 1. Introduction, Should I see a Physician) Create printable documents so providers can easily share relevant information for the issues the patient is experiencing Create electronic materials available through fillable PDFs, a website, or PTM app for smartphones Develop CBT resources for sites without behavioral health providers Add content related to addressing sound tolerance problems Emphasize that although many people already use sound management to help with tinnitus, there can still be benefits to exploring other sound options Include information on the use of podcasts/apps for sound management techniques Create a visual tracker for patients to monitor progress toward their management goals Add real-life military examples into the workbook (e.g., active duty situations in which tinnitus is bothersome) Revise content related to stress, as that relationship has not been empirically demonstrated Provide links to online resources for deep breathing and imagery techniques Create short, simple summaries of sections that patients find most useful (e.g., summary of key points at the end of each chapter) Develop posters or handouts on the correct use of hearing protection Clarify that not everyone is eligible for custom ear protection Alternative formats & other considerations VA clinicians Create posters about PTM workshops for use in clinical settings for patient education Add section on VA apps for people with tinnitus Add more information on the anatomy and physiology of tinnitus to Appendix B (Appendix B) Add tabs to the new workbook to organize content and make it easy to locate Create electronic bundles of the core elements of PTM Create a FAQ section to explain content in the appendices Create electronic versions of all PTM materials Develop new workbook with worksheet pages that are perforated Delete columns three and four from the “Sound Plan Worksheet” to reduce redundant information (Part 2. Step-by-Step Guide: Using Sound to Manage Tinnitus, Develop a Personal “Sound Plan”) Put the Tinnitus Hearing Survey (THS) and Tinnitus Problem Checklist in a location of the workbook that is easy to find for clinicians to support collaboration (Part 2. Step-by-Step Guide: Using Sound to Manage Tinnitus, Develop a Personal “Sound Plan”) Revise workbook with updates to new sound technologies Provide additional materials to support skill-building in the “Changing Thoughts” section (Part 3. Step-by-Step Guide: Changing Thoughts and Feelings to Manage Reactions to Tinnitus, Changing Thoughts) Color code the main chapters to enhance ease of use Add section on practicing mindfulness Update all graphics Create app for pleasant activity scheduling Continue to publish CDs with sounds and make them available on the VA YouTube Channel Create patient materials that are available on the NCRAR website Develop a system that allows clinicians to e-mail patients audio files and soundtracks Create an electronic clickable version of the PTM workbook Add tabs in the hard-copy version of the PTM workbook to make it easier to use Alternative formats & other considerations VA and DOD patients Create PTM app for smartphones with graphics and video testimonials from other patients who benefitted from PTM Develop graphic materials and social media resources for tinnitus management to put in VA clinical spaces Create electronic (PDF) version of the PTM workbook with embedded hyperlinks for different sections for ease of access Add dialog boxes to the electronic version of PTM FAQs on tinnitus Enlarge workbook text Replace graphics with newer more relevant ones Streamline text content with shorter sentences and paragraphs Add DOD-specific information on hearing conservation Revise “Sound Plan” section to clarify that patients should try things with sounds they already have access to and pay attention to how they feel when using those sounds to manage tinnitus (Part 2. Step-by-Step Guide: Using Sound to Manage Tinnitus, Develop a Personal “Sound Plan”) Include explicit statement on why the hearing protection section is included in the workbook Create videos to demonstrate people properly inserting and using hearing protection Create wallet card with info on hearing protection devices that could be used as a buying guide in stores Open in a new tab Note . The comments in bold indicate similar feedback across participant groups. DOD = Department of Defense; ENT = ear, nose, and throat doctor; VA = Veterans Affairs; PTM = progressive tinnitus management; CBT = cognitive behavioral therapy; NCRAR = National Center for Rehabilitative Auditory Research. Table 3. Clinician handbook feedback. Section Participant type Ratings by participants Feedback Appendices VA and DOD clinicians 48% of appendices rated as “not being used often, if at all.” Relief scale, attention scale, and tinnitus contrast activity rated as “rarely used.” Update content related to hearing aids Replace HHI (A/E) with tinnitus-specific self-assessments—THS or TFI Remove tinnitus scales Alternative formats VA and DOD clinicians Increase handbook durability by changing to spiral-bound format Include tabs for ease of navigation Add a “quick-start” guides for key elements to save the clinician time when implementing PTM Open in a new tab Note . HHI (A/E): Hearing Handicap Inventory (Adult/Elderly); VA = Veterans Affairs; DOD = Department of Defense; TFI = Tinnitus Functional Inventory; THS = Tinnitus Hearing Survey; NCRAR = National Center for Rehabilitative Auditory Research; PTM = progressive tinnitus management. Phase 2 Data were collected continuously throughout each digitally recorded pilot PTM 2.0 session, with multiple facilitators taking notes. Qualitative data were discussed with members of a consensus panel, which included clinicians (audiology, behavioral health, and psychology) who have used PTM, as well as experts in WH and implementation science. Results were discussed among researchers through the scope of clinical relevance and, therefore, no formal data analysis was completed. Results Phase 1 Sixteen VA and DOD audiologists ( n = 11, 69%), mental health professionals ( n = 4, 25%), and an ear, nose, and throat doctor ( n = 1, 6%) completed semistructured interviews about the clinician and patient PTM workbooks. Clinician participants were mostly female (88%), non-Hispanic (81%), White (94%), and with an average age of 46 years. Six VA patients and active-duty DOD members completed similar individual structured interviews about the PTM workbook for patients. Patient participants were mostly male (83%), non-Hispanic (67%), White (83%), and an average age of 56 years. Patient participants included members of each of four armed service branches: Army, Air Force, Navy, and Coast Guard. The educational level of the sample ranged from a high school diploma to a master’s degree. See Table 4 for clinician and patient demographics. Table 4. Phase 1 patient and clinician participant demographics. Clinician demographics DOD VA All Patient demographics DOD VA All Age ( M , SD ) 48 (13) 44 (7) 46 (10) Age ( M , SD ) 42 (16) 62 (8) 56 (13) Branch of service ( n , %) Branch of service ( n , %) Air Force 2 (25%) — 2 (13%) Army 1 (50%) 2 (50%) 3 (50%) N/A 6 (75%) 8 (100%) 14 (88%) Air Force 1 (50%) — 1 (17%) Navy — 1 (25%) 1 (17%) Coast Guard — 1 (25%) 1 (17%) Specialty ( n , %) Education level ( n , %) Audiology 6 (75%) 5 (63%) 11 (69%) High school diploma — 1 (25%) 1 (17%) Behavioral health 1 (13%) 3 (38%) 4 (25%) Some college — 1 (25%) 1 (17%) ENT 1 (13%) — 1 (6%) Associate’s degree 1 (50%) 1 (25%) 2 (33%) 4-year college degree — 1 (25%) 1 (17%) Master’s degree 1 (50%) — 1 (17%) Gender ( n , %) Gender ( n , %) Male 2 (25%) 1 (13%) 3 (19%) Male 2 (100%) 3 (75%) 5 (83%) Female 6 (75%) 7 (88%) 13 (88%) Female — 1 (25%) 1 (17%) Ethnicity ( n , %) Ethnicity ( n , %) Hispanic/Latino 1 (13%) 1 (13%) 2 (13%) Hispanic/Latino 1 (50%) 1 (25%) 2 (33%) Not Hispanic/Latino 7 (88%) 7 (88%) 13 (81%) Not Hispanic/Latino 1 (50%) 3 (75%) 4 (67%) Race ( n , %) Race ( n , %) Black/African American — 1 (13%) 1 (6%) Black/African American 1 (50%) — 1 (17%) White 8 (100%) 7 (88%) 5 (94%) White 1 (50%) 4 (100%) 5 (83%) Open in a new tab Note . DOD = Department of Defense; VA = Veterans Affairs; ENT = ear, nose, and throat doctor; N/A = not applicable. Clinicians and patients responded favorably overall to most of the patient workbook chapters. VA clinicians rated each section slightly lower overall than did DOD clinicians, and some VA clinicians said they do not use these sections. Most portions of the clinician handbook and patient workbook were assigned ratings from somewhat helpful to very helpful , with each group suggesting similar revisions. Their suggested changes to the physical format of the workbooks included making the materials spiral bound to improve durability, adding tabs and quick start guides to enhance ease of navigation, color coding the main chapters, and updating graphics to better align with current practices and technologies. Many participants underscored the need to offer the PTM workbook and worksheets in electronic format (e.g., as a PDF, or through a website or smartphone app), as this would be helpful to those completing PTM as well as to those uninterested in completing a formal PTM course. In addition, several participants stated that researchers should consider how to make these revisions less vulnerable to becoming outdated. For example, DOD clinicians suggested removing the “Resources” section (which provides website links for sound devices) entirely so that clinicians could create their own locally relevant and up-to-date resource list. An additional concern for many participants was redundancy of information contained in appendices, particularly regarding content found in the sections titled Tinnitus at a Glance , What is Tinnitus , Effects of Tinnitus , and How People Use Sound to Manage Reactions to Tinnitus , as well as the Sound Plan Worksheet . The Sound Plan Worksheet is a fillable, self-management worksheet for patients to track the types of sounds they have tried, and provide ratings to describe how helpful the sound was to manage their tinnitus. Clinicians in the VA and DOD wished to add behavioral health resources for those who lead PTM programs, specifically at facilities that lack behavioral health professionals or individuals familiar with cognitive behavioral therapy. The remaining feedback included recommendations for removing sections and worksheets rated as not helpful, explicitly suggesting removal of the Tinnitus at a Glance and Should I See a Physician sections to reduce patient worry. In addition, participants suggested adding information to the What is Tinnitus chapter, to address the anatomy, physiology, and common comorbidities associated with tinnitus. Specific participant feedback is outlined in Tables 2 and 3 . Phase 2 Much of the feedback from Phase 1 influenced development of the materials used with participants in Phase 2. The materials for Phase 2 included updated PTM 2.0 PowerPoints that were used to guide each session and associated worksheets. In the original version of PTM, the content of these PowerPoints is closely tied to the content of the patient workbook and clinician handbook. The updated PTM 2.0 PowerPoints and worksheets piloted in Phase 2 are being used to guide the ongoing development of an updated workbook and clinician handbook. Changes to the PTM 2.0 PowerPoints and worksheets for Phase 2 included, but were not limited to, the following: The section on pharmaceuticals was revised so that is it less likely to cause patient concern, sound grids were deleted, PTM 2.0 materials were developed for those uninterested in joining a formal PTM program, and participants are no longer asked to rate how much relief they feel from tinnitus after listening to a sound but are asked instead to rate how soothing the sound was. Summary of Findings The Phase 1 feedback gathered from VA clinicians and patients led to a set of recommendations for updates to PTM 2.0 materials content, format, and adaptations (e.g., electronic formats with a clickable index). Phase 1 feedback informs the ongoing revision of the original PTM books that were published in 2010. A substantial amount of original content is being reduced based on this feedback. In addition, an electronic version of the PTM patient workbook will reduce barriers related to the cost of printing materials and ensure its availability during telehealth sessions. In a recent study on Veterans’ access to PTM, distance and logistical issues associated with busy schedules were cited as barriers for participation in in-person PTM sessions ( Clark et al., 2023 ; Zaugg et al., 2020 ); telehealth sessions can mitigate these barriers. The pilot PTM 2.0 counseling that was completed during Phase 2 was found to be clinically acceptable for the patient panel ( n = 6). Most of their feedback was positive, with participants stating they were happy to be a part of the group. They reported significant therapeutic value from group discussions with others who were empathetic and understanding of their condition. During their final meeting, they asked the research team to share the group’s contact information so that they could continue to hold weekly, informal check-ins with each other, emphasizing the perceived benefit of follow-up interaction. The only concerns expressed by the panel members related to details of the worksheets and other clinical documents. These concerns were consistent with VA and DOD clinician and patient findings from Phase 1. Phase 2 participants agreed that the PowerPoint presentations were useful and easy to understand and that the clinicians were helpful in guiding them through the PTM 2.0 course. As in Phase 1, participants gave constructive feedback regarding the format of the worksheets and associated support materials. Some participants stated they would prefer access to PDFs or other electronic versions. Content was perceived as helpful and easy to understand, including the WH initiative topics, pleasant activities, relaxation exercises, and the use of sound for tinnitus management. This study helped to establish the face validity of integrating PTM 2.0 within the WH care model. Specifically, participants from the Phase 2 pilot sessions understood the relationship between the eight areas of self-care shown in green on the WH wheel (see Figure 1 ). Participants demonstrated that they understood the relationship between these areas—they engaged in one of the areas of self-care between sessions and then mentioned how the changes made in one area impacted other areas. Through their conversations with session facilitators and participants, they also reflected on how self-care relates to functioning and quality of life with tinnitus. At the end of the trial sessions, one of the facilitators pointed out that the materials might undergo further changes. The facilitator asked participants to reflect on which parts of the content were most important and solicited their advice on which components should not be dropped. In each of the two groups, one of the participants spoke up and recommended keeping the WH content. When asked why, the participant said that, for years, it seemed nothing could be done about tinnitus but, now, it was understood that anything done for health and well-being amounted to doing something about tinnitus because they are connected. The other participants nodded in agreement and actively engaged in conversation that demonstrated understanding and agreement. Discussion Guided by feedback from clinicians who provide PTM and by a growing research literature concerning the importance of patients’ input or lived experiences to drive clinical improvement ( Berwick, 2009 ; Clark et al., 2021 ; Frampton et al., 2017 ), we were able to implement important updates to original PTM content. Soliciting and using end-user feedback to inform clinical products development and revision is a key principle in many fields, including but not limited to experience-based co-design projects, coproduction of health care services ( Batalden et al., 2015 ), and human factors frameworks ( Holden et al., 2013 ). Patients’ perspectives matter because they are the recipients of care and so possess important experiential knowledge concerning clinical services delivery ( Berwick, 2009 ). The updates to PTM 2.0 represent an iterative process that has so far extended over a 3-year period (2021–2023) and will continue into 2025. Overall, the project team found this process to be time consuming and worthwhile. We believe that it has been critical to include providers and patients who have used PTM as participants in this process, as well as individuals who were the original developers of PTM. VA and DOD patients and clinicians who use PTM were the optimal sources of information and suggestions for PTM 2.0 revisions. Led by a multidisciplinary clinical and research-focused project team, our mixed-methods approach provided structure to the process of distilling end users’ feedback to modify PTM 2.0 in way that was responsive to their concerns. By combining quantitative and qualitative measures, we were able to determine which sections needed to be updated and/or abbreviated. It was particularly helpful to have clinicians’ and patients’ responses to the same sets of questions. Doing this work in a not-for-profit integrated health care system also contributed positively to the process. In general, our team felt a sense of working together toward a greater good by leveraging the lived experiences of a range of users. Limitations The results of this project should be considered with its potential limitations. It is possible that the Veterans and Service members who volunteered as participants were more likely to have had positive experiences with PTM. Therefore, we may have missed valuable input from Veterans and Service members who did not have positive experiences with PTM. In addition, a larger sample size would have been ideal for both phases of the project; we mitigated this limitation by using a mixed-methods approach with engaged end users. Conclusions Evidence-based practices are often modified or adapted when they are implemented in clinical settings ( Escoffery et al., 2018 ; Evans et al., 2019 ). The revisions that comprise PTM 2.0 are based on input from clinicians, Veterans, and Service members with lived experience using PTM in clinical settings. The engagement of the end users helped to ground our multidisciplinary approach and integrate the biopsychosocial WH care model for tinnitus. The approach outlined in PTM 2.0 emphasizes the importance of a holistic approach to incorporate patients’ goals and values. The modified protocol also recognizes the heterogenous effects of tinnitus across patients and provides for modifications based on symptom severity, patient preference, and self-care tools for self-management. These aspects of PTM, therefore, are consistent with the WH initiative and should serve to benefit Veterans across multiple domains of functioning. Moreover, these modifications were cultivated and approved by two of the original PTM developers (T.Z. and J.H.) who agree that PTM 2.0 retains the necessary core components of PTM. All users of PTM and PTM 2.0 are strongly encouraged to collect outcomes for quality assurance purposes, use a statistically validated outcome instrument for tinnitus (e.g., Tinnitus Functional Index), and compare their outcomes to outcomes published in the literature. Supplementary Material Supplemental Content 1: Clinician workbook NIHMS2167634-supplement-Supplemental_Content_1__Clinician_workbook.docx (54.4KB, docx) Supplemental Content 2: Patient workbook NIHMS2167634-supplement-Supplemental_Content_2__Patient_workbook.docx (50.4KB, docx) Acknowledgments We are grateful to the Veterans, Service members, and clinicians who shared their time and experiences with us as participants in this quality improvement project. This material is the result of work supported with resources and the use of facilities at the Veterans Affairs (VA) Rehabilitation Research & Development National Center for Rehabilitative Auditory Research (Center Award #C2361C/I50 RX002361) at the VA Portland Health Care System in Portland, OR. The Defense Health Agency Hearing Center of Excellence also provided resources for this project. 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