RTSS-Voice and Muscle Tension Dysphonia
Study Details
Study Description
Brief Summary
The NIH grant funding this study has three aims, but all human subjects will be enrolled into the study only during the last (third) aim. Aims 1 and 2 will use expert opinion from nationally recog-nized speech language pathologists to develop unique Rehabilitation Treatment Specification System for Voice (RTSS-Voice) treatment component codes representing nine evidence-based voice therapies for primary muscle tension dysphonia (pMTD). Aim 3 is to develop/test an implementation toolkit to facilitate adoption of those RTSS-Voice codes across 5 Voice Centers: Emory University, Massachusetts General Hospital, New York University, University of Utah, and University of Wisconsin Madison. Specifically, clinicians at these five centers will use the codes to document their standard of care voice therapy for patients with pMTD. Retrospective de-identified patient outcomes will be collected the year before and after RTSS-Voice training. Aim 3 hypothesis: Since the RTSS-Voice will help clinicians think about their treatment more specifically and in relation to 9 evidence-based therapies, the investigators hypothesize adoption will be associated with improved outcomes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The purpose of Aim 3 is to implement the RTSS-Voice as thoroughly as possibly during routine clinical care. So, it will involve the recruitment of all patients with primary Muscle Tension Dysphonia (pMTD) at 5 Voice Centers. The investigators expect 60 patents per year (at minimum) from each site. Since there are 5 sites and 1 year (Year 5) of data collection after starting RTSS-Voice use, estimating that there will be 300 patients with pMTD. For the retrospective analysis during Year 3 (to get outcomes before RTSS-Voice implementation), 300 patients are expected at a minimum, based on the previously supplied numbers. The investigaors hypothesize that RTSS-Voice adoption will be associated with improved outcomes (effectiveness). The RTSS-Voice requires clinicians to think about their therapy in relation to the 9 evidence-based therapies (i.e., increased evidence-based practice) and more carefully consider the specific changes in targets directly related to specific clinical actions, i.e., improved clinical reasoning. To analyze effectiveness data in Aim 3, patient-reported vocal functioning, clinician-reported voice quality, and an objective measure associated with overall voice quality (Cepstral Peak Prominence/CPP) will be extracted from patient clinical records for the year immediately prior to implementation of RTSS-Voice (pre-implementation clinical outcomes). Pre-implementation data will then be compared to outcomes data collected during Year 5 of the project. Linear regression models will examine changes in outcomes from pre- to post-implementation. Patient severity and sex (if correlated to an outcome variable) will be included as a covariate. Because each site uses slightly different perceptual measures, separate analyses will be conducted for each site and analyses where data is pooled from sites using the same measures. Because previous research found very high correlations between the Voice Handicap Index (VHI) and Voice-Related Quality of Life (V-RQOL) (r = -0.91) and between the Grade Roughness Breathiness Asthenia and Strain scale (GRBAS) and Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) (r > 0.8), the site-specific results can be included in a mini meta-analysis. Standardized effect sizes (Cohen's d, r) will be calculated for each site, representing the effect of RTSS-Voice adoption. Using a fixed effects model, an average effect size across sites will be calculated, weighted by sample size. The average effect size across sites will then represent the overall effect of the implementation on vocal functioning, voice quality, CPP, and number of sessions. Power: The investigators anticipate a minimum of 60 patients per site, (total of 300 patients). For site-specific analyses, a sample size of 60 patients for each group (pre-implementation patients versus post-implementation patients) is associated with 80% power to detect the smallest clinically meaningful effect size: d = .5. The effect size d = .5 was chosen because it is the smallest effect that is "visible to the naked eye" associated with rejecting the null hypothesis and supporting the alternative hypothesis in rehabilitation treatment studies and used in multiple voice studies.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pre-RTSS-Voice evidence-based documentation These 300 patients from 5 Voice Centers will receive standard of care voice therapy where their treating clinicians document the voice therapy sessions per usual non-standard practices. |
Behavioral: Standard of care voice therapy with non-standard documentation
Voice therapy is individually tailored to each patient and typically includes behavioral ingredients (e.g., applying pressure to the anterior neck, practice voicing in various ways, feedback on performance, provide information on the importance of therapy concepts) to modify the patient's auditory, somatosensory, vocal, musculoskeletal, respiratory, and mental functions. Documentation will be non-standardized and reflecting current clinical documentation for each individual clinician.
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| Post-RTSS-Voice evidence-based documentation These 300 patients from 5 Voice Centers will receive standard of care voice therapy where their treating clinicians document the voice therapy sessions per standardized, evidence-based RTSS-Voice codes. |
Behavioral: Standard of care voice therapy with RTSS-Voice documentation
In addition to standard of care voice therapy, clinicians will be asked to use standardized evidence-based codes from the RTSS-Voice in their documentation. The RTSS-Voice requires clinicians to think about their therapy in relation to the 9 evidence-based therapies (i.e., increased evidence-based practice) and more carefully consider the specific changes in targets directly related to specific clinical actions, i.e., improved clinical reasoning.
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Outcome Measures
Primary Outcome Measures
- Voice Health Index (VHI) [pre-intervention and immediately after the intervention]
The VHI consists of 30 Likert questions ranging from 0-4 (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always) that estimate how the patient's vocal function effects his/her daily life. A short-form can be used (the VHI-10) that uses a subset of 10 questions from the 30 total questions. This patient-reported outcome measure will be used to evaluate if the patients perceive that therapy helped them function better in their activities of daily living.
- Voice-Related Quality of Life (V-RQOL) [pre-intervention and immediately after the intervention]
The V-RQOL consists of 10 Likert-style questions ranging from 1-5 (1 = none not a problem at all, 2 = a small amount, 3 = a moderate (medium) problem, 4 = a lot, 5 = problem is "as bad as it can be") that estimate how the subject's vocal function effects his/her daily life. This patient-reported outcome measure will be used to evaluate if the patients perceive that therapy helped them function better in their activities of daily living.
- Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) [pre-intervention and immediately after the intervention]
The CAPE-V consists of 4 perceptually judged 100-mm visual analog scales (Overall dysphonia, Breathiness, Strain, Roughness). The patient's treating voice specialized SLP will judge the audio samples. These judgements provide gold-standard, perceptual ratings of voice quality to evaluate if voice therapy is associated with improved voice quality.
- Grade Roughness Breathiness Asthenia Strain (GRBAS) Scale [pre-intervention and immediately after the intervention]
The GRBAS consists of 5 perceptually-judged scales (Grade, Roughness, Breathiness, Asthenia, Strain) on a 0-3 Likert scale (0 = normal, 1 = mild severity, 2 = moderate severity, 3 = severe). The patient's treating voice specialized SLP will judge the audio samples. These judgements provide gold-standard, perceptual ratings of voice quality to evaluate if voice therapy is associated with improved voice quality.
- Cepstral Peak Prominence (CPP) [pre-intervention and immediately after the intervention]
To calculate CPP, all voiced 50-ms frames will undergo two discrete Fourier transforms computed in succession with a logarithmic transformation between them. A regression line is then computed over quefrencies greater than 2 ms (corresponding to a quefrency range minimally affected by subglottal resonances). Finally, the CPP for each frame is defined as the difference, in dB, between the magnitude of the highest peak and the baseline regression level in the power cepstrum. The peak search is limited to quefrencies between 2.5 ms and 12 ms, corresponding to frequencies of 417 Hz and 83 Hz, respectively. The resulting CPP is an estimate of periodicity in the voice signal, which has strongly correlated to overall dysphonia in multiple previous studies. This will be used to quantitatively evaluate if voice therapy was associated with improved overall voice quality.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of pMTD
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Patients with pMTD will be included regardless of subtype (e.g., functional aphonia, vocal fry, ventricular dysphonia) and they can have secondary diagnoses of reflux.
Exclusion Criteria:
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Patients diagnosed with pMTD will be excluded if they have secondary diagnoses related to structural, neurological, or respiratory disorders such as laryngitis, obvious vocal fold nodules, polyps, cyst, granuloma, sulci, paradoxical vocal fold motion, chronic cough, confirmed or possible upper airway paralysis/paresis, dysphagia, polypoid corditis, keratosis, presbylarynx, leukoplakia, or history of radiation to the head/neck. Patients with pMTD will be included regardless of subtype (e.g., functional aphonia, vocal fry, ventricular dysphonia) and they can have secondary diagnoses of reflux.
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Non-English speakers. The RTSS-Voice's standard and operationalized categories are in English.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University | Atlanta | Georgia | United States | 30322 |
| 2 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 3 | New York University | New York | New York | United States | 10017 |
| 4 | University of Utah | Salt Lake City | Utah | United States | 84132 |
| 5 | University of Wisconsin | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Emory University
- New York University
- University of Utah
- University of Wisconsin, Madison
Investigators
- Principal Investigator: Jarrad Van Stan, PhD, CCC-SLP, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023P003127