Clinical trial NCT06152627: Voice Therapy Per the Rehabilitation Treatment Specification System
Official title: Towards a Unified System to Classify Treatments for Muscle Tension Dysphonia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Muscle Tension Dysphonia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Emory University
name: New York University
name: University of Utah
name: University of Wisconsin, Madison
First posted: 2023-11-30
Enrollment: 600
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All recruited patients will be diagnosed with primary Muscle Tension Dysphonia (pMTD) because: \[1\] clinical impact - pMTD is the most commonly treated voice disorder; \[2\] minimal diagnostic confounds - pMTD is ostensibly behavioral (i.e., no variations in disordered anatomy/physiology) and voice therapy is the only curative option (i.e., minimal presence of other treatments like sur-gery); \[3\] comprehensive coverage of therapy concepts - pMTD is the most heterogeneous voice disorder; \[4\] availability of multiple therapies with similar outcomes - allowing us to use previously developed methods for identifying unique targets/ingredients.

Brief summary: The goal of this study is to evaluate if using evidence-based, standard ingredient and target codes from the Rehabilitation Treatment Specification System - Voice Therapy (RTSS-Voice) in standard of care voice therapy documentation can improve outcomes for patients with muscle tension dysphonia (MTD). The main question it aims to answer is: Since the RTSS-Voice will help clinicians think about their treatment more specifically and in relation to nine evidence-based therapies, will its adoption be associated with improved outcomes? Clinicians across five voice centers will be asked to use the RTSS-Voice to document their voice therapy sessions for patients with MTD. Researchers will compare changes in outcomes between two groups of patients: those treated during the clinician's first year using the RTSS-Voice versus those treated during the clinician's second year using the RTSS-Voice.

Detailed description: The purpose of this study is to evaluate if using evidence-based, standard ingredient and target codes from the Rehabilitation Treatment Specification System - Voice Therapy (RTSS-Voice) in standard of care voice therapy documentation can improve outcomes for patients with muscle tension dysphonia (MTD). RTSS-Voice adoption is likely to be associated with improved outcomes because it requires clinicians to think about their therapy in relation to nine 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. Sixty patents will be enrolled per year (at minimum) from each of the five participating voice centers, i.e., 300 patients in Years 1 and 2 (total patients = 600). For each patient, outcomes will be collected before and after therapy including patient-reported vocal functioning, clinician-reported voice quality, an objective measure associated with overall voice quality (Cepstral Peak Prominence/CPP), and total number of sessions. Each voice center uses different patient-reported and clinician-reported measures. Thus, linear regression models will examine changes in outcomes during Year 1 versus Year 2 for each individual site. The different patient- and clinician-reported measures have been found to be highly correlated. Therefore, individual sites will also be pooled together in a mini meta-analysis. Standardized effect sizes (Cohen's d) 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 per year). For site-specific analyses, a sample size of 60 patients for each group (Year 1 versus Year 2) 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary Muscle Tension Dysphonia (pMTD)
* 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:

* 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.
* Non-English speakers. The RTSS-Voice's standard and operationalized categories are in English.

Primary outcomes:
measure: Voice Health Index (VHI)
timeFrame: pre-intervention and immediately after the intervention
measure: Voice-Related Quality of Life (V-RQOL)
timeFrame: pre-intervention and immediately after the intervention
measure: Consensus Auditory Perceptual Evaluation of Voice (CAPE-V)
timeFrame: pre-intervention and immediately after the intervention
measure: Grade Roughness Breathiness Asthenia Strain (GRBAS) Scale
timeFrame: pre-intervention and immediately after the intervention
measure: Cepstral Peak Prominence (CPP)
timeFrame: pre-intervention and immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: New York University
state: New York
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Massachusetts General Hospital
name: Jarrad Van Stan, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: