Voice Therapy Per the Rehabilitation Treatment Specification System

Официальное название

Towards a Unified System to Classify Treatments for Muscle Tension Dysphonia

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Standard of care voice therapy with novice clinician RTSS-Voice 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. During this time, the treating clinicians will be trained to use the RTSS-Voice in their clinical documentation.
• Поведенческое Standard of care voice therapy with expert clinician RTSS-Voice 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. During this time, the treating clinicians will have completed their RTSS-Voice training and using the RTSS-Voice in their clin

Первичные конечные точки

• Voice Health Index (VHI) [Срок оценки: pre-intervention and immediately after the intervention]
• Voice-Related Quality of Life (V-RQOL) [Срок оценки: pre-intervention and immediately after the intervention]
• Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) [Срок оценки: pre-intervention and immediately after the intervention]
• Grade Roughness Breathiness Asthenia Strain (GRBAS) Scale [Срок оценки: pre-intervention and immediately after the intervention]
• Cepstral Peak Prominence (CPP) [Срок оценки: pre-intervention and immediately after the intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 5 центров

• Emory University — Atlanta
• Massachusetts General Hospital — Boston
• New York University — New York
• University of Utah — Salt Lake City
• University of Wisconsin — Madison

Идентификаторы

NCT: NCT06152627 · 2023P003127 · R01DC020247

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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