Voice Therapy Per the Rehabilitation Treatment Specification System

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Massachusetts General Hospital
Study ID
NCT06152627
Status
Recruiting

Conditions

  • Muscle Tension Dysphonia

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of care voice therapy with novice clinician RTSS-Voice documentation — BEHAVIORAL
    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.
  • Standard of care voice therapy with expert clinician RTSS-Voice documentation — BEHAVIORAL
    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 clinical documentation.

Study Details

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.

Key Dates

Start date
Feb 3, 2026
Status verified
May 2026
Primary completion
Jun 29, 2027
Completion
Jun 29, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: First Year of RTSS-Voice use
    These 300 patients from five Voice Centers will receive standard of care voice therapy where their treating clinicians will be trained to use the RTSS-Voice in their documentation.
  • Experimental: Second Year of RTSS-Voice use
    These 300 patients from five Voice Centers will receive standard of care voice therapy where their treating clinicians have already been trained to use the RTSS-Voice in their documentation.

Primary Outcome Measure

Voice Health Index (VHI) [ Time Frame: pre-intervention and immediately after the intervention ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Amanda Gillespie, PhD, CCC-SLP
404-778-3381
Massachusetts General HospitalBostonMassachusetts02114
Jarrad Van Stan, PhD, CCC-SLP
617-643-8410
Jeremy Wolfberg, MS, CCC-SLP
New York UniversityNew YorkNew York10017
Aaron Johnson, PhD, CCC-SLP
646-754-1207
University of UtahSalt Lake CityUtah84132
Julie Barkmeier-Kreamer, PhD, CCC-SLP
801-585-7143
University of WisconsinMadisonWisconsin53792
Susan Thibeault, PhD, CCC-SLP
608-263-6751

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