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Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial

4 september 2026 uppdaterad av: Cara Donohue, Ph.D. CCC-SLP, Vanderbilt University Medical Center

This research study is investigating the efficacy and implementation of expiratory muscle strength training (EMST), standard of care dysphagia treatment, and intensive dysphagia treatment in critically ill adults in the acute care setting. Currently, no targeted, effective, and feasible dysphagia treatment approaches currently exist for use in critically ill adults in the acute care setting. The current study will investigate the impact of EMST, standard of care dysphagia treatment, and intensive dysphagia treatment on pulmonary function, cough function, swallow function, frailty, patient-reported swallow function, and health outcomes in critically ill adults. This study will also examine patient perceptions and clinical speech-language pathologists' perceptions of the acceptability, appropriateness, and feasibility of these interventions.

Critically ill adults will: undergo tests of breathing, cough, and swallow function, complete questionnaires about the treatment, and their swallow function, and complete their respective treatment as prescribed.

Clinical speech-language pathologists will complete questionnaires about the interventions.

A subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study will involve two in-person research evaluations in the hospital that will last 45 minutes- 1 hour and will consist of a screening, breathing and cough testing, swallow function testing, measures of frailty, and completion of questionnaires. Following the initial research evaluation, critically ill adults will complete the intervention they are assigned to as prescribed. The exercises will take 15-20 minutes to complete and adherence to treatment will be tracked. Prior to hospital discharge and after completion of the intervention, critically ill adults will undergo a second research evaluation.

Clinical speech-language pathologists will complete questionnaires about the interventions that will take 10-15 minutes.

A subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups, which will take 45 minutes-1 hour.

Studietyp

Interventionell

Inskrivning (Beräknad)

120

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232
        • Vanderbilt University Medical Center
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion criteria for critically ill adults will be:

  1. Adult ≥ 18 years old
  2. Not pregnant
  3. Underwent a clinical flexible endoscopic evaluation of swallowing (FEES) or videofluoroscopy swallow study (VFSS) with a penetration aspiration scale (PAS) score ≥ 5
  4. Hospitalized in non-neuro intensive care unit (ICU) setting at Vanderbilt University Medical Center (VUMC) at some point during admission
  5. Dysphagia is primarily related to ICU stay and not other medical conditions that may cause dysphagia
  6. medically cleared with no contraindications for expiratory muscle strength training (EMST) or other treatments
  7. Cognitive capacity to follow basic directions
  8. Willing to undergo testing and treatment for the study.

Inclusion criteria for speech-language pathologists (SLPs) will be:

  1. Adult acute care speech-language pathologist who works at VUMC.
  2. Willing to complete surveys and/or participate in a focus group.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Expiratory muscle strength training (EMST)
Critically ill adults will complete EMST as prescribed.
Beteende: Expiratory muscle strength training (EMST)
EMST devices will be set to 60% of participants' maximum expiratory pressure. Participants will complete training 5 days per week by performing 5 sets of 5 repetitions.
Aktiv komparator: Standard of Care Dysphagia Treatment
Critically ill adults will receive dysphagia treatment per standard of care.
Beteende: Standard of Care Dysphagia Treatment
Critically ill adults will perform one set of ten repetitions of each exercise recommended by their clinical speech-language pathologist. Enrolled participants will complete up to two training sessions per week (0-2 pending normal clinical care course) with a clinical speech-language pathologist
Experimentell: Intensive Dysphagia Treatment
Critically ill adults will complete intensive dysphagia treatment as prescribed.
Beteende: Intensive Dysphagia Treatment
Critically ill adults will perform one set of ten repetitions of each exercise (effortful swallow, Masako maneuver, Mendelsohn maneuver, chin tuck against resistance, tongue strengthening exercises, and may also participate in bolus driven therapy). Enrolled participants will complete five training sessions per week (at least 3 days/week with the PI or a trained member of the research team and up to 2 days/week with a member of the clinical speech-language pathology team).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades
Tidsram: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
The DIGEST is a validated, 5-point ordinal rating scale that quantifies global pharyngeal swallow function.
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Penetration Aspiration Scale Scores
Tidsram: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
The penetration aspiration scale is a validated 8-point ordinal rating scale that measures the depth of airway invasion and the patient's response during swallowing. Scores range from 1 to 8 with a score of 1 indicating a safe swallow (best score) and 8 indicating silent aspiration (worst score).
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in maximum expiratory pressure
Tidsram: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
A measure of respiratory strength while breathing out
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in cough peak expiratory flow
Tidsram: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
A measure of cough strength
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Grip strength
Tidsram: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Grip strength be used to quantify clinical frailty using a digital hand dynamometer.
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Swallowing and Eating Related Fatigue Questionnaire (SERF)
Tidsram: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Scores on the SERF range 0-48 with higher scores indicating greater impairment.
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Screening for Oral Frailty Tool (SOFT)
Tidsram: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool.
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Change in Eating Assessment Tool 10 (EAT-10)
Tidsram: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment.
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
Acceptability of Intervention Measure (AIM)
Tidsram: post-treatment prior to hospital discharge, assessed up to 2 weeks
A measure of how acceptable an intervention is with scores ranging from 4-20.
post-treatment prior to hospital discharge, assessed up to 2 weeks
Intervention Appropriateness Measure (IAM)
Tidsram: post-treatment prior to hospital discharge, assessed up to 2 weeks
A measure of how appropriate an intervention is with scores ranging from 4-20.
post-treatment prior to hospital discharge, assessed up to 2 weeks
Feasibility of Intervention Measure (FIM)
Tidsram: post-treatment prior to hospital discharge, assessed up to 2 weeks
A measure of how feasible an intervention is with scores ranging from 4-20.
post-treatment prior to hospital discharge, assessed up to 2 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Vanderbilt University Medical Center

Utredare

  • Huvudutredare: Cara Donohue, PhD CCC-SLP, Vanderbilt University Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 april 2027

Primärt slutförande (Beräknad)

1 oktober 2028

Avslutad studie (Beräknad)

1 februari 2029

Studieregistreringsdatum

Först inskickad

22 juli 2026

Först inskickad som uppfyllde QC-kriterierna

29 juli 2026

Första postat (Faktisk)

30 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 261042

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