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

NCT07736105 | Not Yet Recruiting

• 1 other identifier: Pending from IRB and sponsor
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysphagia; Critical Illness

Keywords

Dysphagia; Swallowing; Deglutition; Deglutition Disorders; Swallowing Disorders; Breathing; Cough; Critical Illness; Treatment

Outcome Measures

Primary Outcomes (2)

• Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades

  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

  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

Secondary Outcomes (9)

• Change in maximum expiratory pressure

  pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

• Change in cough peak expiratory flow

  pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

• Grip strength

  pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

• Change in Swallowing and Eating Related Fatigue Questionnaire (SERF)

  pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

• Change in Screening for Oral Frailty Tool (SOFT)

  pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks

Study Arms (3)

Expiratory muscle strength training (EMST)

EXPERIMENTAL

Critically ill adults will complete EMST as prescribed.

Behavioral: Expiratory muscle strength training (EMST)

Standard of Care Dysphagia Treatment

ACTIVE COMPARATOR

Critically ill adults will receive dysphagia treatment per standard of care.

Behavioral: Standard of Care Dysphagia Treatment

Intensive Dysphagia Treatment

EXPERIMENTAL

Critically ill adults will complete intensive dysphagia treatment as prescribed.

Behavioral: Intensive Dysphagia Treatment

Interventions

Expiratory muscle strength training (EMST) BEHAVIORAL

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.

Expiratory muscle strength training (EMST)

Standard of Care Dysphagia Treatment BEHAVIORAL

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

Standard of Care Dysphagia Treatment

Intensive Dysphagia Treatment BEHAVIORAL

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).

Intensive Dysphagia Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Critical Illness; Respiratory Aspiration; Cough

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Cara Donohue, PhD CCC-SLP

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cara Donohue, PhD CCC-SLP

CONTACT

615-852-5085; cara.donohue@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director of Medical Speech-Language Pathology

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)