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

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Re-verified, no change to tracked fields
  2. Notable Start date pushed from Apr 2027 to Jul 2027
  3. Minor Interventions modified
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 9 entries
  4. Minor Re-verified, no change to tracked fieldsv2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07736105
Lead Sponsor Vanderbilt University Medical Center
Conditions
(from sponsor)
Dysphagia, Critical Illness
Related terms Cough, Critical Illness, Deglutition Disorders, Respiratory Aspiration
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov