Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Expiratory muscle strength training (EMST)
DeviceEMST 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.
Standard of Care Dysphagia Treatment
BehavioralCritically 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
Intensive Dysphagia Treatment
BehavioralCritically 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).
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Expiratory muscle strength training (EMST)Experimental treatment 1 intervention
Group B: Standard of Care Dysphagia TreatmentActive comparator 1 intervention
Group C: Intensive Dysphagia TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks2
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).
Time frame
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeksSecondary outcomes
1
Change in maximum expiratory pressure
A measure of respiratory strength while breathing out
Time frame
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks2
Change in cough peak expiratory flow
A measure of cough strength
Time frame
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks3
Grip strength
Change in Grip strength be used to quantify clinical frailty using a digital hand dynamometer.
Time frame
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks4
Change in Swallowing and Eating Related Fatigue Questionnaire (SERF)
Scores on the SERF range 0-48 with higher scores indicating greater impairment.
Time frame
pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeksSponsors and contacts
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Source ClinicalTrials.gov
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