Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation 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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Cara Donohue, PhD CCC-SLP
- Telefonnummer: 615-852-5085
- E-Mail: cara.donohue@vumc.org
Studienorte
-
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37232
- Vanderbilt University Medical Center
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Kontakt:
- Cara Donohue, PhD CCC-SLP
- Telefonnummer: 615-852-5085
- E-Mail: cara.donohue@vumc.org
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion criteria for critically ill adults will be:
- 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.
Inclusion criteria for speech-language pathologists (SLPs) will be:
- Adult acute care speech-language pathologist who works at VUMC.
- Willing to complete surveys and/or participate in a focus group.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Expiratory muscle strength training (EMST)
Critically ill adults will complete EMST as prescribed.
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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.
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Aktiver Komparator: Standard of Care Dysphagia Treatment
Critically ill adults will receive dysphagia treatment per standard of care.
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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
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Experimental: Intensive Dysphagia Treatment
Critically ill adults will complete intensive dysphagia treatment as prescribed.
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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).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades
Zeitfenster: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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The DIGEST is a validated, 5-point ordinal rating scale that quantifies global pharyngeal swallow function.
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pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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Change in Penetration Aspiration Scale Scores
Zeitfenster: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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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).
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pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in maximum expiratory pressure
Zeitfenster: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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A measure of respiratory strength while breathing out
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pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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Change in cough peak expiratory flow
Zeitfenster: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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A measure of cough strength
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pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
|
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Grip strength
Zeitfenster: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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Change in Grip strength be used to quantify clinical frailty using a digital hand dynamometer.
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pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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Change in Swallowing and Eating Related Fatigue Questionnaire (SERF)
Zeitfenster: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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Scores on the SERF range 0-48 with higher scores indicating greater impairment.
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pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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Change in Screening for Oral Frailty Tool (SOFT)
Zeitfenster: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool.
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pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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Change in Eating Assessment Tool 10 (EAT-10)
Zeitfenster: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment.
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pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
|
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Acceptability of Intervention Measure (AIM)
Zeitfenster: post-treatment prior to hospital discharge, assessed up to 2 weeks
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A measure of how acceptable an intervention is with scores ranging from 4-20.
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post-treatment prior to hospital discharge, assessed up to 2 weeks
|
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Intervention Appropriateness Measure (IAM)
Zeitfenster: post-treatment prior to hospital discharge, assessed up to 2 weeks
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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
|
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Feasibility of Intervention Measure (FIM)
Zeitfenster: post-treatment prior to hospital discharge, assessed up to 2 weeks
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A measure of how feasible an intervention is with scores ranging from 4-20.
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post-treatment prior to hospital discharge, assessed up to 2 weeks
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Cara Donohue, PhD CCC-SLP, Vanderbilt University Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Krankheitsattribute
- Erkrankungen der Atemwege
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Atemstörungen
- Erkrankungen der Speiseröhre
- Otorhinolaryngologische Erkrankungen
- Anzeichen und Symptome, Atmung
- Rachenkrankheiten
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Kritische Krankheit
- Respiratorische Aspiration
- Schluckstörungen
- Husten
Andere Studien-ID-Nummern
- 261042
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