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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cara Donohue, PhD CCC-SLP
- Número de teléfono: 615-852-5085
- Correo electrónico: cara.donohue@vumc.org
Ubicaciones de estudio
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
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Contacto:
- Cara Donohue, PhD CCC-SLP
- Número de teléfono: 615-852-5085
- Correo electrónico: cara.donohue@vumc.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades
Periodo de tiempo: 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
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in maximum expiratory pressure
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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post-treatment prior to hospital discharge, assessed up to 2 weeks
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Feasibility of Intervention Measure (FIM)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cara Donohue, PhD CCC-SLP, Vanderbilt University Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Atributos de la enfermedad
- Enfermedades de las vías respiratorias
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Trastornos de la respiración
- Enfermedades esofágicas
- Enfermedades Otorrinolaringológicas
- Signos y Síntomas Respiratorios
- Enfermedades faríngeas
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Enfermedad crítica
- Aspiración Respiratoria
- Trastornos de la deglución
- Tos
Otros números de identificación del estudio
- 261042
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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