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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Cara Donohue, PhD CCC-SLP
- Número de telefone: 615-852-5085
- E-mail: cara.donohue@vumc.org
Locais de estudo
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
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Contato:
- Cara Donohue, PhD CCC-SLP
- Número de telefone: 615-852-5085
- E-mail: cara.donohue@vumc.org
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in maximum expiratory pressure
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: post-treatment prior to hospital discharge, assessed up to 2 weeks
|
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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Atributos da doença
- Doenças Respiratórias
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Distúrbios Respiratórios
- Doenças Esofágicas
- Doenças Otorrinolaringológicas
- Sinais e Sintomas Respiratórios
- Doenças Faríngeas
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Doença grave
- Aspiração Respiratória
- Distúrbios da Deglutição
- Tosse
Outros números de identificação do estudo
- 261042
Plano para dados de participantes individuais (IPD)
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