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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Expiratory muscle strength training (EMST)
  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.
• Поведенческое Standard of Care Dysphagia Treatment
  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
• Поведенческое Intensive Dysphagia Treatment
  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).

Первичные конечные точки

• Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades [Срок оценки: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks]
• Change in Penetration Aspiration Scale Scores [Срок оценки: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks]

Вторичные конечные точки (9)

• Change in maximum expiratory pressure [Срок оценки: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks]
• Change in cough peak expiratory flow [Срок оценки: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks]
• Grip strength [Срок оценки: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks]
• Change in Swallowing and Eating Related Fatigue Questionnaire (SERF) [Срок оценки: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks]
• Change in Screening for Oral Frailty Tool (SOFT) [Срок оценки: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks]
• Change in Eating Assessment Tool 10 (EAT-10) [Срок оценки: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks]
• Acceptability of Intervention Measure (AIM) [Срок оценки: post-treatment prior to hospital discharge, assessed up to 2 weeks]
• Intervention Appropriateness Measure (IAM) [Срок оценки: post-treatment prior to hospital discharge, assessed up to 2 weeks]
• Feasibility of Intervention Measure (FIM) [Срок оценки: post-treatment prior to hospital discharge, assessed up to 2 weeks]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT07736105 · Pending from IRB and sponsor

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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