Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Intensive Dysphagia Treatment
Critically ill adults will complete intensive dysphagia treatment as prescribed.
干预措施: Intensive Dysphagia Treatment (Behavioral)
Expiratory muscle strength training (EMST)
Critically ill adults will complete EMST as prescribed.
干预措施: Expiratory muscle strength training (EMST) (Behavioral)
Standard of Care Dysphagia Treatment
Critically ill adults will receive dysphagia treatment per standard of care.
干预措施: Standard of Care Dysphagia Treatment (Behavioral)
结局指标
主要结局
Change in Dynamic Imaging Grade of Swallowing Toxicity Scale (DIGEST) Grades
时间窗: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
The DIGEST is a validated, 5-point ordinal rating scale that quantifies global pharyngeal swallow function.
Change in Penetration Aspiration Scale Scores
时间窗: pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks
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).
次要结局
- Change in maximum expiratory pressure(pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks)
- Change in cough peak expiratory flow(pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks)
- Grip strength(pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks)
- Change in Swallowing and Eating Related Fatigue Questionnaire (SERF)(pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks)
- Change in Screening for Oral Frailty Tool (SOFT)(pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks)
- Change in Eating Assessment Tool 10 (EAT-10)(pre-treatment (baseline), and post-treatment prior to hospital discharge, assessed up to 2 weeks)
- Acceptability of Intervention Measure (AIM)(post-treatment prior to hospital discharge, assessed up to 2 weeks)
- Intervention Appropriateness Measure (IAM)(post-treatment prior to hospital discharge, assessed up to 2 weeks)
- Feasibility of Intervention Measure (FIM)(post-treatment prior to hospital discharge, assessed up to 2 weeks)
研究者
Cara Donohue, Ph.D. CCC-SLP
Assistant Professor, Director of Medical Speech-Language Pathology
Vanderbilt University Medical Center