Revisiting Swallow Screening in Patients at Risk of Oropharyngeal Dysphagia

Study Overview
=================
Brief Summary
-----------------
With 98 swallow screening tools already developed, dysphagia remains under-screened and undiagnosed. Even for patients at high risk of oropharyngeal dysphagia (i.e., hospitalized aged, post-stroke, Parkinson's disease, head and neck cancer, or those had ≥ 48 hours of endotracheal intubation), swallow screening is not systematically performed. Nurses, as front-line providers, are bombarded with patients' dysphagia. We witnessed patients' subsequent poor outcomes, including delayed oral intake, dependence on the feeding tube, increased pneumonia, prolonged hospital length of stay, and increased in-hospital. Despite many calls for nurses to perform bedside screens for timely management, there is a lack of census on what tools to use (98 available, many claimed to be valid) and whether nurses are capable of safely performing these screens, especially when facing across-disease patients. Without a screening tool that is used universally across different diseases to assess whether patients can safely engage in oral intake, clinical healthcare professionals will face significant challenges in conducting the screening. Meanwhile, we found the common, shared items, i.e., consciousness, voice/speech, coughing, oral motor movements, and water drinking tests or swallowing trials, are included in most swallow screening tools, suggesting these items are essential basics for oral intake safely. Therefore, instead of creating a new screening tool, the aim of this study is to extract the common, shared items among existing swallowing screening tools and assemble them into a swallow screening protocol that can be administered by nursing staff for triage whether inpatient populations are at risk of unsafe for oral intake. After conducting a systematic review and assessing the quality, we found the Yale Swallow Protocol was identified as a high-quality swallowing screening tool and was used for screening the risk of aspiration across diverse outpatients who were referred for further swallow assessment. However, whether the Yale Swallow Protocol can be implemented in acute care settings to screen for oral intake requires further warranted for its applicability. Therefore, this study aims to test the applicability (i.e., accuracy, responsiveness, time-spending, and safety) of the Yale Swallow Protocol when used to screen for 'oral intake,' with speech therapists' evaluations serving as the reference standard for inpatients across various disease categories.

Official Title
-----------------
Revisiting Swallow Screening in Patients at Risk of Oropharyngeal Dysphagia: A Two-Center Study of Common, Shared Items Among Preexisting Tools and Role of Nurses

Conditions
-----------------
Oral Intake, Dysphagia, Swallow Difficulty

Intervention / Treatment
-----------------
* Diagnostic Test: Yale Swallow Protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with any of the following conditions: (a) head-and-neck cancer, (b) stroke, (c) Parkinson's disease, (d) post-extubated, and (e) aged above 65 years. aged above 18 years. Exclusion Criteria: Patients will be excluded if they are (a) feeding-tube dependent (gastrostomy tube, nasogastric tube), (b) nil per os (NPO), or (c) with airborne-transmitted diseases (e.g., open tuberculosis or SARS).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitalized Patients Across Disease Categories<br>We included the patients, namely, patients with head-and-neck cancer, stroke, and Parkinson's disease, as well as the elderly patients in acute care settings. | Diagnostic Test: Yale Swallow Protocol<br>* All the participants will receive the two swallow screenings, i.e., Yale Swallow Protocol and Speech-language therapist, to classify the participants into either try swallow or NPO status.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy | sensitivity and specificity of Yale Swallow Protocol compared to the screening result by speech-language therapist | the time receiving the screenings | 
| responsiveness | floor effect or ceiling effect of Yale Swallow Protocol | the time receiving the screenings | 
| time-spending to execute Yale Swallow Protocol | the mean and standard deviation | the time receiving the screenings | 
| safety | whether any unanticipated adverse effect exists when executing Yale Swallow Protocol | the time receiving the screenings | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| responsiveness | difficulty of Yale Swallow Protocol analyzed by Item Response Theory | the time receiving the screenings | 
| parsimony | shorten the Yale Swallow Protocol by Item Response Theory | the time receiving the screenings | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Swallow, Dysphagia, Screening