Clinical trial NCT06171165: Screening the Patient for Oral Intake: Applicability of the Yale Swallow Protocol in Patients Across Disease Categories
Official title: Screening the Patient for Oral Intake: Applicability of the Yale Swallow Protocol in Patients Across Disease Categories
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Intake
Dysphagia
Swallow Difficulty
Keywords: Swallow
Dysphagia
Screening
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the acute care setting diagnosed with various conditions

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.


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).

Primary outcomes:
measure: responsiveness
timeFrame: the time receiving the screenings
measure: time-spending to execute Yale Swallow Protocol
timeFrame: the time receiving the screenings
measure: safety
timeFrame: the time receiving the screenings
Secondary outcomes:
measure: responsiveness
timeFrame: the time receiving the screenings
measure: parsimony
timeFrame: the time receiving the screenings
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University School of Nursing
Study officials:
affiliation: National Taiwan University
name: Cheryl Chia-Hui Chen, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang YC, Wu MS, Siao SF, Wang MJ, Xu YJ, Chen CC. Identifying High-Quality Non-Instrumental Dysphagia Screening Tools for Detection of Adult Dysphagia Case in Acute-Care Settings: A Systematic Review. Clin Otolaryngol. 2024 Nov;49(6):687-698. doi: 10.1111/coa.14194. Epub 2024 Jun 28.