Screening the Patient for Oral Intake: Applicability of the Yale Swallow Protocol in Patients Across Disease Categories

NCT06171165 | Completed DMC

• 1 other identifier: 202401146RINE
• Study Type: observational
• Target: 502
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Intake; Dysphagia; Swallow Difficulty

Keywords

Swallow; Dysphagia; Screening

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• responsiveness

  the time receiving the screenings

• parsimony

  the time receiving the screenings

Study Arms (1)

Hospitalized Patients Across Disease Categories

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

Interventions

Yale Swallow Protocol DIAGNOSTIC_TEST

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.

Hospitalized Patients Across Disease Categories

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the acute care setting diagnosed with various conditions

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University School of Nursing

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 38940226 RESULT

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Cheryl Chia-Hui Chen, DNSc

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: February 19, 2024
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)