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

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.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia; Oral Intake; Swallow Difficulty
• Intervention / Treatment: Diagnostic test: Yale Swallow Protocol

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Cheryl Chia-Hui Chen, DNSc; Phone Number: 288438 +886-2-23123456; Email: cherylchen@ntu.edu.tw
• Study Contact Backup: Name: Yu-Chun Chang, MSc; Phone Number: 288438 +886-2-23123456; Email: waskyod@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University School of Nursing
    • Contact: Yu-Chun Chang, MSc; Phone Number: 02-23123456#288438; Email: waskyod@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in the acute care setting diagnosed with various conditions

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Cheryl Chia-Hui Chen, DNSc, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Estimated): February 19, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Dysphagia; Screening; Swallow
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 202401146RINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No