Clinical Decision-Making During FEES: The Impact of Residue Amount and Location

NCT07278076 | Not Yet Recruiting

• 1 other identifier: 25093017
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigator aims to identify the threshold of food residue visualized in the throat during a FEES (fiberoptic endoscopic evaluation of swallowing) that speech-language pathologists allow before restricting a patient from eating. 60 speech-language pathologists will be required to participate, with half of them watching a pre-recorded video detailing current research about residue in the throat of pharynx. The group watching the video will then re-score their images. This investigates the impact of education on clinical decision-making. Finally, 8 clinicians will meet with the researcher individually to share their clinical decision-making rationale. With this information, the researcher hopes to identify a patient population who is at risk for diet restrictions in order to encourage speech-language pathologists to extend the swallow study and trial more compensatory strategies before restricting the patient's diet.

Conditions

Decision Making

Keywords

clinical decision making; pharyngeal residue severity interpretation

Outcome Measures

Primary Outcomes (1)

• If a diet restriction occurs based on the residue amount and location

  Clinicians will be rating if they would restrict an oral diet based on pictures of pharyngeal residue of various amounts (none, trace, mild, medium, severe) in two locations: the valleculae and pyriform sinuses.

  In one year since the initiation of the study

Secondary Outcomes (2)

• Identifying if education impacts how pharyngeal residue is interpreted

  In one year since the initiation of the study

• Ivestigating the rationale behind clinical decision making during pharyngeal residue management

  In one year since the initiation of the study

Study Arms (3)

Identifying the threshold for allowed residue amount and location

NO INTERVENTION

The first aim of this study is to identify the threshold of the volume and location of residue at which clinicians restrict diets. In the quantitative study, clinicians will be presented with the same case study. In the case study, the patient participates in a FEES and two randomized images at a time are displayed to the clinician to represent the patient's valleculae and pyriform sinuses. Each image of the set will have varying amounts of residue. The amount of residue will be controlled to represent each level of pharyngeal residue (i.e. none, trace, mild, moderate, and severe) according to the standardized and validated Yale Pharyngeal Residue Severity Rating. Each participant will score 25 combinations of location and severity. Using a five-point Likert scale, the participants will rate how likely they are to restrict the patient's diet based on the amount of pharyngeal residue displayed in both the valleculae and pyriform sinuses.

Educational intervention is provided

EXPERIMENTAL

Thirty (50%) of the clinicians participating in the study will watch a 30-minute educational presentation about current research on clinical decision making and aspiration risks of pharyngeal residue after they complete the image assessment task (Specific Aim 1). Several peer-reviewed articles will be presented via video recording. These clinicians would then re-test. Using this information, the PI will compare diet restriction patterns between the education (treatment) and no-education (control) groups, potentially demonstrating whether knowledge dissemination can reduce fear-based decision-making. Ordinal logistic regression will be used to examine if any significance difference between the control and experimental groups exists. Any identified significant differences could help change how FEES is conducted and interpreted.

Other: education

Clinician interview during the qualitative portion of this study

NO INTERVENTION

The third aim of this study is to explore the rationale behind the clinician's decision-making. Participants from the quantitative portion of this mixed-methods study will be prompted to justify their clinical reasoning in the second part of the study, during an interview. Independent interviews will be conducted to reduce clinician influences. This aim should help identify possible fear-based decision-making by the clinicians when assessing amounts of pharyngeal residue. The questions presented will also serve to understand if or how clinicians follow evidence-based guidelines during FEES. A semi-structured format will be utilized to allow for follow-up questions. In collecting data, a descriptive approach will be used that is bottom up. A phenomenological inquiry will be utilized to investigate the thought process of each clinician as they navigate through the various factors that can impact their decision to restrict a diet consistently.

Interventions

education OTHER

In the second aim of the study, 30 (50%) of the clinicians participating in the study will watch a 30-minute educational presentation about current research on clinical decision making and aspiration risks of pharyngeal residue after they complete the image assessment task (Specific Aim 1). Several peer-reviewed articles will be presented via video recording. These articles support several key tenets of this research study and include: 1) recommendations should be based on clinical experience and training, not evidence-based practice,8 2) the location of pharyngeal residue does not increase or decrease penetration or aspiration risk,6 and 3) a correlation, not a causation exists between the amount of pharyngeal residue and aspiration risk.14 Other studies indicated that other factors should be investigated, such as the accumulation of residue over time.14 These clinicians would then re-test.

Educational intervention is provided

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Speech language pathologists with at least one year of experience conducting FEES (flexible endoscopic evaluations of swallowing)

You may not qualify if:

• Anyone who is not a speech pathologist, or has less than one year of experience conducting FEES.

Sponsors & Collaborators

• Rush University Medical Center: lead

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Thirty (50%) of the clinicians participating in the study will watch a 30-minute educational presentation about current research on clinical decision making and aspiration risks of pharyngeal residue after the image assessment task is completed. Several peer-reviewed articles will be presented via video recording. These articles support several key tenets of this research study. These clinicians would then re-test. Using this information, the PI will compare diet restriction patterns between the education (treatment) and no-education (control) groups, potentially demonstrating whether knowledge dissemination can reduce fear-based decision-making. Ordinal logistic regression will be used to examine if any significance difference between the control and experimental groups exists. Any identified significant differences could help change how FEES is conducted and interpreted.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 11, 2025
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02