NCT07278076

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this research is to identify the location and threshold of pharyngeal residue at which clinicians restrict diets for patients in the outpatient setting. 60 clinicians will judge 25 pairs of photos from FEES (fiberoptic endoscopic evaluation of swallowing) where each of the five levels of pharyngeal residue (e.g. none, trace, mild, moderate, and severe) are represented. These levels are used by the standardized and validated Yale Pharyngeal Residue Severity Rating Scale (YPRSRS).11 Residue severity in both the valleculae and pyriform sinuses will be presented, creating 25 image combinations. The patient history for each pair of photographs is the same: no airway compromise has occurred, the patient is ambulatory, does not require supplemental oxygen, has no cognitive deficits and is receiving out-patient care. Clinicians will indicate at which severity level of pharyngeal residue they are most likely to restrict the diet using a Likert scale (e.g. "extremely unlikely", "unlikely", "neutral", "likely", and "extremely unlikely"). Observing diet restrictions when pharyngeal residue reaches moderate levels would support our hypothesis that clinicians make risk-averse recommendations. The other aim of this project is to evaluate the impact of evidence-based education on clinician decision-making regarding pharyngeal residue and location. Half of the clinicians will be randomized to the treatment group and watch a recorded 30-minute pre-recorded video presentation about research on pharyngeal residue before they complete the image assessment task. Using this information, a comparison can be made with diet restriction patterns between the educated (treatment) and non-educated (control) groups, potentially demonstrating whether evidence-based clinical research reduces fear-based decision-making. Should the investigators observe that the experimental group restricts diets less than the control group, the hypothesis that clinicians and patients benefit from evidence-based clinical education would be accurate. Finally, the researcher would like to determine the rationale behind clinician decision-making. During the qualitative portion of this study, the researcher will interview eight clinicians. Clinicians will be chosen from the original group of 60 to participate in a structured interview to investigate the rationale behind their clinical decision-making. An analysis will be completed to determine the distribution of clinicians who chose to restrict the diet compared to those who did not. The clinicians chosen will reflect the ratio of restrictive and non-restrictive clinicians. The researchers anticipate that clinicians who watched the recorded research presentation are less likely to restrict diets based on pharyngeal residue alone regardless of the location. In collecting data, a bottom-up descriptive approach will be utilized. A phenomenological framework will investigate the various factors that might impact a clinician's decision to restrict a diet.

Conditions

• Decision Making

Interventions

Type	Name	Description
OTHER	education	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.

Timeline

• Start date: 2026-11-01
• Primary completion: 2027-01-01
• Completion: 2027-05-30
• First posted: 2025-12-11
• Last updated: 2026-02-20