Decision MakingIRALNCT07278076
Clinical Decision-Making During FEES: The Impact of Residue Amount and Location
A study testing education in people with Decision Making, run by Rush University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Decision Making
- What is being tested?
- education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Speech language pathologists with at least one year of experience conducting FEES (flexible endoscopic evaluations of swallowing)
Who cannot join
- Anyone who is not a speech pathologist, or has less than one year of experience conducting FEES.
About this study
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.
Read the 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
- Being tested
- education
- Keywords
- clinical decision making, pharyngeal residue severity interpretation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In one year since the initiation of the study
Secondary outcomes (2)
Identifying if education impacts how pharyngeal residue is interpreted
The secondary measure is to identify if education (a pre-recorded presentation on up to date dysphagia management research) impacts how clinicians interpret the amount and location of pharyngeal residue during FEES. Clinicians will first rate randomized photos of pharyngeal residue of each category. Then the clinicians will watch a video, and will have to re-rate randomized photos. The amounts of pharyngeal residue will be categorized as none, trace, mild, moderate and severe based on the Yale Pharyngeal Residue Severity Rating Scale. Pictures presented will show each residue amount in two locations; the pyriform sinuses and valleculae. Clinicians will indicate if they would restrict oral eating based on the picture of pharyngeal residue.
Measured: In one year since the initiation of the study
Ivestigating the rationale behind clinical decision making during pharyngeal residue management
8 clinicians will be chosen to be interviewed to investigate the rationale behind their clinical decision-making
Measured: In one year since the initiation of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278076
- Sponsor's protocol ID
- 25093017
- Acronym
- IRAL
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision-Making During FEES: The Impact of Residue Amount and Location
- ClinicalTrials.gov ID
- NCT07278076
- Acronym / sponsor ID
- IRAL / 25093017
- Conditions
- Decision Making
- Keywords
- clinical decision making, pharyngeal residue severity interpretation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: educationThirty (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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Speech language pathologists with at least one year of experience conducting FEES (flexible endoscopic evaluations of swallowing)
Key exclusion criteria (1 listed)
- Anyone who is not a speech pathologist, or has less than one year of experience conducting FEES.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educationIn 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. | Other | Educational intervention is provided |
Primary outcome
If a diet restriction occurs based on the residue amount and location
Time frame: In one year since the initiation of the study
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.
2 secondary outcomes
Identifying if education impacts how pharyngeal residue is interpreted
Time frame: In one year since the initiation of the study
Ivestigating the rationale behind clinical decision making during pharyngeal residue management
Time frame: In one year since the initiation of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Decision Making, run by Rush University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
If a diet restriction occurs based on the residue amount and location (time frame: In one year since the initiation of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.