A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients

A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients: Building Bridges Between Detection and Decision-making

Oropharyngeal dysphagia (OD) is a highly prevalent and growing condition in the older population. It affects approximately one in three community-dwelling elderly, almost half of the geriatric patients, and even more than half of elderly nursing home residents.

The main complications of OD are respiratory infections such as aspiration pneumonia, malnutrition, and dehydration. It supposes substantial costs for the healthcare system, increases the risk for (re)admissions and length of stay, and has an important impact on the quality of life of people who suffer from it.

The aim of this study is to develop a predictive model to identify non-hospitalized older patients at risk for oropharyngeal dysphagia, quantify that risk, and facilitate decision-making according to personal, clinical, and socio-emotional characteristics.

Study Overview

• Status: Not yet recruiting
• Conditions: Otorhinolaryngologic Diseases; Deglutition Disorders; Oropharyngeal Dysphagia
• Intervention / Treatment: Other: No intervention

Detailed Description

Given the high prevalence of Oropharyngeal Dysphagia (OD) in older people and the difficulty to detect it, the investigators purpose to develop a predictive model to identify non-hospitalized older patients at risk for OD, quantify that risk, and facilitate decision-making.

Objectives:

Main objective:

- Develop a predictive model for oropharyngeal dysphagia in non-hospitalized older patients (≥ 65 years).

Secondary objectives:

• Identify predictive factors for OD among the studied population.
• Contribute to the characterization of OD in older people through a retrospective analysis of videofluoroscopic studies and clinical evaluations.
• Define different models of intervention from a multidimensional approach.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Víctor Najas Sales, SLP; Phone Number: 37011 +34696554925; Email: vnajas@santpau.cat

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Older patients (≥ 65 years) referred to the Physical Medicine and Rehabilitation Service of Hospital de la Santa Creu i Sant Pau for a swallowing study between 2015 and 2023.

Description

Inclusion Criteria:

• Older people between 65 and 99 years.
• Swallowing assessed with Videofluoroscopy
• Non-hospitalized patients (swallowing assessed on an outpatient basis)

Exclusion Criteria:

• There are no exclusion criteria in relation to the gender or ethnicity of the participants. Failure to meet one of the inclusion criteria will result in the participant's exclusion from the study sample.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysphagia Outcome and Severity Scale (DOSS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	It is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia based on objective assessment and make recommendations for diet level, independence level, and type of nutrition Range: 1 Nothing by mouth (NPO) - 7 Full oral intake, normal.	Up to 8 years
Penetration Aspiration Scale (PAS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	It is a is a rank ordered scale that classifies the depth of penetrated or aspirated material and the patient's response to airway invasion. Range: 1 No airway penetration - 8 Airway aspiration, no cough.	Up to 8 years
Bolus Residue Scale (BRS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	It is a simple, easy-to-carry-out, and accessible analysis method to rate and locate pharyngeal retention. Range: 1 No residue - 6 Residue in valleculae and posterior pharyngeal wall and piriform sinus.	Up to 8 years
Functional Oral Intake Scale (FOIS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	It is a reliable and valid tool to assess functional oral intake of food and liquids in patients with oropharyngeal dysphagia (OD). Range: 1 Nothing by mouth (NPO) - 7 Full oral intake without restrictions.	Up to 8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive value of pharyngeal width at rest for aspiration (JOSCYL width). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	The JOSCYL Width Scale is calculated by averaging two pharyngeal widths: 1) lower margin of the mandible to C2 and 2) epiglottis to C3.	Up to 8 years

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Estimated): June 6, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Older people; Predictive models
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Esophageal Diseases; Deglutition Disorders; Otorhinolaryngologic Diseases
• Other Study ID Numbers: IIBSP-DOF-2022-121

Drug and device information, study documents

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