Patient Reported Experience in Endoscopic Ultrasound

NCT05014347 | Active Not Recruiting

• 1 other identifier: PREUS
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

The evaluation of the patient's experience is becoming increasingly important as a better patient experience can improve the quality of the delivered health service. Patient-reported experience measures (PREMs) are self-reported assessment tools provided by patients about their experience during any health event. There are few PREMs's instruments in the field of gastrointestinal endoscopy, and none is specific for Endoscopic Ultrasound (EUS). The aim of this study is to develop a questionnaire to evaluate the experience of patients undergoing EUS, identifying and prioritizing the factors related to the patient's experience. In order of it, expected results are developing a valid tool of question to value patients experience during EUS and, for ranking, it is iphotized that will be more correlation with patients's and nurses's answer that clinicians's one. In literature is described that nurse's view and patient's view are more similar especially in those aspects concerning empatics and psychological aspects.

Conditions

Pancreatic Diseases; Bile Duct Diseases

Keywords

patient reported experience measures; endoscopic ultrasonography; pancreatic; questionnaire

Outcome Measures

Primary Outcomes (1)

• developing questionnaire

  develop a questionnaire for Patient Reported Experience Measures during Endoscopic Ultrasound. In the first step it will be used a continuos Likert scale from 1 to 10 to analyse Content Validity Index, in the second step it will be used a score from 1 to 5 (1 = poor; 3 = good; 5 = excellent experience)

  9 months

Secondary Outcomes (1)

• ranking

  9 months

Study Arms (3)

Health Care Professionals

Health Care Professionals (HCP) working in PancreatoBiliary Endoscopy and EUS Division of IRCCS San Raffaele (both endoscopists and nurses)

"Expert" patients

a set of at least 30 outpatients undergoing EUS, who already underwent this procedure at least once

Patients

100 consecutive patients undergoing EUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients undergoing EUS in I.R.C.C.S. San Raffaele Hospital (Milan, Lombardy, Italy); HCP involved with EUS in I.R.C.C.S S. Raffaele Hospital (OSR).

You may qualify if:

• Age \> 18 years;
• Outpatients undergoing EUS in I.R.C.C.S. San Raffaele Hospital (Milan, Lombardy, Italy);
• Written informed consent signed

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Gabriele Capurso

Milan, Italy

Location

MeSH Terms

Conditions

Pancreatic Diseases; Bile Duct Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Biliary Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FASGE Associate Professor of Gastroenterology, Vita-Salute San Raffaele University; Head Pancreatico/Biliary Endoscopy & Endosonography Division Pancreas Translational & Clinical Research Center San Raffaele Scientific Institute, Milan,Italy

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

IT (1)