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临床试验/NCT05014347
NCT05014347
进行中(未招募)
不适用

Patient Reported Experience Measure in Endoscopic Ultrasonography: the PREUS Study

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 171 人2021年6月1日

概览

阶段
不适用
干预措施
Health Care Professionals
疾病 / 适应症
Pancreatic Diseases
发起方
IRCCS San Raffaele
入组人数
171
试验地点
1
主要终点
developing questionnaire
状态
进行中(未招募)
最后更新
17天前

概览

简要总结

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.

详细描述

The study will consist of several phases: 1) Tool creation: a "patient reported measure of EUS" (PREUS) questionnaire will be created based on literature review; 2) Face and Content Validity: The PREUS tool will be submitted to 7 experts in the field (physicians, nurses, psychologist, communication expert, patients' advocacy representative) for a two-round evaluation and to "expert" patients who had already undergone EUS at least once. Content Validity Index (CVI) will be calculated and questions with a CVI \< 0.70 will be excluded; 3) Questionnaire Creation: Based on the results of phase 2, a modified "PREUS" tool will be then evaluated by ranking the relevance of the identified questions in the previous phase (from 0 to 10) by 50 outpatients undergoing EUS and Cronbach's alpha will be calculated to determine reliability; 4) Ranking: tool of phase 3 will be also evaluated by 6 physicians and 13 nurses working in IRCCS Ospedale San Raffaele endoscopy Unit to measure the agreement between patients and health care professionals (HCPs) by the Spearman-Brown coefficients.

注册库
clinicaltrials.gov
开始日期
2021年6月1日
结束日期
2031年12月31日
最后更新
17天前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Paolo Giorgio Arcidiacono, MD

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

IRCCS San Raffaele

入排标准

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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

结局指标

主要结局

developing questionnaire

时间窗: 9 months

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)

次要结局

  • ranking(9 months)

研究点 (1)

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