NCT05214625

Brief Summary

This study aims to investigate the knowledge, experience, and opinion on AI among gastroenterology (GI) patients, gastroenterologists, and GI-fellows, particularly concerning implementation and application of AI (in assisting clinicians) in healthcare. The secondary aims are to investigate (dis)advantages of AI use in healthcare and the availability of technical facilities and infrastructures within endoscopy to implement and apply AI in Dutch hospitals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
457

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

January 13, 2022

Last Update Submit

February 3, 2022

Conditions

Gastro-Intestinal Disorders

Keywords

Artificial intelligencePatients' perspectivePhysicians' perspectiveQuestionnaire

Outcome Measures

Primary Outcomes (3)

  • The knowledge on AI investigated by means of a questionnaire

    The knowledge on AI in healthcare among gastroenterology patients and physicians, investigated by means of a questionnaire.

    6 months

  • The experience with AI investigated by means of a questionnaire

    The experience with AI (in healthcare) among gastroenterology patients and physicians, investigated by means of a questionnaire.

    6 months

  • The opinion on AI investigated by means of a questionnaire

    The oninion on AI in healthcare among gastroenterology patients and physicians, investigated by means of a questionnaire.

    6 months

Secondary Outcomes (5)

  • Willingness of physicians to use AI in (gastroenterology) healthcare

    6 months

  • Willingness to apply AI in (gastroenterology) healthcare

    6 months

  • Advantages and disadvantages of AI use in (gastroenterology) healthcare

    6 months

  • Potential domains within gastroenterology and hepatology for AI use

    6 months

  • Mandatory infrastructure for AI use in healthcare

    6 months

Study Arms (2)

Gastroenterology patients

Patient receiving an endoscopic procedure because of regular care will be considered eligible for inclusion. Patients receive an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases. Patients will be asked to complete a questionnaire concerning AI. No intervention will be administered.

Other: Questionnaire

Gastroenterology physicians

GI physicians (both gastroenterologists and gastroenterology fellows), participating in a yearly gastroenterology and hepatology training day, will be asked for their participation in this study. Physician will be asked to complete a questionnaire concerning AI. No intervention will be administered.

Other: Questionnaire

Interventions

QuestionnaireOTHER

Questionnaire concerning artificial intelligence and its implementation in healthcare. GI patients and GI physicians will be provided with slightly different questionnaires.

Gastroenterology patientsGastroenterology physicians

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Gastroenterology patients who will have an outpatient appointment for an endoscopic procedure in the context of the national bowel cancer screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases, in one of two Dutch hospitals between April 2020 and September 2020. Gastroenterologists and gastroenterology fellows working in Dutch hospitals.

You may qualify if:

  • Gastrointestinal (GI) patients with an outpatient appointment in the gastroenterology department for an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases (in one of the two participating hospitals);
  • Gastroenterologists working in Dutch hospitals;
  • Gastroenterology fellows working in Dutch hospitals;
  • Minimal age of 18 years old.

You may not qualify if:

  • No appropriate understanding of the Dutch language;
  • Not willing to sign informed consent;
  • Objection to participate in medical scientific research, reported in the medical file.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maastricht University Medical Center

Maastricht, Limburg, 6202AZ, Netherlands

Location

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (4)

  • Le Berre C, Sandborn WJ, Aridhi S, Devignes MD, Fournier L, Smail-Tabbone M, Danese S, Peyrin-Biroulet L. Application of Artificial Intelligence to Gastroenterology and Hepatology. Gastroenterology. 2020 Jan;158(1):76-94.e2. doi: 10.1053/j.gastro.2019.08.058. Epub 2019 Oct 5.

    PMID: 31593701BACKGROUND

  • Shaban-Nejad A, Michalowski M, Buckeridge DL. Health intelligence: how artificial intelligence transforms population and personalized health. NPJ Digit Med. 2018 Oct 2;1:53. doi: 10.1038/s41746-018-0058-9. eCollection 2018.

    PMID: 31304332BACKGROUND

  • Labovitz DL, Shafner L, Reyes Gil M, Virmani D, Hanina A. Using Artificial Intelligence to Reduce the Risk of Nonadherence in Patients on Anticoagulation Therapy. Stroke. 2017 May;48(5):1416-1419. doi: 10.1161/STROKEAHA.116.016281. Epub 2017 Apr 6.

    PMID: 28386037BACKGROUND

  • Waymel Q, Badr S, Demondion X, Cotten A, Jacques T. Impact of the rise of artificial intelligence in radiology: What do radiologists think? Diagn Interv Imaging. 2019 Jun;100(6):327-336. doi: 10.1016/j.diii.2019.03.015. Epub 2019 May 6.

    PMID: 31072803BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ad Masclee, Prof Dr MD

    Maastricht Universitair Medisch Centrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 31, 2022

Study Start

April 8, 2020

Primary Completion

August 12, 2021

Study Completion

August 12, 2021

Last Updated

February 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Data collected for the study, including individual participant data, will be made available upon request. This data includes deidentified participant data. Additional documents that will be made available are the study protocol, the statistical analysis plan, the questionnaires, and the informed consent forms. Data will be available following publication with no end date. Requests should be methodologically sound proposals with the purpose to achieve aims in the approved proposal. Researchers who request the data should direct the proposal to q.vanderzander@maastrichtuniversity.nl to gain access. Data requestors will need to sign a data access agreement after approval of a proposal.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available following publication with no end date.
Access Criteria
Requests should be methodologically sound proposals with the purpose to achieve aims in the approved proposal. Data requestors will need to sign a data access agreement after approval of a proposal.

Locations

NL(2)