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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05214625
Other study ID # METC 2020-2281
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 8, 2020
Est. completion date August 12, 2021

Study information

Verified date February 2022
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

In recent years, important developments have been made in the field of artificial intelligence (AI). These developments have led to the large-scale application of AI in our everyday lives and AI-research within healthcare. A potentially promising application of AI lies in imaging analysis. For example, within gastroenterology this means the detection and classification of colorectal polyps and Barrett's neoplasia, disease severity scoring of inflammatory bowel diseases, and differentiating pancreatic cancer from chronic pancreatitis. Despite the investments in AI-research, there is a lack in knowledge concerning patients' and physicians' perspectives on AI in healthcare. This prospective questionnaire study investigates these perspectives, obtaining data from both gastroenterology (GI) patients and GI-physicians within the Netherlands. The questionnaires focus on the knowledge, experience, and opinion of AI, particularly concerning the implementation of AI in (gastroenterology) healthcare. Furthermore, the current (endoscopic) infrastructure within Dutch hospitals will be investigated for its readnessy for AI.


Recruitment information / eligibility

Status Completed
Enrollment 457
Est. completion date August 12, 2021
Est. primary completion date August 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

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

Locations

Country Name City State
Netherlands Catharina Ziekenhuis Eindhoven Eindhoven Noord-Brabant
Netherlands Maastricht University Medical Center Maastricht Limburg

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View Citation

Le Berre C, Sandborn WJ, Aridhi S, Devignes MD, Fournier L, Smaïl-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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Willingness of physicians to use AI in (gastroenterology) healthcare The willingness to apply AI in (gastroenterology) healthcare among gastroenterology physicians. 6 months
Secondary Willingness to apply AI in (gastroenterology) healthcare The willingness of gastroenterology patients for their physicians to apply AI in (gastroenterology) healthcare. 6 months
Secondary Advantages and disadvantages of AI use in (gastroenterology) healthcare Important advantages and disadvantages of AI use in (gastroenterology) healthcare among gastroenterology patients and physicians. 6 months
Secondary Potential domains within gastroenterology and hepatology for AI use Potential domains within gastroenterology and hepatology for AI use indicated by GI physicians. 6 months
Secondary Mandatory infrastructure for AI use in healthcare The availability of technical facilities and infrastructures within endoscopy to implement and apply AI in Dutch hospitals. 6 months
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