Questionnaire Study Concerning Artificial Intelligence

February 3, 2022 updated by: Maastricht University Medical Center

Questionnaire Study Concerning Artificial Intelligence and Its Application in (Gastrointestinal) Healthcare - Patients' and Physicians' Perspectives

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

457

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Limburg
      • Maastricht, Limburg, Netherlands, 6202AZ
        • Maastricht University Medical Center
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
        • Catharina Ziekenhuis Eindhoven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The knowledge on AI investigated by means of a questionnaire
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
The oninion on AI in healthcare among gastroenterology patients and physicians, investigated by means of a questionnaire.
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ad Masclee, Prof Dr MD, Maastricht Universitair Medisch Centrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2020

Primary Completion (Actual)

August 12, 2021

Study Completion (Actual)

August 12, 2021

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available following publication with no end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastro-Intestinal Disorders

Clinical Trials on Questionnaire

3
Subscribe