Qualitative Research Among Physicians and Junior Doctors Into the Preconditions for Implementing a CDSS Based on AI in the ICU (KATRINA)

March 20, 2023 updated by: University Ghent

Qualitative Research Among Physicians and Junior Doctors Into the Preconditions for Implementing a Clinical Decision Support System (CDSS) Based on Artificial Intelligence (AI) in the ICU

The goal of this study is to explore the different attitudes and preconditions of potential end-users (doctors & physicians in training) required to achieve successful clinical implementation of models based on artificial intelligence (i.e. both machine learning and knowledge-driven techniques) as clinical decision support software.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

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

  • Belgium
      • Aalst, Belgium
        • OLV Aalst
      • Antwerpen, Belgium
        • ZNA Ziekenhuizen
      • Ghent, Belgium
        • Ghent University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Medical specialists or specialists in training working in intensive care at the time of the study.

Description

Inclusion Criteria:

  • Medical specialist or specialist in training working in intensive care at the time of the study.

Exclusion Criteria:

  • Age < 18 yo

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

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline attitudes towards artificial intelligence and big data in medicine
Time Frame: baseline
Baseline attitudes towards artificial intelligence and big data in medicine will be collected through an online survey where participants will score their agreement with certain statements on a 6-point likert scale (Possible choices: Strongly agree - Agree - Neutral - Disagree - Totally Disagree - Not applicable).
baseline
Identify prerequisites that need to be fulfilled when AI/Big data based clinical decision support systems are used bedside from the viewpoint of the participants.
Time Frame: through study completion, an average of 1 year
Identify prerequisites that need to be fulfilled when AI/Big data based clinical decision support systems are used bedside and identify the most important ones for different aspects of the antimicrobial stewardship cycle from the viewpoint of the participants through a group discussion. Reporting: frequencies.
through study completion, an average of 1 year
Identify subdomains of the antimicrobial stewardship cycle with potential for AI/Big data application
Time Frame: through study completion, an average of 1 year
Identify subdomains of the antimicrobial stewardship cycle for which participants think AI/Big data might be of use through a group discussion/interview. Reporting: frequencies.
through study completion, an average of 1 year
Identify perceived potential benefits and harms when applying AI in the antimicrobial stewardship cycle.
Time Frame: through study completion, an average of 1 year
Identify perceived potential benefits and harms when applying AI in the antimicrobial stewardship cycle through a group discussion. Reporting: frequencies.
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subgroup analysis: age
Time Frame: through study completion, an average of 1 year
Explore if there are variations in the above mentioned outcomes when taking into account the age (years) of the participants.
through study completion, an average of 1 year
Subgroup analysis: gender
Time Frame: through study completion, an average of 1 year
Explore if there are variations in the above mentioned outcomes when taking into account the gender of the participants.
through study completion, an average of 1 year
Subgroup analysis: working environment (type of hospital, type of ICU)
Time Frame: through study completion, an average of 1 year
Explore if there are variations in the above mentioned outcomes when taking into account the working environment (University hospital vs non University hospital, small size hospital vs large size hospital, type of ICU (medical, surgery, mixed ICU, intermediate care)) - data which is collected in the baseline questionnaire) of the participants.
through study completion, an average of 1 year
Subgroup analysis: working experience (basic training and clinical experience).
Time Frame: through study completion, an average of 1 year
Explore if there are variations in the above mentioned outcomes when taking into account the working experience (type of basic training (anesthesiology, internal medicine, surgery, other), clinical experience (years) - data which is collected in the baseline questionnaire) of the participants.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Research Foundation Flanders

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan De Waele, MD, PhD, University Ghent

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BC-9892

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If possible and feasible, anonymised survey data as well as transcript data from the group discussions will be made available on request.

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.

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