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Artificial Intelligent Clinical Decision Support System Simulation Center Study for Technology Acceptance

Artificial Intelligent Clinical Decision Support System Simulation Center Study: Trust and Usefulness of Machine Learning Risk Stratification Tool for Acute Gastrointestinal Bleeding Using the Technology Acceptance Model

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05816473
Enrollment
108
Registered
2023-04-18
Start date
2023-05-23
Completion date
2024-12-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Hemorrhage

Keywords

Implementation science, Artificial intelligence, Decision Support Systems, Clinical, Simulation Training

Brief summary

The purpose of this research study is to measure the effect on of a large language model interface on the usability, attitudes, and provider trust when using a machine learning algorithm-based clinical decision support system in the setting of bleeding from the upper gastrointestinal tract (upper GIB). Specifically, the investigators are looking to assess the optimal implementation of such machine learning algorithms in simulation scenarios to best engender trust and improve usability. Participants will be randomized to either machine learning algorithm alone or algorithm with a large language model interface and exposed to simulation cases of upper GIB.

Detailed description

The experiment will deploy a previously validated machine learning algorithm trained on existing clinical datasets within simulation scenarios in which a patient with acute gastrointestinal bleeding (at low, moderate, and high risk for poor outcome) is evaluated. Prior to the simulation, a baseline educational module about artificial intelligence, machine learning, and clinical decision support will be provided to all participants. The investigators will establish psychological safety by detailing what is available in the room, the opportunity to call a consultant, and availability of laboratory and radiographic studies. Each clinical scenario will run for approximately 10 minutes based on real patient cases where vital signs change over time and laboratory values are made available at specific points in the assessment. The study will evaluate the effect of a large language model-based interaction with the machine learning algorithm with interpretability dashboard compared to the machine learning algorithm with interpretability dashboard alone. Each participant will receive three scenarios in randomized order of risk. For the large language model interaction arm, participants will be provided the computer workstation a LLM chatbot interface of the algorithm and interpretability dashboard For the machine learning dashboard arm, participants will be provided the computer workstation with the algorithm and interpretability dashboard.

Interventions

OTHERLLM

Use of a Large Language Model (LLM) chatbot interface to Interact with the Machine Learning Algorithm and interpretability dashboard.

Sponsors

Yale University
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Internal Medicine residency trainees at study institution * Emergency Medicine residency trainees at study institution

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Median Change in Attitudes Towards Machine Learning Algorithms in Clinical Care Using UTAUTApproximately 60 minutesThe study will use a common set of dependent variables to assess baseline and post-intervention attitudes towards machine learning algorithms in clinical care using an adapted Unified Theory of Acceptance and Use of Technology (UTAUT) survey assessing perceived usefulness of the system, perceived ease of use, attitudes towards using it, behavioral intentions, and trust, measured with a 5-point Likert scale. Percent change in UTAUT survey response between Large Language Model-based Interaction and Machine Learning Dashboard at recruitment prior to administration of scenarios and immediately after completion of scenarios. The difference in time between the two will be approximately 60 minutes. Higher change indicates greater acceptance/intention to use the GutGPT+Dashboard.

Secondary

MeasureTime frameDescription
Clinician Decision Making of Triage of GI BleedingApproximately 60 minutesMean percentage of decision accuracy per participant. Accuracy is defined as the percentage of times participants accurately choose the correct clinical decision for each simulation scenario of acute upper GI bleeding for each treatment condition. Immediately after completion of scenarios (60 minutes from initiation of study for each participant). No further follow up afterwards.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDennis Shung, MD

Yale School of Medicine Section of Digestive Diseases

Baseline characteristics

Characteristic
Age, Customized
18 - 24 years
2 Participants
Age, Customized
25-29 years
60 Participants
Age, Customized
30-34 years
31 Participants
Age, Customized
35-39 years
10 Participants
Age, Customized
40-44 years
2 Participants
Age, Customized
45-49 years
1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Familiarity with Artificial Intelligence (AI)
Not at all or slightly
83 Participants
Familiarity with Artificial Intelligence (AI)
Some AI Coursework
3 Participants
Familiarity with Artificial Intelligence (AI)
Unknown/Did not answer
9 Participants
Mean baseline Unified Theory of Acceptance and Use of Technology (UTAUT) survey score
Behavioral Intention
3.4 score on a scale
STANDARD_DEVIATION 0.1
Mean baseline Unified Theory of Acceptance and Use of Technology (UTAUT) survey score
Effort Expectancy
3.0 score on a scale
STANDARD_DEVIATION 0.1
Mean baseline Unified Theory of Acceptance and Use of Technology (UTAUT) survey score
Facilitating Conditions
2.7 score on a scale
STANDARD_DEVIATION 0.1
Mean baseline Unified Theory of Acceptance and Use of Technology (UTAUT) survey score
Performance Expectancy
3.4 score on a scale
STANDARD_DEVIATION 0.1
Mean baseline Unified Theory of Acceptance and Use of Technology (UTAUT) survey score
Social Influence
3.4 score on a scale
STANDARD_DEVIATION 0.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
24 Participants
Race (NIH/OMB)
Black or African American
7 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
White
26 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
48 Participants
Training level
Medical Student
25 Participants
Training level
Residency
41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 56
other
Total, other adverse events
0 / 520 / 56
serious
Total, serious adverse events
0 / 520 / 56

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026