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

Primary Purpose

Gastrointestinal Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LLM
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gastrointestinal Hemorrhage focused on measuring Implementation science, Artificial intelligence, Decision Support Systems, Clinical, Simulation Training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Internal Medicine residency trainees at study institution Emergency Medicine residency trainees at study institution Exclusion Criteria: N/A

Sites / Locations

  • Yale New Haven HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Large Language Model-based Interaction

Machine Learning Dashboard

Arm Description

LLM-powered chatbot with the machine learning dashboard to provide the risk assessment and provide rationale based on interpretability metrics provided by the dashboard in which study participants can directly interact with using natural language. Participants will be provided the Generative Pre-trained Transformer (GPT) chatbot powered machine learning model dashboard.

Machine learning algorithm output with an interactive dashboard that can be used to explain, or interpret the input factors that contribute most towards the generated risk score. Participants will have access to the machine learning dashboard only.

Outcomes

Primary Outcome Measures

Change in Attitudes Towards Machine Learning Algorithms in Clinical Care using UTAUT
The 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. Change in UTAUT survey response 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.
Clinician Decision Making of Triage of GI bleeding
This study will determine the number of study participants (out of all study participants in the group) who 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.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2023
Last Updated
June 21, 2023
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05816473
Brief Title
Artificial Intelligent Clinical Decision Support System Simulation Center Study for Technology Acceptance
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage
Keywords
Implementation science, Artificial intelligence, Decision Support Systems, Clinical, Simulation Training

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Large Language Model-based Interaction
Arm Type
Experimental
Arm Description
LLM-powered chatbot with the machine learning dashboard to provide the risk assessment and provide rationale based on interpretability metrics provided by the dashboard in which study participants can directly interact with using natural language. Participants will be provided the Generative Pre-trained Transformer (GPT) chatbot powered machine learning model dashboard.
Arm Title
Machine Learning Dashboard
Arm Type
No Intervention
Arm Description
Machine learning algorithm output with an interactive dashboard that can be used to explain, or interpret the input factors that contribute most towards the generated risk score. Participants will have access to the machine learning dashboard only.
Intervention Type
Other
Intervention Name(s)
LLM
Intervention Description
Use of a Large Language Model (LLM) chatbot interface to Interact with the Machine Learning Algorithm and interpretability dashboard.
Primary Outcome Measure Information:
Title
Change in Attitudes Towards Machine Learning Algorithms in Clinical Care using UTAUT
Description
The 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. Change in UTAUT survey response 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.
Time Frame
Approximately 60 minutes
Title
Clinician Decision Making of Triage of GI bleeding
Description
This study will determine the number of study participants (out of all study participants in the group) who 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.
Time Frame
Approximately 60 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Internal Medicine residency trainees at study institution Emergency Medicine residency trainees at study institution Exclusion Criteria: N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunny Chung, MD
Phone
8436189423
Email
sunny.chung@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Shung, MD
Organizational Affiliation
Yale School of Medicine Section of Digestive Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunny Chung, MD
Phone
843-618-9423
Email
sunny.chung@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27521511
Citation
Laine L. Risk Assessment Tools for Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2016 Nov;14(11):1571-1573. doi: 10.1016/j.cgh.2016.08.003. Epub 2016 Aug 10. No abstract available.
Results Reference
background
PubMed Identifier
22310222
Citation
Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.
Results Reference
background
Citation
Leonardi, P. M. 2009. Why do people reject new technologies and stymie organizational changes of which they are in favor? Exploring misalignments between social interactions and materiality. Human Communication Research, 35(3): 407-441.
Results Reference
background
Citation
Venkatesh, V., Morris, M. G., Davis, G. B., & Davis, F. D. (2003). User Acceptance of Information Technology: Toward a Unified View. MIS Quarterly, 27(3), 425-478
Results Reference
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Artificial Intelligent Clinical Decision Support System Simulation Center Study for Technology Acceptance

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