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Evaluation of Impact of AI Assistance on Workload Associated w Preparation of Rare Tumor Case Repts

Primary Purpose

Cognitive Burden, Cognitive Symptom

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artificial Intelligence
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cognitive Burden focused on measuring artificial intelligence, case report

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 1. The subject is a physician, medical student, or postdoctoral student. Exclusion Criteria:

Sites / Locations

  • Lineberger Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Case Report with Artificial Intelligence

Case Report without Artificial Intelligence

Arm Description

Medical students, resident physicians, or attending physicians report rare cases with using Artificial Intelligence.

Medical students, resident physicians, or attending physicians report rare cases without using Artificial Intelligence.

Outcomes

Primary Outcome Measures

Subjective Cognitive workload (CWL)
Subjective Cognitive workload (CWL) will be measured while interviews using The National Aeronautics and Space Administration task load (NASA TLX) index is a tool for measuring and conducting a subjective mental workload (MWL) assessment. The NASA-TLX is a subjective measure of CWL and is used across many disciplines. The NASA-TLX considers six dimensions-Mental, Physical, and Temporal Demands, Frustration, Effort, and Performance. NASA-TLX scores ≥55 have been associated with reduced performance in numerous settings. NASA-TLX is considered to be the most used subjective measure of CWL. The validated two-stage process with participants performing 15 separate pair-wise comparisons between 6 dimensions of NASA-TLX will be used. A workload score will be marked from low and high for each dimension. Score values from 0 -100. The Interpretation Score of NASA TLX for Low 0-9, Medium 10-29, Somewhat high 30-49, High 50-79, and Very high 80-100
Perceived cognitive load
The perceived cognitive load will be measured using System Usability Scale (SUS). SUS is a validated post-test questionnaire that measures user satisfaction. Further, studies confirm that SUS is predictive of the impacts of changes to the user interface on usability when multiple changes to a single product were made over a large number of iterations. SUS is composed of 10 questions- five positive and five negative statements, each having a five-point scale that ranges from strongly disagree to strongly agree. SUS provides a score (range, 0-100) based on the participant's rating of 10 statements regarding usability with higher scores indicating greater satisfaction with usability.

Secondary Outcome Measures

Full Information

First Posted
August 29, 2023
Last Updated
October 10, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT06026098
Brief Title
Evaluation of Impact of AI Assistance on Workload Associated w Preparation of Rare Tumor Case Repts
Official Title
A Prospective Evaluation of Impact of AI Assistance on Workload Associated With Preparation of Rare Tumor Case Reports
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this study is to explore cognitive burden perceptions among physicians in relation to case report writing. Furthermore, this study evaluates the use of artificial intelligence (AI) assistance as a tool to reduce cognitive burden among providers preparing and submitting case reports. If an AI-tool is helpful in this setting, it may potentially help increase reporting of rare medical events and thereby improve the evidence base for care of these patient populations. This study will occur at a single time point which is expected to last approximately 2 hours. This session will include reviewing two rare tumor cases and then writing a clinical vignette with and without AI assistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Burden, Cognitive Symptom
Keywords
artificial intelligence, case report

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case Report with Artificial Intelligence
Arm Type
Experimental
Arm Description
Medical students, resident physicians, or attending physicians report rare cases with using Artificial Intelligence.
Arm Title
Case Report without Artificial Intelligence
Arm Type
No Intervention
Arm Description
Medical students, resident physicians, or attending physicians report rare cases without using Artificial Intelligence.
Intervention Type
Behavioral
Intervention Name(s)
Artificial Intelligence
Intervention Description
Participants will use the Artificial Intelligence assistance tool for case reports.
Primary Outcome Measure Information:
Title
Subjective Cognitive workload (CWL)
Description
Subjective Cognitive workload (CWL) will be measured while interviews using The National Aeronautics and Space Administration task load (NASA TLX) index is a tool for measuring and conducting a subjective mental workload (MWL) assessment. The NASA-TLX is a subjective measure of CWL and is used across many disciplines. The NASA-TLX considers six dimensions-Mental, Physical, and Temporal Demands, Frustration, Effort, and Performance. NASA-TLX scores ≥55 have been associated with reduced performance in numerous settings. NASA-TLX is considered to be the most used subjective measure of CWL. The validated two-stage process with participants performing 15 separate pair-wise comparisons between 6 dimensions of NASA-TLX will be used. A workload score will be marked from low and high for each dimension. Score values from 0 -100. The Interpretation Score of NASA TLX for Low 0-9, Medium 10-29, Somewhat high 30-49, High 50-79, and Very high 80-100
Time Frame
Baseline to 2 hours
Title
Perceived cognitive load
Description
The perceived cognitive load will be measured using System Usability Scale (SUS). SUS is a validated post-test questionnaire that measures user satisfaction. Further, studies confirm that SUS is predictive of the impacts of changes to the user interface on usability when multiple changes to a single product were made over a large number of iterations. SUS is composed of 10 questions- five positive and five negative statements, each having a five-point scale that ranges from strongly disagree to strongly agree. SUS provides a score (range, 0-100) based on the participant's rating of 10 statements regarding usability with higher scores indicating greater satisfaction with usability.
Time Frame
Baseline to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. The subject is a physician, medical student, or postdoctoral student. Exclusion Criteria:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shivani Sud
Phone
984-987-1072
Email
shivani.sud@unchealth.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Xu
Phone
984-974-8744
Email
victoria_xu@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivani Sud
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shivani Sud
Phone
984-987-1072
Email
shivani.sud@unchealth.unc.edu
First Name & Middle Initial & Last Name & Degree
Victoria Xu
Phone
984-974-8744
Email
victoria_xu@med.unc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Learn more about this trial

Evaluation of Impact of AI Assistance on Workload Associated w Preparation of Rare Tumor Case Repts

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