NCT06026098

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2026

First Submitted

Initial submission to the registry

August 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
2.7 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

August 29, 2023

Last Update Submit

April 13, 2026

Conditions

Cognitive BurdenCognitive Symptom

Keywords

artificial intelligencecase report

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline to 2 hours

  • 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.

    Baseline to 2 hours

Study Arms (2)

Case Report with Artificial Intelligence

EXPERIMENTAL

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

Behavioral: Artificial Intelligence

Case Report without Artificial Intelligence

NO INTERVENTION

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

Interventions

Artificial IntelligenceBEHAVIORAL

Participants will use the Artificial Intelligence assistance tool for case reports.

Case Report with Artificial Intelligence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. The subject is a physician, medical student, or postdoctoral student.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

MeSH Terms

Conditions

Neurobehavioral Manifestations

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Officials

  • Shivani Sud

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivani Sud

CONTACT

984-987-1072shivani.sud@unchealth.unc.edu

Victoria Xu

CONTACT

984-974-8744victoria_xu@med.unc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 6, 2023

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)