NCT06163664

Brief Summary

Previous studies have demonstrated that patients frequently undergo significant decision conflict regarding major medical decisions in otolaryngology. There lack validated tools available for decision support for patients. While limited evidence has demonstrated that clinical decision support tools can alleviate decision conflict for patients with diagnosis in otolaryngology, conversational language models were not employed in these studies and may provide additional benefit in this context. This study seeks to evaluate the efficacy of using ChatGPT, a conversational language model with basic clinical knowledge, in alleviating decision conflict for patients with new diagnosis in otolaryngology. For this pilot study, vestibular schwannoma, a benign tumor that develops on the vestibular nerve with known clinical equipoise, has been chosen for the initial study diagnosis. Efficacy will be evaluated by comparison of responses to the Decisional Conflict Scale (DCS) and Satisfaction with Decision (SWD) scores between a group given training in ChatGPT and a control group (no ChatGPT training).

Trial Health

45
At Risk

Trial Health Score

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

Timeline
11mo left

Started Jan 2027

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
3.1 years until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

October 24, 2023

Last Update Submit

January 11, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Changes in scores of Decisional Conflict Scale after ChatGPT use

    The Decisional Conflict Scale (DCS) measures 5 dimensions of decision making (feeling: uncertain, uninformed, unclear about values, unsupported; ineffective decision making). 15-item validated questionnaire. Score range 5-75 (higher score corresponding to higher levels of conflict in decision making)

    baseline, 1 week follow up, 2 week follow up

  • Changes in scores of Satisfaction with Decision after ChatGPT use

    The Satisfaction with Decision (SWD) scale measures satisfaction with health care decisions. 6-item validated questionnaire. Score range 5-30 (higher score corresponding to higher levels of satisfaction with decision)

    baseline, 1 week follow up, 2 week follow up

  • Changes in scores for Knowledge on vestibular schwannoma management after ChatGPT use

    4-item questionnaire (Likert scale) assessing participants' confidence in understanding the diagnosis and treatment options for vestibular schwannoma. Score range 5-20 (higher score corresponding to higher levels of confidence in understanding diagnosis and management of vestibular schwannoma)

    baseline, 1 week follow up, 2 week follow up

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention with 1 week use of ChatGPT

Behavioral: Use of chatGPT for 1 week

Delayed control

ACTIVE COMPARATOR

No ChatGPT use for 1 week and intervention after 1 week

Behavioral: Use of chatGPT for 1 week

Interventions

Use of chatGPT for 1 week

Delayed controlIntervention

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Diagnosed with vestibular schwannoma
  • Have access to internet-enabled device that is compatible with ChatGPT

You may not qualify if:

  • \< 18 years old
  • patient without diagnosis of vestibular schwannoma
  • patient does not have access to internet-enabled device
  • patient who declines study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 24, 2023

First Posted

December 11, 2023

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

January 13, 2026

Record last verified: 2026-01