NCT07140250

Brief Summary

The goal of this clinical trial is to evaluate whether ChatGPT can improve shared decision-making by increasing treatment-related knowledge and reducing decisional conflict in adult patients with chronic rhinosinusitis (CRS) or nasal obstruction who have been deemed candidates for surgery. The main questions it aims to answer are:

  • Does ChatGPT improve patient understanding of CRS/nasal obstruction treatment options compared to widely utilized web searches?
  • Does ChatGPT reduce decisional conflict regarding surgical versus medical management compared to traditional search engine? Researchers will compare a group using Google (standard internet search with AI turned off) after standard counseling to a group using ChatGPT after standard counseling to see if ChatGPT leads to higher knowledge scores, lower decisional conflict scores, and higher satisfaction with the information platform. Participants will:
  • Complete baseline surveys assessing demographics, treatment-related knowledge, and decisional conflict
  • Be randomized to use either Google or ChatGPT to research their surgery for 10 minutes after standard in-office counseling
  • Complete follow-up surveys assessing knowledge, decisional conflict, and satisfaction with the information source
  • Allow the research team to review their medical record for relevant clinical history and disease-specific quality-of-life scores (SNOT-22)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 18, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

sinusitisshared decision makingrhinitischatGPTnasal obstruction

Outcome Measures

Primary Outcomes (1)

  • Decisional Conflict Scale (DCS) score

    Change in Decisional Conflict Scale (DCS) score

    Immediate - Following completion of education using AI vs traditional education

Secondary Outcomes (2)

  • System usability scale (SUS) scores

    Immediate following education

  • Score on treatment-related knowledge questionnaire (MCQ)

    Immediate following education

Study Arms (2)

Shared Decision Making on Sinusitis Treatment Facilitated by ChatGPT

ACTIVE COMPARATOR

Shared decision making (SDM) about sinusitis treatment will be facilitated by ChatGPT through participant driven question and answers using AI support via ChatGPT

Other: Education with AI Technology

Shared Decision Making on Sinusitis Treatment Facilitated by Google

PLACEBO COMPARATOR

Shared decision making (SDM) about sinusitis treatment will be facilitated by traditional internet search engines (Google) with AI mode off. Participate education on sinusitis treatment will be driven by traditional internet searches

Other: Education using Traditional Internet Search Engines

Interventions

Shared decision making (SDM) about sinusitis treatment will be facilitated by AI technology via ChatGPT

Shared Decision Making on Sinusitis Treatment Facilitated by ChatGPT

Participant Education in Sinusitis using Traditional Internet Search Engines through Google

Shared Decision Making on Sinusitis Treatment Facilitated by Google

Eligibility Criteria

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

You may qualify if:

  • Adult (18 years or older) UC San Diego Health System Rhinology patients
  • Diagnosis of chronic rhinosinusitis and/or nasal obstruction based on clinical criteria or radiologic evidence
  • Planning to pursue surgical intervention for CRS or nasal obstruction
  • Ability to complete online survey in English or Spanish

You may not qualify if:

  • Unable to complete survey assessments online via REDCap
  • Under the age of 18 years
  • Vulnerable patient populations such as those who are pregnant and institutionalized individuals
  • Patients with benign and malignant tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

SinusitisNasal ObstructionRhinitis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesAirway ObstructionRespiratory InsufficiencyRespiration Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

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

Study Record Dates

First Submitted

August 18, 2025

First Posted

August 24, 2025

Study Start

June 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations