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Treatment Decision-Making Among Patients With Chronic Rhinosinusitis

NCT07010679 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-18

No results posted yet for this study

Summary

This project aims to develop and pilot-test a bilingual, patient-centered clinical decision support (PC CDS) web application for individuals with chronic rhinosinusitis (CRS), a condition affecting 16% of U.S. adults annually and significantly impacting quality of life. While endoscopic sinus surgery (ESS) is a recommended treatment for medically refractory cases, many patients experience barriers that lead to surgical hesitancy. Prior research at USC revealed significant disparities in ESS uptake (Odds Ratio = 7.92; 95% Confidence Interval: 2.95-21.28), highlighting the need for more tailored decision support.

The PC CDS will include educational resources, Large Language Model-assisted patient narratives, and a provider communication module to facilitate shared decision-making (SDM). The study has three aims: (1) to develop the tool; (2) to evaluate its feasibility in a randomized controlled trial with 50-60 patients from USC clinics; and (3) to assess outcomes using surveys and interviews. Participants will be randomized into either a control group (receiving standard CRS informational handouts) or an intervention group (receiving standard care plus the PC CDS tool).

Quantitative surveys will measure treatment choice, decision quality, SDM involvement, CRS knowledge, provider trust, and care satisfaction. Qualitative interviews will explore participants' healthcare journeys and experiences with the tool. Guided by experts in health technology and rhinology and in collaboration with a Patient Advisory Group, the study aims to ensure patient-centered design and lay the groundwork for future implementation and external funding (e.g., AHRQ).

Conditions

  • Chronic Rhinosinusitis (CRS)

Interventions

OTHER

Patient Centered CRS Treatment Decision Support

The intervention is a web-based tool that includes: * Educational content and Frequently Asked Questions (FAQ) about CRS and treatment options * Patient stories from CRS patient interviews with artificial intelligence-assisted narrative writing * A communication tool to support discussions between patients and their doctors * Culturally tailored components, including Chinese language options and culturally relevant narratives Participants will be introduced to the PC CDS during a routine clinic visit or through a scheduled virtual meeting. They will use the tool before making treatment decisions. The tool is designed to be user-friendly and accessible across devices.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Shinyi Wu, PhD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2026-03-31
Completion
2026-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07010679 on ClinicalTrials.gov