What this study is
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).
What's being tested
- Patient Centered CRS Treatment Decision Support
Intervention · OTHER
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.
Study details
- Official title
- Development and Pilot Testing of a Patient-Centered Clinical Decision Support for Chronic Rhinosinusitis
- Sponsor
- University of Southern California
- Conditions
- Chronic Rhinosinusitis (CRS)
- Enrolling
- 50 people
- Starts
- 2025-06-02
- Est. completion
- 2026-06-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 18 years or older
- Patient receiving care at a USC otolaryngology clinic located in Los Angeles, Glendale, La Cañada, or Arcadia
- Diagnosis of chronic rhinosinusitis (CRS) as defined by the American Academy of Otolaryngology-Head and Neck Surgery criteria
- Medically refractory CRS (i.e., persistent symptoms despite appropriate medical therapy)
- Considered a candidate for endoscopic sinus surgery (ESS) by the treating otolaryngologist
- English- or Chinese-speaking
- Able and willing to provide informed consent
- Access to a smartphone, tablet, or computer with internet connection
You can't join if
- Not offered endoscopic sinus surgery (ESS) as a treatment option by the treating otolaryngologist
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openKeck Medicine of USC
Arcadia, California, United States
Study team
Sponsor
University of Southern California
Study ID UP-22-00453-AM008
Principal investigator
Shinyi Wu, PhD
University of Southern California
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.