Clinical Trial

Treatment Decision-Making Among Patients With Chronic Rhinosinusitis

Study acronym: CRS-AID
Enrolling by Invitation
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Record status
This record was last updated December 18, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-29.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-12-09
Trial Details
NCT Number NCT07010679
Lead Sponsor University of Southern California
Conditions Chronic Rhinosinusitis (CRS)
Enrollment 50 participants
Start Date 2025-06-02
Primary Completion 2026-03-31 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-18