Treatment Decision-Making Among Patients With Chronic Rhinosinusitis

Conditions

• Chronic Rhinosinusitis (CRS)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Patient Centered CRS Treatment Decision Support — 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

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).

Key Dates

Start date

Jun 2, 2025

Status verified

Dec 2025

Primary completion

Mar 31, 2026

Completion

Jun 1, 2026

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Intervention Group
  Participants in this group will use the patient centered clinical decision support (PC CDS) tool in addition to receiving standard care.
• No Intervention: Control Group
  Participants in this group will receive standard care, which includes informational handouts about CRS management.

Primary Outcome Measure

Proportion of Participants Choosing Endoscopic Sinus Surgery (ESS) vs. Nonsurgical Management at 4-Month Follow-up [ Time Frame: Up to 4 months post-enrollment ]

Locations (1)

Find similar trials in Arcadia, CA

Related Studies

• Efficacy of Lavender Aromatherapy on Anxiety and Pain Reduction During Awake Otolaryngologic Procedures
  Recruiting · Cedars-Sinai Medical Center · Los Angeles, California
• Active vs. Passive VR During Office-based ENT Procedures
  Not Yet Recruiting · Cedars-Sinai Medical Center · Los Angeles, California
• Sinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
  PHASE3 · Recruiting · Indiana University · Indianapolis, Indiana