Treatment Decision-Making Among Patients With Chronic Rhinosinusitis

NCT07010679 | Enrolling By Invitation

• 2 other identifiers: UP-22-00453-AM008APP-25-00437
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Patient decision aid; Patient-centered Clinical Decision Support

Outcome Measures

Primary Outcomes (5)

• Proportion of Participants Choosing Endoscopic Sinus Surgery (ESS) vs. Nonsurgical Management at 4-Month Follow-up

  The primary outcome will be the proportion of participants in each study arm (PC CDS intervention vs. standard care control) who elect to pursue either endoscopic sinus surgery (ESS) or nonsurgical treatment within four months following enrollment. Treatment decisions will be assessed via self-report and confirmed through medical record review. Data will be summarized as percentages for each group, and between-group differences will be compared using chi-square or Fisher's exact tests. This measure will evaluate the effect of the PC CDS tool on surgical acceptance rates among patients with medically refractory chronic rhinosinusitis (CRS).

  Up to 4 months post-enrollment

• Decision Concordance as Measured by an Adapted Decision Quality Instrument for Chronic Rhinosinusitis (DQI-CRS)

  Decision concordance will be assessed using an adapted version of the Decision Quality Instrument (DQI) tailored to chronic rhinosinusitis (CRS). Participants will identify their top treatment goals and report the treatment option they ultimately selected (e.g., surgery or continued medical management). Concordance will be evaluated by comparing the stated treatment preference (based on ranked goals) to the actual treatment decision. A concordance score will be calculated as the percentage of participants whose treatment choice matches their top-ranked goals and concerns. Higher scores reflect better alignment between patients' preferences and treatment decisions. The adapted concordance assessment will be reviewed by clinical experts and a Patient Advisory Group prior to administration.

  At 4 weeks post-enrollment

• Shared Decision-Making Experience as Measured by the 9-item Shared Decision Making Questionnaire (SDM-Q-9)

  Shared decision-making experience will be assessed using the 9-item Shared Decision Making Questionnaire (SDM-Q-9), a validated patient-reported measure that evaluates the extent to which patients perceive involvement in the clinical decision-making process. Each item is rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree), yielding a total score between 0 and 45. Scores will be linearly transformed to a 0-100 scale, with higher scores indicating a more positive SDM experience. The SDM-Q-9 will be administered 4 weeks after enrollment to evaluate the impact of the PC CDS tool on patient-perceived engagement in decision-making for CRS treatment.

  At 4 weeks post-enrollment

• CRS Knowledge Score Based on a 10-Item Investigator-Developed Questionnaire

  Patient knowledge of chronic rhinosinusitis (CRS) will be assessed using a 10-item questionnaire developed by the investigative team. The questionnaire includes multiple-choice and multi-response items covering key domains of CRS knowledge, such as disease definition, diagnostic criteria, treatment options (including endoscopic sinus surgery), associated risk factors, and expected surgical outcomes. One question uses a multi-select format in which the correct answer requires selecting all appropriate responses. Each item is scored as correct or incorrect, with one point awarded for each correct answer (including full accuracy on the multi-select item), resulting in a total score ranging from 0 to 10. Higher scores indicate greater factual knowledge about CRS and its treatment.

  At baseline and at 4 weeks post-enrollment

• Trust in Physician as Measured by the 10-item Wake Forest Physician Trust Scale (WFPTS)

  Trust in the treating physician will be assessed using the 10-item Wake Forest Physician Trust Scale (WFPTS), a validated patient-reported measure that evaluates interpersonal trust across multiple domains, including fidelity, competence, honesty, confidentiality, and dependability. Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with total scores ranging from 10 to 50. Higher scores indicate greater trust in the physician. The WFPTS has demonstrated strong psychometric properties, including high internal consistency (Cronbach's alpha = 0.93) and unidimensional factor structure, as evidenced by exploratory and confirmatory factor analyses. The scale has been adapted and validated in various cultural contexts, supporting its applicability across diverse patient populations.

  At baseline and at 4 weeks post-enrollment

Secondary Outcomes (2)

• Disease-specific quality of life related to chronic rhinosinusitis (CRS) as measured by the SinoNasal Outcome Test - 22 items

  at baseline and also either 1 and 3 months after surgery, or 2 and 4 months after baseline if patient do not undergo surgery

• Patient-Reported Satisfaction with CRS Knowledge and Treatment Decision Confidence

  At 4 weeks post-enrollment

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this group will use the patient centered clinical decision support (PC CDS) tool in addition to receiving standard care.

Other: Patient Centered CRS Treatment Decision Support

Control Group

NO INTERVENTION

Participants in this group will receive standard care, which includes informational handouts about CRS management.

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify if:

• Not offered endoscopic sinus surgery (ESS) as a treatment option by the treating otolaryngologist

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck Medicine of USC

Arcadia, California, 91007, United States

Location

Study Officials

• Shinyi Wu, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 8, 2025
• Study Start: June 2, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be shared beginning 6 months after publication of the main results and will be available for up to 36 months thereafter.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal and agree to a data use agreement. Requests should be submitted to the study principal investigator via institutional email.

Locations

US (1)