Clinical trial NCT07010679: Treatment Decision-Making Among Patients With Chronic Rhinosinusitis
Official title: Development and Pilot Testing of a Patient-Centered Clinical Decision Support for Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Rhinosinusitis (CRS)
Keywords: Patient decision aid
Patient-centered Clinical Decision Support
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: This research aims to develop and pilot-test a patient-centered clinical decision support (PC CDS) web application specifically for patients with chronic rhinosinusitis (CRS). CRS, which affects approximately 16% of U.S. adults annually, significantly impacts quality of life (QOL). Endoscopic sinus surgery (ESS) is a recommended treatment for those unresponsive to medical therapy; however, many patients face unique barriers that contribute to surgical hesitancy and suboptimal outcomes. A previous study conducted at the University of Southern California (USC) revealed significant differences in the likelihood of undergoing ESS among patient subgroups (Odds Ratio = 7.92; 95% Confidence Interverval: 2.95-21.28; p \< 0.001). To address these disparities, the proposed PC CDS will integrate patient-centered support components tailored for individuals hesitant or resistant to ESS, including educational resources, Large Language Model-assisted patient narratives, and a patient-provider communication feature within a bilingual decision aid.

The project includes three primary aims: (1) develop the PC CDS to facilitate shared decision-making (SDM) between patients and clinicians, with the goal of reducing surgical hesitancy and improving outcomes; (2) recruit 50-60 medically refractory CRS patients from USC clinics in Los Angeles for a randomized controlled feasibility trial comparing standard care to the PC CDS intervention; and (3) assess patient healthcare journey outcomes, as well as the acceptability and usability of the PC CDS, through pre- and post-intervention evaluations using both quantitative and qualitative methods.

Participants will be randomly assigned to one of two groups:

Control Group: Will receive standard care, including informational handouts on CRS management.

Intervention Group: Will receive access to the PC CDS tool in addition to standard care.

Data will be collected through surveys and interviews to evaluate healthcare experiences and the influence of the PC CDS tool.

Surveys (Quantitative Measures):

To evaluate whether the PC CDS affects treatment decision-making in CRS care, participants in both groups will complete surveys capturing:

Treatment selection (surgery or no surgery) Quality of decision-making experience, including alignment with patient goals Level of involvement in shared decision-making Knowledge of CRS and trust in the healthcare provider Overall satisfaction with care

Interviews (Qualitative Measures):

Trained interviewers will conduct qualitative interviews with all participants to gain deeper insight into healthcare experiences, engagement with the educational materials or PC CDS tool, and factors influencing treatment decisions.

The research team, led by experts in health technology and rhinology, will collaborate with a Patient Advisory Group to ensure the tool is patient-centered and responsive to community needs.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of Participants Choosing Endoscopic Sinus Surgery (ESS) vs. Nonsurgical Management at 4-Month Follow-up
timeFrame: Up to 4 months post-enrollment
measure: Decision Concordance as Measured by an Adapted Decision Quality Instrument for Chronic Rhinosinusitis (DQI-CRS)
timeFrame: At 4 weeks post-enrollment
measure: Shared Decision-Making Experience as Measured by the 9-item Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: At 4 weeks post-enrollment
measure: CRS Knowledge Score Based on a 10-Item Investigator-Developed Questionnaire
timeFrame: At baseline and at 4 weeks post-enrollment
measure: Trust in Physician as Measured by the 10-item Wake Forest Physician Trust Scale (WFPTS)
timeFrame: At baseline and at 4 weeks post-enrollment
Secondary outcomes:
measure: Disease-specific quality of life related to chronic rhinosinusitis (CRS) as measured by the SinoNasal Outcome Test - 22 items
timeFrame: at baseline and also either 1 and 3 months after surgery, or 2 and 4 months after baseline if patient do not undergo surgery
measure: Patient-Reported Satisfaction with CRS Knowledge and Treatment Decision Confidence
timeFrame: At 4 weeks post-enrollment
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern California
name: Shinyi Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: