Treatment Decision-Making Among Patients With Chronic Rhinosinusitis
NCT ID: NCT07010679
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
50 participants
INTERVENTIONAL
2025-06-02
2026-06-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
Participants in this group will use the patient centered clinical decision support (PC CDS) tool in addition to receiving standard care.
Patient Centered CRS Treatment Decision Support
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.
Control Group
Participants in this group will receive standard care, which includes informational handouts about CRS management.
No interventions assigned to this group
Interventions
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Patient Centered CRS Treatment Decision Support
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Responsible Party
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Shinyi Wu
Associate Professor
Principal Investigators
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Shinyi Wu, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Keck Medicine of USC
Arcadia, California, United States
Countries
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Other Identifiers
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APP-25-00437
Identifier Type: OTHER
Identifier Source: secondary_id
UP-22-00453-AM008
Identifier Type: -
Identifier Source: org_study_id