NCT07010679

Treatment Decision-Making Among Patients With Chronic Rhinosinusitis

Enrolling by Invitation
NAAges 18+InterventionalTreatment
University of Southern California
~50 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Patient Centered CRS Treatment Decision Support

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants Choosing Endoscopic Sinus Surgery (ESS) vs. Nonsurgical Management at 4-Month Follow-up
Measured over Up to 4 months post-enrollment
+4 more outcomes measured
Chronic Rhinosinusitis (CRS)
1 sites across 1 states
California1
  • Shinyi Wu, PhD · PRINCIPAL_INVESTIGATOR · University of Southern California

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Eligibility criteria

Inclusion

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
  • Proportion of Participants Choosing Endoscopic Sinus Surgery (ESS) vs. Nonsurgical Management at 4-Month Follow-upUp to 4 months post-enrollment

    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).

  • Decision Concordance as Measured by an Adapted Decision Quality Instrument for Chronic Rhinosinusitis (DQI-CRS)At 4 weeks post-enrollment

    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.

  • Shared Decision-Making Experience as Measured by the 9-item Shared Decision Making Questionnaire (SDM-Q-9)At 4 weeks post-enrollment

    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.

  • CRS Knowledge Score Based on a 10-Item Investigator-Developed QuestionnaireAt baseline and at 4 weeks post-enrollment

    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.

  • Trust in Physician as Measured by the 10-item Wake Forest Physician Trust Scale (WFPTS)At baseline and at 4 weeks post-enrollment

    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.