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临床试验/NCT07010679
NCT07010679Enrolling By Invitation不适用

Development and Pilot Testing of a Patient-Centered Clinical Decision Support for Chronic Rhinosinusitis

University of Southern California2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年6月2日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
50
试验地点
2
主要终点
Proportion of Participants Choosing Endoscopic Sinus Surgery (ESS) vs. Nonsurgical Management at 4-Month Follow-up

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: Up 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).

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

时间窗: 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.

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

时间窗: 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.

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

时间窗: At 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)

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shinyi Wu

Associate Professor

University of Southern California

研究点 (2)

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