Designing Visual Tools to Enhance Cancer Surgeon Decision-making
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Discussion of Risks and Benefits
研究概览
简要总结
This prospective study will compare pre-post pilot test of surgeon-facing, visual decision support among urologists seeing patients with newly diagnosed localized prostate and kidney cancer. Up to 20 urologists (10 academic and 10 community) will be enrolled. The goal will be to capture up to 10 pre- and 10 post-intervention patient encounters for each urologist with an accrual target of 200 unique patient visits (100 pre and 100 post-intervention) over a half-year period. Patient encounters pre- and post-intervention will be audio recorded, transcribed, and coded for discussion of risks/benefits of surgery and strength of recommendation. Patients and urologists will complete additional surveys on their perceptions of patient-provider communication. Urologists will further describe their experience and rate their satisfaction with visual decision support. Communication (content and perceived) will be compared pre- and post-intervention with secondary comparisons by race and care setting.
It was hypothesized that the discussion of risks and benefits of cancer surgery will increase post-intervention and that the strength of recommendation and perceptions of patient-provider communication will change. The secondary hypothesis is that these changes will differ by patient race and care setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
- •Verbal informed consent was obtained to participate in the study.
- •Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- •Age ≥ 18 years at the time of consent.
- •For patient subjects, HIPAA authorization for the release of personal health information and a new histologic diagnosis of localized prostate cancer based on prostate biopsy or clinical diagnosis of T1 renal mass (≤7 cm in diameter) Suspicion for kidney cancer based on cross-sectional imaging. New diagnosis is defined as within 6 months of consent. T1 renal masses include solid masses or Bosniak III/IV cystic masses.
- •For physician subjects, practicing urologist in North Carolina at UNC Health, Novant Health, or an affiliated site and sees patients with suspected or confirmed prostate or kidney cancer.
排除标准
- •The subjects meeting the following criteria will be excluded from study participation:
- •Non-English speaking.
- •Unwilling or unable to complete informed consent.
- •For patient subjects:
- •Has staging information indicating locally advanced or metastatic disease. This would include PSA >50 ng/ml, imaging suggestive of distant metastasis, or lymph node involvement, renal masses >7 cm or invading in renal sinus or tumor thrombus.
- •Histologic or clinical diagnosis >6 months before date of consent.
研究组 & 干预措施
Patient participants
Patient participants will complete a 10-minute baseline survey, 15-minute after-visit survey and 5-minute 6-month survey.
干预措施: No intervention (Other)
Physician participants
Physician participants seeing patients with newly diagnosed localized prostate cancer and clinical T1 renal masses suspicious for kidney cancer.
干预措施: Visual (Behavioral)
结局指标
主要结局
Discussion of Risks and Benefits
时间窗: Baseline (Patient-Physician Encounter)
The impact of visual decision support on patient-physician communication will be assessed using coding-based thematic analysis of the debriefing interviews. The Informed Decision-Making coding system, which includes 9 elements which includes the nature of the clinical problem (e.g., cancer mortality risk, life expectancy), treatment options (e.g., surgery, alternatives), risks and benefits (e.g., complications, side effects, functional outcomes), and uncertainties (e.g., range of possible outcomes). Audio-recorded patient encounters will be coded. Paired coders will score these domains as a 0 (absent), 1 (partial, brief, or one-way), or 2 (complete, two-way discussion).
次要结局
- The impact of the visual decision support on the strength of the recommendations - observer(Baseline (Patient-Physician Encounter))
- The impact of the visual decision support on the strength of the recommendations - surgeon rated(Baseline (After-Visit))
- Patient-Centered Communication(Baseline (After-Visit))
- Physician Satisfaction Scale(Baseline (After-Visit))
- Patient-Physician Communication(Baseline (After-Visit))
- Patient Decision-Making(Up to 6 months)
- Physician Decision-Making(Baseline (After-Visit))
- Treatment Selection/Quality(Up to12 months)
- Perceived Usability Ratings(Up to 6 months)
- Physician Debriefing Interview(Up to 6 months)