Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 4
- 主要终点
- Proportion of Eligible Patients for Feasibility
研究概览
简要总结
There is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer and conduct a pilot clinical trial to evaluate the feasibility of conducting a larger efficacy study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >18 years old presenting for evaluation of a thyroid nodule
排除标准
- •Patients with hyperthyroidism
- •Patients with previous biopsy of the nodule of interest
- •Pregnant patients
- •Prisoners
结局指标
主要结局
Proportion of Eligible Patients for Feasibility
时间窗: at 6 months of follow up
Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up).
次要结局
- Distress Due to Thyroid Nodule (6 Months)(6 months)
- Patient's Acceptance to Participate in the Study(first visit)
- Adequate Randomization(initial clinical visit)
- Completeness of Baseline Survey (Patients)(baseline)
- Patient Survey (6 Months)(6 months)
- Clinician Baseline Survey(baseline)
- Knowledge(baseline)
- Decisional Conflict(baseline)
- OPTION Score(baseline)
- Visit Duration(baseline)
- Diagnostic Decision(baseline)
- Fidelity(baseline)
- Risk Communication(baseline)
- Satisfaction With the Communication (Patient)(baseline)
- Satisfaction With the Visit (Clinician)(baseline)
- Worry About Thyroid Cancer(baseline)