Testing of a Tool to Elicit Patient Preferences for CTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Decisional Conflict Scale
研究概览
简要总结
This study will complete a randomized controlled trial to quantitatively measure patient decisional conflict (Decisional Conflict Scale) in 150 patients treated for CTS with the tool compared to 150 patients treated with standard care. The investigators hypothesize patients treated for CTS will have lower decisional conflict with the tool.
详细描述
The investigators will measure decisional conflict in 150 new patients being evaluated for CTS with the tool compared to 150 patients being evaluated for CTS with standard care. Those patients randomized to receiving the tool will use it to identify their preferences for certain attributes of care. Patients will then be presented with their preference data and the surgeon will have a discussion with the patient regarding CTS. Surgeons will have their standard discussion with the patients randomized to the standard care group (no tool). The tool will be operationalized on a Health Insurance Portability and Accountability Act compliant data platform, such as Qualtrics, and no identifiable data will be collected. De-identified data will be shared from study cites with our team at Stanford. This data will be backed up on a computer encrypted by Stanford.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
No masking will occur
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
- •New patient
- •English fluency and literacy
- •Able to take informed consent
- •clinical diagnosis of carpal tunnel syndrome
排除标准
- •Prior diagnostic testing for carpal tunnel (nerve test, ultrasound)
- •Prior carpal tunnel release
- •Diagnosis of C5/6 radiculopathy (double crush)
- •Peripheral neuropathy (ex: diabetic)
- •Worker Compensation/EMG Required
- •Symptoms of Cubital tunnel syndrome
研究组 & 干预措施
Control
None- normal care
Intervention
Patients will use a preference elicitation tool to determine their preferences for diagnosis and treatment of CTS
干预措施: Preference Elicitation tool (Other)
结局指标
主要结局
Decisional Conflict Scale
时间窗: Immediately after using tool (up to 5 minutes to complete survey)
The Decisional Conflict Scale measures uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. The survey consists of 16 statements with 5 response categories. Scoring: total scale-0 (no decisional conflict) to 100 (extreme decisional conflict). Lower values indicate lower decisional conflict- i.e. a better outcome for use of the tool. Calculation: Summed, divided by # of items, multiplied by 25
次要结局
未报告次要终点
研究者
Robin Kamal
Assistant Professor
Stanford University