Feasibility, Acceptability, and Effectiveness of an Online Decision Aid for Patients With Parkinson's Disease Considering Deep Brain Stimulation Surgery Using a Pragmatic, Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Acceptability tool from the Ottawa Hospital Research Institute
研究概览
简要总结
The goal of this clinical trial is to learn if a Decision Aid can help patients with Parkinson's disease make a decision about undergoing Deep Brain Stimulation surgery. The main questions it aims to answer are:
- Is the Decision Aid acceptable to patients with Parkinson's disease considering Deep Brain Stimulation surgery?
- Does the decision aid improve decision quality (informed, value-based decision) and uncertainty about the decision?
Researchers will compare immediate use of the decision aid during the evaluation process for deep brain stimulation surgery to delayed introduction of the decision aid.
Participants will:
- Receive the decision aid at the beginning of the evaluation process or towards the end
- Complete surveys at 5 visits (remote or in-person) over approximately 6 months
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
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
- •Adults with a diagnosis of Parkinson's disease referred for deep brain stimulation surgery evaluation at the University of Colorado
排除标准
- •Atypical Parkinsonism
- •Diagnosis of Dementia
结局指标
主要结局
Acceptability tool from the Ottawa Hospital Research Institute
时间窗: 2 weeks after decision for deep brain stimulation surgery
This tool measures the comprehensibility of components of the decision aid including its length, amount of information, balance and suitability for decision-making. Higher scores indicate that the tool is more acceptable.
Decisional Conflict Scale (DCS)
时间窗: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
次要结局
- Expectations(2 weeks after decision for deep brain stimulation surgery)
- Shared Decision-Making Questionnaire - 9(2 weeks after decision for deep brain stimulation surgery)
- Decision Self-Efficacy scale(2 weeks after decision for deep brain stimulation surgery)
- Satisfaction with Decision Scale(2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery)
- Trust in the Surgeon Scale(2 weeks after decision for deep brain stimulation surgery)
- Decision Quality Worksheet(2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery)
- Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)(2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery)
- Decision Readiness Instrument(2 weeks after decision for deep brain stimulation surgery)