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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Acceptability tool from the Ottawa Hospital Research Institute
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults with a diagnosis of Parkinson's disease referred for deep brain stimulation surgery evaluation at the University of Colorado
Exclusion Criteria
- •Atypical Parkinsonism
- •Diagnosis of Dementia
Arms & Interventions
Early Decision Aid
Participants will receive the Decision Aid at baseline.
Intervention: Deep Brain Stimulation Decision Aid (Other)
Delayed Decision Aid
Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.
Intervention: Deep Brain Stimulation Decision Aid (Other)
Outcomes
Primary Outcomes
Acceptability tool from the Ottawa Hospital Research Institute
Time Frame: 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)
Time Frame: 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.
Acceptability tool from the Ottawa Hospital Research Institute
Time Frame: Baseline
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)
Time Frame: Baseline
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.
Decisional Conflict Scale (DCS)
Time Frame: 1 Month
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.
Decisional Conflict Scale (DCS)
Time Frame: 3 Months
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.
Decisional Conflict Scale (DCS)
Time Frame: 2 weeks after decision for deep brain stimulation 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.
Secondary Outcomes
- 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)
- 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 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)
- Expectations(1 Month)
- Decision Quality Worksheet(2 weeks after decision for deep brain stimulation surgery)
- Decision Self-Efficacy scale(Baseline)
- Decision Self-Efficacy scale(3 Months)
- Decision Readiness Instrument(Baseline)
- Decision Readiness Instrument(1 Month)
- Decision Readiness Instrument(3 Months)
- Satisfaction with Decision Scale(2 weeks after decision for deep brain stimulation surgery)
- Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)(Baseline)
- Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)(2 weeks after decision for deep brain stimulation surgery)
- Expectations(Baseline)
- Expectations(3 Months)
- Shared Decision-Making Questionnaire - 9(1 Month)
- Shared Decision-Making Questionnaire - 9(3 Months)