Parkinson Disease
Conditions
Keywords
Deep Brain Stimulation, Decision Aid
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
Interventions
OTHERDeep Brain Stimulation Decision Aid
An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability tool from the Ottawa Hospital Research Institute | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decision Readiness Instrument | Baseline | This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 not at all ready to 5 completely ready. |
| Satisfaction with Decision Scale | 2 weeks after decision for deep brain stimulation surgery | This scale measures how satisfied the participant is with their decision about whether or not to undergo deep brain stimulation surgery. The areas of satisfaction include how informed they were, if the decision was the best for them, if the decision was consistent with their values and if they had as much input as they wanted. Scores range from 6 to 30. Higher scores indicate higher satisfaction with the decision. |
| Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8) | Baseline | This questionnaire measures quality of life in Parkinson's disease related to the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Scores range from 0 to 100 with higher scores indicating lower quality of life. |
| Decision Quality Worksheet | 2 weeks after decision for deep brain stimulation surgery | The worksheet measures how well participants understood the options and outcomes presented in the decision aid, as well as if their decision was consistent with their goals and values. For the knowledge portion of the worksheet, the scores range from 0 to 10, with higher scores indicating increased knowledge about DBS. |
| Shared Decision-Making Questionnaire - 9 | 1 Month | This questionnaire measures the degree of shared decision-making that took place in physician visits discussing deep brain stimulation surgery. The scores range from 0 (no perceived shared decision-making) to 100 (highest level of perceived shared decision-making). |
| Trust in the Surgeon Scale | 2 weeks after decision for deep brain stimulation surgery | This scale measures how much the participant trusts their surgeon. The scale ranges from 11 to 55, with higher scores indicating a higher level of trust. |
| Expectations | Baseline | Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery. |
| Decision Self-Efficacy scale | Baseline | This scale measures the participant's self-confidence in or belief in one's ability to make decisions and participate in shared decision-making. The scores range from 0 to 100. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy. |
Countries
United States
Contacts
Primary ContactMichelle E Fullard, MD
Backup ContactErika Shelton
Outcome results
None listed