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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
42
An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.
University of Colorado Anschutz
Aurora, Colorado, United States
RECRUITINGAcceptability tool from the Ottawa Hospital Research Institute
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.
Time frame: Baseline
Acceptability tool from the Ottawa Hospital Research Institute
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.
Time frame: 2 weeks after decision for deep brain stimulation surgery
Decisional Conflict Scale (DCS)
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.
Time frame: Baseline
Decisional Conflict Scale (DCS)
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.
Time frame: 1 Month
Decisional Conflict Scale (DCS)
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.
Time frame: 3 Months
Decisional Conflict Scale (DCS)
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.
Time frame: 2 weeks after decision for deep brain stimulation surgery
Decisional Conflict Scale (DCS)
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.
Time frame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Decision Quality Worksheet
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.
Time frame: 2 weeks after decision for deep brain stimulation surgery
Decision Quality Worksheet
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.
Time frame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Decision Self-Efficacy scale
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".
Time frame: Baseline
Decision Self-Efficacy scale
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".
Time frame: 3 Months
Decision Self-Efficacy scale
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".
Time frame: 2 weeks after decision for deep brain stimulation surgery
Decision Readiness Instrument
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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".
Time frame: Baseline
Decision Readiness Instrument
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".
Time frame: 1 Month
Decision Readiness Instrument
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".
Time frame: 3 Months
Decision Readiness Instrument
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".
Time frame: 2 weeks after decision for deep brain stimulation surgery
Satisfaction with Decision Scale
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.
Time frame: 2 weeks after decision for deep brain stimulation surgery
Satisfaction with Decision Scale
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.
Time frame: 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)
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.
Time frame: Baseline
Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
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.
Time frame: 2 weeks after decision for deep brain stimulation surgery
Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
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.
Time frame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Expectations
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Time frame: Baseline
Expectations
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Time frame: 1 Month
Expectations
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Time frame: 3 Months
Expectations
Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Time frame: 2 weeks after decision for deep brain stimulation surgery
Shared Decision-Making Questionnaire - 9
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).
Time frame: 1 Month
Shared Decision-Making Questionnaire - 9
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).
Time frame: 3 Months
Shared Decision-Making Questionnaire - 9
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).
Time frame: 2 weeks after decision for deep brain stimulation surgery
Trust in the Surgeon Scale
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.
Time frame: 2 weeks after decision for deep brain stimulation surgery