Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06446505
• Other study ID #: 23-2390
• Secondary ID: K12AR084226
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 2026

Study information

• Verified date: June 2024
• Source: University of Colorado, Denver
• Contact: Michelle E Fullard, MD
• Phone: 3037242194
• Email: michelle.fullard[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Deep Brain Stimulation Decision Aid
An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	2 weeks after decision for deep brain stimulation surgery
Primary	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.	Baseline
Primary	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.	1 Month
Primary	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.	3 Months
Primary	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.	2 weeks after decision for deep brain stimulation surgery
Primary	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.	2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Secondary	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.	2 weeks after decision for deep brain stimulation surgery
Secondary	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.	2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Secondary	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".	Baseline
Secondary	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".	3 Months
Secondary	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".	2 weeks after decision for deep brain stimulation surgery
Secondary	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".	Baseline
Secondary	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".	1 Month
Secondary	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".	3 Months
Secondary	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".	2 weeks after decision for deep brain stimulation surgery
Secondary	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.	2 weeks after decision for deep brain stimulation surgery
Secondary	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.	2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Secondary	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.	Baseline
Secondary	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.	2 weeks after decision for deep brain stimulation surgery
Secondary	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.	2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Secondary	Expectations	Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.	Baseline
Secondary	Expectations	Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.	1 Month
Secondary	Expectations	Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.	3 Months
Secondary	Expectations	Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.	2 weeks after decision for deep brain stimulation surgery
Secondary	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).	1 Month
Secondary	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).	3 Months
Secondary	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).	2 weeks after decision for deep brain stimulation surgery
Secondary	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.	2 weeks after decision for deep brain stimulation surgery