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

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Other: Deep Brain Stimulation Decision Aid

• Registration Number: NCT06446505
• Lead Sponsor: University of Colorado, Denver

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-05-22
• Status Verified: 2024-06
• Study Start: 2024-06
• Study First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Study First Posted: 2024-06-06
• Last Update Posted: 2024-06-06
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Adults with a diagnosis of Parkinson's disease referred for deep brain stimulation surgery evaluation at the University of Colorado

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Exclusion Criteria

• Atypical Parkinsonism
• Diagnosis of Dementia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Decision Aid	Deep Brain Stimulation Decision Aid	Participants will receive the Decision Aid at baseline.
Delayed Decision Aid	Deep Brain Stimulation Decision Aid	Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.

Primary Outcome Measures

Name	Time	Method
Acceptability tool from the Ottawa Hospital Research Institute	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)	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.

Secondary Outcome Measures

Name	Time	Method
Expectations	2 weeks after decision for deep brain stimulation surgery	Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
Shared Decision-Making Questionnaire - 9	2 weeks after decision for deep brain stimulation surgery	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).
Decision Self-Efficacy scale	2 weeks after decision for deep brain stimulation surgery	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".
Satisfaction with Decision Scale	2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo 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.
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.
Decision Quality Worksheet	2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo 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.
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	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 Readiness Instrument	2 weeks after decision for deep brain stimulation surgery	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".

Trial Locations

Locations (1)

University of Colorado Anschutz; 🇺🇸 Aurora, Colorado, United States