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

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

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 Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Deep Brain Stimulation Decision Aid

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle E Fullard, MD; Phone Number: 3037242194; Email: michelle.fullard@cuanschutz.edu
• Study Contact Backup: Name: Erika Shelton; Phone Number: 3037244644; Email: erika.shelton@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz
      • Contact: Michelle E Fullard; Phone Number: 303-724-2194; Email: michelle.fullard@cuanschutz.edu
      • Contact: Erika Shelton; Phone Number: Fullard 3037244644; Email: erika.shelton@cuanschutz.edu
      • Principal Investigator: Michelle E Fullard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Decision Aid; Participants will receive the Decision Aid at baseline.	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.
Active Comparator: Delayed Decision Aid; Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Expectations	Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.	Baseline
Expectations	Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.	1 Month
Expectations	Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.	3 Months
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Michelle E Fullard, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; Decision Aid
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 23-2390; K12AR084226 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We plan to share the de-identified dataset after the primary results have been accepted for publication. No patient identifiers will be included in the shared data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No