Clinical trial NCT06446505: Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Decision Aid
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2024-06-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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

Primary outcomes:
measure: Acceptability tool from the Ottawa Hospital Research Institute
timeFrame: Baseline
measure: Acceptability tool from the Ottawa Hospital Research Institute
timeFrame: 2 weeks after decision for deep brain stimulation surgery
measure: Decisional Conflict Scale (DCS)
timeFrame: Baseline
measure: Decisional Conflict Scale (DCS)
timeFrame: 1 Month
measure: Decisional Conflict Scale (DCS)
timeFrame: 3 Months
measure: Decisional Conflict Scale (DCS)
timeFrame: 2 weeks after decision for deep brain stimulation surgery
measure: Decisional Conflict Scale (DCS)
timeFrame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
Secondary outcomes:
measure: Decision Quality Worksheet
timeFrame: 2 weeks after decision for deep brain stimulation surgery
measure: Decision Quality Worksheet
timeFrame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
measure: Decision Self-Efficacy scale
timeFrame: Baseline
measure: Decision Self-Efficacy scale
timeFrame: 3 Months
measure: Decision Self-Efficacy scale
timeFrame: 2 weeks after decision for deep brain stimulation surgery
measure: Decision Readiness Instrument
timeFrame: Baseline
measure: Decision Readiness Instrument
timeFrame: 1 Month
measure: Decision Readiness Instrument
timeFrame: 3 Months
measure: Decision Readiness Instrument
timeFrame: 2 weeks after decision for deep brain stimulation surgery
measure: Satisfaction with Decision Scale
timeFrame: 2 weeks after decision for deep brain stimulation surgery
measure: Satisfaction with Decision Scale
timeFrame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
measure: Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
timeFrame: Baseline
measure: Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
timeFrame: 2 weeks after decision for deep brain stimulation surgery
measure: Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
timeFrame: 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
measure: Expectations
timeFrame: Baseline
measure: Expectations
timeFrame: 1 Month
measure: Expectations
timeFrame: 3 Months
measure: Expectations
timeFrame: 2 weeks after decision for deep brain stimulation surgery
measure: Shared Decision-Making Questionnaire - 9
timeFrame: 1 Month
measure: Shared Decision-Making Questionnaire - 9
timeFrame: 3 Months
measure: Shared Decision-Making Questionnaire - 9
timeFrame: 2 weeks after decision for deep brain stimulation surgery
measure: Trust in the Surgeon Scale
timeFrame: 2 weeks after decision for deep brain stimulation surgery
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Michelle E Fullard, MD
role: PRINCIPAL_INVESTIGATOR
References: