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

NCT06446505 | Recruiting

• 2 other identifiers: 23-2390K12AR084226
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation; Decision Aid

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (22)

• Decision Quality Worksheet

  2 weeks after decision for deep brain stimulation surgery

• Decision Quality Worksheet

  2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery

• Decision Self-Efficacy scale

  Baseline

• Decision Self-Efficacy scale

  3 Months

• Decision Self-Efficacy scale

  2 weeks after decision for deep brain stimulation surgery

Study Arms (2)

Early Decision Aid

EXPERIMENTAL

Participants will receive the Decision Aid at baseline.

Other: Deep Brain Stimulation Decision Aid

Delayed Decision Aid

ACTIVE COMPARATOR

Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.

Other: Deep Brain Stimulation Decision Aid

Interventions

Deep Brain Stimulation Decision Aid OTHER

An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.

Delayed Decision Aid; Early Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Atypical Parkinsonism
• Diagnosis of Dementia

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Michelle E Fullard, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle E Fullard, MD

CONTACT

3037242194; michelle.fullard@cuanschutz.edu

Erika Shelton

CONTACT

3037244644; erika.shelton@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 6, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)