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NCT Number: NCT06446505

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acceptability tool from the Ottawa Hospital Research Institute

    Time frame: Baseline

    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. Acceptability tool from the Ottawa Hospital Research Institute

    Time frame: 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.

  3. Decisional Conflict Scale (DCS)

    Time frame: Baseline

    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.

  4. Decisional Conflict Scale (DCS)

    Time frame: 1 Month

    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.

  5. Decisional Conflict Scale (DCS)

    Time frame: 3 Months

    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.

  6. Decisional Conflict Scale (DCS)

    Time frame: 2 weeks after decision for deep brain stimulation 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.

  7. Decisional Conflict Scale (DCS)

    Time frame: 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 outcomes

  1. Decision Quality Worksheet

    Time frame: 2 weeks after decision for deep brain stimulation 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.

  2. Decision Quality Worksheet

    Time frame: 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.

  3. Decision Self-Efficacy scale

    Time frame: Baseline

    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".

  4. Decision Self-Efficacy scale

    Time frame: 3 Months

    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".

  5. Decision Self-Efficacy scale

    Time frame: 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".

  6. Decision Readiness Instrument

    Time frame: Baseline

    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".

  7. Decision Readiness Instrument

    Time frame: 1 Month

    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".

  8. Decision Readiness Instrument

    Time frame: 3 Months

    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".

  9. Decision Readiness Instrument

    Time frame: 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".

  10. Satisfaction with Decision Scale

    Time frame: 2 weeks after decision for deep brain stimulation 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.

  11. Satisfaction with Decision Scale

    Time frame: 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.

  12. Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)

    Time frame: Baseline

    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.

  13. Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)

    Time frame: 2 weeks after decision for deep brain stimulation 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.

  14. Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)

    Time frame: 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.

  15. Expectations

    Time frame: Baseline

    Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.

  16. Expectations

    Time frame: 1 Month

    Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.

  17. Expectations

    Time frame: 3 Months

    Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.

  18. Expectations

    Time frame: 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.

  19. Shared Decision-Making Questionnaire - 9

    Time frame: 1 Month

    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).

  20. Shared Decision-Making Questionnaire - 9

    Time frame: 3 Months

    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).

  21. Shared Decision-Making Questionnaire - 9

    Time frame: 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).

  22. Trust in the Surgeon Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erika Shelton

CONTACT

[email protected]

3037244644

Michelle E Fullard, MD

CONTACT

[email protected]

3037242194

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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