Decision Making Support for Parkinson's Disease

Overseen By Jiayun Xu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Purdue University

Disqualifiers: Dementia, Vision impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with Parkinson's disease and their family caregivers in planning future medical decisions. The study tests a new online tool designed to facilitate these conversations before communication and memory issues become too challenging. Participants will use this tool for about an hour and complete surveys before and after. It suits those with Parkinson’s who can use the internet and do not have dementia. Family caregivers should also be comfortable using the internet and involved in future medical decision-making. As an unphased study, this trial offers a unique opportunity to contribute to research that could simplify future medical planning for Parkinson's patients and their families.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for Parkinson's disease patients and their care partners?

Research shows a lack of specific safety data for decision-making support in Parkinson's Disease. However, this study focuses on a decision-making intervention involving activities like online surveys and conversations. These activities are generally safe because they don't involve medication or physical procedures.

This support aids people with Parkinson's and their families in planning future medical decisions. Since no drugs or physical interventions are involved, unwanted side effects are unlikely. Participants will engage in discussions and complete surveys, which are common and non-invasive activities.

Overall, similar studies have reported no safety issues, indicating the intervention is well-tolerated. It's always important to ask questions and ensure comfort before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parkinson's medical decision-making support intervention because it addresses a crucial aspect often overlooked in standard care: empowering patients with informed choices. Unlike current treatments that primarily focus on managing symptoms with medications like Levodopa or dopamine agonists, this approach enhances patient autonomy by providing a structured framework to navigate their treatment options. This method may improve patient satisfaction and adherence to treatment plans, ultimately enhancing overall quality of life for those with Parkinson's disease.

What evidence suggests that this intervention is effective for Parkinson's disease decision making?

Research has shown that planning ahead benefits people with Parkinson's disease. Studies have found that these conversations are most effective when guided by skilled professionals. In this trial, participants will use the Parkinson's medical decision-making support intervention, which includes tools like the Parkinson Support workbook to involve patients and their families in these important discussions. Initiating these talks early can significantly aid in future medical decision-making. This approach ensures that patients and their families are prepared and comfortable with the choices they may encounter later. ^{1 4 6 7 8}

Who Is on the Research Team?

Jiayun Xu

Principal Investigator

Purdue University

Are You a Good Fit for This Trial?

This trial is for English-speaking Parkinson's disease patients without dementia, who can navigate websites or have assistance to do so. They must have reliable phone or internet access and not have used the intervention resources before. Those with severe vision impairment even with glasses, or a low cognitive status score are excluded.

Inclusion Criteria

Have access to a reliable phone or internet connection

Does not have a diagnosis of dementia

Have access to an online connection through a smartphone, tablet, or computer device

Exclusion Criteria

You have already used the treatment before.

You scored lower than 28 on a test to check memory and thinking skills during a phone call.

You have trouble seeing even with glasses and can't read a newspaper.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual or in-person)

Intervention

Participants complete an online medical decision making intervention

2 weeks

1 session (online)

Follow-up

Participants are monitored for engagement and acceptability of the intervention

2 weeks

1 follow-up survey (online)

What Are the Treatments Tested in This Trial?

Interventions

• Parkinson's medical decision making support

Trial Overview The study tests a new program designed to help Parkinson's patients and their caregivers prepare for future medical decisions. It involves early conversations about potential choices they may face as the disease progresses, aiming to ease decision-making before serious communication and cognitive issues arise.

How Is the Trial Designed?

Group I: Parkinson's medical decision making support intervention group Experimental Treatment 1 Intervention

All participants will complete an online medical decision making intervention, lasting about 60 minutes, and complete pre and post surveys.

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

Published Research Related to This Trial

A significant number of people with Parkinson's disease in Germany have advance directives, but these documents often lack specific details regarding complications related to Parkinson's disease, highlighting a need for improvement.

A Delphi study involving 22 experts led to consensus on 14 out of 24 recommendations for Parkinson's disease-specific advance directives, emphasizing the importance of dopaminergic and non-oral therapy options, which should be integrated into patient counseling and advance directive development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus-Based Recommendations for Advance Directives of People with Parkinson's Disease in Regard to Typical Complications by German Movement Disorder Specialists. Klietz, M., Berndt, JM., Wegner, F., et al.[2020]

A qualitative study involving 33 people with Parkinson's disease and their relatives revealed that individuals with PD are generally reluctant to engage in advance care planning, preferring to focus on the future rather than the present.

Three main reasons for this reluctance were identified: limited awareness of advance care planning and Parkinson's disease, uncertainty about living with the condition, and complex decision-making processes, highlighting the need for health professionals to better educate and support patients in planning for their future care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding how people with Parkinson's disease and their relatives approach advance care planning. Churm, D., Dickinson, C., Robinson, L., et al.[2022]

In a study involving dyads of people with advanced Parkinson's disease and their caregivers, decisions about health care and living preferences were made collaboratively, focusing on options like home services, assisted living, and hospice care.

The study found high decision quality among participants, indicated by low levels of decisional conflict and regret, suggesting that caregivers and patients can effectively navigate complex health care choices together.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic Decision-Making in Advanced Parkinson's Disease: A Mixed Methods Study. Habermann, B., Shin, JY., Shearer, G.[2021]

Individuals with Parkinson's disease (PD) are significantly more likely to have advance directives, such as durable power of attorney, compared to non-caregiver controls, with a likelihood increase of 4.08 times for durable power of attorney and 2.08 times for durable power of attorney for healthcare.

Caregivers of individuals with atypical parkinsonian disorders (APD) also show increased utilization of advance directives, being 1.58 times more likely to have a living will and 2.21 times more likely to have a durable power of attorney for healthcare than controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End of life planning in parkinsonian diseases. Gillard, DM., Proudfoot, JA., Simões, RM., et al.[2020]

A systematic review of 27 studies highlighted the importance of individualized and timely advance care planning discussions for patients with parkinsonian disorders, emphasizing that these discussions should be initiated early and occur regularly.

The study identified eight effective components for optimal advance care planning, including the need for skilled professionals to lead discussions, early involvement of palliative care services, and support for family carers, which can enhance the overall care experience for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of advance care planning in Parkinson's disease and atypical parkinsonian disorders: a mixed methods systematic review. Nimmons, D., Hatter, L., Davies, N., et al.[2021]

Patients with Parkinson disease (PD) and their care partners have varied personal definitions of advance care planning (ACP), highlighting the need for tailored approaches in clinical settings.

Barriers to engaging in ACP include patient-related factors, relationship dynamics, and healthcare system challenges, suggesting that interdisciplinary care teams should proactively address these issues to improve ACP integration into PD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Framing advance care planning in Parkinson disease: Patient and care partner perspectives. Lum, HD., Jordan, SR., Brungardt, A., et al.[2020]

A study involving 104 participants with Parkinson's disease revealed that 76% were unaware of Advance Care Planning (ACP), although 69% expressed interest in learning more about it.

Despite low awareness, most participants had engaged in some form of planning, primarily practical rather than healthcare-related, indicating a need for healthcare professionals to proactively discuss ACP with patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Do Patients With Parkinson's Disease Approach Advance Care Planning? A UK-Based Mixed Methods Study. Churm, D., Dickinson, C., Robinson, L., et al.[2022]

The study aims to evaluate the feasibility of a shared decision-making (SDM) intervention for patients with advanced Parkinson's disease, focusing on its acceptability, implementation, and initial efficacy through a mixed methods design involving both patients and healthcare professionals.

The SDM intervention includes an Option Grid™ decision aid and a value clarification tool, which are designed to enhance patient involvement in treatment decisions, potentially leading to better-informed choices regarding advanced therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving shared decision-making in advanced Parkinson's disease: protocol of a mixed methods feasibility study. Nijhuis, FAP., Elwyn, G., Bloem, BR., et al.[2023]

In a study involving 20 qualitative interviews with individuals living with Parkinson's disease, it was found that safety events related to medication errors are common and often perceived as more severe by patients than they are objectively assessed.

The research highlights the importance of understanding both the objective and subjective experiences of safety events, as patients may feel that minor errors are significant, especially if communication about these errors is poor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distinguishing objective from subjective assessments of the severity of medication-related safety events among people with Parkinson's disease: a qualitative study. Buetow, S., Henshaw, J., Cha, R., et al.[2012]

A study involving 87 physicians in Germany revealed that while most agreed on the usefulness of Parkinson's disease-specific recommendations for advance directives (ADs), only 24% actually implemented these recommendations in their practice.

Consultations regarding PD-specific ADs were infrequent and brief, indicating a need for better integration of these guidelines into routine care to enhance advance care planning for people with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Parkinson's Disease Outpatient Counselling for Advance Directive Creation: A Cross-Sectional Questionnaire-Based Survey of German General Practitioners and Neurologists. Jensen, I., Bretschneider, A., Stiel, S., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-parkinson-disease-11-2022-01440

Decision Making Support for Parkinson's Disease The study identified eight effective components for optimal advance care planning, including the need for skilled professionals to lead discussions, early ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8355553/

Advanced Care Planning in Parkinson's Disease This study aims to explore the experiences, needs, and preferences of PD patients regarding the content and timing of ACP.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8382049/

Advance Care Planning and Care Coordination for People ... The Parkinson Support workbook is designed as a strategy to increase active engagement of patients and FCs in the ACP conversations about the future.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ene.14424

Experiences of advance care planning in Parkinson's ... This evidence was used to highlight eight effective components to support optimal advance care planning in parkinsonian disorders.

5. sma.org sma.org/southern-medical-journal/article/advance-care-planning-and-proxy-decision-making-for-patients-with-advanced-parkinson-disease/

Advance Care Planning and Proxy Decision Making for ... Objectives: To examine advance care planning practices and proxy decision making by family healthcare proxies for patients with advanced Parkinson disease (PD).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7592650/

Personalized Care Management for Persons with Parkinson's ... We present an integrated and personalized care management model for persons with Parkinson's disease costing of five core elements.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10010098/

Understanding support systems for Parkinson's disease ... This study aimed to develop a European understanding of how health and social care professionals can collaborate with stakeholders from different organizations ...

8. researchgate.net researchgate.net/publication/391360882_Advanced_Care_Planning_in_Parkinson's_Disease_Completed_in_the_Electronic_Medical_Record

Completed in the Electronic Medical Record? | Request PDF Advanced Care Planning in Parkinson's Disease: Completed in the Electronic Medical Record? May 2025; Journal of Pain and Symptom Management 69(5):e549-e550.