Does Outpatient Palliative Care Improve Patient-centered Outcomes in Parkinson's Disease?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve outcomes for persons living with Parkinson's Disease (PD) and their family caregivers. The investigators hypothesize that outpatient interdisciplinary palliative care will improve patient-centered outcomes for PD patients at high-risk for poor outcomes.

Detailed Description
-----------------
Palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease. To date there have been minimal attempts to apply these principles to PD although preliminary evidence suggests that PD patients have significant unmet needs under current models of care which may be amenable through a palliative care model. This study will provide critical information to forward this field including data on the comparative effectiveness of outpatient palliative care for PD versus current standards of care; effects of this intervention on cost and service utilization; and the characteristics of patients most likely to benefit from such an approach and the specific services most needed by PD patients and their caregivers.

Official Title
-----------------
Does Outpatient Palliative Care Improve Patient-centered Outcomes in Parkinson's Disease?

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: Interdisciplinary outpatient palliative care
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fluent in English UK Brain Bank criteria for diagnosis of probable PD or Multiple Systems Atrophy (MSA) or Corticobasal Degeneration (CBD) or Progressive Supranuclear Palsy (PSP) or Lewy Body Dementia (LBD) At high risk for poor outcomes as identified by the Palliative Care Needs Assessment Tool (PC-NAT) Exclusion Criteria: Immediate and urgent palliative care needs Unable or unwilling to commit to study procedures including; randomization, study visits or the addition of a neurologist to their care team Presence of additional chronic medical illnesses which may require palliative services Already receiving palliative care and/or hospice services.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care<br>Usual care as in including both a Primary Care Physician (PCP) and neurologist. | Other: Standard of Care<br>* Usual care defined as including both a PCP and neurologist<br>|
| Active Comparator: Interdisciplinary outpatient palliative care<br>Usual care augmented by an outpatient interdisciplinary palliative care team. | Other: Interdisciplinary outpatient palliative care<br>* Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Subjects Quality of Life (QOL) | The QOL-AD (Quality of Life in Alzheimer's Disease) survey will be used to measure the differences in the quality of life between groups.Higher numbers indicate better outcomes. The scale ranges from 4 to 52. | 0 to 6 months | 
| Changes in Caregiver Distress | The Zarit Caregiver Burden Interview Form (ZBI) will be used to measure differences in Caregiver Distress between groups. Higher scores indicate worse outcomes. Scale ranges from 0 to 48. | 0 to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Patient Anxiety | The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in patient anxiety. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | 0 to 6 months | 
| Changes in Patient Depression | The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in patient depression. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | 0 to 6 months | 
| Changes in Caregiver Anxiety | The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in caregiver anxiety. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | 0 to 6 months | 
| Changes in Caregiver Depression | The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in caregiver depression. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | 0 to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative Care, Parkinson's Disease