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

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

Sponsors

Lead sponsor: University of Colorado, Denver

Collaborator: University of California, San Francisco
University of Alberta

Source University of Colorado, Denver
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.

Overall Status Completed
Start Date October 2015
Completion Date September 30, 2019
Primary Completion Date September 20, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in the Subjects Quality of Life (QOL) 0 to 6 months
Changes in Caregiver Distress 0 to 6 months
Secondary Outcome
Measure Time Frame
Changes in Patient Anxiety 0 to 6 months
Changes in Patient Depression 0 to 6 months
Changes in Caregiver Anxiety 0 to 6 months
Changes in Caregiver Depression 0 to 6 months
Enrollment 210
Condition
Intervention

Intervention type: Other

Intervention name: Interdisciplinary outpatient palliative care

Description: 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.

Arm group label: Interdisciplinary outpatient palliative care

Intervention type: Other

Intervention name: Standard of Care

Description: Usual care defined as including both a PCP and neurologist

Arm group label: Standard of Care

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;

1. randomization,

2. study visits or

3. 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.

Gender: All

Minimum age: 40 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Benzi Kluger Principal Investigator University of Colorado - Anschutz Medical Campus
Location
facility
University of California, San Francisco | San Francisco, California, 94143, United States
University of Colorado Hospital | Aurora, Colorado, 80045, United States
University of Alberta Canada | Edmonton, Alberta, T6G 2E1, Canada
Location Countries

Canada

United States

Verification Date

January 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Standard of Care

Arm group type: Other

Description: Usual care as in including both a Primary Care Physician (PCP) and neurologist.

Arm group label: Interdisciplinary outpatient palliative care

Arm group type: Active Comparator

Description: Usual care augmented by an outpatient interdisciplinary palliative care team.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov