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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533921
• Other study ID #: 15-0814
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: September 30, 2019
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Interdisciplinary outpatient palliative care
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.
• Standard of Care
Usual care defined as including both a PCP and neurologist

Locations

Country	Name	City	State
Canada	University of Alberta Canada	Edmonton	Alberta
United States	University of Colorado Hospital	Aurora	Colorado
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	University of Alberta, University of California, San Francisco

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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