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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: Standard of Care; Other: Interdisciplinary outpatient palliative care

• Registration Number: NCT02533921
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-27
• Study Start: 2015-10
• Primary Completion: 2018-09-20
• Status Verified: 2019-01
• Results First Submitted: 2019-01-10
• Study Completion: 2019-09-30
• Results First Submitted QC: 2020-01-22
• Last Update Submitted: 2020-01-22
• Results First Posted: 2020-01-31
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Interdisciplinary outpatient palliative care	Interdisciplinary outpatient palliative care	Usual care augmented by an outpatient interdisciplinary palliative care team.

Primary Outcome Measures

Name	Time	Method
Changes in Caregiver Distress	0 to 6 months	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.
Changes in the Subjects Quality of Life (QOL)	0 to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Patient Anxiety	0 to 6 months	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.
Changes in Patient Depression	0 to 6 months	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.
Changes in Caregiver Anxiety	0 to 6 months	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.
Changes in Caregiver Depression	0 to 6 months	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.

Trial Locations

Locations (3)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

University of Alberta Canada; 🇨🇦 Edmonton, Alberta, Canada