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Trial record 1 of 1 for:    NCT02533921
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Does Outpatient Palliative Care Improve Patient-centered Outcomes in Parkinson's Disease?

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ClinicalTrials.gov Identifier: NCT02533921
Recruitment Status : Completed
First Posted : August 27, 2015
Results First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Collaborators:
University of California, San Francisco
University of Alberta
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Interdisciplinary outpatient palliative care Other: Standard of Care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Outpatient Palliative Care Improve Patient-centered Outcomes in Parkinson's Disease?
Study Start Date : October 2015
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Standard of Care
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
 Other: Standard of Care
Usual care defined as including both a PCP and neurologist
Active Comparator: Interdisciplinary outpatient palliative care
Usual care augmented by an outpatient interdisciplinary palliative care team.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the Subjects Quality of Life (QOL) [ Time Frame: 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.

  2. Changes in Caregiver Distress [ Time Frame: 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.


Secondary Outcome Measures :
  1. Changes in Patient Anxiety [ Time Frame: 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.

  2. Changes in Patient Depression [ Time Frame: 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.

  3. Changes in Caregiver Anxiety [ Time Frame: 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.

  4. Changes in Caregiver Depression [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533921


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Canada, Alberta
University of Alberta Canada
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Colorado, Denver
University of California, San Francisco
University of Alberta
Investigators
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Principal Investigator: Benzi Kluger University of Colorado - Anschutz Medical Campus
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Study Protocol and Statistical Analysis Plan  [PDF] April 7, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02533921    
Other Study ID Numbers: 15-0814
First Posted: August 27, 2015    Key Record Dates
Results First Posted: January 31, 2020
Last Update Posted: January 31, 2020
Last Verified: January 2019
Keywords provided by University of Colorado, Denver:
Palliative Care
Parkinson's Disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases