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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Parkinson's Disease

Treatments

Other: Interdisciplinary outpatient palliative care
Other: Standard of Care

Study type

Interventional

Funder types

Other

Identifiers

NCT02533921
15-0814

Details and patient eligibility

About

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.

Full 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.

Enrollment

210 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

210 participants in 2 patient groups

Standard of Care
Other group
Description:
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Treatment:
Other: Standard of Care
Interdisciplinary outpatient palliative care
Active Comparator group
Description:
Usual care augmented by an outpatient interdisciplinary palliative care team.
Treatment:
Other: Interdisciplinary outpatient palliative care

Trial documents
1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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