Clinical trial NCT02533921: Does Outpatient Palliative Care Improve Patient-centered Outcomes in Parkinson's Disease?
Official title: Does Outpatient Palliative Care Improve Patient-centered Outcomes in Parkinson's Disease?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Palliative Care
Parkinson's Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of Alberta
First posted: 2015-08-27
Enrollment: 210
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in the Subjects Quality of Life (QOL)
timeFrame: 0 to 6 months
measure: Changes in Caregiver Distress
timeFrame: 0 to 6 months
Secondary outcomes:
measure: Changes in Patient Anxiety
timeFrame: 0 to 6 months
measure: Changes in Patient Depression
timeFrame: 0 to 6 months
measure: Changes in Caregiver Anxiety
timeFrame: 0 to 6 months
measure: Changes in Caregiver Depression
timeFrame: 0 to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Edmonton
country: Canada
facility: University of Alberta Canada
state: Alberta
Study officials:
affiliation: University of Colorado, Denver
name: Benzi Kluger
role: PRINCIPAL_INVESTIGATOR
References:
citation: Macchi ZA, Miyasaki J, Katz M, Galifianakis N, Sillau S, Kluger BM. Prevalence and Cumulative Incidence of Caregiver-Reported Aggression in Advanced Parkinson Disease and Related Disorders. Neurol Clin Pract. 2021 Dec;11(6):e826-e833. doi: 10.1212/CPJ.0000000000001110.
citation: Koljack CE, Miyasaki J, Prizer LP, Katz M, Galifianakis N, Sillau SH, Kluger BM. Predictors of Spiritual Well-Being in Family Caregivers for Individuals with Parkinson's Disease. J Palliat Med. 2022 Apr;25(4):606-613. doi: 10.1089/jpm.2020.0797. Epub 2021 Nov 24.
citation: Kluger BM, Miyasaki J, Katz M, Galifianakis N, Hall K, Pantilat S, Khan R, Friedman C, Cernik W, Goto Y, Long J, Fairclough D, Sillau S, Kutner JS. Comparison of Integrated Outpatient Palliative Care With Standard Care in Patients With Parkinson Disease and Related Disorders: A Randomized Clinical Trial. JAMA Neurol. 2020 May 1;77(5):551-560. doi: 10.1001/jamaneurol.2019.4992.