Does Outpatient Palliative Care Improve Patient-centered Outcomes in Parkinson's Disease?
NCT ID: NCT02533921
Last Updated: 2020-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2015-10-31
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Standard of Care
Usual care defined as including both a PCP and neurologist
Interdisciplinary outpatient palliative care
Usual care augmented by an outpatient interdisciplinary palliative care team.
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.
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
University of Alberta
OTHER
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Benzi Kluger
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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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
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15-0814
Identifier Type: -
Identifier Source: org_study_id
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