More Than a Movement Disorder: Applying Palliative Care to Parkinson's Disease

NCT03076671 | Completed

• 2 other identifiers: 16-1400R01NR016037-01A1
• Study Type: interventional
• Target: 783
• Locations: 1 country
• Sites: 2

Brief Summary

This is a two-center (University of Colorado, University of California San Francisco) community-based comparative effectiveness study of outpatient palliative care for Parkinson's disease (PD) and related disorders (progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), multiple systems atrophy (MSA), Lewy Body Dementia (LBD). In September 2018, the study was amended to also include Alzheimer's disease (AD) and related disorders (Frontotemporal Dementia (FTD), Primary Progressive Aphasia (PPA), Vascular Dementia). It will utilize a randomized stepped-wedge design to compare patient and caregiver outcomes between usual care in the community versus usual care augmented by palliative training and telemedicine support to provide other resources (e.g. social work).

Conditions

Parkinson Disease; Parkinsonism; Lewy Body Disease; Supranuclear Palsy, Progressive; Parkinsonism Vascular; Multiple System Atrophy; Corticobasal Degeneration; Alzheimer Disease; Frontotemporal Dementia; Primary Progressive Aphasia; Vascular Dementia

Keywords

Palliative Care; Supportive Care; Movement Disorders; Brain Disease; Neurodegeneration; Parkinson's Disease; Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Quality of Life Alzheimer's Disease (QOL-AD)

  Measures of Quality of Life

  Up to 48 months

• Zarit Burden of Care Instrument (ZBI)

  Measures of Care Partner Distress

  Up to 48 months

Secondary Outcomes (14)

• McGill Quality of Life Questionnaire (MQOL)

  Up to 48 months

• Hospital Anxiety and Depression Scale (HADS)

  Up to 48 months

• Edmonton Symptom Assessment Scale (ESAS_PD)

  Up to 48 months

• Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SP 12 Item)

  Up to 48 months

• Prolonged Grief Questionnaire (PG-12)

  Up to 48 months

Study Arms (3)

Standard of Care

NO INTERVENTION

Patients to get usual care from their established neurology care team that is enrolled in the study.

Standard of Care plus Palliative Care

EXPERIMENTAL

Patients to get usual care, augmented by palliative care, provided by their established neurology care team that is affiliated with the study, with additional support provided by the University of Colorado Denver Neurology Palliative Care team.

Behavioral: Palliative Care

Clinicians

EXPERIMENTAL

Clinicians enrolled in the study will receive an 8-hour supportive and palliative care training, followed by monthly coaching and the availability of telemedicine visits for enrolled patients with the university neuro-palliative care team. The unit of randomization is the time when they receive training. Four to five clinical practices will receive training every 6 months during years 2 and 3, at which time all of their enrolled patients will be switched from usual care to the intervention arm.

Behavioral: Palliative Care

Interventions

Palliative Care BEHAVIORAL

Palliative care training for community neurologists and use of telemedicine for team-based support of patients

Also known as: Supportive Care

Clinicians; Standard of Care plus Palliative Care

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be fluent English Speakers,
• Must be over age 18,
• They must meet United Kingdom (UK) Brain Bank criteria for probable PD, or
• They must meet standard criteria for
• progressive supranuclear palsy (PSP),
• corticobasal degeneration (CBD),
• multiple systems atrophy (MSA),
• vascular parkinsonism, or
• Lewy Body Dementia (LBD)
• Alzheimer's dementia (AD)
• Primary progressive aphasia
• Vascular dementia.
• Patients must be at high risk for poor outcomes as defined by the Brief Needs Assessment Tool (BNAT) which screens for psychosocial issues, symptoms, and caregiver burden.
• Caregivers will be identified by asking the patient: "Could (participant) tell us the one person who helps (participant) the most with (participant's) PD outside of clinic?"
• Caregivers may be self-identified in cases of severe dementia in order to obtain data relevant to this vulnerable and underrepresented group.

You may not qualify if:

• Unable or unwilling to commit to study procedures;
• Presence of additional chronic medical illnesses which may require palliative services (e.g. metastatic cancer); or
• Already receiving palliative care or hospice services.
• Not expecting to continue care with enrolled physician for at least 6 months.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Nursing Research (NINR): collaborator
• University of California, San Francisco: collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (4)

• Kluger BM, Katz M, Galifianakis NB, Pantilat SZ, Hauser JM, Khan R, Friedman C, Vaughan CL, Goto Y, Long SJ, Martin CS, Dini M, McQueen RB, Palmer L, Fairclough D, Seeberger LC, Sillau SH, Kutner JS. Patient and Family Outcomes of Community Neurologist Palliative Education and Telehealth Support in Parkinson Disease. JAMA Neurol. 2024 Jan 1;81(1):39-49. doi: 10.1001/jamaneurol.2023.4260.

  PMID: 37955923 DERIVED

• Mahes A, Macchi ZA, Martin CS, Katz M, Galifianakis NB, Pantilat SZ, Kutner JS, Sillau S, Kluger BM. The "Surprise Question" for Prognostication in People With Parkinson's Disease and Related Disorders. J Pain Symptom Manage. 2024 Jan;67(1):e1-e7. doi: 10.1016/j.jpainsymman.2023.10.004. Epub 2023 Oct 13.

  PMID: 37838080 DERIVED

• Ayele R, Macchi ZA, Dini M, Bock M, Katz M, Pantilat SZ, Jones J, Kluger BM. Experience of Community Neurologists Providing Care for Patients With Neurodegenerative Illness During the COVID-19 Pandemic. Neurology. 2021 Sep 7;97(10):e988-e995. doi: 10.1212/WNL.0000000000012363. Epub 2021 Jun 14.

  PMID: 34489348 DERIVED

• Macchi ZA, Ayele R, Dini M, Lamira J, Katz M, Pantilat SZ, Jones J, Kluger BM. Lessons from the COVID-19 pandemic for improving outpatient neuropalliative care: A qualitative study of patient and caregiver perspectives. Palliat Med. 2021 Jul;35(7):1258-1266. doi: 10.1177/02692163211017383. Epub 2021 May 18.

  PMID: 34006157 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Lewy Body Disease; Supranuclear Palsy, Progressive; Multiple System Atrophy; Corticobasal Degeneration; Alzheimer Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Dementia, Vascular; Movement Disorders; Brain Diseases; Nerve Degeneration

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Dementia; Neurocognitive Disorders; Mental Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Benzi M Kluger, MD, MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a stepped-wedge design, meaning that during the first year all patients enrolled will continue to receive usual care provided by their neurologist, who is also enrolled in the study. During years 2 and 3, every 6 months, 4-5 neurologists will receive training in supportive and palliative care. The timing of the training will be randomly assigned. Once their neurologist has received training, all of their enrolled patients will be switched to the intervention arm, and be eligible for additional care via telemedicine with the university supportive and palliative care team. During the final year of the study, all the neurologists will have received care, and all of their patients will be in the intervention arm. On a separate level, we will be evaluating the effects of training on the enrolled neurologists through assessments of palliative skills, knowledge, and attitudes before and after the training, as well as through qualitative interviews.

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: March 10, 2017
• Study Start: March 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)