More Than a Movement Disorder: Applying Palliative Care to Parkinson's Disease
Condition: 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
MeSH terms: Parkinson Disease; Alzheimer Disease; Dementia; Aphasia; Movement Disorders; Multiple System Atrophy; Shy-Drager Syndrome; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Parkinsonian Disorders; Dementia, Vascular; Lewy Body Disease; Corticobasal Degeneration; Supranuclear Palsy, Progressive
Study type: Interventional

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).
    

Detailed description: 
      Parkinson's disease (PD) is the second most common neurodegenerative illness affecting
      approximately 1.5 million Americans and is the 14th leading cause of death in the United
      States. PD is traditionally described as a movement disorder with characteristic motor
      symptoms (e.g. tremor). However, more recent research demonstrates the impact of nonmotor
      symptoms such as pain, depression, and dementia on mortality, quality of life (QOL), nursing
      home placement and caregiver distress. Regarding models of care for PD, evidence suggests
      that care including a neurologist results in lower mortality and nursing home placement than
      care solely from a primary care physician. Unfortunately, there is also significant evidence
      that many of the needs most important to PD patients and their caregivers (e.g. depression,
      planning for the future) are poorly addressed under current models of care. Palliative care
      is an approach to caring for individuals with life-threatening illnesses that focuses on
      addressing potential causes of suffering including physical and psychiatric symptoms,
      psychosocial issues and spiritual needs. While developed for cancer patients, palliative care
      approaches have been successfully applied in other chronic progressive illnesses including
      heart failure and pulmonary disease. To date there have been minimal attempts to apply these
      principles to PD although evidence suggests that PD patients' unmet needs under current
      models of care may be amenable to palliative care. A small but growing cadre of centers offer
      outpatient palliative care for PD with early evidence of efficacy and a randomized trial of
      an academic-based outpatient palliative care is underway led by investigators on this
      proposal. While this work is critical to forwarding this field, further work is needed to
      provide a model that can be widely disseminated. The current proposal addresses this gap by
      assessing the effectiveness and feasibility of a novel community-based intervention that
      empowers community neurology practices to improve care for PD patients and caregivers through
      palliative care training, coaching and telemedicine resources. The investigators hypothesize
      that this intervention will improve patient QOL and caregiver burden and will prove feasible
      and acceptable to community providers. The investigators Specific Aims are to: 1) Determine
      the a) effectiveness and b) feasibility of a novel community-based outpatient palliative care
      intervention for PD.; 2) Describe the effects of a this intervention on patient and caregiver
      costs and service utilization; and 3) Identify opportunities to optimize community-based
      palliative care for this population by: a) describing patient and caregiver characteristics
      associated with intervention benefits; and b) through direct patient, caregiver and provider
      interviews. Innovations of the investigators approach include a novel model of providing
      disease-specific community-based palliative care not dependent on limited palliative
      specialist resources, a stepped-wedge trial design and use of telemedicine resources to
      provide multidisciplinary care. The research is significant because it will create a
      foundation for future community-based dissemination studies in PD and the broader field of
      palliative care.

      In September 2018, supplemental support from NIH was granted in order to explore outcomes
      among an Alzheimer's dementia population. Alzheimer's disease (AD) is the most common
      neurodegenerative illness affecting 10% of adults over age 65. This incurable and
      relentlessly progressive disease affects approximately 1.5 million Americans and is the 6th
      leading cause of death in the United States. Care for community-dwelling patients with AD is
      typically focused on the assessment and pharmacologic management of cognitive and behavioral
      symptoms, although there is growing recognition of the need to expand care to address other
      issues, including advance care planning. There is significant evidence that many of the most
      important needs of the AD patients and their caregivers are poorly addressed under current
      models of care, including management of medical and psychiatric symptoms (e.g. pain and
      depression), caregiver support, advance care planning, and spiritual wellbeing. Importantly,
      while the top goal of care for the majority of patients is avoidance of institutionalization,
      our current models of care invest more resources in institutionalized patients rather than
      proactively supporting community-dwelling individuals which may prevent institutionalization
      and reduce overall healthcare costs. Our supplemental study will thus additionally target
      this population for a 12-month period.
    

Intervention name(s): Palliative Care
Intervention type(s): Behavioral
Intervention description(s): Palliative care training for community neurologists and use of telemedicine for team-based support of patients
Other intervention name(s): Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Palliative Care; Supportive Care; Movement Disorders; Brain Disease; Neurodegeneration; Parkinson's Disease; Alzheimer's Disease