Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03076671 |
| Other study ID # |
16-1400 |
| Secondary ID |
R01NR016037-01A1 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2017 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
May 2021 |
| Source |
University of Colorado, Denver |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
