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

Només els usuaris registrats poden traduir articles
Inicieu sessió / registreu-vos
L'enllaç es desa al porta-retalls
EstatReclutament
Patrocinadors
University of Colorado, Denver
Col·laboradors
National Institute of Nursing Research (NINR)
University of California, San Francisco

Paraules clau

Resum

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).

Descripció

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.

Dates

Darrera verificació: 03/31/2020
Primer enviat: 02/06/2017
Inscripció estimada enviada: 03/05/2017
Publicat per primera vegada: 03/09/2017
Última actualització enviada: 04/01/2020
Publicació de l'última actualització: 04/05/2020
Data d'inici de l'estudi real: 02/28/2017
Data estimada de finalització primària: 03/30/2021
Data estimada de finalització de l’estudi: 03/30/2021

Condició o malaltia

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

Intervenció / tractament

Behavioral: Palliative Care

Fase

-

Grups de braços

BraçIntervenció / tractament
No Intervention: Standard of Care
Patients to get usual care from their established neurology care team that is enrolled in the study.
Experimental: Standard of Care plus Palliative Care
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.
Experimental: Clinicians
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.

Criteris d'elegibilitat

Edats elegibles per estudiar 18 Years Per a 18 Years
Sexes elegibles per estudiarAll
Accepta voluntaris saludables
Criteris

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

The investigators have purposefully kept our inclusion/exclusion criteria broad to allow for greater generalizability of results and to ensure inclusion of potentially underrepresented and understudied subgroups.

Resultat

Mesures de resultats primaris

1. Quality of Life Alzheimer's Disease (QOL-AD) [Up to 48 months]

Measures of Quality of Life

2. Zarit Burden of Care Instrument (ZBI) [Up to 48 months]

Measures of Care Partner Distress

Mesures de resultats secundaris

1. McGill Quality of Life Questionnaire (MQOL) [Up to 48 months]

Measures of Quality of Life

2. Hospital Anxiety and Depression Scale (HADS) [Up to 48 months]

Measures of mood

3. Edmonton Symptom Assessment Scale (ESAS_PD) [Up to 48 months]

Measures of symptom burden

4. Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SP 12 Item) [Up to 48 months]

Measures of spiritual wellbeing

5. Prolonged Grief Questionnaire (PG-12) [Up to 48 months]

Measures of grief (sense of loss)

6. Semi-structured Qualitative Interview [At 12 months]

Measures of participant views on the study including their outcomes and the implementation of this model of community-based palliative care.

7. Montreal Cognitive Assessment (MOCA) [At baseline]

Measures of cognitive function

8. Healthcare Utilization Form [Up to 48 months]

Measures of type and frequency of healthcare utilized

9. Palliative Performance Scale [Up to 48 months]

Measures of Disease Severity

10. Clinical Global Impression of Change [Up to 48 months]

Measures of change in disease burden

11. Treatment Documentation Form [Up to 48 months]

Measures of treatments used for disease management

12. Modified Caregiver Strain Index [Up to 48 months]

Measures of care partner distress

13. Needs at End of Life Screening Tool [Up to 12 months]

Detects and measures needs for end of life

14. Neuropsychiatric Inventory [Up to 6 months]

Measures dementia-related symptoms

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