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Trial record 2 of 41 for:    neurology AND university of california, san francisco | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by University of Colorado, Denver
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
University of California, San Francisco
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT03076671
First received: February 7, 2017
Last updated: March 6, 2017
Last verified: March 2017
  Purpose
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 (PSP, CBD, MSA, DLB). 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).

Condition Intervention
Parkinson Disease
Parkinsonism
Lewy Body Disease
Supranuclear Palsy, Progressive
Parkinsonism Vascular
Multiple System Atrophy
Corticobasal Degeneration
Behavioral: Palliative Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: More Than a Movement Disorder: Applying Palliative Care to Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Quality of Life Alzheimer's Disease (QOL-AD) [ Time Frame: Up to 48 months ]
    Measures of Quality of Life

  • Zarit Burden of Care Instrument (ZBI) [ Time Frame: Up to 48 months ]
    Measures of Care Partner Distress


Secondary Outcome Measures:
  • McGill Quality of Life Questionnaire (MQOL) [ Time Frame: Up to 48 months ]
    Measures of Quality of Life

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Up to 48 months ]
    Measures of mood

  • Edmonton Symptom Assessment Scale (ESAS_PD) [ Time Frame: Up to 48 months ]
    Measures of symptom burden

  • Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SP 12 Item) [ Time Frame: Up to 48 months ]
    Measures of spiritual wellbeing

  • Prolonged Grief Questionnaire (PG-12) [ Time Frame: Up to 48 months ]
    Measures of grief (sense of loss)

  • Semi-structured Qualitative Interview [ Time Frame: At 12 months ]
    Measures of participant views on the study including their outcomes and the implementation of this model of community-based palliative care.

  • Montreal Cognitive Assessment (MOCA) [ Time Frame: At baseline ]
    Measures of cognitive function

  • Healthcare Utilization Form [ Time Frame: Up to 48 months ]
    Measures of type and frequency of healthcare utilized

  • Palliative Performance Scale [ Time Frame: Up to 48 months ]
    Measures of Disease Severity

  • Clinical Global Impression of Change [ Time Frame: Up to 48 months ]
    Measures of change in disease burden

  • Treatment Documentation Form [ Time Frame: Up to 48 months ]
    Measures of treatments used for disease management

  • Modified Caregiver Strain Index [ Time Frame: Up to 48 months ]
    Measures of care partner distress


Estimated Enrollment: 360
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: September 30, 2021
Estimated Primary Completion Date: February 28, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of Care
Patients to get usual care from their established neurology care team that is affiliated with 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.
Behavioral: Palliative Care
Palliative care training for community neurologists and use of telemedicine for team-based support of patients
Other Name: Supportive Care

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.
  Eligibility

Ages Eligible for Study:   18 Years to 105 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be fluent English Speakers,
  • Must be over age 40,
  • 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), or
    • Lewy Body Dementia (LBD).
  • 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 you tell us the one person who helps you the most with your 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:

  • Urgent palliative care needs (these patients will not be randomized and offered appropriate services immediately);
  • 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.

We 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03076671

Contacts
Contact: Christine S Martin 303-724-8885 christine.martin@ucdenver.edu
Contact: Laura Palmer 303-724-8287 laura.palmer@ucdenver.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Nieves Lopez-Barrera, MD    415-353-9453    Nieves.Lopez-Barerra@ucsf.edu   
Contact: Nicholas Gallifianakis, MD    415-353-2311    Nicholas.Galifianakis@ucsf.edu   
Principal Investigator: Nicholas Gallifianakis, MD         
Sub-Investigator: Maya Katz, MD         
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Nursing Research (NINR)
University of California, San Francisco
Investigators
Principal Investigator: Benzi M Kluger, MD, MS University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03076671     History of Changes
Other Study ID Numbers: 16-1400
R01NR016037-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: February 7, 2017
Last Updated: March 6, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Palliative Care
Supportive Care
Movement Disorders
Brain Disease
Neurodegeneration
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Atrophy
Movement Disorders
Parkinsonian Disorders
Multiple System Atrophy
Shy-Drager Syndrome
Lewy Body Disease
Supranuclear Palsy, Progressive
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Dementia
Neurocognitive Disorders
Mental Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on March 30, 2017