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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03076671
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : April 4, 2019
National Institute of Nursing Research (NINR)
University of California, San Francisco
Information provided by (Responsible Party):
University of Colorado, Denver

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). 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 or disease Intervention/treatment Phase
Parkinson Disease Parkinsonism Lewy Body Disease Supranuclear Palsy, Progressive Parkinsonism Vascular Multiple System Atrophy Corticobasal Degeneration Behavioral: Palliative Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 632 participants
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
Official Title: More Than a Movement Disorder: Applying Palliative Care to Parkinson's Disease
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
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.
Behavioral: Palliative Care
Palliative care training for community neurologists and use of telemedicine for team-based support of patients
Other Name: Supportive Care

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.
Behavioral: Palliative Care
Palliative care training for community neurologists and use of telemedicine for team-based support of patients
Other Name: Supportive Care

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

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

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

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

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

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

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

  6. 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.

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

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

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

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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03076671

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Contact: Christine S Martin 303-724-8885
Contact: Laura Palmer 303-724-8287

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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jana Guenther    415-514-8273   
Contact: Nicholas Gallifianakis, MD    415-353-2311   
Principal Investigator: Nicholas Gallifianakis, MD         
Sub-Investigator: Maya Katz, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Christine S Martin, BA BS    303-724-8885   
Contact: Laura Palmer, BS    303-724-8287   
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Nursing Research (NINR)
University of California, San Francisco
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Principal Investigator: Benzi M Kluger, MD, MS University of Colorado, Denver

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Responsible Party: University of Colorado, Denver Identifier: NCT03076671     History of Changes
Other Study ID Numbers: 16-1400
R01NR016037-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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