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

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Brief Title

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

Official Title

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

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). 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.
    


Study Type

Interventional


Primary Outcome

Quality of Life Alzheimer's Disease (QOL-AD)

Secondary Outcome

 McGill Quality of Life Questionnaire (MQOL)

Condition

Parkinson Disease

Intervention

Palliative Care

Study Arms / Comparison Groups

 Standard of Care
Description:  Patients to get usual care from their established neurology care team that is enrolled in the study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

783

Start Date

March 1, 2017

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 105 Years

Accepts Healthy Volunteers

No

Contacts

Benzi M Kluger, MD, MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03076671

Organization ID

16-1400

Secondary IDs

R01NR016037-01A1

Responsible Party

Sponsor

Study Sponsor

University of Colorado, Denver

Collaborators

 National Institute of Nursing Research (NINR)

Study Sponsor

Benzi M Kluger, MD, MS, Principal Investigator, University of Colorado, Denver


Verification Date

May 2021