Clinical trial NCT05222386: Community Outreach for Palliative Engagement -- Parkinson Disease
Official title: Building Online Community to Improve Patient and Caregiver Outcomes in Parkinson Disease, Lewy Body Dementia and Related Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease Dementia
Parkinson Disease
Parkinson's Disease and Parkinsonism
Lewy Body Parkinsonism
Dementia With Lewy Bodies
Progressive Supranuclear Palsy
Corticobasal Degeneration
Multiple System Atrophy
Vascular Parkinsonism
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Stanford University
name: Massachusetts General Hospital
First posted: 2022-02-03
Enrollment: 710
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a pragmatic comparative effectiveness trial using a stepped-wedge design to randomize neurology practices (clusters).
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn more about the effectiveness of palliative care training for community physicians and telemedicine support services for patients and carepartners with Parkinson's disease and Lewy Body Dementia (LBD) or related conditions and their care partners. Palliative care is a treatment approach focused on improving quality of life by relieving suffering in the areas of physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Telemedicine is the use of technology that allows participants to interact with a health care provider without being physically near the provider.

Detailed description: Investigators propose to conduct a pragmatic stepped-wedge comparative effectiveness trial comparing a novel model of providing community-based palliative care for persons living with Parkinson's disease (PD), Lewy Body Dementia (LBD) and related disorders through online communities to usual care. Our intervention includes support for both community neurologists (using the ECHO model of clinician support) as well as family caregivers and patients. Investigators hypothesize that this model of care will improve patient quality of life and caregiver burden as well as other important secondary outcomes such as patient symptom burden and clinician burnout. This study will recruit neurology providers (MD and APPs) from 24 community neurology practices. These practices will identify participants for the study who have PD, LBD or a related condition and moderate to high palliative care needs. Under usual care, community providers will deliver their usual care and center coordinators will collect data on our outcomes every 3 months. After one year of baseline data collection, 6 practices will be randomized to the intervention, which will include clinician training and coaching as well as access to online services for their patients. Per the stepped-wedge design an additional six practices will be randomized 18 months into the data collection period, six at 24 months, and the final six will enter the intervention 30 months into the data collection period to allow for 12 months intervention recruitment for all practices.

Eligibility criteria: Inclusion Criteria:

PATIENT INCLUSION CRITERIA:

• Over age 40 years and diagnosed with PD or other causes of parkinsonism, such as progressive supranuclear palsy, multiple system atrophy and Lewy Body Dementia by their community neurologist.

Exclusion Criteria:

PATIENT EXCLUSION CRITERIA:

* Potential patient subjects who are unable or unwilling to commit to study procedures
* Presence of additional medical illnesses which requires palliative services (e.g. metastatic cancer)
* Already receiving palliative care or hospice services.

Primary outcomes:
measure: Quality of Life: Alzheimer's Disease (QOL-AD)
timeFrame: 6 Months
measure: Zarit Caregiver Burden Interview short form (ZBI)
timeFrame: 6 Months
Secondary outcomes:
measure: Patient Measures Edmonton Symptom Assessment Scale
timeFrame: 3, 6, 9, 12 Months
measure: Patient Measures Hospital Anxiety and Depression Scale
timeFrame: 3, 6, 9, 12 Months
measure: Patient Measures (FACIT-SP 12)
timeFrame: 3, 6, 9, 12 Months
measure: Patient Measures (PG-12)
timeFrame: 3, 6, 9, 12 Months
measure: Carepartner Measures Hospital Anxiety and Depression Scale
timeFrame: 3, 6, 9, 12 Months
measure: Carepartner Measures (FACIT-SP 12)
timeFrame: 3, 6, 9, 12 Months
Other outcomes:
measure: Qualitative Interviews: Patient (Validate data)
timeFrame: 6 Months
measure: Qualitative Interviews: Patient (Health Economic data)
timeFrame: 6 Months
measure: Qualitative Interviews: Carepartner (Validate data)
timeFrame: 6 Months
measure: Qualitative Interviews: Carepartner (Health Economic data)
timeFrame: 6 Months
measure: Qualitative Interviews: Clinician
timeFrame: 6 Months
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center for Health + Technology
state: New York
Study officials:
affiliation: University of Rochester
name: Benzi Kluger, MD
role: PRINCIPAL_INVESTIGATOR
References: