Community Outreach for Palliative Engagement -- Parkinson Disease

Not Applicable

Recruiting

• Conditions: Progressive Supranuclear Palsy; Parkinson's Disease and Parkinsonism; Corticobasal Degeneration; Multiple System Atrophy; Lewy Body Parkinsonism; Vascular Parkinsonism; Parkinson Disease Dementia; Parkinson Disease; Dementia With Lewy Bodies
• Interventions: Other: Online Community-Supported Palliative Care; Other: Parkinson Disease Standard Care

• Registration Number: NCT05222386
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-03
• Study Start: 2022-04-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 710

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Online Community-Supported Palliative Care Intervention	Online Community-Supported Palliative Care	Community neurologists get training in palliative care via teleconferences (ECHO model), in addition to other support from our team. Patients and carepartners will also have access to additional support services when their providers enter the intervention (Online support groups, tailored education)
Usual Care	Parkinson Disease Standard Care	Community neurologists provide their usual care to enrolled participants. The clinicians may utilize other community resources to support patients and families as per their usual practice.

Primary Outcome Measures

Name	Time	Method
Zarit Caregiver Burden Interview short form (ZBI)	6 Months	Primary Outcome: Caregiver (Zarit Caregiver Burden Interview ): Investigators will use the Zarit Caregiver Burden Interview (ZBI) short form to understand the specific challenges and support preferences of persons living with Parkinson disease. Range 0-48 with higher scores = more burden
Quality of Life: Alzheimer's Disease (QOL-AD)	6 Months	Primary Outcome: Patient (Quality of Life): Investigators will use the Quality of Life: Alzheimer's Disease (QOL-AD) to understand the specific challenges and support preferences of persons living with PD, their family care partner, and healthcare professionals, through the Quality of Life: Alzheimer's Disease (QOL-AD). Range 13-52, higher scores = better QOL

Secondary Outcome Measures

Name	Time	Method
Carepartner Measures (FACIT-SP 12)	3, 6, 9, 12 Months	Carepartner Measures: Investigators will use the Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SP 12 Item) - Carepartner Spiritual Wellbeing
Patient Measures Hospital Anxiety and Depression Scale	3, 6, 9, 12 Months	Patient Measures: Investigators will use the Hospital Anxiety and Depression Scale (HADS) - Patient Mood. Hospital Anxiety and Depression Scale (HADS)- 0-3 score range per item; higher score= worse outcome (scale broken down into depression score and anxiety score, each with 7 items)
Patient Measures Edmonton Symptom Assessment Scale	3, 6, 9, 12 Months	Patient Measures: Investigators will use the Edmonton Symptom Assessment Scale (ESAS-PD) - Patient symptom. Edmonton Symptom Assessment Scale (ESAS-PD) - 1-10 score range per item (13 item ESAS-PD); 0-130/higher score= worse outcome
Patient Measures (PG-12)	3, 6, 9, 12 Months	Patient Measures: Investigators will use the Prolonged Grief Questionnaire (PG-12) - Patient Grief. Range 10-50 with higher scores = greater grief
Patient Measures (FACIT-SP 12)	3, 6, 9, 12 Months	Patient Measures: Investigators will use the Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SP 12 Item) - Patient Spiritual Wellbeing. Range 0-48 with higher scores = better spiritual wellbeing
Carepartner Measures Hospital Anxiety and Depression Scale	3, 6, 9, 12 Months	Carepartner Measures: Investigators will use the Hospital Anxiety and Depression Scale (HADS) - Carepartner Mood. Hospital Anxiety and Depression Scale (HADS) - 0-3 score range per item; higher score= worse outcome (scale broken down into depression score and anxiety score, each with 7 items)

Trial Locations

Locations (1)

University of Rochester Medical Center for Health + Technology; 🇺🇸 Rochester, New York, United States