Acceptability of Palliative Care in Parkinson Disease Care

NCT03697434 | Completed

• 1 other identifier: 72429
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the feasibility of using specific criteria to standardize the referral of individuals with Parkinson disease to a group of medical providers known as palliative care specialists. Palliative care specialists provide supportive care to individuals living with serious illnesses. The specialty focuses on providing relief from the symptoms and stress of serious illness.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of enrolled participants who have at least 1 visit with a palliative care provider within 3 months of referral

  We will assess the feasibility of standardized referral to palliative care by calculating the proportion of enrolled participants with Parkinson disease who have at least 1 visit with a palliative care provider within 3 months of referral.

  3 months

Secondary Outcomes (6)

• Change in mean symptom burden

  Baseline to 3 months

• Change in mean quality of life as assessed by the Quality of Life-Alzheimer Disease questionnaire (QoL-AD)

  Baseline to 3 months

• Change in mean caregiver burden

  Baseline to 3 months

• Change in mean caregiver self-efficacy

  Baseline to 3 months

• Barriers to palliative care referral

  Baseline

Study Arms (1)

Palliative Care referral

EXPERIMENTAL

Participants with specific uncontrolled symptoms or critical events in course of their Parkinson disease will be referred to a palliative care specialist for supportive care.

Behavioral: Palliative Care referral

Interventions

Palliative Care referral BEHAVIORAL

Individuals with Parkinson disease identified as having specific uncontrolled symptoms or critical events will undergo standardized referral to palliative care, who will provide supportive care. During the palliative care referral, participants and their care partners may discuss symptoms, disease burden (physical, emotion, financial, and psychological), quality of life, goals of care, and advance directive completion. Palliative care specialists may recommend interventions to manage bothersome symptoms or to improve disease burden for both participants and care partners.

Palliative Care referral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic PD confirmed as most likely diagnosis with participant's treating provider
• years of age or older
• Participant or care partner able to provide informed consent
• Presence of one or more of the following:
• Uncontrolled symptoms (over prior week):
• Depression
• Pain
• Fatigue
• Critical events (over prior 6 months):
• ≥3 falls
• Unintended weight loss
• Wheelchair dependence (\>50% of time)

You may not qualify if:

• Diagnosis of atypical or secondary parkinsonism
• Outpatient palliative care visit scheduled or within the prior 6 months of the screening visit
• Subjects who are care partners:
• Care partner of enrolled participant in the study
• years of age or older
• Able to provide informed consent

Sponsors & Collaborators

• University of Rochester: lead
• American Academy of Neurology: collaborator

Study Sites (1)

URMC Neurology; 919 Westfall Rd, Building C

Rochester, New York, 14618, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: November 16, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 2, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)