Acceptability of Palliative Care in Parkinson Disease Care (Palliate-PD)

• ClinicalTrials.gov Identifier: NCT03697434
• Recruitment Status: Completed
• First Posted: October 5, 2018
• Last Update Posted: December 9, 2019
• Sponsor: University of Rochester
• Collaborator: American Academy of Neurology
• Information provided by (Responsible Party): Christopher Tarolli, University of Rochester

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Behavioral: Palliative Care referral	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Pilot to Assess the Acceptance of Palliative Care Referral Among Those With Parkinson Disease
• Actual Study Start Date: November 16, 2018
• Actual Primary Completion Date: June 1, 2019
• Actual Study Completion Date: June 2, 2019

Arms and Interventions

Arm

Intervention/treatment

Experimental: Palliative Care referral; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Proportion of enrolled participants who have at least 1 visit with a palliative care provider within 3 months of referral [ Time Frame: 3 months ]
   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.

Secondary Outcome Measures :

1. Change in mean symptom burden [ Time Frame: Baseline to 3 months ]
   Symptom burden will be measured using the Edmonton Symptom Assessment Scale-Revised for Parkinson Disease (ESAS-R: PD), which measures the severity of 14 symptoms on a 1-10 scale. Scores range from 0-140 with higher scores indicating higher symptom burden.
2. Change in mean quality of life as assessed by the Quality of Life-Alzheimer Disease questionnaire (QoL-AD) [ Time Frame: Baseline to 3 months ]
   Quality of life will be measured using the Quality of Life-Alzheimer Disease questionnaire, which is a 13-item measure that assesses overall quality of life with a focus on physical, social, psychological, and spiritual well-being. Scores range from 13-52 with higher scores indicating better quality of life.
3. Change in mean caregiver burden [ Time Frame: Baseline to 3 months ]
   Caregiver burden will be measured using the Zarit Burden interview, which is a 22-item questionnaire that assesses caregiver fear, anger, guilt, perspective, hope, and overall quality of life. Scores range from 0-88 with a score of 0-21 associated with little or no burden, 21-40 mild to moderate burden, 41-60 moderate to severe burden, and 61-88 severe burden.
4. Change in mean caregiver self-efficacy [ Time Frame: Baseline to 3 months ]
   Caregiver self-efficacy will be measured using the Revised Scale for Caregiver Self-efficacy, which is a 15-item questionnaire with 3 sub-sections (self-efficacy for obtaining respite, self-efficacy for responding to disruptive patient behaviors, and self-efficacy for controlling upsetting thoughts about caregiving). Respondents rate their certainty of being able to complete each task from 0% (cannot perform task at all) to 100% (certain that task can be performed). Scores on each of the sub-sections range from 0-500 with a higher score indicating greater self-efficacy.
5. Barriers to palliative care referral [ Time Frame: Baseline ]
   Barriers to palliative care referral will be measured using a novel qualitative survey that assesses perceived barriers to referral and drivers of desire for referral to palliative care among those with Parkinson disease. The measure includes a qualitative survey of 9 potential barriers to consultation and 5 potential reasons to undergo consultation. Respondents can select as many barriers or reasons as applicable to their perception of referral and can provide free text responses. Overall frequency of selection of each identified barrier among participants will be assessed both at baseline and at 3 months following palliative care referral. Barriers and reasons for referral with higher frequency will be considered to be more important in hindering or driving desire for referral, respectively.
6. Barriers to palliative care referral [ Time Frame: 3 months ]
   Barriers to palliative care referral will be measured using a novel qualitative survey that assesses perceived barriers to referral and drivers of desire for referral to palliative care among those with Parkinson disease. The measure includes a qualitative survey of 9 potential barriers to consultation and 5 potential reasons to undergo consultation. Respondents can select as many barriers or reasons as applicable to their perception of referral and can provide free text responses. Overall frequency of selection of each identified barrier among participants will be assessed both at baseline and at 3 months following palliative care referral. Barriers and reasons for referral with higher frequency will be considered to be more important in hindering or driving desire for referral, respectively.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Subjects with Parkinson disease:

Inclusion Criteria:

• Diagnosis of idiopathic PD confirmed as most likely diagnosis with participant's treating provider
• 18 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)

Exclusion Criteria:

• 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:

Inclusion Criteria:

• Care partner of enrolled participant in the study
• 18 years of age or older
• Able to provide informed consent

Exclusion Criteria:

• No care partner specific exclusion criteria

Contacts and Locations

Locations

United States, New York

URMC Neurology; 919 Westfall Rd, Building C

Rochester, New York, United States, 14618

Sponsors and Collaborators

University of Rochester

American Academy of Neurology

More Information

• Responsible Party: Christopher Tarolli, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03697434
• Other Study ID Numbers: 72429
• First Posted: October 5, 2018
• Last Update Posted: December 9, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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