Back to resultsAcceptability of Palliative Care in Parkinson Disease Care (Palliate-PD)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative Care referral
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson Disease
Eligibility 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
Sites / Locations
- URMC Neurology; 919 Westfall Rd, Building C
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Palliative Care referral
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in mean symptom burden
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.
Change in mean quality of life as assessed by the Quality of Life-Alzheimer Disease questionnaire (QoL-AD)
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.
Change in mean caregiver burden
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.
Change in mean caregiver self-efficacy
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.
Barriers to palliative care referral
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.
Barriers to palliative care referral
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.
Full Information
NCT ID
NCT03697434
First Posted
October 3, 2018
Last Updated
December 5, 2019
Sponsor
University of Rochester
Collaborators
American Academy of Neurology
1. Study Identification
Unique Protocol Identification Number
NCT03697434
Brief Title
Acceptability of Palliative Care in Parkinson Disease Care
Acronym
Palliate-PD
Official Title
Pilot to Assess the Acceptance of Palliative Care Referral Among Those With Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
American Academy of Neurology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Palliative Care referral
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Palliative Care referral
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of enrolled participants who have at least 1 visit with a palliative care provider within 3 months of referral
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in mean symptom burden
Description
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.
Time Frame
Baseline to 3 months
Title
Change in mean quality of life as assessed by the Quality of Life-Alzheimer Disease questionnaire (QoL-AD)
Description
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.
Time Frame
Baseline to 3 months
Title
Change in mean caregiver burden
Description
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.
Time Frame
Baseline to 3 months
Title
Change in mean caregiver self-efficacy
Description
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.
Time Frame
Baseline to 3 months
Title
Barriers to palliative care referral
Description
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.
Time Frame
Baseline
Title
Barriers to palliative care referral
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
URMC Neurology; 919 Westfall Rd, Building C
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acceptability of Palliative Care in Parkinson Disease Care
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