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Acceptability of Palliative Care in Parkinson Disease Care

Not Applicable
Completed
Conditions
Parkinson Disease
Interventions
Behavioral: Palliative Care referral
Registration Number
NCT03697434
Lead Sponsor
University of Rochester
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Palliative Care referralPalliative Care referralParticipants with specific uncontrolled symptoms or critical events in course of their Parkinson disease will be referred to a palliative care specialist for supportive care.
Primary Outcome Measures
NameTimeMethod
Proportion of enrolled participants who have at least 1 visit with a palliative care provider within 3 months of referral3 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
NameTimeMethod
Change in mean symptom burdenBaseline 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.

Change in mean caregiver self-efficacyBaseline 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.

Barriers to palliative care referral3 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.

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

Change in mean caregiver burdenBaseline 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.

Trial Locations

Locations (1)

URMC Neurology; 919 Westfall Rd, Building C

🇺🇸

Rochester, New York, United States

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