Advance Care Planning and Care Coordination for People With Parkinson's Disease

Study Overview
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Brief Summary
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Background: People with Parkinson's disease (PD), including parkinsonisms, experience complex motor and non-motor symptoms, which become more hindering in the advanced stages of PD. Advance care planning (ACP) enables individuals to define goals and preferences for future medical treatment and serves to ensure that people receive treatment and care that is in line with their preferences during serious chronic illness. The effectiveness of ACP for PD is currently unknown. Methods: The investigators will evaluate the effectiveness of a multicenter, open-label randomized controlled trial, with a parallel group design in seven European countries (Austria, Estonia, Germany, Greece, Italy, Sweden and United Kingdom). The PD_Pal intervention comprises (1) several consultations with a trained nurse who will perform ACP conversations and support care coordination and (2) use of a patient-directed Parkinson Support Plan-workbook. The intervention group will be compared to a care-as-usual group. Documented ACP-decisions in the medical records/patient's central file assessed at 6 months after baseline will be the primary endpoint. Secondary endpoints include patients' and family caregivers' quality of life, perceived care coordination, patients' symptom burden, and cost-effectiveness. Assessments will take place at baseline, 6 months after baseline and 12 months after baseline. In parallel, we will perform a process evaluation, to understand the feasibility of the intervention. Hypothesis: The investigators hypothesize that the PD_Pal intervention will result in an increased number of participants with ACP documentation in the medical records/patient's central file, as compared to care-as-usual. Secondly, the investigators expect that, due to the PD_Pal intervention, patients and their FC will experience better care coordination, better quality of life, a reduced patient symptom burden and the FC will experience a reduction in caregiver burden.

Official Title
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Evaluating the Clinical and Cost-effectiveness of a Combined Person-centred Intervention of Advance Care Planning (ACP) and Care Coordination for People With Parkinson's Disease and Their Family Caregiver(s)

Conditions
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Parkinson Disease, Parkinsonism

Intervention / Treatment
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* Behavioral: PD_Pal intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for people with Parkinson's disease: Capable to participate , meaning that the subject is able to: understand information about the decision remember that information use that information to make a decision communicate their decision by talking, using sign language or any other means Able to provide informed consent; Meeting the MDS clinical diagnostic criteria for PD, including Parkinsonisms; Hoehn & Yahr ≥ 3; Progressive deterioration in physical and/or cognitive function despite optimal therapy, according to the primary physician; and Availability of a family caregiver or informal caregiver. Exclusion Criteria: Inability to communicate independently, with or without supportive communication tools; - Unable or unwilling to commit to study procedures; Presence of additional chronic medical illnesses which may require palliative services (e.g. metastatic cancer); Already receiving palliative care or hospice services; Already participating in a clinical study for palliative care. Inclusion criteria for family caregivers (FCs): Identified by the patient as the person closest to them; Willing to provide written informed consent; Willing and able to complete questionnaires; Aging ≥ 18 years. FC can only participate when the patient participates.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD_Pal intervention<br>Participants with Parkinson's disease receive usual care from their established neurology and/or home care team + the PD_Pal intervention. | Behavioral: PD_Pal intervention<br>* The PD_Pal intervention will be delivered by a nurse that is specifically trained to deliver the PD_Pal intervention, i.e. the PD_Pal nurse. In the PD_Pal intervention, the patient, family caregiver and PD_Pal nurse complete four steps wherein they discuss and compose a: 1) Individual care plan; 2) Proactive care plan; 3) Quality of life and end-of-life plan and; 4) Coordination and revision plan. Together these steps lead to the Parkinson Support Plan. To facilitate patients in taking these steps, all patients receive a Parkinson Support Plan workbook. This workbook consists of information and questions aligned with the four steps. Patients can utilize this workbook before, during, or after the conversations with the PD_Pal nurse.<br>|
| No Intervention: Control group<br>Participants with Parkinson's disease receive usual care from their established neurology and/or home care team. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advance care planning documentation in the medical records | Percentage of participants with documented advance care planning (ACP) preferences and wishes in the medical records at 6 months. Only participants who did not have documented ACP at baseline are included in this calculation. | 6 months after baseline; score range: 0-100; higher scores indicate higher percentages (though higher scores are not better per definition). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advance care planning documentation in the medical records | Percentage of participants with documented advance care planning (ACP) preferences and wishes in the medical records at 12 months. Only participants who did not have documented ACP at baseline are included in the calculation. | 12 months after baseline; score range: 0-100; higher scores indicate higher percentages (though higher scores are not better per definition). | 
| Integrated Palliative Care Outcome Scale (IPOS) | Change from baseline in palliative phase symptom severity | 6 and 12 months after baseline; IPOS score range = 0-64; higher scores are worse | 
| Edmonton Symptom Assessment Scale for Parkinson's Disease (ESAS-PD) | Change from baseline in disease specific symptoms | 6 months after baseline; ESAS-PD score range = 0-140; higher scores are worse | 
| Beck Depression Inventory (BDI-I) | Change from baseline in depression severity | 6 months after baseline; BDI-I score range = 0-63; higher scores are worse | 
| Parkinson's Disease Questionnaire-39 (PDQ-39) | Change from baseline in quality of life | 6 and 12 months after baseline; PDQ-39 score range = 0-100; higher scores are worse | 
| EQ-5D-5L (patient) | Change from baseline in self-rated health status in 5 domains | 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse | 
| Self-rated health status (patient), on a 0-100 point VAS scale | Change from baseline in self-rated health status | 6 and 12 months after baseline; score range: 0-100; higher scores indicated better self-rated health status | 
| EQ-5D-5L (family caregiver) | Change from baseline of caregiver's health status in 5 domains | 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse | 
| Quality of life questionnaire for carers - PQoL Carer | Change from baseline in burden experienced by family caregiver | 6 and 12 months after baseline; PQoL Carer score range = 0-100; higher scores are worse | 
| Modified Nijmegen Continuity Questionnaire (mNCQ) | Change from baseline in perceived care coordination | 6 and 12 months after baseline; mNCQ score range = 1-5; higher scores are worse | 
| Short Assessment of Patient Satisfaction (SAPS) | Change from baseline in quality of care | 6 months after baseline; SAPS score range = 0-32; higher scores are worse | 
| Experienced involvement in decision making (CollaboRATE) | Change from baseline in experienced involvement in decision making. | 6 months after baseline; CollaboRATE score range = 0-5; higher scores are worse | 
| MDS Non-Motor Rating Scale (MDS-NMS) | Change from baseline in non-motor symptom severity | 6 and 12 months after baseline; MDS-MMS score range = 0-832; higher scores are worse | 
| Quality of Dying and Death questionnaire (QoDD), if applicable | Quality of the dying process, experienced by family caregiver | 30 days after death of patient; QoDD score range = 0-100; lower scores are worse | 
| Resource Utilization questionnaire (RUD) adapted for PD | Change from baseline in resource utilisation | 6 and 12 months after baseline; RUD score range not applicable | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advance Care Planning