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

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)

University of Padova, University of Ioannina, University College, London, Estonian Movement Disorders Society, Paracelsus Medical University, Philipps University Marburg Medical Center, Skane University Hospital, Mediolanum Cardio Research

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.

The participant and care provider (PD_Pal nurse) will not be blinded. The outcome assessor will be blinded.

Participants with Parkinson's disease receive usual care from their established neurology and/or home care team + the PD_Pal intervention.

Participants with Parkinson's disease receive usual care from their established neurology and/or home care team.

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.

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).

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).

6 and 12 months after baseline; score range: 0-100; higher scores indicated better self-rated health status

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.