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

Summary

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.

Conditions

• Parkinson Disease
• Parkinsonism

Interventions

BEHAVIORAL

PD_Pal intervention

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.

Sponsors & Collaborators

• University of Padova

  collaborator OTHER

• University of Ioannina

  collaborator OTHER

• University College, London

  collaborator OTHER

• Estonian Movement Disorders Society

  collaborator UNKNOWN

• Paracelsus Medical University

  collaborator OTHER

• Philipps University Marburg

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Mediolanum Cardio Research

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Angelo Antonini, MD, PhD · University of Padova

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-08-06

Primary Completion

2023-03-17

Completion

2023-03-17

Countries

• Austria
• Estonia
• Germany
• Greece
• Italy
• Sweden
• United Kingdom

Study Locations