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

NCT ID: NCT05954013

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-06
• Study Completion Date: 2023-03-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

PD_Pal intervention

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

Group Type: EXPERIMENTAL

PD_Pal intervention

Intervention Type: BEHAVIORAL

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Padova

OTHER

Sponsor Role: collaborator

University of Ioannina

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

Estonian Movement Disorders Society

UNKNOWN

Sponsor Role: collaborator

Paracelsus Medical University

OTHER

Sponsor Role: collaborator

Philipps University Marburg

OTHER

Sponsor Role: collaborator

Skane University Hospital

OTHER

Sponsor Role: collaborator

Mediolanum Cardio Research

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angelo Antonini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

Paracelsus Medical University

Salzburg, , Austria

Estonian Movement Disorders Society

Tartu, , Estonia

Philipps University Marburg Medical Center

Marburg, , Germany

University of Ioannina

Ioannina, , Greece

University of Padova

Padua, , Italy

Skane University Hospital

Lund, , Sweden

University College, London

London, , United Kingdom

Countries

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

Other Identifiers

NL8180

Identifier Type: REGISTRY

Identifier Source: secondary_id

108177

Identifier Type: -

Identifier Source: org_study_id