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

NCT05954013 | Completed DMC

• 2 other identifiers: 108177NL8180
• Study Type: interventional
• Target: 189
• Locations: 7 countries
• Sites: 7

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

Keywords

Advance Care Planning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Advance care planning documentation in the medical records

  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)

  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)

  6 months after baseline; ESAS-PD score range = 0-140; higher scores are worse

• Beck Depression Inventory (BDI-I)

  6 months after baseline; BDI-I score range = 0-63; higher scores are worse

• Parkinson's Disease Questionnaire-39 (PDQ-39)

  6 and 12 months after baseline; PDQ-39 score range = 0-100; higher scores are worse

Study Arms (2)

PD_Pal intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

PD_Pal intervention 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.

PD_Pal intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (7)

Paracelsus Medical University

Salzburg, Austria

Location

Estonian Movement Disorders Society

Tartu, Estonia

Location

Philipps University Marburg Medical Center

Marburg, Germany

Location

University of Ioannina

Ioannina, Greece

Location

University of Padova

Padua, Italy

Location

Skane University Hospital

Lund, Sweden

Location

University College, London

London, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Angelo Antonini, MD, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participant and care provider (PD\ Pal nurse) will not be blinded. The outcome assessor will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 20, 2023
• Study Start: August 6, 2020
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: July 20, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); GR (1); GB (1); AU (1); SE (1); DE (1); IT (1)