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

Radboud University Medical Center189 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Interventions

PD_Pal interventionBEHAVIORAL

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (7)

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

Padova, Italy

Skane University Hospital

Lund, Sweden

University College, London

London, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 6 months after baseline; score range: 0-100; higher scores indicate higher percentages (though higher scores are not better per definition).

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 6 and 12 months after baseline; RUD score range not applicable