Advance Care Planning and Care Coordination for People With Parkinson's Disease
- Conditions
- Parkinson DiseaseParkinsonism
- Interventions
- Behavioral: PD_Pal intervention
- Registration Number
- NCT05954013
- Lead Sponsor
- Radboud University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 189
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PD_Pal intervention PD_Pal intervention Participants with Parkinson's disease receive usual care from their established neurology and/or home care team + the PD_Pal intervention.
- Primary Outcome Measures
Name Time Method Advance care planning documentation in the medical records 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 6 months. Only participants who did not have documented ACP at baseline are included in this calculation.
- Secondary Outcome Measures
Name Time Method Integrated Palliative Care Outcome Scale (IPOS) 6 and 12 months after baseline; IPOS score range = 0-64; higher scores are worse Change from baseline in palliative phase symptom severity
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). 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.
Beck Depression Inventory (BDI-I) 6 months after baseline; BDI-I score range = 0-63; higher scores are worse Change from baseline in depression severity
Parkinson's Disease Questionnaire-39 (PDQ-39) 6 and 12 months after baseline; PDQ-39 score range = 0-100; higher scores are worse Change from baseline in quality of life
EQ-5D-5L (patient) 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse Change from baseline in self-rated health status in 5 domains
MDS Non-Motor Rating Scale (MDS-NMS) 6 and 12 months after baseline; MDS-MMS score range = 0-832; higher scores are worse Change from baseline in non-motor symptom severity
Edmonton Symptom Assessment Scale for Parkinson's Disease (ESAS-PD) 6 months after baseline; ESAS-PD score range = 0-140; higher scores are worse Change from baseline in disease specific symptoms
Short Assessment of Patient Satisfaction (SAPS) 6 months after baseline; SAPS score range = 0-32; higher scores are worse Change from baseline in quality of care
Experienced involvement in decision making (CollaboRATE) 6 months after baseline; CollaboRATE score range = 0-5; higher scores are worse Change from baseline in experienced involvement in decision making.
Quality of Dying and Death questionnaire (QoDD), if applicable 30 days after death of patient; QoDD score range = 0-100; lower scores are worse Quality of the dying process, experienced by family caregiver
Self-rated health status (patient), on a 0-100 point VAS scale 6 and 12 months after baseline; score range: 0-100; higher scores indicated better self-rated health status Change from baseline in self-rated health status
EQ-5D-5L (family caregiver) 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse Change from baseline of caregiver's health status in 5 domains
Quality of life questionnaire for carers - PQoL Carer 6 and 12 months after baseline; PQoL Carer score range = 0-100; higher scores are worse Change from baseline in burden experienced by family caregiver
Modified Nijmegen Continuity Questionnaire (mNCQ) 6 and 12 months after baseline; mNCQ score range = 1-5; higher scores are worse Change from baseline in perceived care coordination
Resource Utilization questionnaire (RUD) adapted for PD 6 and 12 months after baseline; RUD score range not applicable Change from baseline in resource utilisation
Trial Locations
- Locations (7)
University of Padova
🇮🇹Padova, Italy
University of Ioannina
🇬🇷Ioánnina, Greece
Estonian Movement Disorders Society
🇪🇪Tartu, Estonia
Skane University Hospital
🇸🇪Lund, Sweden
Philipps University Marburg Medical Center
🇩🇪Marburg, Germany
University College, London
🇬🇧London, United Kingdom
Paracelsus Medical University
🇦🇹Salzburg, Austria