Clinical trial NCT05954013: Advance Care Planning and Care Coordination for People With Parkinson's Disease
Official title: Evaluating the Clinical and Cost-effectiveness of a Combined Person-centred Intervention of Advance Care Planning (ACP) and Care Coordination for People With Parkinson's Disease and Their Family Caregiver(s)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Parkinsonism
Keywords: Advance Care Planning
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Padova
name: University of Ioannina
name: University College, London
name: Estonian Movement Disorders Society
name: Paracelsus Medical University
name: Philipps University Marburg
name: Skane University Hospital
name: Mediolanum Cardio Research
First posted: 2023-07-20
Enrollment: 189
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Advance care planning documentation in the medical records
timeFrame: 6 months after baseline; score range: 0-100; higher scores indicate higher percentages (though higher scores are not better per definition).
Secondary outcomes:
measure: Advance care planning documentation in the medical records
timeFrame: 12 months after baseline; score range: 0-100; higher scores indicate higher percentages (though higher scores are not better per definition).
measure: Integrated Palliative Care Outcome Scale (IPOS)
timeFrame: 6 and 12 months after baseline; IPOS score range = 0-64; higher scores are worse
measure: Edmonton Symptom Assessment Scale for Parkinson's Disease (ESAS-PD)
timeFrame: 6 months after baseline; ESAS-PD score range = 0-140; higher scores are worse
measure: Beck Depression Inventory (BDI-I)
timeFrame: 6 months after baseline; BDI-I score range = 0-63; higher scores are worse
measure: Parkinson's Disease Questionnaire-39 (PDQ-39)
timeFrame: 6 and 12 months after baseline; PDQ-39 score range = 0-100; higher scores are worse
measure: EQ-5D-5L (patient)
timeFrame: 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse
measure: Self-rated health status (patient), on a 0-100 point VAS scale
timeFrame: 6 and 12 months after baseline; score range: 0-100; higher scores indicated better self-rated health status
measure: EQ-5D-5L (family caregiver)
timeFrame: 6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse
measure: Quality of life questionnaire for carers - PQoL Carer
timeFrame: 6 and 12 months after baseline; PQoL Carer score range = 0-100; higher scores are worse
measure: Modified Nijmegen Continuity Questionnaire (mNCQ)
timeFrame: 6 and 12 months after baseline; mNCQ score range = 1-5; higher scores are worse
measure: Short Assessment of Patient Satisfaction (SAPS)
timeFrame: 6 months after baseline; SAPS score range = 0-32; higher scores are worse
measure: Experienced involvement in decision making (CollaboRATE)
timeFrame: 6 months after baseline; CollaboRATE score range = 0-5; higher scores are worse
measure: MDS Non-Motor Rating Scale (MDS-NMS)
timeFrame: 6 and 12 months after baseline; MDS-MMS score range = 0-832; higher scores are worse
measure: Quality of Dying and Death questionnaire (QoDD), if applicable
timeFrame: 30 days after death of patient; QoDD score range = 0-100; lower scores are worse
measure: Resource Utilization questionnaire (RUD) adapted for PD
timeFrame: 6 and 12 months after baseline; RUD score range not applicable
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Paracelsus Medical University
city: Tartu
country: Estonia
facility: Estonian Movement Disorders Society
city: Marburg
country: Germany
facility: Philipps University Marburg Medical Center
city: Ioánnina
country: Greece
facility: University of Ioannina
city: Padova
country: Italy
facility: University of Padova
city: Lund
country: Sweden
facility: Skane University Hospital
city: London
country: United Kingdom
facility: University College, London
Study officials:
affiliation: University of Padova
name: Angelo Antonini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: