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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 7
- 主要终点
- Advance care planning documentation in the medical records
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The participant and care provider (PD_Pal nurse) will not be blinded. The outcome assessor will be blinded.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
PD_Pal intervention
Participants with Parkinson's disease receive usual care from their established neurology and/or home care team + the PD_Pal intervention.
干预措施: PD_Pal intervention (Behavioral)
Control group
Participants with Parkinson's disease receive usual care from their established neurology and/or home care team.
结局指标
主要结局
Advance care planning documentation in the medical records
时间窗: 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.
次要结局
- Quality of life questionnaire for carers - PQoL Carer(6 and 12 months after baseline; PQoL Carer score range = 0-100; higher scores are worse)
- Modified Nijmegen Continuity Questionnaire (mNCQ)(6 and 12 months after baseline; mNCQ score range = 1-5; higher scores are worse)
- Integrated Palliative Care Outcome Scale (IPOS)(6 and 12 months after baseline; IPOS score range = 0-64; higher scores are worse)
- 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).)
- 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)
- EQ-5D-5L (patient)(6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse)
- MDS Non-Motor Rating Scale (MDS-NMS)(6 and 12 months after baseline; MDS-MMS score range = 0-832; 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)
- Short Assessment of Patient Satisfaction (SAPS)(6 months after baseline; SAPS score range = 0-32; higher scores are worse)
- Experienced involvement in decision making (CollaboRATE)(6 months after baseline; CollaboRATE score range = 0-5; higher scores are worse)
- Quality of Dying and Death questionnaire (QoDD), if applicable(30 days after death of patient; QoDD score range = 0-100; lower scores are worse)
- 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)
- EQ-5D-5L (family caregiver)(6 and 12 months after baseline; EQ-5D-5L score range = 11111-55555; higher scores are worse)
- Resource Utilization questionnaire (RUD) adapted for PD(6 and 12 months after baseline; RUD score range not applicable)