Patient-centred Integrated Palliative Care Pathways in Advanced Cancer and Chronic Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 576
- 试验地点
- 5
- 主要终点
- Change from baseline Experiences with IPC initiatives at 3 months
研究概览
简要总结
Rationale: Palliative care integration in treatment pathways, palliative care networks and institutional collaborations in health services delivery seems a promising approach reducing fragmentation and discontinuity. Integrated Palliative Care (IPC) approaches in Europe are largely unknown and under-investigated. The investigators aim is to explore experiences of patients with advanced cancer, Chronic Obstructive Pulmonary Disease (COPD) and Chronic Heart Failure (CHF), family and professional caregivers within with IPC. This includes perceived quality of life, quality of care, burden/rewards of care giving, symptoms and collaboration between caregivers in the patient's care network.
Objectives: To investigate how patients with advanced cancer, COPD and CHF, their family and professional caregivers within a selection of IPC initiatives in Belgium, Germany, Hungary, The Netherlands and United Kingdom experience care delivery in the last phase of disease.
- To investigate what opinions patients and family caregivers have on the (continuity and) quality of care delivered
- To investigate how patients rate their symptoms and quality of life
- To investigate how family caregivers rate their burden / rewards of care giving
- To investigate how the care network of the patient is organised with respect to the type, properties and quality of relationships between patients and family / professional caregivers
Study design: Longitudinal multiple embedded case study.
Study population: Adult patients with advanced cancer, COPD, and CHF under the care of IPC initiatives in five participating countries, their family and professional caregivers. The investigators aim to enroll up to 288 patients, 288 family caregivers and 192 professional caregivers in total.
Study parameters: Experiences with IPC initiatives, quality of care, quality of life, perceived symptoms, perceived collaboration between professional caregivers, burden and rewards of care giving.
Methods: Semi-structured interviews, patient diary, Social Network Analysis and the following questionnaires: Palliative care Outcome Scale; Canhelp Lite, Caregiver Reaction Assessment. Patients and family caregivers will be followed over 3 months at 4 consecutive contact points. The diary (containing two questions) will be kept weekly by patients. There will be group or individual interviews with professional caregivers.
Analysis: The overall analysis will involve a synthesis of the qualitative and quantitative data. For more information see Detailed Description.
详细描述
Monitoring and Quality Assurance:
Training for researchers:
In order to ensure the best quality of the study, researchers will take part in at least two compulsory training sessions. During the training ethical and professional issues will also be discussed, such as:
- ethical issues (e.g. handling vulnerable groups in interview situations)
- data management (protection of privacy of medical and research records)
- interview training in order to standardise interview techniques
- how to analyse qualitative and quantitative data, and how to synthesize them in this research (to the analysing researchers in the partner countries).
Qualitative data:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 year or above
- •Able to communicate in the national language (Dutch, English, German, Hungarian)
- •Cognitively able to complete questionnaires and to participate in interviews.
- •Additional inclusion criteria for patients:
- •Surprise question "Would the patient's attending doctor be surprised if the patient died within 1 year?" is answered "No" by the patient's attending doctor
- •Patients need to meet on of the following clinical criteria:
- •Malignant disease: Advanced cancer (cancer with local progression and / or distant metastasis at presentation).
- •Chronic Heart Failure: Severe heart failure (in accordance with New York Heart Association (NYHA) classification stage III-IV)
- •COPD: Gold stage IV classification
- •Exclusion criteria:
- •People who lack mental capacity to give interviews and fill in questionnaires
排除标准
- 未提供
结局指标
主要结局
Change from baseline Experiences with IPC initiatives at 3 months
时间窗: Baseline and Month 3
The semi-structured interviews will be used to explore views of patients and family caregivers about their experiences with the integrated palliative care initiative. Topics include: * An exploration of problems and needs of the patient * An exploration of the contacts and relationships of patients and family caregivers with professional caregivers * An exploration of satisfaction and perceived deficits in service provision from the perspective of patients and family caregivers * An exploration of the views of patients and family caregivers on collaboration between professional care providers in the care network of the patient.
Change from baseline Quality of life at 1, 2, and 3 months
时间窗: Baseline, Month 1, Month 2, Month 3
Quality of Life will be measured using the Palliative Care Outcome Scale (POS) version 1. Outcomes will be explored in the interviews, see also "Experiences with IPC initiatives"
Change from Perceived collaboration between professional caregivers at 3 months
时间窗: Baseline, Month 3
Quality of Life will be measured using Social Network Analysis method (SNA). Outcomes will be explored in the interviews, see also "Experiences with IPC initiatives"
Change from baseline Quality of care at 1, 2 and 3 months
时间窗: Baseline, Month 1, Month 2, Month 3
Quality of care/satisfaction will be measured using the Canhelp Lite and the Social Network Analysis (SNA) method. Outcomes will be explored in the interviews, see also "Experiences with IPC initiatives"
Change from baseline Perceived symptoms at 1, 2, and 3 months
时间窗: Baseline, Month 1, Month 2, Month 3
Quality of Life will be measured using the Palliative Care Outcome Scale (POS) version 1. Outcomes will be explored in the interviews, see also "Experiences with IPC initiatives".
Change from baseline Burden and rewards of care giving at 1, 2, and 3 months
时间窗: Baseline, Month 1, Month 2, Month 3
Burden and rewards of care giving will be measured using the Caregiver Reaction Assessment.
次要结局
未报告次要终点