Palli-MONITOR: A Phase II Mixed-Methods Study to Implement and Test the Electronic Version of the Integrated Palliative Care Outcome Scale (eIPOS) in an Specialist Palliative Home Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Acceptance of electronical monitoring
研究概览
简要总结
In palliative care, the Integrated Palliative Care Outcome Scale (IPOS) is widely used as a patient reported outcome measure (PROM) and covers patients' main concerns, common symptoms, patient and family distress, existential wellbeing, sharing feelings with family, information received, and practical concerns. The IPOS is validated for patients with advanced cancer or non-cancer disease and is available as patients and professional carer version.
The implementation of a PROM in the home care setting is more challenging compared to the inpatient setting.
Palli-MONITOR will develop, implement and test the feasibility of an internet-based real-time monitoring of palliative needs of patients with advanced diseases using the electronic version of IPOS (eIPOS) including a clinical decision support tool for specialist palliative home care.
The project is conducted in two parts:
- A pilot study to develop an electronical monitoring that is acceptable for both palliative patients and professionals of specialist palliative home care teams.
- A feasibility study to implement and test eIPOS in specialist palliative home care teams.
详细描述
In palliative care, the Integrated Palliative Care Outcome Scale (IPOS) is widely used as a patient reported outcome measure. IPOS covers patients' main concerns, common symptoms, patient and family distress, existential wellbeing, sharing feelings with family, information received, and practical concerns. IPOS is validated for patients with advanced cancer or non-cancer disease and is available as patients and professional carer version.
The implementation of a PROM in the home care setting is more challenging compared to the inpatient setting. Furthermore, IPOS currently only exists as a paper version. If patients complete the IPOS at home, there is a potential delay until the home care team receives the information and a potential benefit through patient reported outcome measurement might be missed.
Palli-MONITOR will develop, implement and test the feasibility an internet-based real-time monitoring of palliative needs of patients with advanced disease using the electronic version of IPOS (eIPOS) including a clinical decision support tool for specialist palliative home care.
The project is conducted in two parts (phase I and phase II). Phase I will consist of two components and serve as a pilot study: a qualitative part and a cross-over randomised controlled trial (RCT). In the qualitative part, the investigators will conduct semi-structured interviews and focus groups with patients and professionals of the participating specialist palliative home care teams. In the RCT, the investigators will determine the validity of the eIPOS in comparison to IPOS in paper version. The investigators will also develop an evidence-based Clinical Decision Support Tool (CDS), using guidelines and a Delphi study for evaluation of the proposed CDS.
Phase II (study design described in more detail below) will serve as a feasibility study and consist of an observational case-control study as well as a qualitative part, which again will include semi-structured interviews and focus groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Participants cared for by one of the participating specialist palliative home care teams
- •Participants who have the capacity to give informed consent to participate the study in writing and are able to participate in research
- •Participants who are not too distressed or ill to participate in the study
排除标准
- •Participants with cognitive impairment
结局指标
主要结局
Acceptance of electronical monitoring
时间窗: up to 4 weeks after enrollment
Based on qualitative data
Technical feasibility of electronical monitoring: Integrated Palliative Care Outcome Scale
时间窗: up to 4 weeks after enrollment
Completeness of the electronic Integrated Palliative Care Outcome Scale (eIPOS). IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support. Five answer options for each question are possible (scored 0 to 4; higher scores indicate higher burden). The overall IPOS score is the sum of the scores from each of the 17 questions. The overall IPOS score can therefore range from zero to 68.
Influence of electronical monitoring on provided care
时间窗: up to 4 weeks after enrollment
Assess care modifications consecutive of initial care
Recruitment rates
时间窗: 1 year
The recruitment rates of each specialist palliative home care teams will be calculated as the percentage of eligible participants who agreed to participate in the study divided by the total number of eligible participants approached to participate in the study.
次要结局
- Unplanned hospital submissions(up to 3 weeks after enrollment)
- Palliative needs (IPOS)(up to 4 weeks after enrollment)
- EORTC QLQ-C15-PAL(At baseline and 2 weeks)
- Symptom burden (ESAS)(At baseline and 2 weeks)
研究者
Claudia Bausewein
Professor for Palliative Medicine
Ludwig-Maximilians - University of Munich