NCT06605079招募中不适用
Enhancing Palliative Care in ICU
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,040
- 试验地点
- 58
- 主要终点
- Length of intensive care stay
研究概览
简要总结
The aim of this study is to reduce the suffering in intensive care through palliative care consultations.
详细描述
This project investigates the effectiveness and cost-effectiveness of palliative care consultations in the Intensive care unit. Charité will implement the Working Package 2 "Europe-wide harmonized and recommended palliative care practice for ICU" of the approved HORIZON funding application EPIC, to which this ethics application refers.
An accompanying anonymous employee survey (doctors/nurses) is conducted once in the intervention phase and once in the control phase in all study centers (see secondary endpoints 57-68 and 71).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Patients in ICU who can give consent and those who can not (via their authorized representative or legal guardian, also possible with delayed consent)
- •From 18 years
- •The leading cause of critical illness is not cancer
- •New admission on the participating ICU > 72h
- •Assessment of the need for palliative care by the in-charge physi-cian of the ICU, because (1) there is a significant disagreement about ICU treatment or (2) because the physician considers ther-apy limitations for the patient or (3) the physician considers a benefit from specialized PC consultation for ICU physician, nurse, or patient or family.
排除标准
- •- Patient is moribund and is expected to die within the next 24h
- •Study cohort relatives:
- •Inclusion criteria:
- •- At least one relative(s) of a patient. This may or may not be the legal representative, depending on national legislation.
- •Exclusion criteria:
- •Refusal by the relative
- •Refusal of the patient to participate in the intervention study
- •<18 years of age
- •Cohort of employees:
- •Inclusion criteria
- •Employed on the ITS as a doctor/nurse
- •Employed in the clinical center as a member of the palliative care consultation service
- •Exclusion criterion Refusal to participate
结局指标
主要结局
Length of intensive care stay
时间窗: During intensive care unit stay, an average of 5 days
The primary endpoint is the number of days the patient spent in each Intensive Care Unit (ICU) of the index hospital during the first hospitalization. For example, if the patient was transferred from the first ICU participating in the EPIC study to another, second ICU within the same hospital, or if the patient was transferred back from a ward to the first ICU, the duration of the secondary ICU is included in the calculation of the primary endpoint.
次要结局
- Costs(During intensive care unit stay, an average of 5 days)
- Cost effectiveness(During intensive care unit stay, an average of 5 days)
- Readmissions to intensive care unit(During hospital stay, an expected average of 8 days)
- Maximum Sepsis-related organ failure assessment score (SOFA Score) in the intensive care unit(During intensive care unit stay, an average of 5 days)
- Palliative Care assessment(During intensive care unit stay, an average of 5 days)
- Presence of refractory symptoms I(During hospital stay, an expected average of 8 days)
- Presence of refractory symptoms II(During intensive care unit stay, an average of 5 days)
- Presence of refractory symptoms III(During intensive care unit stay, an average of 5 days)
- Presence of refractory symptoms IV(During intensive care unit stay, an average of 5 days)
- Incidence of delirium(During intensive care unit stay, an average of 5 days)
- Presence and nature of treatment limitations(During intensive care unit stay, an average of 5 days)
- Length of hospital stay(During hospital stay, an average of 8 days)
- Informations on discharge(During intensive care unit stay, an average of 5 days)
- Specialized palliative care expert(During hospital stay, an average of 8 days)
- Mortality(Up to three months)
- Social Status of the patient(Up to three months)
- Place of stay after hospitalization(Up to three months)
- Home care after hospitalization(Up to three months)
- Stress thermometer(Up to three months)
- Facilitators and barriers to high quality palliative care I(Up to three months)
- Facilitators and barriers to high quality palliative care II(Up to three months)
- Symptom management by intensive care staff I(Up to three months)
- Symptom management by intensive care staff II(Up to three months)
- Treatment evaluation I(Up to three months)
- Treatment evaluation II(Up to three months)
- Evaluation of the provider's question about goals for treatment I(Up to three months)
- Evaluation of the provider's question about goals for treatment II(Up to three months)
- Satisfaction with regard to communication I(Up to three months)
- Satisfaction with regard to communication II(Up to three months)
- Evaluation of the quality of information regarding the treatment I(Up to three months)
- Evaluation of the quality of information regarding the treatment II(Up to three months)
- Suitability of care from the patient's perspective(Up to three months)
- Outpatient resource utilization(Up to three months)
- Utilization of medical resources I(Up to three months)
- Utilization of medical resources II(Up to three months)
- Utilization of medical resources III(Up to three months)
- Utilization of medical resources IV(Up to three months)
- Medical utilization after discharge from hospital I(During intensive care unit stay, an average of 5 days)
- Medical utilization after discharge from hospital II(Up to three months)
- Medical utilization after discharge from hospital III(Up to three months)
- Medical utilization after discharge from hospital IV(Up to three months)
- Medical utilization after discharge from hospital V(Up to three months)
- Patient Health Questionnaire-4 I(Up to three months)
- Patient Health Questionnaire-4 II(Up to three months)
- Health related quality of life I(Up to three months)
- Question about the opinion of relatives on the unnecessary prolongation of life(Up to three months)
- Question about opinion of relatives on discomfort during the final hours before death(Up to three months)
- Question about opinion of relatives on loneliness during dying process.(Up to three months)
- Patient and family friendliness of intensive care unit care I(Up to three months)
- Patient and family friendliness of intensive care unit care II(Up to three months)
- Informal care by relatives I(Up to three months)
- Informal care by relatives II(Up to three months)
- Informal care by relatives III(Up to three months)
- Informal care by relatives IV(Up to three months)
- Burnout Assessment Tool (BAT-12)(Up to 34 months.)
- Inappropriate therapy(Up to 34 months)
- Moral distress(Up to 34 months)
- Implementation of the end-of-life practice(Up to 34 months)
- Ethical decision-making climate in the intensive care unit(Up to 34 months)
- Questions on the existence of Standard Operating Procedures(Up to 34 months)
- Questions about using the ABCDEF bundle(Up to 34 months)
- Questions about supporting measures(Up to 34 months)
- Perception of palliative care and law(Up to 34 months)
- Question about hurdles to palliative care(Up to 34 months)
- Question about supporting factors(Up to 34 months)
- Comments after beginning of the intervention phase(Up to 34 months)
研究者
Claudia Spies
Head of the Department of Anesthesiology and Intensive Care Medicine,Charité- University Berlin
Charite University, Berlin, Germany
研究点 (58)
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