The VIP-3 (Very Old Intensive Care Patients) Study: Decision-making in the Older Intensive Care Unit (ICU) Patient: How Are Family Meetings Implemented Across Diverse Cultures in Europe?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Number of patients with a structured/planned family meeting
研究概览
简要总结
The demographics of the global population is changing with increasing numbers of elderly and co-morbid patients. As a result, more elderly patients will be admitted to the Intensive Care Unit (ICU), which will bring several ethical challenges. It is for this reason the investigators have chosen to focus on this historically neglected and important patient population.
Little is known about how family meetings are implemented in ICUs in Europe and other parts of the world. However, these meetings contribute to building trust between the family and the ICU team. They are a crucial component for planning and conducting a time limited trials as they provide the opportunity for shared-decision making with the ICU team and with other stakeholders.
The investigators plan to determine the current practice of communication between ICU staff and patients and their relatives. The investigators expect to find a substantial variation in approaches to family meetings. This information may then help design and further investigate targeted interventions enabling shared decision-making focused on family and patient values.
The investigators research aim is to to investigate whether Family meetings are used in ICUs across Europe and other regions and, if so, how they are conducted and the influence on patient-centred outcome measures.
详细描述
This is a prospective observational cohort study in patients aged 75 years old and above admitted as an emergency to the ICU and expected to have a length of stay of 3 days or more.
Consent varies between European countries. In some countries it will be taken on admission, in some (UK) it will be taken after the family meeting or on discharge from ICU and in others it has been waived.
- information about the study will be given to the patient/consultee and around 24 hours will be allowed for them to have a think about participating or ask the research team any questions
- If consent has been gained, the research team will record basic demographics of the patient and specific physiological data from the day of admission to the ICU.
- The research nurse will have a conversation with the patient or next of kin regarding how the patient was prior to admission. If there are no next of kin information will be taken from the notes. From this information, the investigator can determine the clinical frailty scale which will be determined by looking at a proforma and determining which category of frailty the patient best fits. Other baseline information taken will be activities of daily living and co-morbidities.
- The research nurse will document whether a Family Meeting (FM) takes place, if it does, they will document information about the FM in the electronic CRF. The information will be sought from the patient notes and the doctor or nurse who was in the meeting. If a FM does not take place this will be recorded. In the UK only ,a separate questionnaire about communication on ICU will be given to family members to complete.
- The outcome of the FM and the patient will be documented
- survival at 30 days, discharge information and location will be recorded by looking at the hospital records.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the Intensive Care Unit (ICU) of participating centres
- •Age 75 years and above
- •Expected Length of stay (LOS) > 3 days
排除标准
- •Refusal to participate
- •Limitation of treatment upon ICU arrival (other than Cardiopulmonary Resuscitation-CPR)
- •Planned admission
研究组 & 干预措施
Patients age 75 and above admitted as an emergency to Intensive Care
The investigators will be looking at communication whilst these patients are on the Intensive Care Unit (ICU). In particular whether a family meeting takes place (to discuss progress and patient wishes) and if so what is discussed in the meeting.
In addition to the information taken during the family meeting, the investigators will be collecting the following: baseline demographics, physiological data, frailty score and baseline function, treatments received and outcome data
结局指标
主要结局
Number of patients with a structured/planned family meeting
时间窗: Until Intensive care unit (ICU) discharge
The number of patients that have a family meeting during the intensive care stay
次要结局
- Median day since Intensive care unit (ICU) admission when the family meeting took place(Until ICU discharge)
- Number of people present in the Family Meeting(Until ICU discharge)
- Categorical description of people present in the Family Meeting(Until ICU discharge)
- The treatment level after the family meeting(Until ICU discharge)
- Change in SOFA (Sequential Organ Failure Assessment) score between ICU admission and day of Family Meeting (FM)(Until ICU discharge)
- Survival until intensive care unit discharge(ICU discharge)
- Intensive care unit (ICU) length of stay(ICU discharge)
- Hospital survival(From randomisation to hospital discharge, assessed up to 3 months)
- Hospital length of stay(From randomisation to hospital discharge, assessed up to 3 months)
- Discharge location(From randomisation to hospital discharge, assessed up to 3 months)
- Decision to limit life sustaining treatment(Until ICU discharge)
- Time between limiting life sustaining treatment and death or ICU discharge(From ICU admission until the first documented progression or date of death from any cause, whichever came first, assessed up to 30 days)