Reported Experience Measurement on Reducing Patient Discomfort in Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,242
- 试验地点
- 1
- 主要终点
- Overall discomfort score
研究概览
简要总结
Hospitalisation in intensive care is always traumatic and can lead to a long rehabilitation process, slowed down by symptoms of anxiety and/or depression, and/or post-traumatic stress disorder (PTSD). These psychiatric disorders, or post-intensive care syndrome (PICS), can persist for several years after hospitalisation in intensive care and cause functional disability. They are associated with the use of psychotropic drugs and mental health services, and impair health-related quality of life.
This research is based on the hypothesis that the traumatic nature of intensive care hospitalisation can be reduced by implementing programmes to improve intensive care hospitalisation conditions, promoting changes in the practices of all healthcare professionals involved in intensive care.
IPREA3 study (Kalfon et al, 2017) demonstrated that implementation of a tailor-made, multi-component programme, led by a doctor/non-medical caregiver significantly reduced the overall discomfort score (derived from the IPREA questionnaire) perceived by patients hospitalised in an intensive care unit with sufficient experience in applying this programme, having used it for at least 5 months (Kalfon et al, 2017) .
The originality and interest of this research, in comparison with the IPREA3 study, lie in the following aspects:
- the use of the most recent version of the IPREA questionnaire,
- the questionnaire was completed by the patient themselves without the intervention of a caregiver (self-administration)
- the fact that new care practices, aimed at humanising a stay in intensive care and making the experience of a stay in intensive care less traumatic, were described after the publication of the IPREA3 study a
- a longer programme learning period of 9 months (compared to 5 months during the IPREA3 study)
- the launch of the PREMREA programme with a conference led by a patient expert
详细描述
Hospitalisation in intensive care is always traumatic and can lead to a long rehabilitation process, slowed down by symptoms of anxiety and/or depression, and/or post-traumatic stress disorder (PTSD). These psychiatric disorders, or post-intensive care syndrome (PICS), can persist for several years after hospitalisation in intensive care and cause functional disability. They are associated with the use of psychotropic drugs and mental health services, and impair health-related quality of life.
This research is based on the hypothesis that the traumatic nature of intensive care hospitalisation can be reduced by implementing programmes to improve intensive care hospitalisation conditions, promoting changes in the practices of all healthcare professionals involved in intensive care.
IPREA3 study (Kalfon et al, 2017) demonstrated that implementation of a tailor-made, multi-component programme, led by a doctor/non-medical caregiver duo and based on:
- a systematic assessment by the caregiver in charge of the patient on the day of discharge from intensive care of any discomfort experienced during the entire stay, based on a specific questionnaire (Inconforts des Patients de REAnimation - IPREA - comprising 16 items of discomfort (Kalfon et al, 2010),
- immediate feedback to caregivers with reminders of simple predetermined measures,
- monthly comparative feedback to promote a positive spirit of emulation among participating intensive care units, significantly reduced the overall discomfort score (derived from the IPREA questionnaire) perceived by patients hospitalised in an intensive care unit with sufficient experience in applying this programme, having used it for at least 5 months (Kalfon et al, 2017) .
The originality and interest of this research, in comparison with the IPREA3 study, lie in the following aspects:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 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
- •Patient, male or female, aged ≥ 18 years
- •Patient discharged alive from intensive care
- •Patient hospitalised in intensive care for at least three calendar days
- •Patient affiliated with or beneficiary of a social security scheme
- •Patient who speaks French and has signed an informed consent form
排除标准
- •Patients whose situation is incompatible with completing the IPREA questionnaire
- •Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision
- •Patients hospitalised without consent
- •Pregnant and/or breastfeeding women
研究组 & 干预措施
Arm PREMREA -
Patients in this arm do not benefit from measures taken from PREMREA program
Arm PREMREA +
Patients in this arm will benefit from measures taken from PREMREA program
干预措施: PREMREA program (Other)
结局指标
主要结局
Overall discomfort score
时间窗: 3 months
Overall discomfort score is obtained from the 18-item IPREA questionnaire. It consists of 18 pre-established items describing the most common sources of discomfort in intensive care : noise, excessive light, discomfort related to unfamiliar bedding, lack of sleep, thirst, hunger, cold, heat, pain, restriction of autonomy due to cables and infusion lines, lack of privacy, anxiety, isolation, limited visits from loved ones, lack of a telephone, insufficient information about current health status, difficulty breathing, depression (Baumstarck et al, 2019). For each of the 18 discomfort items, the patient gives a score between 0 (no discomfort at all) and 10 (maximum discomfort imaginable). The overall discomfort score is calculated as the average of the 18 discomfort scores multiplied by 10, resulting in a score between 0 and 100
次要结局
未报告次要终点