Participation of Relative or Surrogate in the Patient's Care in Reanimation
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change from baseline HAD scale at ICU's discharge
研究概览
简要总结
ICUs have always perceived by the public has a very technical unit with a restricted and/or forbidden access. Physical alteration of the patient, seeing the patient sedated, the large numbers of devices, the alarms and an uncertain prognosis. All this factors can be perceived by people close to the patient as a source of stress. In the literature, numerous studies have shown that families develop anxiety and depression symptoms while their loved one is hospitalized in the ICU. French intensive care societies thought of ways to prevent or diminish these symptoms. The 6th consensus conference on " Live better in the ICU " recommends: effective and adapted information, large visiting hours to reach an unrestricted access and family participation in care.
The unit has taken this path to improve patient and family centered care by: creating a welcome leaflet, a room dedicated to meetings with families and an ICU open 24/7bto families, with the possibility for children to visit their parents. Hence, spontaneously, relatives have expressed the wish to participate to certain care and when participating, expressed their satisfaction. This observation and testimonies from family members and patients led us to think about the impact of participation of care. Two major French studies have shown contradictory outcomes: 16% of families would have been willing to participate in the first study against 97% in the second one. These studies were survey done after the ICU discharge.
No study today has assessed the actual impact of family participation in care. The aim of this clinical trial is to diminish anxiety and depression symptoms. By participating in care, relatives can develop or strengthen a relationship of trust with caregivers. It could contribute also to a better understanding of the plan of care and an easier context to announce negative outcomes.
详细描述
Randomisation visit - D1:
After checking the eligibilities criteria, a member of the staff will explain to the patient and his relative or surrogate the purpose and the planning of the study. The inform consent will be signed by the physician of the study. Two informs consents will be signed : one by the patient and the other one by the relative or surrogate. The randomisation will be done after collecting these consents.
After the draw, the subjects will be randomized either in the control group "Conventional support" or the experimental group "Intervention".
Questionnaires to be completed by the :
- relatives or surrogates: Hospital Anxiety and Depression scale (HAD scale), Multidimensional Fatigue Inventory (MFI20), Zarit Burden Interview (ZARIT sale) , Beck Depression Inventory (Beck), State-Trait Anxiety Scale (STAI) and "preliminary"
- patient if possible: HAD scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline HAD scale at ICU's discharge
时间窗: From baseline and at the patient's discharge from the ICU assessed up to 3 months
HAD Scale : The primary outcome measure is the relative or surrogate HAD (Hospital Anxiety and Depression Scale) score evolution. The expected result is a reduction by two points of the total HAD score through active participation in care.
次要结局
- Evaluation of the satisfaction's relatives or surrogates regarding their participation in the ICU patient care by a questionnaire(At the patient's ICU discharge assessed up to 3 months)
- Evolution of the relative or surrogate anxiety/depression(at baseline and at ICU's discharge assessed up to 3 months)
- Quantify which care have been realized by the relatives or surrogates(Through study completion an average of 12 months)
- HAD scale of the patient(At the ICU discharge assessed up to 3 months)
- Evaluation of the satisfaction of the ICU staff by a questionnaire(Through study completion an average of 12 months)