Improve the Quality of Life After a Hospitalization in Critical Care Thanks to a Program of Prevention of Discomforts Perceived by the Patients of Critical Care Base on Targeted Measures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,006
- 试验地点
- 12
- 主要终点
- Improve the reduction of depressive symptoms
研究概览
简要总结
Demonstrate that the IPREA3 program (Study: Impact of Multicomponent Intervention to Reduce Perceived Discomforts of the patients in intensive care) reducing discomforts perceived by the patients of intensive care, implemented at the level of the whole intensive care unit, reduce the incidence of the depressive symptoms one year after intensive care exit.
详细描述
AQVAR is a study of type not exposed presentations, study ancillary of controlled study, multicentric with randomization to cluster, the study IPREA3, for which a financing was already obtained within the framework of the Hospital National Clinical Program of Research on 2012, current study, the inclusions of which began on October 1st, 2014 after the obtaining of all the necessary authorizations. To date, more than 4300 patients were included in the study IPREA3 within 34 departments or intensive care units participating on approval. All the patients included in the study AQVAR will be patients included before in the study IPREA3 and which a complete questionnaire IPREA3 of measure of the discomforts collected by all the patients of intensive care will be available.
The AQVAR study leans on the original current research IPREA3 which consists of the evaluation of a program with multiple components of reduction of the discomforts collected by the patients of including in intensive care:
- The preliminary identification of a binomial doctor-nurse of local coordinating experts of the program IPREA3
- A systematic measure of the discomforts collected by means of the questionnaire IPREA administered the day of the exit.
- An immediate return of the scores of discomfort in every nursing administering the questionnaire IPREA
- The implementation of measures targeted by reduction of the discomforts, based on the analysis of the results appropriate to the intensive care unit.
The innovative character is also brought by the research for the association between conditions of hospitalization in intensive care according to the perception of the patient and very remote quality of life of the hospitalization in intensive care , as well as by the evaluation of a method of primary prevention of the psychiatric morbidity post-intensive care.
The individual profits waited for the patient hospitalized in an intensive care unit having implemented the program of reduction of the discomforts IPREA3 are the improvement of its conditions of hospitalization during its whole stay in intensive care, such as the patient perceives them at the exit of intensive care, then remote, a reduction of the risk of arisen a state of post-traumatic stress, anxious and/or depressive symptoms, and cognitive dysfunctions. This reduction of the psychiatric morbidity should lead to an improvement of its quality of life bound to the health, but also to the recourse to the consultations in an emergency department or to the new hospitalizations.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The same criteria of the IPREA3 study
- •Taken out alive of intensive care
- •Hospitalization in intensive care extending at least over three calendar days.
排除标准
- •Deaths in intensive care
- •Age 18-year-old inferior
- •Under guardianship patient
- •Incompatible situation with the administration of the IPREA questionnaire at the exit of intensive care: presence of neuropsychic disorders, language barrier, transfer under mechanical ventilation, taken out of intensive care in urgency
- •Patient refused to participate in the study IPREA3
- •Patient refused to participate in the study AQVAR
结局指标
主要结局
Improve the reduction of depressive symptoms
时间窗: up to 52 weeks of the hospitalization
A score 8 (maximal score of 21) allows to hold the presence of clinically significant depressive symptoms.
次要结局
- Duration of hospitalization(Consecutive to the hospitalization in intensive care)
- Score IES-R ( impact of Events Scale-Revised)(up to 52 weeks of the hospitalization)
- Questionnaire EQ-5D(up to 52 weeks of the hospitalization)
- Score of the sub-scale A of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale)(up to 52 weeks of the hospitalization)
- Describe quality of life(up to 52 weeks of the hospitalization)