Impact of an Intensive Care Diary on Post-traumatic Stress Disorder on Patients After a Resuscitated Sudden Death and His Relatives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Rate of occurrence of "post traumatic stress disorder"
研究概览
简要总结
Sudden death is a public health problem with more than 300,000 cases per year in USA and 40,000 cases per year in France. Moreover, despite all recent therapeutic improvements (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains drastically poor and less than 50% of the patients admitted alive at hospital will survive to the event at 1 year.
Outside all medications and technical care to improve patient prognosis, a psychological evaluation looks also critical to detect the occurrence of a "post traumatic stress syndrome". In fact, along with the event severity, a variable period of amnesia related to coma may favor the occurrence of such a syndrome and psychological issues, which at the end may lead to impairment of patient quality of life.
Previous studies have evaluated the impact of an intensive care unit diary on psychological distress in patients and relatives in the context of severe traumatisms. Such an evaluation has however never been done in the specific setting of sudden death and the frequency of this syndrome is unknown in this context.
Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on the occurrence of a "post traumatic stress syndrome" after a sudden death.
Secondary objectives
- To evaluate the frequency of the occurrence of a "post traumatic stress syndrome" and other psycho traumatic symptoms after sudden death
- To evaluate the impact of an intensive care unit diary on the severity of this syndrome, psycho traumatic symptoms, and psychopathologic comorbidities
- To evaluate the impact of the diary on psycho traumatic symptoms and their severity in patient's relatives
- To evaluate the satisfaction of the patients and their relatives regarding medical cares in both groups (with and without diary)
- Comparison of nurse diagnostic (psychological distress) and diagnostic made by dedicated personal with a specific formation in psychology
- Qualitative evaluation of the diary
- Evaluation of the paramedical feeling before and after the diary input in practice
详细描述
The COREABOR Study is an open label, prospective, that will compare patients with sudden death who will be included during 2 successive periods of time: first a period of control and then a period of intervention.
Interventional study.
Altogether, 330 patients with resuscitated sudden death will be screened during the whole study period allowing to include 96 patients in the study (alive at 3 months after the event, estimated survival rate of 30%). For each screened patient, 2 relatives will be selected to participate to the study (n=660).
To avoid biases, the control group of 48 patients will be included first and treated as recommended with usual care in center. Then, the 48 patients of the intervention group will be included during the second period of the study and the intensive care unit diary will be implemented only at this time.
In the intervention group (second period with diary), a maximal delay of 8 hours is allowed to implement the diary for each patient after admission in centre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients who experienced a sudden death and who are admitted alive in our center
- •Patients who benefited from therapeutic hypothermia (and/or care to limit fever occurrence)
- •Relative's inclusion criteria :
- •Relatives of a patient that fit inclusion/
排除标准
- •Exclusion Criteria =
- •Patient's non-inclusion criteria :
- •Death or transfer in another center within the first 8 hours of admission in our center
- •Pregnancy
- •Patients who refuse to participate after being awake after initial coma
- •Relative's non-inclusion criteria :
- •Relatives who refuse to participate after being awake after initial coma
结局指标
主要结局
Rate of occurrence of "post traumatic stress disorder"
时间窗: 3 months
Rate of occurrence of "post traumatic stress syndrome" (CAPS score over 39) at 3 months after resuscitation after sudden death
次要结局
- Peritraumatic Distress Inventory (PDI) Scale(1 month)
- Psychiatric comorbidities(3 and 6 months)
- Rate of "Post traumatic stress disorder" for patients(6 months)
- Qualitative evaluation of the diary(6 months)
- Rate of "Post traumatic stress disorder" for relatives(3 and 6 months)
- Nurse diagnosis(3 months)