Post-traumatic Stress Disorder in Relatives of Patients Admitted to the ICU: a Multicenter, Observational, Prospective Study (FAME Observational)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,346
- 试验地点
- 56
- 主要终点
- To define a predictive model of PTSD in this population
研究概览
简要总结
The aim of the present research is to set up a large multicentric, prospective cohort of family members of patients admitted to intensive care. The data collected will concern the patients and their family members, the caregivers and the functioning of the services during the collection period. This cohort will allow:
- to carry out a quantitative evaluation of post-traumatic stress disorder (PTSD) in a large number of family members, to determine the risk factors in relation to the characteristics of the family members, and to define a predictive model of PTSD in this population
- to determine the factors related to the operating conditions of the resuscitation services that favor the occurrence of PTSD in the family members,
- to create a biological bank from blood samples taken from family members,
- to carry out a qualitative study allowing a psychological and sociological analysis of the experience of the family members concerning the hospitalization in intensive care of their loved one.
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
- •≥18 years old
- •Treated in the ICU with invasive mechanical ventilation for 48 hours
- •Having been visited by at least one family member within 72 hours of the 48th hour of intubation in intensive care
- •Having been informed of the study and not having objected to the use of their medical medical data prior to discharge from the ICU if they are able to receive the information the information at the time of inclusion or consent of the family member obtained for the inclusion of the patient if the patient is not able to do so at the time of at the time of inclusion
- •Family members :
- •≥18 years old
- •Identified if possible by the patient as the person to be referred or to be informed, or, in the case of a patient unable to express him/herself, identified by the caregivers as the "patient's close referent".
- •Understanding and speaking French
- •Having been informed of the study and having consented to participate in it during a visit of the patient
- •Inclusion between H48 and H120 post-intubation of the patient in the ICU (if the patient is still intubated at the time of inclusion)
- •Having given their telephone number
- •Being covered by a social security plan.
- •Only one relative of the patient is included in the study Service Professionals: All professionals in all categories and in all participating participating services who have been informed of the study and have consented to participate.
排除标准
- •No family member or no family member visit
- •No consent to participate from family member
- •Organ donation planned or contemplated
- •Pregnant or parturient woman
- •Detained or deprived of liberty
- •Under guardianship or curator
- •No social security
- •Family members :
- •Social context making follow-up and telephone interviews difficult (homeless, not residing in Europe or in the DOM)
- •Inability to give a "stable" personal cell phone number
- •Under guardianship or curator
- •Unable to communicate on the phone (hearing impairment...)
- •Service Professionals:
- •Not on duty (locum tenens or interim team, only on-call) on call)
- •Not qualified (Physician: at least intern, nurse DE)
结局指标
主要结局
To define a predictive model of PTSD in this population
时间窗: at 3 months after the patient's discharge from the ICU
The primary endpoint is the proportion of family members who developed PTSD 3 months after the patient's discharge from the ICU assessed by the Post-traumatic stress disorder CheckList (PCL-5) version Diagnostic and Statistical Manual of Mental Disorders (DSM-5) scale. This scale consists of 20 items on the symptoms of PTSD according to the DSM-5 criteria. Each item is rated from 0 ("not at all") to 4 ("extremely"). The maximum score is 80.
To determine the factors associated with post-traumatic stress disorder (PTSD) in family members of patients admitted to the ICU, and.
时间窗: at 3 months after the patient's discharge from the ICU
The primary endpoint is the proportion of family members who developed PTSD 3 months after the patient's discharge from the ICU assessed by the Post-traumatic stress disorder CheckList (PCL-5) version Diagnostic and Statistical Manual of Mental Disorders (DSM-5) scale. This scale consists of 20 items on the symptoms of PTSD according to the DSM-5 criteria. Each item is rated from 0 ("not at all") to 4 ("extremely"). The maximum score is 80.
次要结局
- To identify the impact on the consumption of care and medical procedures of PTSD in family members of patients admitted to the ICU(at 3 and 6 months after discharge of the patient from the intensive care unit)
- Assessing the psychological impact of a family member stay in intensive care(at 6 months after the patient's death in intensive care)