Efficacité d'Interventions Pour améliorer le vécu Des Proches de Patients hospitalisés en réanimation. RELIEF, un Essai Plateforme
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 562
- 主要终点
- Post-Traumatic Stress Disorder (PTSD)
研究概览
简要总结
The admission of a patient to an intensive care unit (ICU) is associated with high levels of acute stress, anxiety, and depression among relatives, as well as extreme emotions such as fear, guilt, distress, and helplessness. In addition to these emotions, relatives also struggle to understand the information provided by the medical team-only half of the information is fully understood. These emotional and cognitive difficulties can become obstacles in decision-making processes and may have medium- and long-term consequences on their psychological well-being, particularly in terms of post-traumatic stress disorder (PTSD), anxiety, and depression. Three months after the patient is discharged from the ICU, one-third of relatives exhibit symptoms of PTSD.
The aim of this research is to propose a variety of informational and educational tools to improve relatives' understanding of both the ICU context and the information provided, with the goal of reducing the risk of developing PTSD in the months following the patient's discharge or death.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 是
入选标准
- •Relatives of patients with the following characteristics: ≥18 years old, treated in intensive care with invasive mechanical ventilation for at least 48 hours having received a visit from at least one relative within the first 72 hours.
- •≥18 years old
- •Identified, if possible, by the patient as the reference person or person to be informed, or, if the patient is unable to communicate, identified by the healthcare providers as the "patient's reference relative."
- •Understanding and speaking French • Having provided their phone contact information Only one relative of the patient is included in the study.
- •Relatives of patients with the following characteristics: ≥18 years old, having been treated in intensive care with invasive mechanical ventilation for at least 48 hours, for whom a decision of withhold or withdraw treatment has been made with expected death in intensive care.
- •≥18 years old
- •Identified, if possible, by the patient as the reference person or person to be informed, or, if the patient is unable to communicate, identified by healthcare providers as the "patient's reference relative."
- •Present at the end-of-life conference (announcement of the EOL decision)
- •Understanding and speaking French
- •Having provided their phone contact information
- •Only one relative of the patient is included in the study. They are included just before or just after the end-of-life conference.
排除标准
- •Planned or considered organ donation
- •Detained or deprived of liberty
- •Under guardianship or curatorship
- •No social security
- •Relatives :
- •Social context making follow-up and telephone interviews difficult (homeless individuals, not residing in Europe or the overseas territories)
- •Inability to provide a "stable" personal mobile number (temporary phone number or not in their own name or the name of their spouse/partner)
- •Under guardianship or curatorship
- •Inability to communicate by phone (hearing impairments, etc.)
研究组 & 干预措施
Trial 2 : set of "end-of-life and grief" informational and educational tools
干预措施: Set of "end-of-life and grief" informational and educational tools (Other)
Trial 1 : Control
Standard care with universal welcome leaflet. The control group is a hybrid, also including historical external controls from the cohort "Syndrome de Stress Post-traumatique chez les Proches de Patients Admitted to the Intensive Care Unit: A Multicentric, Observational, Prospective Study" according to the center's usual practice
干预措施: Standard of Care (SOC) (Other)
Trial 1 : Video Capsule arm
干预措施: Video capsules (Other)
Trial 1 : Cartoon arm
干预措施: Cartoon (Other)
Trial 1 : Virtual reality arm
干预措施: Virtual reality (Other)
Trial 2 : Control
Standard care with universal welcome leaflet. The control group is a hybrid, also including historical external controls from the cohort "Syndrome de Stress Post-traumatique chez les Proches de Patients Admitted to the Intensive Care Unit: A Multicentric, Observational, Prospective Study" according to the center's usual practice
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Post-Traumatic Stress Disorder (PTSD)
时间窗: At 3 months
Assessed with PCL-5 scale three months after the patient's discharge or death. The PCL-5 scale, Post-traumatic stress disorder CheckList version DSM-5 (PCL-5) \[PCL-5, 8/14/2013, Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr - National Center for PTSD\] includes 20 items addressing PTSD symptoms according to DSM-5 criteria. Each item is rated from 0 ("not at all") to 4 ("extremely") for a total score between 0 and 80).
次要结局
- Trial 1 : Measure the impact of each of the 3 sets of tools on the overall understanding of relatives in intensive care(Up to 6 months)
- Trial 1 : Measure the impact of each of the 3 sets of tools on the anxiety and depression symptoms of relatives(Up to 6 months)
- Trial 1 & 2 : Sleep quality of relatives(At 6 months)
- Trial 1 & 2 : Symptoms of post-traumatic dissociation(At inclusion)
- Trial 1 & 2 : satisfaction of relatives regarding communication with the intensive care teams(At 3 months)
- Trial 1 & 2 Post-traumatic stress disorder(At 6 months)
- Trial 1 & 2 : anxiety and depression symptoms of relatives(At 6 months)
- Trial 1 & 2 : Past traumatic experiences(At 3 months)
- Trial 1 & 2 : Risk of developing prolonged grief 6 months after the patient's death(At 6 months)
- Trial 1 & 2 : Consumption of medical care and acts by relatives(Up to 6 months)
- Trial 1&2 : Feasability of use of the tool(Up to 6 months)
- Trial 1 & 2 : Quality of tools assessed by families by a self-assessment questionnaire(At 3 months)
- Trial 1 & 2 : Sleep quality of relatives(At inclusion)
- Trial 1 & 2 : Sleep quality of relatives(At 3 months)
- Trial 1 & 2 : anxiety and depression symptoms of relatives(At 3 months)
- Trial 1 & 2 : Consumption of medical care and acts by relatives(At inclusion)