Effectiveness of Informational and Educational Tools to Improve the Experience of Relatives of ICU Patients. RELIEF, a Platform Trial

Официальное название

Efficacité d'Interventions Pour améliorer le vécu Des Proches de Patients hospitalisés en réanimation. RELIEF, un Essai Plateforme

Обзор

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.

Вмешательства

• Другое Standard of Care (SOC)
  Universal welcome leaflet on patient admission
• Другое Video capsules
  3 video capsules of 3 minutes each
• Другое Cartoon
  3 cartoons
• Другое Virtual reality
  3 virtual reality programs
• Другое Set of "end-of-life and grief" informational and educational tools
  Including a video capsule, a cartoon, and a kit of two leaflets
• Другое Standard of Care (SOC)
  Universal welcome leaflet on patient admission

Первичные конечные точки

• Post-Traumatic Stress Disorder (PTSD) [Срок оценки: At 3 months]

Вторичные конечные точки (12)

• Trial 1 : Measure the impact of each of the 3 sets of tools on the overall understanding of relatives in intensive care [Срок оценки: 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 [Срок оценки: Up to 6 months]
• Trial 1 & 2 : Sleep quality of relatives [Срок оценки: At inclusion]
• Trial 1 & 2 : Sleep quality of relatives [Срок оценки: At 3 months]
• Trial 1 & 2 : Sleep quality of relatives [Срок оценки: At 6 months]
• Trial 1 & 2 : Symptoms of post-traumatic dissociation [Срок оценки: At inclusion]
• Trial 1 & 2 : satisfaction of relatives regarding communication with the intensive care teams [Срок оценки: At 3 months]
• Trial 1 & 2 Post-traumatic stress disorder [Срок оценки: At 6 months]
• Trial 1 & 2 : anxiety and depression symptoms of relatives [Срок оценки: At 3 months]
• Trial 1 & 2 : anxiety and depression symptoms of relatives [Срок оценки: At 6 months]
• Trial 1 & 2 : Past traumatic experiences [Срок оценки: At 3 months]
• Trial 1 & 2 : Risk of developing prolonged grief 6 months after the patient's death [Срок оценки: At 6 months]

Критерии участия

Критерии включения

Trial 1 :

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.

Trial 2 :

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.

Критерии исключения

Patients :

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06851884 · APHP240666

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗