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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Post-Traumatic Stress Disorder (PTSD) [Time frame: At 3 months]

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06851884 · APHP240666

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗