Clinical trial NCT06851884: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder PTSD
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized platform trial designed to investigate a clinical question across multiple subpopulations and involving multiple interventions.

The trials integrated into the platform trial are randomized and may be either conventional trials or adaptive MAMS (Multi-Arms Multi-Stage) trials. These involve multiple arms and phases, allowing for the adaptive evaluation of several interventions, with the possibility of adding or removing interventions during the trial.

Additionally, the trials include a hybrid control arm that combines randomized concurrent controls and historical external controls from an observational cohort.

Trial 1 : randomization according to a 1:2:2:2 ratio into one of the 4 arms:

* Control
* Video capsules
* Comic strips
* Virtual reality

Trial 2 : randomization according to a 1:2 ratio into the control or intervention arm (set of "end-of-life and grief" informational and educational tools, including a video capsule, a cartoon, and a kit of 2 leaflets).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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.)

Primary outcomes:
measure: Post-Traumatic Stress Disorder (PTSD)
timeFrame: At 3 months
Secondary outcomes:
measure: Trial 1 : Measure the impact of each of the 3 sets of tools on the overall understanding of relatives in intensive care
timeFrame: Up to 6 months
measure: Trial 1 : Measure the impact of each of the 3 sets of tools on the anxiety and depression symptoms of relatives
timeFrame: Up to 6 months
measure: Trial 1 & 2 : Sleep quality of relatives
timeFrame: At inclusion
measure: Trial 1 & 2 : Sleep quality of relatives
timeFrame: At 3 months
measure: Trial 1 & 2 : Sleep quality of relatives
timeFrame: At 6 months
measure: Trial 1 & 2 : Symptoms of post-traumatic dissociation
timeFrame: At inclusion
measure: Trial 1 & 2 : satisfaction of relatives regarding communication with the intensive care teams
timeFrame: At 3 months
measure: Trial 1 & 2 Post-traumatic stress disorder
timeFrame: At 6 months
measure: Trial 1 & 2 : anxiety and depression symptoms of relatives
timeFrame: At 3 months
measure: Trial 1 & 2 : anxiety and depression symptoms of relatives
timeFrame: At 6 months
measure: Trial 1 & 2 : Past traumatic experiences
timeFrame: At 3 months
measure: Trial 1 & 2 : Risk of developing prolonged grief 6 months after the patient's death
timeFrame: At 6 months
measure: Trial 1 & 2 : Consumption of medical care and acts by relatives
timeFrame: At inclusion
measure: Trial 1 & 2 : Consumption of medical care and acts by relatives
timeFrame: Up to 6 months
measure: Trial 1&2 : Feasability of use of the tool
timeFrame: Up to 6 months
measure: Trial 1 & 2 : Quality of tools assessed by families by a self-assessment questionnaire
timeFrame: At 3 months
Other outcomes:
Locations:
Study officials:
References: