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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Post Traumatic Stress Disorder PTSD

Treatments: Other: Virtual reality; Other: Standard of Care (SOC); Other: Cartoon; Other: Set of "end-of-life and grief" informational and educational tools; Other: Video capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT06851884

APHP240666

Details and patient eligibility

About

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.

Enrollment: 562 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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562 participants in 6 patient groups

Trial 1 : Control

Active Comparator group

Description:

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

Treatment:

Other: Standard of Care (SOC)

Other: Standard of Care (SOC)

Trial 1 : Video Capsule arm

Experimental group

Treatment:

Other: Video capsules

Trial 1 : Cartoon arm

Experimental group

Treatment:

Other: Cartoon

Trial 1 : Virtual reality arm

Experimental group

Treatment:

Other: Virtual reality

Trial 2 : Control

Active Comparator group

Description:

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

Treatment:

Other: Standard of Care (SOC)

Other: Standard of Care (SOC)

Trial 2 : set of "end-of-life and grief" informational and educational tools

Experimental group

Treatment:

Other: Set of "end-of-life and grief" informational and educational tools