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

NCT ID: NCT06851884

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 562 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-01-31

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.

Conditions

Post Traumatic Stress Disorder PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: OTHER

Universal welcome leaflet on patient admission

Trial 1 : Video Capsule arm

Group Type: EXPERIMENTAL

Video capsules

Intervention Type: OTHER

3 video capsules of 3 minutes each

Trial 1 : Cartoon arm

Group Type: EXPERIMENTAL

Cartoon

Intervention Type: OTHER

3 cartoons

Trial 1 : Virtual reality arm

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

3 virtual reality programs

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

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: OTHER

Universal welcome leaflet on patient admission

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Including a video capsule, a cartoon, and a kit of two leaflets

Interventions

Standard of Care (SOC)

Universal welcome leaflet on patient admission

Intervention Type: OTHER

Video capsules

3 video capsules of 3 minutes each

Intervention Type: OTHER

Cartoon

3 cartoons

Intervention Type: OTHER

Virtual reality

3 virtual reality programs

Intervention Type: OTHER

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

Including a video capsule, a cartoon, and a kit of two leaflets

Intervention Type: OTHER

Standard of Care (SOC)

Universal welcome leaflet on patient admission

Intervention Type: OTHER

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Nancy Kentish-Barnes, MD

Role: CONTACT

nancy.kentish@aphp.fr

+33142499421 ext. +33

Jérôme Lambert, MD PhD

Role: CONTACT

jerome.lambert@u-paris.fr

+33142499742

Other Identifiers

APHP240666

Identifier Type: -

Identifier Source: org_study_id