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

NCT06851884 | Not Yet Recruiting

• 1 other identifier: APHP240666
• Study Type: interventional
• Target: 562
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Post-Traumatic Stress Disorder (PTSD)

  Assessed with PCL-5 scale three months after the patient's discharge or death. The PCL-5 scale, Post-traumatic stress disorder CheckList version DSM-5 (PCL-5) \[PCL-5, 8/14/2013, Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr - National Center for PTSD\] includes 20 items addressing PTSD symptoms according to DSM-5 criteria. Each item is rated from 0 ("not at all") to 4 ("extremely") for a total score between 0 and 80).

  At 3 months

Secondary Outcomes (16)

• Trial 1 : Measure the impact of each of the 3 sets of tools on the overall understanding of relatives in intensive care

  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

  Up to 6 months

• Trial 1 & 2 : Sleep quality of relatives

  At inclusion

• Trial 1 & 2 : Sleep quality of relatives

  At 3 months

• Trial 1 & 2 : Sleep quality of relatives

  At 6 months

Study Arms (6)

Trial 1 : Control

ACTIVE COMPARATOR

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

Other: Standard of Care (SOC)

Trial 1 : Video Capsule arm

EXPERIMENTAL

Other: Video capsules

Trial 1 : Cartoon arm

EXPERIMENTAL

Other: Cartoon

Trial 1 : Virtual reality arm

EXPERIMENTAL

Other: Virtual reality

Trial 2 : Control

ACTIVE COMPARATOR

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

Other: Standard of Care (SOC)

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

EXPERIMENTAL

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

Interventions

Standard of Care (SOC) OTHER

Universal welcome leaflet on patient admission

Trial 1 : Control

Video capsules OTHER

3 video capsules of 3 minutes each

Trial 1 : Video Capsule arm

Cartoon OTHER

3 cartoons

Trial 1 : Cartoon arm

Virtual reality OTHER

3 virtual reality programs

Trial 1 : Virtual reality arm

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Combat Disorders

Interventions

Standard of Care; Videotape Recording

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Central Study Contacts

Nancy Kentish-Barnes, MD

CONTACT

+33142499421; nancy.kentish@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 28, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-01