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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Traumatic Stress Disorder PTSD
• Intervention / Treatment: Other: Standard of Care (SOC); Other: Video capsules; Other: Cartoon; Other: Virtual reality; Other: Set of "end-of-life and grief" informational and educational tools

• Study Type: Interventional
• Enrollment (Estimated): 562
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy Kentish-Barnes, MD; Phone Number: +33 +33142499421; Email: nancy.kentish@aphp.fr
• Study Contact Backup: Name: Jérôme Lambert, MD PhD; Phone Number: +33142499742; Email: jerome.lambert@u-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: Standard of Care (SOC); Universal welcome leaflet on patient admission
Experimental: Trial 1 : Video Capsule arm	Other: Video capsules; 3 video capsules of 3 minutes each
Experimental: Trial 1 : Cartoon arm	Other: Cartoon; 3 cartoons
Experimental: Trial 1 : Virtual reality arm	Other: Virtual reality; 3 virtual reality programs
Active Comparator: 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	Other: Standard of Care (SOC); Universal welcome leaflet on patient admission
Experimental: Trial 2 : set of "end-of-life and grief" informational and educational tools	Other: Set of "end-of-life and grief" informational and educational tools; Including a video capsule, a cartoon, and a kit of two leaflets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial 1 : Measure the impact of each of the 3 sets of tools on the overall understanding of relatives in intensive care	Measure the impact of each of the 3 sets of informational and educational tools on the overall understanding of relatives in intensive care (diagnosis, prognosis, treatment) at the time of discharge from intensive care (questionnaire)	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	Measure the impact of each of the 3 sets of informational and educational tools on the anxiety and depression symptoms of relatives at the time of discharge from intensive care (HADS scale). HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).	Up to 6 months
Trial 1 & 2 : Sleep quality of relatives	Evaluated by ISI : Insomnia Severity Index It is a 7 questions scale. Each question is rated on a scale from 0 to 4, with 0 indicating no problems and 4 indicating very severe problems. The total score can range from 0 to 28, with higher scores indicating more severe insomnia.	At inclusion
Trial 1 & 2 : Sleep quality of relatives	Evaluated by ISI : Insomnia Severity Index It is a 7 questions scale. Each question is rated on a scale from 0 to 4, with 0 indicating no problems and 4 indicating very severe problems. The total score can range from 0 to 28, with higher scores indicating more severe insomnia.	At 3 months
Trial 1 & 2 : Sleep quality of relatives	Evaluated by ISI : Insomnia Severity Index It is a 7 questions scale. Each question is rated on a scale from 0 to 4, with 0 indicating no problems and 4 indicating very severe problems. The total score can range from 0 to 28, with higher scores indicating more severe insomnia.	At 6 months
Trial 1 & 2 : Symptoms of post-traumatic dissociation	Evaluated by PDEQ : Post-traumatic Dissociation Questionnaire. Total score ranges from 0 to 48. The higher the score the more severe the dissociation symptoms are.	At inclusion
Trial 1 & 2 : satisfaction of relatives regarding communication with the intensive care teams	Satisfaction assessed on a 8-step scale regarding communication with intensive care team	At 3 months
Trial 1 & 2 Post-traumatic stress disorder	Trial 1 : Measure the impact of each of the 3 sets of informational and educational tools on the risk of developing post-traumatic stress disorder Trial 2 : Measure the impact of EOL of informational and educational tools on the risk of developing post-traumatic stress disorder Assessed with PCL-5 scale six 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). 6 months after the patient's discharge or death	At 6 months
Trial 1 & 2 : anxiety and depression symptoms of relatives	Trial 1 : Measure the impact of each of the 3 sets of informational and educational tools on the risk of developing anxiety and depression symptoms in relatives Trial 2 : Measure the impact of EOL informational and educational tools on the risk of developing anxiety and depression symptoms in relatives HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11). 3 months after the patient's discharge or death	At 3 months
Trial 1 & 2 : anxiety and depression symptoms of relatives	Trial 1 : Measure the impact of each of the 3 sets of informational and educational tools on the risk of developing anxiety and depression symptoms in relatives Trial 2 : Measure the impact of EOL informational and educational tools on the risk of developing anxiety and depression symptoms in relatives HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11). 6 months after the patient's discharge or death	At 6 months
Trial 1 & 2 : Past traumatic experiences	Trauma History Screen (THS) The THS typically asks individuals to respond to a series of yes/no questions about whether they've experienced specific types of trauma. They include : Physical abuse, Sexual abuse, Witnessing violence, Accidents or natural disasters, Military combat, Emotional abuse, Neglect. The score is the number of traumatic events.	At 3 months
Trial 1 & 2 : Risk of developing prolonged grief 6 months after the patient's death	Trial 1 : Measure, in bereaved relatives, the impact of informational and educational tools on the risk of developing prolonged grief Trial 2 : Measure the impact of EOL informational and educational tools on the risk of developing prolonged grief Prolonged Grief Disorder Scale PG-13 The score ranges from 0 to 52. Total scores of 30 or above generally indicate that the individual may be experiencing Prolonged Grief Disorder (PGD) and should be considered for further evaluation. Lower scores suggest that the individual is not experiencing clinically significant prolonged grief symptom	At 6 months
Trial 1 & 2 : Consumption of medical care and acts by relatives	Using MEDEC tool (medical care consumption and acts) It summarizes frequency and type of care	At inclusion
Trial 1 & 2 : Consumption of medical care and acts by relatives	Using MEDEC tool (medical care consumption and acts) It summarizes frequency and type of care During the 6 months following the patient's discharge or death	Up to 6 months
Trial 1&2 : Feasability of use of the tool	Trial 1 : Percentage of care provider who were able to hand over the 3 sets of informational and educational tools to the patient's relatives, as well as their satisfaction Trial 2 : Percentage of care provider who wereable to hand over the EOL informational and educational tools to the patient's relatives, as well as their satisfaction	Up to 6 months
Trial 1 & 2 : Quality of tools assessed by families by a self-assessment questionnaire	self-assessment questionnaire with 14 items	At 3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: APHP240666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No