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

Not Applicable

Not yet recruiting

• Conditions: Post Traumatic Stress Disorder PTSD

• Registration Number: NCT06851884
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Study Start: 2025-03-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 562

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-Traumatic Stress Disorder (PTSD)	At 3 months	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).

Secondary Outcome Measures

Name	Time	Method
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	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)
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	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).
Trial 1 & 2 : Sleep quality of relatives	At 6 months	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.
Trial 1 & 2 : Symptoms of post-traumatic dissociation	At inclusion	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.
Trial 1 & 2 : satisfaction of relatives regarding communication with the intensive care teams	At 3 months	Satisfaction assessed on a 8-step scale regarding communication with intensive care team
Trial 1 & 2 Post-traumatic stress disorder	At 6 months	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
Trial 1 & 2 : anxiety and depression symptoms of relatives	At 6 months	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
Trial 1 & 2 : Past traumatic experiences	At 3 months	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.
Trial 1 & 2 : Risk of developing prolonged grief 6 months after the patient's death	At 6 months	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
Trial 1 & 2 : Consumption of medical care and acts by relatives	Up to 6 months	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
Trial 1&2 : Feasability of use of the tool	Up to 6 months	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
Trial 1 & 2 : Quality of tools assessed by families by a self-assessment questionnaire	At 3 months	self-assessment questionnaire with 14 items