Post Traumatic Stress Disorder PTSD
Conditions
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.
Interventions
OTHERStandard of Care (SOC)
Universal welcome leaflet on patient admission
OTHERVideo capsules
3 video capsules of 3 minutes each
OTHERCartoon
3 cartoons
OTHERVirtual reality
3 virtual reality programs
OTHERSet of end-of-life and grief informational and educational tools
Including a video capsule, a cartoon, and a kit of two leaflets
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 inclusion | 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 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 : 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 : 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 | At inclusion | Using MEDEC tool (medical care consumption and acts) It summarizes frequency and type of care |
| 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 |
| Trial 1 & 2 : anxiety and depression symptoms of relatives | At 3 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). 3 months after the patient's discharge or death |
Contacts
Primary ContactNancy Kentish-Barnes, MD
Backup ContactJérôme Lambert, MD PhD
Outcome results
None listed