Critical Illness
Conditions
Keywords
Critical care, Post-traumatic stress disorder, Discomfort, Tailored program, Patient-reported outcome, ICU, COVID-19
Brief summary
Reducing discomfort in the intensive care unit (ICU) should be beneficial to longterm outcomes. This study assesses whether a tailored multicomponent program for discomfort reduction may be effective in reducing post-traumatic stress disorder (PTSD) symptoms at 1-year in general ICU survivors. The psychiatric morbidity may be increased by the COVID-19 epidemic and its consequences on the healthcare system (patient care, reorganization of French ICUs). The main objective of PTSD-REA\_COVID cohort is to assess this psychiatric morbidity 6 months after an ICU stay during the epidemic period.
Detailed description
After carrying out the cluster-randomized controlled IPREA3 study demonstrating that a tailored multicomponent program based on assessment of self-perceived discomfort, feedback to the healthcare teams, and tailored site-targeted measures was effective to decrease self-perceived overall discomfort, we performed the 1-year follow-up of ICUs survivors included in the IPREA3 study to assess psychiatric morbidity at 1 year. Our tailored multicomponent program was also associated with less PTSD at 1 year after ICU discharge. Based on this positive long-term result, this study confirms the need to implement a new strategy for reducing discomfort in the ICU based on such programs. PTSD-REA is a stepped wedge cluster randomized trial involving 18 ICUs. The exposure will be the implementation of a tailored multicomponent program consisting of assessment of ICU-related self-perceived discomforts, immediate and monthly feedback to the healthcare team, and site-specific tailored interventions. The eligible patients will be exposed vs. unexposed general adult ICU survivors. The prevalence of substantial posttraumatic stress disorder (PTSD) symptoms at 1 year will be assessed by using diagnostic criteria adapted to the new definition of PTSD according to DSM-5. The current context of the COVID-19 pandemic has considerably disrupted the ICUs organizations as well as the patients care which may lead to increased psychiatric morbidity. In this context, it seems necessary to assess this phenomenon in order to anticipate the consequences on patients but also on the healthcare system. The objectives of the PTSD-REA\_COVID cohort are to assess the prevalence of PTSD symptoms, 6 months after ICU stay during COVID-19 epidemic and to compare the psychiatric morbidity at 1 year after an ICU stay during epidemic period and non epidmic period.
Interventions
On the day of the ICU discharge, the bedside nurse administers to the patient the 18-item IPREA questionnaire i.e the nurse asks the patient to rate from 0 to 10 the severity of each discomfort source contained in the IPREA3 questionnaire experienced during the entire stay in the ICU
After the nurse had administered the questionnaire, warning messages are displayed on the screen corresponding to the key points to prevent the three discomforts reported with the highest scores
These targeted interventions are implemented through the coordination of two local champions. The central coordination IPREA3 team sends each month to the local champions monthly and cumulative discomfort scores of their unit (overall score of discomfort and scores for each item) and their ranking relative to other units assigned to the interventional arm i.e applying the IPREA3 program. The local champions organize monthly meetings with the unit staff to present the results in terms of perceived discomforts measured by the IPREA questionnaire, identify main discomfort sources and actions to be conducted to reduce the discomforts reported with the highest scores in the unit and those that are most easily preventable, and assess the efficacy of already applied measures.
OTHER6 months follow-up to assess the prevalence of PTSD symptoms
Psychologist will collect the PCL-5, HAD-S, WHOQOL-BREF, LEC-5 items during the telephone follow-up, 6 months after ICU discharge .
OTHER1 year follow-up to assess psychiatric morbidity
Psychologist will collect the PCL-5, HAD-S, WHOQOL-BREF, LEC-5 and CTQ items during the telephone follow-up, 1 year after ICU discharge .
Sponsors
Centre Hospitalier of Chartres
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
Stepped wedge cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who survived an ICU stay of at least 3 calendar days * Affiliation to a social security scheme * First stay in ICU during current short-term hospitalization * Patient's oral consent to participate in the PTSD-REA\_COVID cohort
Exclusion criteria
* Deceased during the ICU stay * Minors * Under trusteeship * Without affiliation to a social security scheme * Transferred to another ICU * Already hospitalized in ICU during the current short stay * Already included in the study * Limitation and cessation of active treatment * Advance healthcare directive indicating the refusal of ICU stay * Irreversible state like diminished cognitive capacity based on the investigator's opinion or not understanding French sufficiently to be questioned (language barrier) * Subject not consenting to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of posttraumatic stress disorder (PTSD) symptoms at one year after ICU discharge and 6 months ( PTSD-REA_COVID cohort) | One year after ICU discharge | PTSD symptoms at one year will be assessed from the PCL-5 which is a 20-item self-report measure that assesses the 20 DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) symptoms of PTSD. Each item is rated from 0 Not at all to 4 Extremely. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A provisional PTSD diagnosis can be made by treating each item rated as 2 = Moderately or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days with mechanical ventilation | The day of ICU discharge | — |
| Overall score of discomfort assessed from the IPREA3 questionnaire | The day of ICU discharge | — |
| The duration of hospital stay after ICU discharge | 6 months ( PTSD-REA_COVID cohort) or 1 year after ICU discharge and | — |
| Intrusion Symptom Category B assessed from the PCL-5 (Posttraumatic Stress Disorder Checklist ) (Items 1-5) | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | Recurrent or involuntary distressing dreams, memories, thoughts, or feelings related to the traumatic event(s) |
| Persistent Avoidance Category C assessed from the PCL-5 (Items 6-7) | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | Avoidance or efforts to avoid internal or external reminders of the traumatic event(s) |
| Negative Alterations in Cognitions and Mood Category D assessed from PCL 5 (Items 8-14) | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | Persistent and exaggerated negative beliefs about oneself, the world, others, negative mood states, inability to experience positive emotions |
| Alterations in arousal and reactivity Category E assessed from the PCL-5 (Items 15-20) | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | Marked increase in arousal or reactivity such as irritability, hypervigilance, exaggerated startle response, sleep or concentration problems exaggerated startle response |
| ICU stay's duration | The day of ICU discharge | — |
| Score of the sub-scale D of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale) | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | Allowing to estimate the presence of anxious symptoms. The scale HAD contains 14 items rated from 0 to 3. The score of Anxiety ( total A) is obtained by summing items 1-3-5-7-9-11-13 and the depressive dimension (total D) is obtained by summing items 2-4-6-8-10-12-14. The maximal note for each of them is 21. 8 points is a minimum threshold for determining whether Depression is clinically meaningful |
| Score obtained from The World Health Organization Quality of Life (WHOQOL-BREF) | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | The WHOQOL-BREF measure the following broad domains: physical health, psychological health, social relationships, and environment. Each item is rated from 0 to 5. The score of each domain is obtained by summing items then standardized on a scale of 0 (worst quality of life related to health in the dimension explored) to 100 (better quality of liferelated to health in the dimension explored). |
| Number of emergency stays | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | Since ICU discharge |
| Number of hospitalization | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | Since ICU discharge |
| Number of psychiatric or psychological consultation | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | Since ICU discharge |
| The place of leaving after ICU stay | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | Evaluated in population of patients living at home before the ICU stay. |
| Presence of professional activity | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | Evaluated in population of patients with a professional activity before ICU stay |
| Score of the sub-scale A of the questionnaire HAD-S (Hospital and Anxiety Depression Scale) | 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge | Allowing to estimate the presence of anxious symptoms. The scale HAD contains 14 items rated from 0 to 3. The score of Anxiety ( total A) is obtained by summing items 1-3-5-7-9-11-13 and the depressive dimension (total D) is obtained by summing items 2-4-6-8-10-12-14. The maximal note for each of them is 21. 8 points is a minimum threshold for determining whether the anxiety is clinically meaningful |
Countries
France
Outcome results
None listed