Reducing Post-traumatic Stress Disorder After ICU Discharge With the IPREA3 Program

Centre Hospitalier of Chartres3,312 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Interventions

Administration of the IPREA3 questionnaireOTHER

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

Immediate feedback through electronic reminder messagesOTHER

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

Targeted interventions in each ICU to reduce discomfortsOTHER

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.

6 months follow-up to assess the prevalence of PTSD symptomsOTHER

Psychologist will collect the PCL-5, HAD-S, WHOQOL-BREF, LEC-5 items during the telephone follow-up, 6 months after ICU discharge .

1 year follow-up to assess psychiatric morbidityOTHER

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 .

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (33)

CHU Angers

Angers, France

CHU d'Angers

Angers, France

CH d'Auxerre

Auxerre, France

CH de Blois

Blois, France

Clinique Convert

Bourg-en-Bresse, France

CH Bourges

Bourges, France

Hôpital Louis Pasteur

Chartres, France

CHU de Dijon

Dijon, France

CH de Douai

Douai, France

CH Emile Roux

Le Puy-en-Velay, France

...and 23 more locations

Outcomes

Primary Outcomes

Presence of posttraumatic stress disorder (PTSD) symptoms at one year after ICU discharge and 6 months ( PTSD-REA_COVID cohort)

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).

Time frame: One year after ICU discharge

Secondary Outcomes

ICU stay's duration

Time frame: The day of ICU discharge

Number of days with mechanical ventilation

Time frame: The day of ICU discharge

Overall score of discomfort assessed from the IPREA3 questionnaire

Time frame: The day of ICU discharge

The duration of hospital stay after ICU discharge

Time frame: 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)

Recurrent or involuntary distressing dreams, memories, thoughts, or feelings related to the traumatic event(s)