Clinical trial NCT03991611: Reducing Post-traumatic Stress Disorder After ICU Discharge With the IPREA3 Program
Official title: Tailored Multicomponent Program for Discomfort Reduction in Critically il Patients May Decrease Post-traumatic Stress Disorder in General ICU Survivors at One Year
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Keywords: Critical care
Post-traumatic stress disorder
Discomfort
Tailored program
Patient-reported outcome
ICU
COVID-19
Lead sponsor: Centre Hospitalier of Chartres
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 3312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge cluster randomized trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of posttraumatic stress disorder (PTSD) symptoms at one year after ICU discharge and 6 months ( PTSD-REA_COVID cohort)
timeFrame: One year after ICU discharge
Secondary outcomes:
measure: ICU stay's duration
timeFrame: The day of ICU discharge
measure: Number of days with mechanical ventilation
timeFrame: The day of ICU discharge
measure: Overall score of discomfort assessed from the IPREA3 questionnaire
timeFrame: The day of ICU discharge
measure: The duration of hospital stay after ICU discharge
timeFrame: 6 months ( PTSD-REA_COVID cohort) or 1 year after ICU discharge and
measure: Intrusion Symptom Category B assessed from the PCL-5 (Posttraumatic Stress Disorder Checklist ) (Items 1-5)
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
measure: Persistent Avoidance Category C assessed from the PCL-5 (Items 6-7)
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
measure: Negative Alterations in Cognitions and Mood Category D assessed from PCL 5 (Items 8-14)
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
measure: Alterations in arousal and reactivity Category E assessed from the PCL-5 (Items 15-20)
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
measure: Score of the sub-scale A of the questionnaire HAD-S (Hospital and Anxiety Depression Scale)
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
measure: Score of the sub-scale D of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale)
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
measure: Score obtained from The World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
measure: Number of emergency stays
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
measure: Number of hospitalization
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
measure: Number of psychiatric or psychological consultation
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
measure: The place of leaving after ICU stay
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
measure: Presence of professional activity
timeFrame: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Angers
country: France
facility: CHU d'Angers
city: Auxerre
country: France
facility: CH d'Auxerre
city: Blois
country: France
facility: CH de Blois
city: Bourg-en-Bresse
country: France
facility: Clinique Convert
city: Bourges
country: France
facility: CH Bourges
city: Chartres
country: France
facility: Hôpital Louis Pasteur
city: Dijon
country: France
facility: CHU de Dijon
city: Douai
country: France
facility: CH de Douai
city: Le Puy-en-Velay
country: France
facility: CH Emile Roux
city: Lens
country: France
facility: CH de Lens
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille
country: France
facility: Hôpital Européen de Marseille
city: Marseille
country: France
facility: Hôpital Nord_APHM
city: Marseille
country: France
facility: Hôpital Nord_APHM
city: Montargis
country: France
facility: CH de l'Agglomération Montargoise
city: Mulhouse
country: France
facility: GHR Mulhouse Sud-Alsace
city: Mâcon
country: France
facility: CH de Mâcon
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Paré
city: Nice
country: France
facility: Hôpital Pasteur 2_CHU de Nice
city: Paris
country: France
facility: Hôpital Saint-Louis_APHP
city: Paris
country: France
facility: Gaston Cordier_GH La Pitié-Salpêtrière-Charles Foix_APHP
city: Paris
country: France
facility: GH La Pitié-Salpêtrière-Charles Foix_APHP
city: Paris
country: France
facility: Husson Mourier_GH La Pitié-Salpêtrière-Charles Foix_APHP
city: Poitiers
country: France
facility: CHU de Poitiers
city: Quincy-sous-Sénart
country: France
facility: Hôpital privé Claude Galien
city: Roubaix
country: France
facility: CH Victor Provo
city: Saint-Cyr-sur-Loire
country: France
facility: NCT+ - St Gatien
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil_CHU de Strasbourg
city: Strasbourg
country: France
facility: Hôpital de Hautepierre_CHU de Strasbourg
city: Toulon
country: France
facility: Hôpital Sainte Musse
city: Tours
country: France
facility: CHRU de Tours
city: Troyes
country: France
facility: CH de Troyes
Study officials:
affiliation: CH Chartres
name: Pierre KALFON, MD PhD
role: PRINCIPAL_INVESTIGATOR
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