Reducing Post-traumatic Stress Disorder After ICU Discharge With the IPREA3 Program (PTSD-REA)

Tailored Multicomponent Program for Discomfort Reduction in Critically il Patients May Decrease Post-traumatic Stress Disorder in General ICU Survivors at One Year

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Critical Illness
• Intervention / Treatment: Other: Administration of the IPREA3 questionnaire; Other: Immediate feedback through electronic reminder messages; Other: Targeted interventions in each ICU to reduce discomforts; Other: 1 year follow-up to assess psychiatric morbidity; Other: 6 months follow-up to assess the prevalence of PTSD symptoms

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.

• Study Type: Interventional
• Enrollment (Actual): 3312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU d'Angers
  • Angers, France, 49100
    • CHU Angers
  • Auxerre, France, 89000
    • CH d'Auxerre
  • Blois, France, 41016
    • CH de Blois
  • Bourg-en-Bresse, France, 01000
    • Clinique Convert
  • Bourges, France, 18033
    • CH Bourges
  • Chartres, France, 28000
    • Hôpital Louis Pasteur
  • Dijon, France, 21079
    • CHU de Dijon
  • Douai, France, 59507
    • CH de Douai
  • Le Puy-en-Velay, France, 43000
    • CH Emile Roux
  • Lens, France, 62300
    • CH de Lens
  • Lyon, France, 69437
    • Hôpital Edouard Herriot
  • Marseille, France, 13003
    • Hôpital Européen de Marseille
  • Marseille, France, 13015
    • Hôpital Nord_APHM
  • Marseille, France, 13326
    • Hôpital Nord_APHM
  • Montargis, France, 45207
    • CH de l'Agglomération Montargoise
  • Mulhouse, France, 68100
    • GHR Mulhouse Sud-Alsace
  • Mâcon, France, 71000
    • CH de Macon
  • Neuilly-sur-Seine, France, 92200
    • Clinique Ambroise Paré
  • Nice, France, 06006
    • Hôpital Pasteur 2_CHU de Nice
  • Paris, France, 75010
    • Hôpital Saint-Louis_APHP
  • Paris, France, 75013
    • Gaston Cordier_GH La Pitié-Salpêtrière-Charles Foix_APHP
  • Paris, France, 75013
    • GH La Pitié-Salpêtrière-Charles Foix_APHP
  • Paris, France, 75013
    • Husson Mourier_GH La Pitié-Salpêtrière-Charles Foix_APHP
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Quincy-sous-Sénart, France, 91480
    • Hôpital Privé Claude Galien
  • Roubaix, France, 59100
    • CH Victor PROVO
  • Saint-Cyr-sur-Loire, France, 37540
    • NCT+ - St Gatien
  • Strasbourg, France, 67091
    • Nouvel Hôpital Civil_CHU de Strasbourg
  • Strasbourg, France, 67098
    • Hôpital de Hautepierre_CHU de Strasbourg
  • Toulon, France, 83000
    • Hôpital Sainte Musse
  • Tours, France, 37044
    • CHRU de Tours
  • Troyes, France, 1000
    • CH de Troyes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IPREA3 program; Application of the IPREA 3 program (multicomponent intervention to reduce perceived discomforts in critically ill patients) for at least 5 months	Other: Administration of the IPREA3 questionnaire; 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; Other: Immediate feedback through electronic reminder messages; 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; Other: Targeted interventions in each ICU to reduce discomforts; 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.; Other: 1 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 .
OTHER: Intermediate group; Application of the IPREA 3 program (multicomponent intervention to reduce perceived discomforts in critically ill patients) for less than 5 months	Other: Administration of the IPREA3 questionnaire; 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; Other: Immediate feedback through electronic reminder messages; 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; Other: Targeted interventions in each ICU to reduce discomforts; 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.
ACTIVE_COMPARATOR: Standard care	Other: Administration of the IPREA3 questionnaire; 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; Other: 1 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 .
OTHER: PTSD-REA_COVID cohort; ICU admission between March 1, 2020 and April 30, 2020.	Other: 1 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 .; Other: 6 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	One year after ICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU stay's duration		The day of ICU discharge
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)	Recurrent or involuntary distressing dreams, memories, thoughts, or feelings related to the traumatic event(s)	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
Persistent Avoidance Category C assessed from the PCL-5 (Items 6-7)	Avoidance or efforts to avoid internal or external reminders of the traumatic event(s)	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
Negative Alterations in Cognitions and Mood Category D assessed from PCL 5 (Items 8-14)	Persistent and exaggerated negative beliefs about oneself, the world, others, negative mood states, inability to experience positive emotions	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
Alterations in arousal and reactivity Category E assessed from the PCL-5 (Items 15-20)	Marked increase in arousal or reactivity such as irritability, hypervigilance, exaggerated startle response, sleep or concentration problems exaggerated startle response	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
Score of the sub-scale A of the questionnaire HAD-S (Hospital and Anxiety Depression Scale)	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	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
Score of the sub-scale D of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale)	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	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
Score obtained from The World Health Organization Quality of Life (WHOQOL-BREF)	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).	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
Number of emergency stays	Since ICU discharge	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
Number of hospitalization	Since ICU discharge	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
Number of psychiatric or psychological consultation	Since ICU discharge	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
The place of leaving after ICU stay	Evaluated in population of patients living at home before the ICU stay.	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge
Presence of professional activity	Evaluated in population of patients with a professional activity before ICU stay	6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

Collaborators and Investigators

• Sponsor: Centre Hospitalier of Chartres
• Investigators: Principal Investigator: Pierre KALFON, MD PhD, CH Chartres

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ANTICIPATED): July 31, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (ACTUAL): June 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; ICU; Critical care; Discomfort; Patient-reported outcome; Post-traumatic stress disorder; Tailored program
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Critical Illness
• Other Study ID Numbers: 2019-A00151-56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No