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

NCT03991611 | Unknown DMC

• 1 other identifier: 2019-A00151-56
• Study Type: interventional
• Target: 3,312
• Locations: 1 country
• Sites: 33

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.

Conditions

Critical Illness

Keywords

Critical care; Post-traumatic stress disorder; Discomfort; Tailored program; Patient-reported outcome; ICU; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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)

  6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

Study Arms (4)

IPREA3 program

EXPERIMENTAL

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; 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

Intermediate group

OTHER

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; Other: Immediate feedback through electronic reminder messages; Other: Targeted interventions in each ICU to reduce discomforts

Standard care

ACTIVE COMPARATOR

Standard care

Other: Administration of the IPREA3 questionnaire; Other: 1 year follow-up to assess psychiatric morbidity

PTSD-REA_COVID cohort

OTHER

ICU admission between March 1, 2020 and April 30, 2020.

Other: 6 months follow-up to assess the prevalence of PTSD symptoms; Other: 1 year follow-up to assess psychiatric morbidity

Interventions

Administration of the IPREA3 questionnaire OTHER

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

IPREA3 program; Intermediate group; Standard care

Immediate feedback through electronic reminder messages OTHER

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

IPREA3 program; Intermediate group

Targeted interventions in each ICU to reduce discomforts OTHER

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.

IPREA3 program; Intermediate group

6 months follow-up to assess the prevalence of PTSD symptoms OTHER

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

PTSD-REA_COVID cohort

1 year follow-up to assess psychiatric morbidity OTHER

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 .

IPREA3 program; PTSD-REA_COVID cohort; Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier of Chartres: lead

Study Sites (33)

CHU Angers

Angers, 49100, France

Location

CHU d'Angers

Angers, 49933, France

Location

CH d'Auxerre

Auxerre, 89000, France

Location

CH de Blois

Blois, 41016, France

Location

Clinique Convert

Bourg-en-Bresse, 01000, France

Location

CH Bourges

Bourges, 18033, France

Location

Hôpital Louis Pasteur

Chartres, 28000, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CH de Douai

Douai, 59507, France

Location

CH Emile Roux

Le Puy-en-Velay, 43000, France

Location

CH de Lens

Lens, 62300, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Hôpital Européen de Marseille

Marseille, 13003, France

Location

Hôpital Nord_APHM

Marseille, 13015, France

Location

Hôpital Nord_APHM

Marseille, 13326, France

Location

CH de Mâcon

Mâcon, 71000, France

Location

CH de l'Agglomération Montargoise

Montargis, 45207, France

Location

GHR Mulhouse Sud-Alsace

Mulhouse, 68100, France

Location

Clinique Ambroise Paré

Neuilly-sur-Seine, 92200, France

Location

Hôpital Pasteur 2_CHU de Nice

Nice, 06006, France

Location

Hôpital Saint-Louis_APHP

Paris, 75010, France

Location

Gaston Cordier_GH La Pitié-Salpêtrière-Charles Foix_APHP

Paris, 75013, France

Location

GH La Pitié-Salpêtrière-Charles Foix_APHP

Paris, 75013, France

Location

Husson Mourier_GH La Pitié-Salpêtrière-Charles Foix_APHP

Paris, 75013, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Hôpital privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

CH Victor Provo

Roubaix, 59100, France

Location

NCT+ - St Gatien

Saint-Cyr-sur-Loire, 37540, France

Location

Nouvel Hôpital Civil_CHU de Strasbourg

Strasbourg, 67091, France

Location

Hôpital de Hautepierre_CHU de Strasbourg

Strasbourg, 67098, France

Location

Hôpital Sainte Musse

Toulon, 83000, France

Location

CHRU de Tours

Tours, 37044, France

Location

CH de Troyes

Troyes, 1000, France

Location

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MeSH Terms

Conditions

Critical Illness; Stress Disorders, Post-Traumatic; COVID-19

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pierre KALFON, MD PhD

  CH Chartres

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster randomized trial

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 19, 2019
• Study Start: November 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: January 1, 2023
• Last Updated: March 23, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (33)