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

Centre Hospitalier of Chartres

Status: Unknown

Conditions: Critical Illness

Treatments: Other: Targeted interventions in each ICU to reduce discomforts; Other: Immediate feedback through electronic reminder messages; Other: 6 months follow-up to assess the prevalence of PTSD symptoms; Other: 1 year follow-up to assess psychiatric morbidity; Other: Administration of the IPREA3 questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT03991611

2019-A00151-56

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,312 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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3,312 participants in 4 patient groups

IPREA3 program

Experimental group

Description:

Application of the IPREA 3 program (multicomponent intervention to reduce perceived discomforts in critically ill patients) for at least 5 months

Treatment:

Other: Immediate feedback through electronic reminder messages

Other: 1 year follow-up to assess psychiatric morbidity

Other: Administration of the IPREA3 questionnaire

Other: Targeted interventions in each ICU to reduce discomforts

Intermediate group

Other group

Description:

Application of the IPREA 3 program (multicomponent intervention to reduce perceived discomforts in critically ill patients) for less than 5 months

Treatment:

Other: Immediate feedback through electronic reminder messages

Other: Administration of the IPREA3 questionnaire

Other: Targeted interventions in each ICU to reduce discomforts

Standard care

Active Comparator group

Description:

Standard care

Treatment:

Other: 1 year follow-up to assess psychiatric morbidity

Other: Administration of the IPREA3 questionnaire

PTSD-REA_COVID cohort

Other group

Description:

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

Treatment:

Other: 1 year follow-up to assess psychiatric morbidity

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