Clinical trial NCT05193123: Psychological Trauma and Resilience After Critical Illness
Official title: Psychological Trauma and Resilience After ICU Stay in Patients Treated With Mechanical Ventilation for Severe Critical Illness: the Multicenter, Prospective, Observational RESIREA Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Failure
Shock
Keywords: critical illness
mechanical ventilation
shock
post-traumatic stress disorder
resilience
psychological trauma
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in the NUTRIREA3 study will be contacted by phone calls to complete the quality of life scale (SF-36) 3 and 12 months after inclusion in the trial. Patients included in 24 of the 61 ICUs participating to the NUTRIREA-3 trial will be asked to participate to the RESIREA study at the 3-month phone call, by completing 4 additional questionnaires (IES-R, CD-RISC, MSPSS, B-IPQ), 3 and 12 month after their inclusion in the NUTRIREA-3 trial.

Brief summary: Critically ill patients experience a severe physical disease, associated with a psychotrauma, which may lead to post-traumatic stress disorder (17 to 30% of patients after critical illness) and persistent symptoms of anxiety and depression. RESIREA study will study psychodrama, resilience and factors associated with resilience in patients previously included in the NUTRIREA-3 randomized controlled trial designed to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding in a well-defined group of severely ill ICU patients requiring at least MV and vasoactive drugs.

Detailed description: Social demographic data (gender, age, marital status, psychological information and medical background) and medical data (severity of the disease, duration of ICU stay, SOFA score) will be collected, as for the NUTRIREA-3 trial.

Before leaving the ICU, patient who agreed to participate to the NUTRIREA 3 study were asked to participate to the RESIREA study.

Patients will be called by phone by a psychologist 3 months after their inclusion in the NUTRIREA-3 trial to complete the SF-36 score. Then, they will be asked to confirm their participation to the RESIREA study by completing four additional questionnaires (post-trauma stress disorder: IES-R; Resilience: CD-RISC; Social support: MSPSS; Perception of the disease: B-IPQ). If the patient does not respond to the phone call at the first time, he/she will be contacted again within a period of 2 weeks maximum (1 call/day). If the patient remains unreachable, he/she will be considered as lost for the study. Patients will be called again 12 months after their inclusion in the NUTRIREA-3 trial and will be asked to complete the five questionnaires (SF-36, IES-R, CD-RISC, MSPSS and B-IPQ).

During this last phone call, 40 patients will be asked to a third interview by phone. These patients will be spotted thanks to their score at the IES-R and CD-RISC. This interview of 30 to 45 minutes will be planned within 15 days after the T12 call and recorded. This semi structured interview will be lead by an experienced clinical psychologist and follow 4 main topics :

1. Experience of ICU's
2. Perception of the disease or/and post intensive care disorders
3. Difficulties and capacities of coping
4. Difficult events in the patient's life

Eligibility criteria: Inclusion Criteria:

* Invasive mechanical ventilation started within the past 24 h, or started before ICU admission with ICU admission within the past 24 h, for an expected duration of at least 48 hours after inclusion
* Treatment with vasoactive agent for shock (adrenaline, dobutamine, or noradrenaline)
* Nutritional support expected to be started within 24 h after intubation
* Age older than 18 years
* Informed consent to participation in the study

Exclusion Criteria:

* Invasive mechanical ventilation started more than 24 hours earlier
* Specific nutritional needs, such as pre-existing long-term home enteral or parenteral nutrition, or for chronic bowel disease
* Dying patient, not-to-be-resuscitated order, or other treatment limitation decision at ICU admission
* Pregnancy, recent delivery, or lactation

Primary outcomes:
measure: Proportion of patients with post-traumatic disorders
timeFrame: 3 months after ICU stay
Secondary outcomes:
measure: Proportion of resilient patients
timeFrame: 3 and 12 months after ICU stay
measure: proportion of patients with impaired Quality of life
timeFrame: 3 and 12 months after ICU stay
measure: Proportion of patients with post-traumatic disorders
timeFrame: 12 months after ICU stay
measure: Social support
timeFrame: 3 and 12 months after ICU stay
measure: perception of the disease
timeFrame: 3 and 12 months after ICU stay
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie nord
city: Amiens
country: France
facility: CHU Amiens Picardie sud
city: Angers
country: France
facility: CHU Angers
city: Angoulême
country: France
facility: CH Angoulême
city: Annecy
country: France
facility: CH Annecy Genevois
city: Argenteuil
country: France
facility: CH Argenteuil
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Béthune
country: France
facility: CH de Béthune
city: Chartres
country: France
facility: CH Chartres Louis Pasteur
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpided
city: Dieppe
country: France
facility: CH Dieppe
city: Garches
country: France
facility: APHP - Hôpital Raymond Poincaré
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Mans
country: France
facility: CH du Mans
city: Lens
country: France
facility: CH de Lens
city: Lille
country: France
facility: CHR- Roger Salengro
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: APHP - Hôpital Cochin
city: Tarbes
country: France
facility: CH de Bigorre
city: Tours
country: France
facility: CHRU Bretonneau
city: Valenciennes
country: France
facility: CHU de Valenciennes
city: Vannes
country: France
facility: CHBA - Vannes Auray
Study officials:
affiliation: Nantes University Hospital
name: Jean REIGNIER, PhD
role: PRINCIPAL_INVESTIGATOR
References: