Clinical trial NCT04470869: Impact on the OLAF Intervention to Prevent Post Traumatic Disorders During the Confinement.
Official title: Impact of the Psychiatric Intervention OLAF on the Post Traumatic Disorder in the Relatives of Patients Hospitalized in Intensive Care Unit During the SARS-Cov-2 Pandemic Confinement in France.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: intensive care unit
confinement
SARS-CoV-2
post-traumatic stress disorder
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: In this study we aimed to investigated the impact of this intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group of relatives that loved ones were hospitalized after the confinement measure but before the OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF intervention.
Primary purpose: PREVENTION

Brief summary: The investigators thought that the confinement measure took in France could induce an increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during this period indeed the restricted visit and the limited interaction with ICU team are documented risk factors for PTSD in this population. The investigators designed an intervention in order to prevent the effect of the confinement measures on PTSD in relatives named OLAF. In this research the investigators aimed to study the impact on this intervention on PTSD.

Detailed description: The hospitalization of a relative in an intensive care unit is an important stress factor for his/ her relatives and previous studies demonstrated that 33% post traumatic disorder (PTSD) following the ICU stay of their loved ones. To response to this issue specific approach have been designed to decrease the stress of the relatives named family centered care. Those approaches are based on the interaction between the ICU team and the relatives and included large time for visiting the patient in the ward. In France the restrictive measures (confinement) took to combat the SARS-CoV-2 pandemic from the 17 march 2020 impacted negatively those family centered care approach by prohibiting the visit in ICU and limiting to interaction between ICU team and relatives to phone calls. The investigators thought that this context could have for consequence an increase in relative anxiety and PTSD. The investigators designed a care intervention named OLAF in order to limit the impact of the confinement on relative psychological state. OLAF intervention permits to the two closest relatives of the patient to be contacted by a psychiatrist and could benefit from a specialized follow up. This intervention is completed by the implementation of virtual visits by video conference that were proposed to the relatives as well as video interview with the ICU team. In this study the investigators aimed to investigated the impact of this intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group of relatives that loved ones were hospitalized after the confinement measure but before the OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF intervention.

The relative will benefit from psychiatric interview 3 months after their loved ones leave the ICU or died to collect information by phone about the confinement situation they experiment, the satisfaction they had about the patient stay in ICU and their anxiety and depression state. Three-month, six month and twelve months after the discharge of the dead the relative information will be collected by phone about PTSD symptoms, anxiety and depression and complicated grief in case of death of the patient.

Eligibility criteria: Inclusion Criteria:

* Contact person (defined as the person that bring a support to the patient et with who the patient had close relationship) aged from more than 18 years old of a patient hospitalized during the confinement and the restricted visited during the SARS-CoV2 pandemic. Two contact persons maximum will be included by patient.
* Affiliated to the social security
* Agreed to participated by oral consent

Exclusion Criteria:

* Physical visits permitted by the end of the confinement
* Language barrier
* Sensorial handicap (blindness or deafness) compromising the comprehension of the information
* Legal protection of adults
* Refusal of participation

Primary outcomes:
measure: incidence of PTSD observed 6 months after patient's discharge from the intensive care unit
timeFrame: Month 6
Secondary outcomes:
measure: incidence of PTSD observed 6 months after patient's death in the intensive care unit
timeFrame: Month 6
measure: PTSD incidence at month 3
timeFrame: Month 3
measure: PTSD incidence at month 12
timeFrame: Month 12
measure: Symptoms incidence at month 3
timeFrame: Month 3
measure: Symptoms incidence at month 6
timeFrame: Month 6
measure: Symptoms incidence at month 12
timeFrame: Month 12
measure: incidence of persistent complicated grief at month 3
timeFrame: Month 3
measure: incidence of persistent complicated grief at month 6
timeFrame: Month 6
measure: incidence of persistent complicated grief at month 12
timeFrame: Month 12
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
state: Occitanie
Study officials:
affiliation: University Hospital, Toulouse
name: Juliette SALLES, MD
role: PRINCIPAL_INVESTIGATOR
References: