Impact on the OLAF Intervention to Prevent Post Traumatic Disorders During the Confinement.

NCT ID: NCT04470869

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-12
• Study Completion Date: 2021-10-12

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.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

OLAF group

The interventional group (OLAF) benefit from a psychiatric follow up, from virtual visiting of the patient and video interview with ICU team.

Group Type: EXPERIMENTAL

Phone call

Intervention Type: OTHER

The relatives of both groups will be contacted by phone one month after the discharge of the ICU of the death, three month after, six month after and twelve month after. During these interviews the PTSD symptoms, the anxiety and depression symptoms, the complicated grief symptoms (in case of death) and the satisfaction about the ICU stay will be collected.

Control

The control group contains the relatives of patients hospitalized after the confinement measure but before the OLAF intervention. This group benefit from phone contact with the ICU team at the admission in ICU then two contact per week minimum to one contact per day maximum during the stay, excepting the specific phone calls associated with favorable or unfavorable evolution.

Group Type: PLACEBO_COMPARATOR

Phone call

Intervention Type: OTHER

The relatives of both groups will be contacted by phone one month after the discharge of the ICU of the death, three month after, six month after and twelve month after. During these interviews the PTSD symptoms, the anxiety and depression symptoms, the complicated grief symptoms (in case of death) and the satisfaction about the ICU stay will be collected.

Interventions

Phone call

The relatives of both groups will be contacted by phone one month after the discharge of the ICU of the death, three month after, six month after and twelve month after. During these interviews the PTSD symptoms, the anxiety and depression symptoms, the complicated grief symptoms (in case of death) and the satisfaction about the ICU stay will be collected.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliette SALLES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, Occitanie, France

Countries

France

References

Raymond V, Aitout C, Ducos G, Coullomb A, Ferre F, Vardon-Bounes F, Riu-Poulenc B, Seguin T, Boukhatem L, Geeraerts T, Minville V, Fourcade O, Birmes P, Arbus C, Silva S, Salles J. Effectiveness of psychiatric support for PTSD among a cohort of relatives of patients hospitalized in an intensive care unit during the French COVID-19 lockdown-The OLAF (Operation Liaison et Aide aux Familles): A quasi-randomized clinical trial. Gen Hosp Psychiatry. 2023 Sep-Oct;84:266-267. doi: 10.1016/j.genhosppsych.2023.06.009. Epub 2023 Jun 21. No abstract available.

Reference Type: DERIVED

PMID: 37357092 (View on PubMed)

Other Identifiers

RC31/20/0190

Identifier Type: -

Identifier Source: org_study_id