Clinical trial NCT03846323: Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder
Official title: Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder (PTSD) in Family Members.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD in Family Members of ICU Patients
Keywords: Posttraumatic stress disorder (PTSD)
ICU
visiting hours policies
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 1289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This was a cluster randomized study of an ICU level intervention to reduce high risk of post-traumatic stress disorder (PTSD) in family members of ICU patients.

Participating ICUs had restrictive visiting policies (i.e., \<6 hours/day) before randomization.

After an observational period and a washout period, participating ICUs were randomized either to maintain their visiting policies or to liberalize their visiting policies (24 hours a day, 7 days a week.)

Detailed description: Family members of ICU patients are particularly exposed to anxiety, depressive, acute stress disorder, and posttraumatic stress disorder symptoms (PTSD).

It is currently unknown what type of interventions/ strategies to cope with postintensive care syndrome family would produce the best improvement. Experts suggest that symptoms in family members are potentially amenable to intervention by ICU staff. One intervention to reduce PTSD could be a liberalization of the visiting hours. However, restrictions on visiting hours in the intensive care unit (ICU) are usually adopted worldwide.

Eligibility criteria: Inclusion criteria :

Patient and family member \> 18 years or older,

* mechanical ventilation expected for more than 48 h and inclusion between day 3 and 5 from the beginning of mechanical ventilation,
* patient having a family member speaking and understanding French, and with the ability to visit his/her relative during the ICU stay,
* patient and his/her relative consenting to participate in the study, or obtention of family consent in case of patient incompetency

Exclusion criteria :

- Patient without family available or family not speaking or understanding French"

Primary outcomes:
measure: Symptoms related to posttraumatic stress disorder (PTSD)
timeFrame: at day-90 from patient's ICU discharge
Secondary outcomes:
measure: Beliefs and attitudes of healthcare workers toward visiting hours
timeFrame: 120 days
measure: Family member's needs
timeFrame: At inclusion
measure: Family members' symptoms of anxiety and depression
timeFrame: At inclusion and Day-90 from patient's ICU discharge
measure: the proportion of family members with High risk of PTSD occurrence
timeFrame: At day-90 from patients'ICU discharge
measure: Patients' symptoms of anxiety and depression
timeFrame: At day-90 from patients'ICU discharge
measure: the proportion of patients with High risk of PTSD occurrence
timeFrame: At day-90 from patients'ICU discharge
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: LILA BOUADMA
role: PRINCIPAL_INVESTIGATOR
References: