Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder (OPEN-UNIT)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: PTSD in Family Members of ICU Patients

Treatments: Other: Restriction of visiting policies < 6 hours; Other: Visiting policies: 24 hours a day, 7 days a week

Study type: Interventional

Funder types: Other

Identifiers

NCT03846323

AOM08226

Details and patient eligibility

About

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.)

Full 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.

Enrollment: 1,289 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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"

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1,289 participants in 2 patient groups

Visiting policies: open 24h/24

Experimental group

Description:

Visiting policies: 24 hours a day, 7 days a week

Treatment:

Other: Visiting policies: 24 hours a day, 7 days a week

Restriction of visiting policies

Other group

Description:

Restriction of visiting policies \< 6 hours

Treatment:

Other: Restriction of visiting policies < 6 hours