Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder

NCT ID: NCT03846323

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1289 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-18
• Study Completion Date: 2018-02-12

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.

Conditions

PTSD in Family Members of ICU Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Visiting policies: open 24h/24

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Restriction of visiting policies

Restriction of visiting policies \< 6 hours

Group Type: OTHER

Restriction of visiting policies < 6 hours

Intervention Type: OTHER

Interventions

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

Intervention Type: OTHER

Restriction of visiting policies < 6 hours

Intervention Type: OTHER

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"

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

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LILA BOUADMA

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Other Identifiers

AOM08226

Identifier Type: -

Identifier Source: org_study_id