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

Assistance Publique - Hôpitaux de Paris1,289 enrolled

Overview

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.)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,289

Conditions

PTSD in Family Members of ICU Patients

Interventions

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

Restriction of visiting policies < 6 hoursOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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"

Outcomes

Primary Outcomes

Symptoms related to posttraumatic stress disorder (PTSD)

Impact event scale (IES). The Impact of Event scale (IES), which assesses symptoms related to post-traumatic stress disorder (PTSD); scores range from 0 (no PTSD-related symptoms) to 75 (severe PTSD-related symptoms).

Time frame: at day-90 from patient's ICU discharge

Secondary Outcomes

Beliefs and attitudes of healthcare workers toward visiting hours

Beliefs and Attitudes toward Visitation in ICU Questionnaire (BAVIQ). Beliefs and attitudes of ICU staff members were recorded at the beginning of period 1 (observation period) and at the end of period 2 (intervention period) using a questionnaire named the Beliefs and Attitudes toward Visitation in ICU Questionnaire (BAVIQ). The "Beliefs" questionnaire contains both positively and negatively formulated questions. To calculate an overall score for nurses 'beliefs, we recoded the responses on the negatively formulated questions. Subsequently, we computed the average score over all the belief items. A score of zero corresponded with beliefs that are strongly opposed to open visitation and a score of 4 corresponded with beliefs that are strongly in favor of open visitation.

Time frame: 120 days

Family member's needs

Critical Care Family Needs Inventory (CCFNI) Family needs and satisfaction was measured by a modified version of the Critical Care Family Needs Inventory (CCFNI). The satisfaction score was calculated as the sum of the scores on all items; the smallest possible score was 0 (extreme dissatisfaction) and the highest possible score was 14 (extreme satisfaction).

Time frame: At inclusion

Family members' symptoms of anxiety and depression

Hospital and Anxiety Depression Scale (HADS) The Hospital and Anxiety and Depression Scale (HADS), subscale scores range from 0 (no distress) to 21 (severe distress), HADS subscales scores 5Anxiety and Depression) above 8 were considered to indicate clinically significant symptoms of anxiety or depression.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.