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

Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder (PTSD) in Family Members.

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.)

Study Overview

• Status: Completed
• Conditions: PTSD in Family Members of ICU Patients
• Intervention / Treatment: Other: Visiting policies: 24 hours a day, 7 days a week; Other: Restriction of visiting policies < 6 hours

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.

• Study Type: Interventional
• Enrollment (Actual): 1289
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visiting policies: open 24h/24; Visiting policies: 24 hours a day, 7 days a week	Other: Visiting policies: 24 hours a day, 7 days a week
Other: Restriction of visiting policies; Restriction of visiting policies < 6 hours	Other: Restriction of visiting policies < 6 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at day-90 from patient's ICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	At inclusion and Day-90 from patient's ICU discharge
the proportion of family members with High risk of PTSD occurrence	Score IES > 30 points	At day-90 from patients'ICU discharge
Patients' 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 (Anxiety and Depression) above 8 were considered to indicate clinically significant symptoms of anxiety or depression.	At day-90 from patients'ICU discharge
the proportion of patients with High risk of PTSD occurrence	Score IES > 30 points	At day-90 from patients'ICU discharge

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: LILA BOUADMA, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2009
• Primary Completion (Actual): December 17, 2013
• Study Completion (Actual): February 12, 2018

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: ICU; Posttraumatic stress disorder (PTSD); visiting hours policies
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: AOM08226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No