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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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PTSD in Family Members of ICU Patients

Intervention / Treatment
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* Other: Visiting policies: 24 hours a day, 7 days a week
* Other: Restriction of visiting policies < 6 hours


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic stress disorder (PTSD), ICU, visiting hours policies