Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder
- Conditions
- PTSD in Family Members of ICU Patients
- Interventions
- Other: Restriction of visiting policies < 6 hours
- Registration Number
- NCT03846323
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1289
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Restriction of visiting policies Restriction of visiting policies < 6 hours Restriction of visiting policies \< 6 hours
- Primary Outcome Measures
Name Time Method Symptoms related to posttraumatic stress disorder (PTSD) at day-90 from patient's ICU discharge 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).
- Secondary Outcome Measures
Name Time Method Beliefs and attitudes of healthcare workers toward visiting hours 120 days 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.
the proportion of family members with High risk of PTSD occurrence At day-90 from patients'ICU discharge Score IES \> 30 points
Patients' symptoms of anxiety and depression At day-90 from patients'ICU discharge 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.
the proportion of patients with High risk of PTSD occurrence At day-90 from patients'ICU discharge Score IES \> 30 points
Family member's needs At inclusion 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).
Family members' symptoms of anxiety and depression At inclusion and Day-90 from patient's ICU discharge 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.