PTSD in Family Members of ICU Patients Clinical Trial
— OPEN-UNITOfficial title:
Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder (PTSD) in Family Members.
| Verified date | May 2018 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.)
| Status | Completed |
| Enrollment | 1289 |
| Est. completion date | February 12, 2018 |
| Est. primary completion date | December 17, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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" |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | the proportion of family members with High risk of PTSD occurrence | Score IES > 30 points | At day-90 from patients'ICU discharge | |
| Secondary | 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 | |
| Secondary | the proportion of patients with High risk of PTSD occurrence | Score IES > 30 points | At day-90 from patients'ICU discharge |