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OpenTrials
Completed

NCT Number: NCT03846323

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

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.)

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Key information

Conditions

PTSD in Family Members of ICU Patients Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

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

Other

Restriction of visiting policies < 6 hours

Other

Primary outcomes

  1. Symptoms related to posttraumatic stress disorder (PTSD)

    Time frame: 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 outcomes

  1. Beliefs and attitudes of healthcare workers toward visiting hours

    Time frame: 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.

  2. Family member's needs

    Time frame: 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).

  3. Family members' symptoms of anxiety and depression

    Time frame: 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.

  4. the proportion of family members with High risk of PTSD occurrence

    Time frame: At day-90 from patients'ICU discharge

    Score IES > 30 points

  5. Patients' symptoms of anxiety and depression

    Time frame: 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.

  6. the proportion of patients with High risk of PTSD occurrence

    Time frame: At day-90 from patients'ICU discharge

    Score IES > 30 points

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: OPEN-UNIT

Important dates

Study start
2009
Primary completion
2013
Study completion
2018
First posted
Feb 19, 2019
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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