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

Primary Purpose

PTSD in Family Members of ICU Patients

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Visiting policies: 24 hours a day, 7 days a week
Restriction of visiting policies < 6 hours
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PTSD in Family Members of ICU Patients focused on measuring Posttraumatic stress disorder (PTSD), ICU, visiting hours policies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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"

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Visiting policies: open 24h/24

    Restriction of visiting policies

    Arm Description

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

    Restriction of visiting policies < 6 hours

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.
    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).
    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.
    the proportion of family members with High risk of PTSD occurrence
    Score IES > 30 points
    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.
    the proportion of patients with High risk of PTSD occurrence
    Score IES > 30 points

    Full Information

    First Posted
    December 6, 2018
    Last Updated
    February 18, 2019
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03846323
    Brief Title
    Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder
    Acronym
    OPEN-UNIT
    Official Title
    Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder (PTSD) in Family Members.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 18, 2009 (Actual)
    Primary Completion Date
    December 17, 2013 (Actual)
    Study Completion Date
    February 12, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PTSD in Family Members of ICU Patients
    Keywords
    Posttraumatic stress disorder (PTSD), ICU, visiting hours policies

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    1289 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Visiting policies: open 24h/24
    Arm Type
    Experimental
    Arm Description
    Visiting policies: 24 hours a day, 7 days a week
    Arm Title
    Restriction of visiting policies
    Arm Type
    Other
    Arm Description
    Restriction of visiting policies < 6 hours
    Intervention Type
    Other
    Intervention Name(s)
    Visiting policies: 24 hours a day, 7 days a week
    Intervention Type
    Other
    Intervention Name(s)
    Restriction of visiting policies < 6 hours
    Primary Outcome Measure Information:
    Title
    Symptoms related to posttraumatic stress disorder (PTSD)
    Description
    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).
    Time Frame
    at day-90 from patient's ICU discharge
    Secondary Outcome Measure Information:
    Title
    Beliefs and attitudes of healthcare workers toward visiting hours
    Description
    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.
    Time Frame
    120 days
    Title
    Family member's needs
    Description
    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).
    Time Frame
    At inclusion
    Title
    Family members' symptoms of anxiety and depression
    Description
    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.
    Time Frame
    At inclusion and Day-90 from patient's ICU discharge
    Title
    the proportion of family members with High risk of PTSD occurrence
    Description
    Score IES > 30 points
    Time Frame
    At day-90 from patients'ICU discharge
    Title
    Patients' symptoms of anxiety and depression
    Description
    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.
    Time Frame
    At day-90 from patients'ICU discharge
    Title
    the proportion of patients with High risk of PTSD occurrence
    Description
    Score IES > 30 points
    Time Frame
    At day-90 from patients'ICU discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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"
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    LILA BOUADMA
    Organizational Affiliation
    Assistance Publique - Hôpitaux de Paris
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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