PTSD in Family Members of ICU PatientsOPEN-UNITNCT03846323
Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder
A study testing Visiting policies: 24 hours a day, 7 days a week and Restriction of visiting policies < 6 hours in people with PTSD in Family Members of ICU Patients, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD in Family Members of ICU Patients
- What is being tested?
- Visiting policies: 24 hours a day, 7 days a week and Restriction of visiting policies < 6 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,289 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2009to 12 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient without family available or family not speaking or understanding French"
About this study
Official title: Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder (PTSD) in Family Members.
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.)
Read the 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.
- Conditions
- PTSD in Family Members of ICU Patients
- Being tested
- Visiting policies: 24 hours a day, 7 days a week, Restriction of visiting policies < 6 hours
- Keywords
- Posttraumatic stress disorder (PTSD), ICU, visiting hours policies
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visiting policies: 24 hours a day, 7 days a weekOther
Restriction of visiting policies < 6 hoursOther
| Study group | Role | What they receive |
|---|---|---|
| Visiting policies: open 24h/24 | Experimental | Visiting policies: 24 hours a day, 7 days a week Receives: Other: Visiting policies: 24 hours a day, 7 days a week |
| Restriction of visiting policies | Other | Restriction of visiting policies < 6 hours Receives: Other: Restriction of visiting policies < 6 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at day-90 from patient's ICU discharge
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: At day-90 from patients'ICU discharge
the proportion of patients with High risk of PTSD occurrence
Score IES > 30 points
Measured: At day-90 from patients'ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start18 Apr 2009
- Primary completion17 Dec 2013
- Study completion12 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD in Family Members of ICU PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LILA BOUADMA, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846323
- Sponsor's protocol ID
- AOM08226
- Acronym
- OPEN-UNIT
- Status last verified
- May 2018
- First submitted
- 6 Dec 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder (PTSD) in Family Members.
- ClinicalTrials.gov ID
- NCT03846323
- Acronym / sponsor ID
- OPEN-UNIT / AOM08226
- Conditions
- PTSD in Family Members of ICU Patients
- Keywords
- Posttraumatic stress disorder (PTSD), ICU, visiting hours policies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,289 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Apr 2009 (actual)
- Primary completion
- 17 Dec 2013 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visiting policies: open 24h/24 | Experimental | Other: Visiting policies: 24 hours a day, 7 days a weekVisiting policies: 24 hours a day, 7 days a week |
| Restriction of visiting policies | Other | Other: Restriction of visiting policies < 6 hoursRestriction of visiting policies < 6 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patient without family available or family not speaking or understanding French"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visiting policies: 24 hours a day, 7 days a week | Other | Visiting policies: open 24h/24 |
| Restriction of visiting policies < 6 hours | Other | Restriction of visiting policies |
Primary outcome
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).
6 secondary outcomes
Beliefs and attitudes of healthcare workers toward visiting hours
Time frame: 120 days
Family member's needs
Time frame: At inclusion
Family members' symptoms of anxiety and depression
Time frame: At inclusion and Day-90 from patient's ICU discharge
the proportion of family members with High risk of PTSD occurrence
Time frame: At day-90 from patients'ICU discharge
Patients' symptoms of anxiety and depression
Time frame: At day-90 from patients'ICU discharge
the proportion of patients with High risk of PTSD occurrence
Time frame: At day-90 from patients'ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LILA BOUADMA principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Visiting policies: 24 hours a day, 7 days a week and Restriction of visiting policies < 6 hours in people with PTSD in Family Members of ICU Patients, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms related to posttraumatic stress disorder (PTSD) (time frame: at day-90 from patient's ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.