Critically Ill PatientsFAMIREAXVNCT01147978
Proactive Communication Strategy in Intensive Care Unit and Post Traumatic Stress Symptoms
A study testing End of ICU stay conference in people with Critically Ill Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The investigators propose an interventional multicentric (23 ICUs) study measuring the impact of a consultation at the end of ICU stay for the patients and his/her families on the prevalence of symptoms of PTSD and anxiety or depression 3 months and one year after discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- End of ICU stay conference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Nov 2012
- 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 alive at the end of ICU stay
- age > 18 years
- more than 48 hours of mechanical ventilation
- accepting to be called back 3-month and on one year after discharge of ICU.
- non French-speaking patients
- impossibility to agree for participation
- end of life situation (survival at 3 months very improbable)
- deaf-dumb patients.
Who cannot join
- chronic cognitive deterioration before ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Proactive Strategy of Communication With Patients Hospitalized in ICU and Their Families With the Aim of Reducing Their Anxious and Depressive Symptoms and Their Post Traumatic Stress Symptoms
The investigators propose an interventional multicentric (23 ICUs) study measuring the impact of a consultation at the end of ICU stay for the patients and his/her families on the prevalence of symptoms of PTSD and anxiety or depression 3 months and one year after discharge. Patients will be randomly assigned to a intervention or control group. In the intervention group, the patient and his/her family will benefit from an conference by the intensivist at the end of the ICU stay, regarding information about the progress of his stay in ICU, his orientation after discharge, the possibility of consulting a GP, etc. Patients and proxies will be interviewed by phone three months and one year after discharge from ICU. Main instruments are Hospital Anxiety and Depression Scale, and Impact of Events Scale Revised.
Read the detailed description
There are many risk factors of stress for a patient during a stay in Intensive care unit. This stress can be responsible for psychiatric symptoms hindering seriously the quality of life of the patient in the months following discharge from ICU. Survivors of ICU suffer from traumatic memories (nightmares, acute anxiety), who can be associated to post traumatic stress disorder (PTSD) or of anxious and depressive symptoms. Prevalence of PTSD in the months following ICU stay is estimated between 14 and 41 %, that of the symptoms of anxiety between 12 % and 47 %, and that of the symptoms of depression between 10 % and 30 %. Recent studies showed that these symptoms could concern several thousand patients every year in France.
We propose an interventional multicentric (23 ICUs) study measuring the impact of a consultation at the end of ICU stay for the patients and his/her families on the prevalence of symptoms of PTSD and anxiety or depression 3 months and one year after discharge.
Patients will be randomly assigned to a intervention or control group. In the intervention group, the patient and his/her family will benefit from an conference by the intensivist at the end of the ICU stay, regarding information about the progress of his stay in ICU, his orientation after discharge, the possibility of consulting a general practitioner (GP), etc. The family, if present, will be invited to attend the conference. In the control group, patients will be cared in a usual way (without end of stay conference) as it is made in all the intensive care units in France. Inclusion criteria are 1) patient alive at the end of ICU stay, 2) Age > 18 years, 3) more than 48 hours of mechanical ventilation 4) accepting to be called back 3-month and on one year after discharge of ICU. Exclusion criteria are 1) Chronic cognitive deterioration before ICU admission, 2) inclusion in another interventional randomized essay 3) non French-speaking patients, 4) impossibility to agree 5) End of life situation (survival at 3 months very improbable), 6) deaf-dumb patients. Patients and proxies will be interviewed by phone three months and one year after discharge from ICU. Main instruments are Hospital Anxiety and Depression Scale, and Impact of Events Scale Revised. Number of patients to include takes into account an estimated prevalence of PTSD of 20 %, and the impact expected from the intervention is to obtain 10 % of PTSD in the intervention group. With a beta power of 90 % and a risk of 5 %, number of patients needed three months after discharge is 438 (219 in every group), i.e 525 patients (263 in every arm because of the late deaths and lost sight). This study should supply updated and relevant data on prevalence and risk factors of symptoms of PTSD and Anxiety-depression three months and one year after discharge from ICU. Furthermore, we propose an intervention that could demonstrate that a brief and easily reproducible communication strategy could significantly reduce prevalence of PTSD and anxiety-depression for patients and their families after discharge from ICU
- Conditions
- Critically Ill Patients
- Being tested
- End of ICU stay conference
- Keywords
- ICU, Anxiety, Depression, PTSD
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End of ICU stay conferenceBehavioural
Conference with patient and proxies, senior physician and nurse regarding the ICU stay and the orientation of the patient
| Study group | Role | What they receive |
|---|---|---|
| End of ICU stay conference | Experimental | Conference with patient and proxies, senior physician and nurse regarding the ICU stay and the orientation of the patient Receives: Behavioral: End of ICU stay conference |
| Usual Procedure | No intervention | Usual discharge procedure from the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of PTSD in ICU patients
Measured: three months after discharge from ICU
Secondary outcomes (4)
Symptoms of PTSD, anxiety, and depression in ICU patients
Measured: three months after discharge from ICU
Symptoms of PTSD, anxiety, and depression in ICU patients
Measured: one year after discharge from ICU
Symptoms of PTSD, anxiety, and depression in families
Measured: three months after discharge from ICU
Symptoms of PTSD, anxiety, and depression in families
Measured: one year after discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startApr 2009
- Primary completionAug 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University Paris 7 - Denis Diderot, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Elie AZOULAY, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147978
- Sponsor's protocol ID
- K070101
- Other IDs
- ID RCB / 2007-A01044-49
- Acronym
- FAMIREAXV
- Status last verified
- Apr 2014
- First submitted
- 18 Jun 2010
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Proactive Strategy of Communication With Patients Hospitalized in ICU and Their Families With the Aim of Reducing Their Anxious and Depressive Symptoms and Their Post Traumatic Stress Symptoms
- ClinicalTrials.gov ID
- NCT01147978
- Acronym / sponsor ID
- FAMIREAXV / K070101
- Conditions
- Critically Ill Patients
- Keywords
- ICU, Anxiety, Depression, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- University Paris 7 - Denis Diderot, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Apr 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- 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.
The investigators propose an interventional multicentric (23 ICUs) study measuring the impact of a consultation at the end of ICU stay for the patients and his/her families on the prevalence of symptoms of PTSD and anxiety or depression 3 months and one year after discharge. Patients will be randomly assigned to a intervention or control group. In the intervention group, the patient and his/her family will benefit from an conference by the intensivist at the end of the ICU stay, regarding information about the progress of his stay in ICU, his orientation after discharge, the possibility of consulting a GP, etc. Patients and proxies will be interviewed by phone three months and one year after discharge from ICU. Main instruments are Hospital Anxiety and Depression Scale, and Impact of Events Scale Revised.
Detailed description
There are many risk factors of stress for a patient during a stay in Intensive care unit. This stress can be responsible for psychiatric symptoms hindering seriously the quality of life of the patient in the months following discharge from ICU. Survivors of ICU suffer from traumatic memories (nightmares, acute anxiety), who can be associated to post traumatic stress disorder (PTSD) or of anxious and depressive symptoms. Prevalence of PTSD in the months following ICU stay is estimated between 14 and 41 %, that of the symptoms of anxiety between 12 % and 47 %, and that of the symptoms of depression between 10 % and 30 %. Recent studies showed that these symptoms could concern several thousand patients every year in France.
We propose an interventional multicentric (23 ICUs) study measuring the impact of a consultation at the end of ICU stay for the patients and his/her families on the prevalence of symptoms of PTSD and anxiety or depression 3 months and one year after discharge.
Patients will be randomly assigned to a intervention or control group. In the intervention group, the patient and his/her family will benefit from an conference by the intensivist at the end of the ICU stay, regarding information about the progress of his stay in ICU, his orientation after discharge, the possibility of consulting a general practitioner (GP), etc. The family, if present, will be invited to attend the conference. In the control group, patients will be cared in a usual way (without end of stay conference) as it is made in all the intensive care units in France. Inclusion criteria are 1) patient alive at the end of ICU stay, 2) Age > 18 years, 3) more than 48 hours of mechanical ventilation 4) accepting to be called back 3-month and on one year after discharge of ICU. Exclusion criteria are 1) Chronic cognitive deterioration before ICU admission, 2) inclusion in another interventional randomized essay 3) non French-speaking patients, 4) impossibility to agree 5) End of life situation (survival at 3 months very improbable), 6) deaf-dumb patients. Patients and proxies will be interviewed by phone three months and one year after discharge from ICU. Main instruments are Hospital Anxiety and Depression Scale, and Impact of Events Scale Revised. Number of patients to include takes into account an estimated prevalence of PTSD of 20 %, and the impact expected from the intervention is to obtain 10 % of PTSD in the intervention group. With a beta power of 90 % and a risk of 5 %, number of patients needed three months after discharge is 438 (219 in every group), i.e 525 patients (263 in every arm because of the late deaths and lost sight). This study should supply updated and relevant data on prevalence and risk factors of symptoms of PTSD and Anxiety-depression three months and one year after discharge from ICU. Furthermore, we propose an intervention that could demonstrate that a brief and easily reproducible communication strategy could significantly reduce prevalence of PTSD and anxiety-depression for patients and their families after discharge from ICU
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End of ICU stay conference | Experimental | Behavioral: End of ICU stay conferenceConference with patient and proxies, senior physician and nurse regarding the ICU stay and the orientation of the patient |
| Usual Procedure | No intervention | –Usual discharge procedure from the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patient alive at the end of ICU stay
- age > 18 years
- more than 48 hours of mechanical ventilation
- accepting to be called back 3-month and on one year after discharge of ICU.
- non French-speaking patients
Key exclusion criteria (1 listed)
- chronic cognitive deterioration before ICU admission
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 |
|---|---|---|
| End of ICU stay conferenceConference with patient and proxies, senior physician and nurse regarding the ICU stay and the orientation of the patient | Behavioural | End of ICU stay conference |
Primary outcome
Symptoms of PTSD in ICU patients
Time frame: three months after discharge from ICU
4 secondary outcomes
Symptoms of PTSD, anxiety, and depression in ICU patients
Time frame: three months after discharge from ICU
Symptoms of PTSD, anxiety, and depression in ICU patients
Time frame: one year after discharge from ICU
Symptoms of PTSD, anxiety, and depression in families
Time frame: three months after discharge from ICU
Symptoms of PTSD, anxiety, and depression in families
Time frame: one year after discharge from ICU
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 23 Apr 2014.
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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.
Elie AZOULAY, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End of ICU stay conference in people with Critically Ill Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 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 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 of PTSD in ICU patients (time frame: three months after discharge from ICU). 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 23 Apr 2014.