Clinical trial NCT01147978: Proactive Communication Strategy in Intensive Care Unit and Post Traumatic Stress Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill Patients
Keywords: ICU
Anxiety
Depression
PTSD
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: University Paris 7 - Denis Diderot
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2010-06-22
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* chronic cognitive deterioration before ICU admission
* inclusion in another interventional randomized essay
* non French-speaking patients
* impossibility to agree for participation
* end of life situation (survival at 3 months very improbable)
* deaf-dumb patients.

Primary outcomes:
measure: Symptoms of PTSD in ICU patients
timeFrame: three months after discharge from ICU
Secondary outcomes:
measure: Symptoms of PTSD, anxiety, and depression in ICU patients
timeFrame: three months after discharge from ICU
measure: Symptoms of PTSD, anxiety, and depression in ICU patients
timeFrame: one year after discharge from ICU
measure: Symptoms of PTSD, anxiety, and depression in families
timeFrame: three months after discharge from ICU
measure: Symptoms of PTSD, anxiety, and depression in families
timeFrame: one year after discharge from ICU
Other outcomes:
Locations:
city: Paris
country: France
facility: Medical ICU
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Elie AZOULAY, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: