Proactive Communication Strategy in Intensive Care Unit and Post Traumatic Stress Symptoms

NCT ID: NCT01147978

Last Updated: 2014-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-11-30

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

Conditions

Critically Ill Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

End of ICU stay conference

Conference with patient and proxies, senior physician and nurse regarding the ICU stay and the orientation of the patient

Group Type: EXPERIMENTAL

End of ICU stay conference

Intervention Type: BEHAVIORAL

Conference with patient and proxies, senior physician and nurse regarding the ICU stay and the orientation of the patient

Usual Procedure

Usual discharge procedure from the ICU

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

End of ICU stay conference

Conference with patient and proxies, senior physician and nurse regarding the ICU stay and the orientation of the patient

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Paris 7 - Denis Diderot

OTHER

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elie AZOULAY, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Medical ICU

Paris, Paris, France

Countries

France

Other Identifiers

ID RCB / 2007-A01044-49

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

K070101

Identifier Type: -

Identifier Source: org_study_id