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

NCT01147978 | Completed

• 2 other identifiers: K070101ID RCB / 2007-A01044-49
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill Patients

Keywords

ICU; Anxiety; Depression; PTSD

Outcome Measures

Primary Outcomes (1)

• Symptoms of PTSD in ICU patients

  three months after discharge from ICU

Secondary Outcomes (4)

• Symptoms of PTSD, anxiety, and depression in ICU patients

  three months after discharge from ICU

• Symptoms of PTSD, anxiety, and depression in ICU patients

  one year after discharge from ICU

• Symptoms of PTSD, anxiety, and depression in families

  three months after discharge from ICU

• Symptoms of PTSD, anxiety, and depression in families

  one year after discharge from ICU

Study Arms (2)

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

Behavioral: End of ICU stay conference

Usual Procedure

NO INTERVENTION

Usual discharge procedure from the ICU

Interventions

End of ICU stay conference BEHAVIORAL

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

End of ICU stay conference

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• chronic cognitive deterioration before ICU admission
• non French-speaking patients
• impossibility to agree for participation
• end of life situation (survival at 3 months very improbable)
• deaf-dumb patients.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• University Paris 7 - Denis Diderot: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Medical ICU

Paris, Paris, 75010, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Elie AZOULAY, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: June 22, 2010
• Study Start: April 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

FR (1)