ICU Diaries Impact of an ICU Diary on the Psychological Well-being of the Patients and Their Relatives. Mixed Multicenter Randomized Study With Blind Evaluation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Disorders Post Traumatic
- Sponsor
- Fondation Hôpital Saint-Joseph
- Enrollment
- 715
- Locations
- 1
- Primary Endpoint
- Post traumatic stress disorder symptoms in patients
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to assess the influence of an ICU diary implemented during the ICU stay on the psychological well-being of patients and families after ICU discharge.
Detailed Description
Implementation of an ICU diary in a randomized design in 36 ICUs in France The ICU diary contains entries from staff and families or relatives Quantitative description of psychological well-being of the patients and families or relatives are evaluated 3 months after ICU discharge Qualitative evaluation of how the patient uses the diary is scheduled by a phone interview 6 months after ICU discharge. An amendment of the ethic committee permitted to increase in 2016/02 both the number of eligible patients to 700 and the number of centers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with his family admitted in an ICU and mechanically ventilated more than 48 hours
Exclusion Criteria
- •Patients without families admitted in an ICU and mechanically ventilated more than 48 hours
- •Patients or families not fluent in French
- •Patients moribund
- •Patients with a neurologic or psychiatric disease responsible for admission or pre-existing before the ICU admission
- •Patients admitted after a cardiac arrest
- •Deaf and mute patients
Outcomes
Primary Outcomes
Post traumatic stress disorder symptoms in patients
Time Frame: 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire
IES-R score \> 22
Secondary Outcomes
- Anxiety and depression related symptoms in patients(3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale)
- Anxiety and depression related symptoms in families(3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale)
- Post traumatic stress disorder symptoms in families(3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire)
- Recollection of the memories of the ICU stay by the patient(3 months after ICU discharge as measured by the memory tool questionnaire)