Impact of an ICU Diary on the Well-being of Patients and Families. A Prospective Multicenter Mixed Study

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Stress Disorders Post Traumatic

Intervention / Treatment
-----------------
* Other: ICU diary


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With diary<br>a ICU diary is open by staff for the patient and his relatives during the ICU stay | Other: ICU diary<br>* The intervention is the elaboration of an ICU diary by caregivers and families The first pages of the diary is standardized to include an explanation of the purpose of the diary. The diary is maintained by the family and ICU staff. The only instruction given to the families and staff members about diary entries is to refrain from writing about confidential matters that could not be shared among the patients, the staff and the relatives. Staff members are free to express compassion and their hope, or absence thereof, that the patient would recover. Relatives can speak freely with the patients without receiving guidance from the ICU staff. At the minimum, the ICU staff write a brief entry at each weekly staff meeting. For patients discharged to wards and if he can receive the diary, the diary is given to the patient. If the patient died, the diary is given to the family.<br>|
| No Intervention: Without diary<br>No diary is open during the ICU stay | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post traumatic stress disorder symptoms in patients | IES-R score > 22 | 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post traumatic stress disorder symptoms in families | IES-R score > 22 | 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire | 
| Anxiety and depression related symptoms in patients | HADS score > 8 | 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale | 
| Anxiety and depression related symptoms in families | HADS score > 8 | 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale | 
| Recollection of the memories of the ICU stay by the patient | questionnaire ICU tool | 3 months after ICU discharge as measured by the memory tool questionnaire | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family, PTSD, Anxiety disorders, Depression disorders, Qualitative research