Stress Disorders Post Traumatic
Conditions
Keywords
Family, PTSD, Anxiety disorders, Depression disorders, Qualitative research
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.
Interventions
OTHERICU diary
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.
Sponsors
Fondation de France
Fondation Hôpital Saint-Joseph
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
the psychologist is blind for the study for assessing outcome measures
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post traumatic stress disorder symptoms in patients | 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire | IES-R score \> 22 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post traumatic stress disorder symptoms in families | 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire | IES-R score \> 22 |
| Anxiety and depression related symptoms in patients | 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale | HADS score \> 8 |
| Anxiety and depression related symptoms in families | 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale | HADS score \> 8 |
| Recollection of the memories of the ICU stay by the patient | 3 months after ICU discharge as measured by the memory tool questionnaire | questionnaire ICU tool |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of the diary by the patient | 6 months after ICU discharge | Qualitative research using phenomenology interpretative analysis and thematic analysis |
Countries
France
Outcome results
None listed