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

Not Applicable

Completed

• Conditions: Stress Disorders Post Traumatic
• Interventions: Other: ICU diary

• Registration Number: NCT02519725
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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.

Study Timeline

• Study Start: 2015-06-11
• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-08-06
• Study First Posted: 2015-08-11
• Status Verified: 2016-06
• Primary Completion: 2017-02-02
• Study Completion: 2017-08-09
• Last Update Submitted: 2018-03-09
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 715

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With diary	ICU diary	a ICU diary is open by staff for the patient and his relatives during the ICU stay

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Medical and surgical Intensive Care unit; 🇫🇷 Paris, France