NCT02519725

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 715 (actual)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Disorders Post Traumatic

Interventions

Type	Name	Description
OTHER	ICU 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.

Timeline

• Start date: 2015-06-11
• Primary completion: 2017-02-02
• Completion: 2017-08-09
• First posted: 2015-08-11
• Last updated: 2018-03-12

Locations

1 site across 1 country: France