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

Stress Disorders Post Traumatic Clinical Trial

— ICU-diary  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519725
• Other study ID #: ICU DIARY
• Status: Completed
• Phase: N/A
• First received: July 13, 2015
• Last updated: March 9, 2018
• Start date: June 11, 2015
• Est. completion date: August 9, 2017

Study information

• Verified date: June 2016
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 715
• Est. completion date: August 9, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders Post Traumatic

Intervention

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.

Locations

Country	Name	City	State
France	Medical and surgical Intensive Care unit	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph	Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of the diary by the patient	Qualitative research using phenomenology interpretative analysis and thematic analysis	6 months after ICU discharge
Primary	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	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
Secondary	Anxiety and depression related symptoms in patients	HADS score > 8	3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale
Secondary	Anxiety and depression related symptoms in families	HADS score > 8	3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale
Secondary	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

External Links

•   Impact of an intensive care unit diary on psychological distress in patients and relatives
•   Phenomenologic analysis of healthcare worker perceptions of intensive care unit diaries.
•   Writing in and reading ICU diaries: qualitative study of families' experience in the ICU.