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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorders Post Traumatic
• Intervention / Treatment: Other: ICU diary

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 Type: Interventional
• Enrollment (Actual): 715
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Medical and surgical Intensive Care unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: With diary; a ICU diary is open by staff for the patient and his relatives during the ICU stay	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.
No Intervention: Without diary; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of the diary by the patient	Qualitative research using phenomenology interpretative analysis and thematic analysis	6 months after ICU discharge

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Collaborators: Fondation de France
• Investigators: Principal Investigator: Maité Garrouste-Orgeas, MD, GHPSJoseph

Publications and helpful links

General Publications

• Flahault C, Vioulac C, Fasse L, Bailly S, Timsit JF, Garrouste-Orgeas M. "A story with gaps": An interpretative phenomenological analysis of ICU survivors' experience. PLoS One. 2022 Mar 3;17(3):e0264310. doi: 10.1371/journal.pone.0264310. eCollection 2022.
• Garrouste-Orgeas M, Flahault C, Vinatier I, Rigaud JP, Thieulot-Rolin N, Mercier E, Rouget A, Grand H, Lesieur O, Tamion F, Hamidfar R, Renault A, Parmentier-Decrucq E, Monseau Y, Argaud L, Bretonniere C, Lautrette A, Badie J, Boulet E, Floccard B, Forceville X, Kipnis E, Soufir L, Valade S, Bige N, Gaffinel A, Hamzaoui O, Simon G, Thirion M, Bouadma L, Large A, Mira JP, Amdjar-Badidi N, Jourdain M, Jost PH, Maxime V, Santoli F, Ruckly S, Vioulac C, Leborgne MA, Bellalou L, Fasse L, Misset B, Bailly S, Timsit JF. Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):229-239. doi: 10.1001/jama.2019.9058.
• Garrouste-Orgeas M, Flahault C, Fasse L, Ruckly S, Amdjar-Badidi N, Argaud L, Badie J, Bazire A, Bige N, Boulet E, Bouadma L, Bretonniere C, Floccard B, Gaffinel A, de Forceville X, Grand H, Halidfar R, Hamzaoui O, Jourdain M, Jost PH, Kipnis E, Large A, Lautrette A, Lesieur O, Maxime V, Mercier E, Mira JP, Monseau Y, Parmentier-Decrucq E, Rigaud JP, Rouget A, Santoli F, Simon G, Tamion F, Thieulot-Rolin N, Thirion M, Valade S, Vinatier I, Vioulac C, Bailly S, Timsit JF. The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs. Trials. 2017 Nov 15;18(1):542. doi: 10.1186/s13063-017-2283-y.

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2015
• Primary Completion (Actual): February 2, 2017
• Study Completion (Actual): August 9, 2017

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 11, 2015

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 9, 2018
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: PTSD; Family; Qualitative research; Anxiety disorders; Depression disorders
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic
• Other Study ID Numbers: ICU DIARY