Clinical trial NCT02519725: Impact of an ICU Diary on the Well-being of Patients and Families. A Prospective Multicenter Mixed Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders Post Traumatic
Keywords: Family
PTSD
Anxiety disorders
Depression disorders
Qualitative research
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
Collaborators: name: Fondation de France
First posted: 2015-08-11
Enrollment: 715
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post traumatic stress disorder symptoms in patients
timeFrame: 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire
Secondary outcomes:
measure: Post traumatic stress disorder symptoms in families
timeFrame: 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire
measure: Anxiety and depression related symptoms in patients
timeFrame: 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale
measure: Anxiety and depression related symptoms in families
timeFrame: 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale
measure: Recollection of the memories of the ICU stay by the patient
timeFrame: 3 months after ICU discharge as measured by the memory tool questionnaire
Other outcomes:
measure: Use of the diary by the patient
timeFrame: 6 months after ICU discharge
Locations:
city: Paris
country: France
facility: Medical and surgical Intensive Care unit
Study officials:
affiliation: GHPSJoseph
name: Maité Garrouste-Orgeas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.