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

Primary Purpose

Stress Disorders Post Traumatic

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ICU diary
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Disorders Post Traumatic focused on measuring Family, PTSD, Anxiety disorders, Depression disorders, Qualitative research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical and surgical Intensive Care unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

With diary

Without diary

Arm Description

a ICU diary is open by staff for the patient and his relatives during the ICU stay

No diary is open during the ICU stay

Outcomes

Primary Outcome Measures

Post traumatic stress disorder symptoms in patients
IES-R score > 22

Secondary Outcome Measures

Post traumatic stress disorder symptoms in families
IES-R score > 22
Anxiety and depression related symptoms in patients
HADS score > 8
Anxiety and depression related symptoms in families
HADS score > 8
Recollection of the memories of the ICU stay by the patient
questionnaire ICU tool

Full Information

First Posted
July 13, 2015
Last Updated
March 9, 2018
Sponsor
Fondation Hôpital Saint-Joseph
Collaborators
Fondation de France
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1. Study Identification

Unique Protocol Identification Number
NCT02519725
Brief Title
Impact of an ICU Diary on the Well-being of Patients and Families. A Prospective Multicenter Mixed Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 11, 2015 (Actual)
Primary Completion Date
February 2, 2017 (Actual)
Study Completion Date
August 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph
Collaborators
Fondation de France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders Post Traumatic
Keywords
Family, PTSD, Anxiety disorders, Depression disorders, Qualitative research

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
the psychologist is blind for the study for assessing outcome measures
Allocation
Randomized
Enrollment
715 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With diary
Arm Type
Active Comparator
Arm Description
a ICU diary is open by staff for the patient and his relatives during the ICU stay
Arm Title
Without diary
Arm Type
No Intervention
Arm Description
No diary is open during the ICU stay
Intervention Type
Other
Intervention Name(s)
ICU diary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post traumatic stress disorder symptoms in patients
Description
IES-R score > 22
Time Frame
3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire
Secondary Outcome Measure Information:
Title
Post traumatic stress disorder symptoms in families
Description
IES-R score > 22
Time Frame
3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire
Title
Anxiety and depression related symptoms in patients
Description
HADS score > 8
Time Frame
3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale
Title
Anxiety and depression related symptoms in families
Description
HADS score > 8
Time Frame
3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale
Title
Recollection of the memories of the ICU stay by the patient
Description
questionnaire ICU tool
Time Frame
3 months after ICU discharge as measured by the memory tool questionnaire
Other Pre-specified Outcome Measures:
Title
Use of the diary by the patient
Description
Qualitative research using phenomenology interpretative analysis and thematic analysis
Time Frame
6 months after ICU discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maité Garrouste-Orgeas, MD
Organizational Affiliation
GHPSJoseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical and surgical Intensive Care unit
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35239692
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.
Results Reference
derived
PubMed Identifier
31310299
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.
Results Reference
derived
PubMed Identifier
29141694
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22584757
Description
Impact of an intensive care unit diary on psychological distress in patients and relatives
URL
http://www.ncbi.nlm.nih.gov/pubmed/23336394
Description
Phenomenologic analysis of healthcare worker perceptions of intensive care unit diaries.
URL
http://www.ncbi.nlm.nih.gov/pubmed/25329581
Description
Writing in and reading ICU diaries: qualitative study of families' experience in the ICU.

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

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