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

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ClinicalTrials.gov Identifier: NCT02519725
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Fondation de France
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

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.

Condition or disease Intervention/treatment Phase
Stress Disorders Post Traumatic Other: ICU diary Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 715 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: the psychologist is blind for the study for assessing outcome measures
Primary Purpose: Prevention
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
Actual Study Start Date : June 11, 2015
Actual Primary Completion Date : February 2, 2017
Actual Study Completion Date : August 9, 2017

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



Primary Outcome Measures :
  1. Post traumatic stress disorder symptoms in patients [ Time Frame: 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire ]
    IES-R score > 22


Secondary Outcome Measures :
  1. Post traumatic stress disorder symptoms in families [ Time Frame: 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire ]
    IES-R score > 22

  2. Anxiety and depression related symptoms in patients [ Time Frame: 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale ]
    HADS score > 8

  3. Anxiety and depression related symptoms in families [ Time Frame: 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale ]
    HADS score > 8

  4. Recollection of the memories of the ICU stay by the patient [ Time Frame: 3 months after ICU discharge as measured by the memory tool questionnaire ]
    questionnaire ICU tool


Other Outcome Measures:
  1. Use of the diary by the patient [ Time Frame: 6 months after ICU discharge ]
    Qualitative research using phenomenology interpretative analysis and thematic analysis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519725


Locations
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France
Medical and surgical Intensive Care unit
Paris, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Fondation de France
Investigators
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Principal Investigator: Maité Garrouste-Orgeas, MD GHPSJoseph

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02519725     History of Changes
Other Study ID Numbers: ICU DIARY
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: June 2016
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Family
PTSD
Anxiety disorders
Depression disorders
Qualitative research
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders