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Completed

NCT Number: NCT02519725

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

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.

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Key information

Conditions

Stress Disorders Post Traumatic Anxiety Disorders Combat Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical and surgical Intensive Care unit

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICU diary

Other

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 outcomes

  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 outcomes

  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 outcomes

  1. Use of the diary by the patient

    Time frame: 6 months after ICU discharge

    Qualitative research using phenomenology interpretative analysis and thematic analysis

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Collaborators

  • Fondation de France

Registry information

Official study 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

Acronym: ICU-diary

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2015
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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