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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

715 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-11

Study Completion Date

2017-08-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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Stress Disorders Post Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

the psychologist is blind for the study for assessing outcome measures

Study Groups

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With diary

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

Group Type ACTIVE_COMPARATOR

ICU diary

Intervention Type 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.

Without diary

No diary is open during the ICU stay

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No