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

NCT02519725 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 715

Last updated 2018-03-12

No results posted yet for this study

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.

Conditions

  • Stress Disorders Post Traumatic

Interventions

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.

Sponsors & Collaborators

  • Fondation de France

    collaborator OTHER

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Maité Garrouste-Orgeas, MD · GHPSJoseph

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-11
Primary Completion
2017-02-02
Completion
2017-08-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02519725 on ClinicalTrials.gov