NCT02329418

Brief Summary

Relatives of patients in situation of withholding and withdrawing life-sustaining therapies often show post traumatic stress disorder (PTSD) (60%)\[1\]. This number is even greater when family members are active in this decision (81%) or when communication is not optimal between medical team and family members. There are several ways to assist families of patients in intensive care units \[2\], amongst them the use of a written document to explain the environment, therapies and possible outcomes. Here the investigators want to test the impact of a written document in the context of end-of-life conference in intensive care units. Specifically, this research addresses wether such written support could decrease 3-months post-traumatic stress disorder, anxiety and depression exhibited by the closest family member or the patient representative.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 27, 2019

Status Verified

December 1, 2019

Enrollment Period

3.1 years

First QC Date

December 29, 2014

Last Update Submit

December 26, 2019

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • Rate of PTSD

    PTSD is assessed with Impact Event Scale (IES) on the family representative

    3 months

Secondary Outcomes (9)

  • Rate of depression

    3 months

  • Rate of anxiety

    3 months

  • Mean level of HADS (anxiety and depression subscales)

    3 months

  • Mean level of IES

    3 months

  • Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge

    An average of 6 days

  • +4 more secondary outcomes

Study Arms (2)

Written document

EXPERIMENTAL

Accompanying relatives with a written document when discussing withholding and withdrawing life-sustaining therapies . All other procedures are standard.

Other: Explaining withholding and withdrawing life-sustaining therapies along with a written document

Standard

ACTIVE COMPARATOR

Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document

Other: Explaining withholding and withdrawing life-sustaining therapies following standard procedure

Interventions

Explaining withholding and withdrawing life-sustaining therapies along with a written documentOTHER

The document describes the law and the role of family members and medical team in the decision.

Written document
Explaining withholding and withdrawing life-sustaining therapies following standard procedureOTHER
Standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical team anticipates a decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
  • verbal consent to participate
  • Able to communicate in French

You may not qualify if:

  • representant of a patient \< 18 years old
  • representant of a patient whose stay in ICU lasted less than 48 hours
  • representant of a patient without social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology and Critical Care Depratment, Grenoble University Hospital

Grenoble, 38043, France

Location

Related Publications (3)

  • Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.

    PMID: 15665319BACKGROUND

  • Schmidt M, Azoulay E. Having a loved one in the ICU: the forgotten family. Curr Opin Crit Care. 2012 Oct;18(5):540-7. doi: 10.1097/MCC.0b013e328357f141.

    PMID: 22914431BACKGROUND

  • Robin S, Labarriere C, Sechaud G, Dessertaine G, Bosson JL, Payen JF. Information Pamphlet Given to Relatives During the End-of-Life Decision in the ICU: An Assessor-Blinded, Randomized Controlled Trial. Chest. 2021 Jun;159(6):2301-2308. doi: 10.1016/j.chest.2021.01.072. Epub 2021 Feb 5.

    PMID: 33549600DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2014

First Posted

December 31, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2017

Study Completion

March 1, 2018

Last Updated

December 27, 2019

Record last verified: 2019-12

Locations

FR(1)