Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit (LATA)

Impact of a Written Document on Post Traumatic Stress Disorder (PTSD) Diagnosed in Family Members After Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit

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.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Other: Explaining withholding and withdrawing life-sustaining therapies along with a written document; Other: Explaining withholding and withdrawing life-sustaining therapies following standard procedure

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Anesthesiology and Critical Care Depratment, Grenoble University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

The study will enroll patient representant (family member or close friends designed by the family or pre-admission legal representant).

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Written document; 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; The document describes the law and the role of family members and medical team in the decision.
Active Comparator: Standard; Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document	Other: Explaining withholding and withdrawing life-sustaining therapies following standard procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of PTSD	PTSD is assessed with Impact Event Scale (IES) on the family representative	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of depression	Depression is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative	3 months
Rate of anxiety	Anxiety is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative	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
Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies		An average of 6 days
Rate of decision to withhold and withdraw life-sustaining therapies in different intensive care units from the hospital		ICU discharge (an average of 3 weeks)
Medical Doctor satisfaction with the processus		ICU discharge (an average of 3 weeks)
Description of the processus		ICU discharge (an average of 3 weeks)

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: December 29, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2014-A00758-39