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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Other: Explaining withholding and withdrawing life-sustaining therapies along with a written document
* Other: Explaining withholding and withdrawing life-sustaining therapies following standard procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |