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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Post Traumatic Stress Disorder

Treatments: Other: Explaining withholding and withdrawing life-sustaining therapies following standard procedure; Other: Explaining withholding and withdrawing life-sustaining therapies along with a written document

Study type: Interventional

Funder types: Other

Identifiers

NCT02329418

2014-A00758-39

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Written document

Experimental group

Description:

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

Treatment:

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

Standard

Active Comparator group

Description:

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

Treatment:

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