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

Not Applicable

Completed

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

• Registration Number: NCT02329418
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-12-29
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-31
• Primary Completion: 2017-10
• Study Completion: 2018-03
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Explaining withholding and withdrawing life-sustaining therapies following standard procedure	Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document
Written document	Explaining withholding and withdrawing life-sustaining therapies along with a written document	Accompanying relatives with a written document when discussing withholding and withdrawing life-sustaining therapies . All other procedures are standard.

Primary Outcome Measures

Name	Time	Method
Rate of PTSD	3 months	PTSD is assessed with Impact Event Scale (IES) on the family representative

Secondary Outcome Measures

Name	Time	Method
Rate of depression	3 months	Depression is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
Mean level of HADS (anxiety and depression subscales)	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
Medical Doctor satisfaction with the processus	ICU discharge (an average of 3 weeks)
Description of the processus	ICU discharge (an average of 3 weeks)
Rate of anxiety	3 months	Anxiety is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
Mean level of IES	3 months
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)

Trial Locations

Locations (1)

Anesthesiology and Critical Care Depratment, Grenoble University Hospital; 🇫🇷 Grenoble, France