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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02329418
Acronym
LATA
Enrollment
74
Registered
2014-12-31
Start date
2014-09-30
Completion date
2018-03-31
Last updated
2019-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

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.

Interventions

OTHERExplaining 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.

OTHERExplaining withholding and withdrawing life-sustaining therapies following standard procedure

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Rate of PTSD3 monthsPTSD is assessed with Impact Event Scale (IES) on the family representative

Secondary

MeasureTime frameDescription
Rate of depression3 monthsDepression is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
Rate of anxiety3 monthsAnxiety is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
Mean level of HADS (anxiety and depression subscales)3 months
Mean level of IES3 months
Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) dischargeAn average of 6 days
Respectfulness of the law regarding withholding and withdrawing life-sustaining therapiesAn average of 6 days
Rate of decision to withhold and withdraw life-sustaining therapies in different intensive care units from the hospitalICU discharge (an average of 3 weeks)
Medical Doctor satisfaction with the processusICU discharge (an average of 3 weeks)
Description of the processusICU discharge (an average of 3 weeks)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026