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Completed

NCT Number: NCT02329418

Written Document to Assist Family During Decision of 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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesiology and Critical Care Depratment, Grenoble University Hospital

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

The document describes the law and the role of family members and medical team in the decision.

Explaining withholding and withdrawing life-sustaining therapies following standard procedure

Other

Primary outcomes

  1. Rate of PTSD

    Time frame: 3 months

    PTSD is assessed with Impact Event Scale (IES) on the family representative

Secondary outcomes

  1. Rate of depression

    Time frame: 3 months

    Depression is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative

  2. Rate of anxiety

    Time frame: 3 months

    Anxiety is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative

  3. Mean level of HADS (anxiety and depression subscales)

    Time frame: 3 months

  4. Mean level of IES

    Time frame: 3 months

  5. Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge

    Time frame: An average of 6 days

  6. Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies

    Time frame: An average of 6 days

  7. Rate of decision to withhold and withdraw life-sustaining therapies in different intensive care units from the hospital

    Time frame: ICU discharge (an average of 3 weeks)

  8. Medical Doctor satisfaction with the processus

    Time frame: ICU discharge (an average of 3 weeks)

  9. Description of the processus

    Time frame: ICU discharge (an average of 3 weeks)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: LATA

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Dec 31, 2014
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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