Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit (LATA)
Primary Purpose
Post Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Explaining withholding and withdrawing life-sustaining therapies along with a written document
Explaining withholding and withdrawing life-sustaining therapies following standard procedure
Sponsored by
About this trial
This is an interventional supportive care trial for Post Traumatic Stress Disorder
Eligibility 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
Sites / Locations
- Anesthesiology and Critical Care Depratment, Grenoble University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Written document
Standard
Arm Description
Accompanying relatives with a written document when discussing withholding and withdrawing life-sustaining therapies . All other procedures are standard.
Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document
Outcomes
Primary Outcome Measures
Rate of PTSD
PTSD is assessed with Impact Event Scale (IES) on the family representative
Secondary Outcome Measures
Rate of depression
Depression is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
Rate of anxiety
Anxiety is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
Mean level of HADS (anxiety and depression subscales)
Mean level of IES
Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies
Rate of decision to withhold and withdraw life-sustaining therapies in different intensive care units from the hospital
Medical Doctor satisfaction with the processus
Description of the processus
Full Information
NCT ID
NCT02329418
First Posted
December 29, 2014
Last Updated
December 26, 2019
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT02329418
Brief Title
Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit
Acronym
LATA
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Written document
Arm Type
Experimental
Arm Description
Accompanying relatives with a written document when discussing withholding and withdrawing life-sustaining therapies . All other procedures are standard.
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document
Intervention Type
Other
Intervention Name(s)
Explaining withholding and withdrawing life-sustaining therapies along with a written document
Intervention Description
The document describes the law and the role of family members and medical team in the decision.
Intervention Type
Other
Intervention Name(s)
Explaining withholding and withdrawing life-sustaining therapies following standard procedure
Primary Outcome Measure Information:
Title
Rate of PTSD
Description
PTSD is assessed with Impact Event Scale (IES) on the family representative
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Rate of depression
Description
Depression is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
Time Frame
3 months
Title
Rate of anxiety
Description
Anxiety is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
Time Frame
3 months
Title
Mean level of HADS (anxiety and depression subscales)
Time Frame
3 months
Title
Mean level of IES
Time Frame
3 months
Title
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
Title
Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies
Time Frame
An average of 6 days
Title
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)
Title
Medical Doctor satisfaction with the processus
Time Frame
ICU discharge (an average of 3 weeks)
Title
Description of the processus
Time Frame
ICU discharge (an average of 3 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Anesthesiology and Critical Care Depratment, Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
15665319
Citation
Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
Results Reference
background
PubMed Identifier
22914431
Citation
Schmidt M, Azoulay E. Having a loved one in the ICU: the forgotten family. Curr Opin Crit Care. 2012 Oct;18(5):540-7. doi: 10.1097/MCC.0b013e328357f141.
Results Reference
background
PubMed Identifier
33549600
Citation
Robin S, Labarriere C, Sechaud G, Dessertaine G, Bosson JL, Payen JF. Information Pamphlet Given to Relatives During the End-of-Life Decision in the ICU: An Assessor-Blinded, Randomized Controlled Trial. Chest. 2021 Jun;159(6):2301-2308. doi: 10.1016/j.chest.2021.01.072. Epub 2021 Feb 5.
Results Reference
derived
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Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit
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