Clinical trial NCT02329418: Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit
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
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Rate of PTSD
timeFrame: 3 months
Secondary outcomes:
measure: Rate of depression
timeFrame: 3 months
measure: Rate of anxiety
timeFrame: 3 months
measure: Mean level of HADS (anxiety and depression subscales)
timeFrame: 3 months
measure: Mean level of IES
timeFrame: 3 months
measure: Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
timeFrame: An average of 6 days
measure: Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies
timeFrame: An average of 6 days
measure: Rate of decision to withhold and withdraw life-sustaining therapies in different intensive care units from the hospital
timeFrame: ICU discharge (an average of 3 weeks)
measure: Medical Doctor satisfaction with the processus
timeFrame: ICU discharge (an average of 3 weeks)
measure: Description of the processus
timeFrame: ICU discharge (an average of 3 weeks)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Anesthesiology and Critical Care Depratment, Grenoble University Hospital
Study officials:
References:
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.
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.
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.