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

Post Traumatic Stress Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329418
• Other study ID #: 2014-A00758-39
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: March 2018

Study information

• Verified date: December 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Explaining 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.
• Explaining withholding and withdrawing life-sustaining therapies following standard procedure

Locations

Country	Name	City	State
France	Anesthesiology and Critical Care Depratment, Grenoble University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (2)

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, Larché 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. Epub 2005 Jan 21. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of PTSD	PTSD is assessed with Impact Event Scale (IES) on the family representative	3 months
Secondary	Rate of depression	Depression is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative	3 months
Secondary	Rate of anxiety	Anxiety is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative	3 months
Secondary	Mean level of HADS (anxiety and depression subscales)		3 months
Secondary	Mean level of IES		3 months
Secondary	Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge		An average of 6 days
Secondary	Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies		An average of 6 days
Secondary	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)
Secondary	Medical Doctor satisfaction with the processus		ICU discharge (an average of 3 weeks)
Secondary	Description of the processus		ICU discharge (an average of 3 weeks)