Clinical trial NCT03320902: Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims
Official title: Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Death
Keywords: Family members
sudden death
sudden death counseling
depression
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-10-25
Enrollment: 625
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: Assessment of the psychological benefit of the proposition by prehospital medical team of a sudden death counselling on family members of sudden death victims.

Detailed description: Family members are often shocked and devastated by the death of their loved one, especially when it is sudden and unexpected. On the scene, families often don't really believe it happened because they didn't have time to absorb the fact of their loss. They hear the words and explanation given by the prehospital emergency medical services (EMS) team, but do not comprehend the full impact. Emotions seem frozen. They feel disoriented, restless, stunned and unable to think.

Most often, after cardiac arrest resuscitation attempt, the prehospital EMS team leaves the scene, letting the family without any further medical bond and support. Families are left alone facing this tragedy. After a while, families need medical counseling trying to understand what happens and why but they don't know who to consult. Instead, they remain without medical explanation or guidance with the fear regarding their own future, in particular, regarding the risk of dying from sudden death. This fear may be based on the knowledge of the eventuality of familial diseases increasing the risk of sudden death, or simply on a mechanism of identification with the deceased.

One important factor credited by experts is to encourage first-degree family members to seek sudden death counselling. However, the literature concerning this problem lacks of reliable data.

The aim of this clinical trial is to evaluate the psychological consequences of a sudden death counselling on family member after a relative's sudden death compared to the usual family management.

This study will compare the percentage of depression in a group of family members after a relative's sudden death for whom a sudden death counselling has been proposed by the prehospital medical team versus a group for whom the medical team has not modified its usual strategy.

Eligibility criteria: Inclusion Criteria:

A first-degree relative of a:

* patient aged 18-75 years
* with an out-of-hospital sudden death\*
* and cardiopulmonary resuscitation attempted Relative aged ≥ 18 years Given consent for the study. Sudden death definition\*: An unexpected cardiac arrest without obvious extracardiac cause, leading to a collapse in front of a witness (or in the absence of witnesses, occurring within the hour after the onset of symptoms).

Exclusion Criteria:

Relative under guardianship/curatorship Relative unable to communicate Relative not affiliated to a medical insurance

Primary outcomes:
measure: Hospital Anxiety and Depression Scale, sub-section Depression (HADSD) >10
timeFrame: at 3 months from the sudden death
measure: Hospital Anxiety and Depression Scale, sub-section Anxiety (HADSA) >10
timeFrame: At 3 months from the sudden death
Secondary outcomes:
measure: Impact of Event Scale-revised score (IES-R) ≥ 33
timeFrame: at 3 months from the sudden death
measure: Medical Outcome Study Short Form Health Survey (SF-12)
timeFrame: At 3 months from the sudden death
measure: Visits number to the general physician
timeFrame: At 3 months from the sudden death
measure: Drug use
timeFrame: At 3 months from the sudden death
measure: Visits number to the psychologist and/or psychiatrist
timeFrame: At 3 months from the sudden death
measure: Relatives number integrating a grief recovery support group
timeFrame: At 3 months from the sudden death
measure: Feeling of the sudden death consultation or not by the relatives
timeFrame: At 3 months from the sudden death
measure: Proportion of identified causes of sudden death
timeFrame: At 3 months from the sudden death
measure: Proportion of familial screening
timeFrame: At 3 months from the sudden death
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Patricia JABRE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: