Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims (SUIVIPROCHE)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Sudden Death

Treatments: Behavioral: Sudden death counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT03320902

K160905J

2017-A0098-45 (Other Identifier)

Details and patient eligibility

About

Assessment of the psychological benefit of the proposition by prehospital medical team of a sudden death counselling on family members of sudden death victims.

Full 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.

Enrollment: 625 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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625 participants in 2 patient groups

Sudden death counselling

Active Comparator group

Description:

The emergency physician of the prehospital EMS who intervenes at the scene will systematically give the family member allocated to the intervention the option to attend a sudden death counselling during the first month after the event.

Treatment:

Behavioral: Sudden death counselling

Usual practice

No Intervention group

Description:

The physician will act as usual. The relatives will not systematically benefit from this option.