Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims

Sudden Death Clinical Trial

— SUIVIPROCHE  

Official title:

Sudden Death Counselling and Its Impact on Family Members of Sudden Death Victims

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320902
• Other study ID #: K160905
• Secondary ID: 2017-A0098-45
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: March 25, 2024

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: March 25, 2024
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Death, Sudden
• Sudden Death

Intervention

Behavioral:
• Sudden death counselling
The Sudden Death Counselling with included relatives at 1 month (+/-15 days) after the eventafter the event will be at the Europeen Georges Pompidou hospital in Paris. The purpose of this Sudden Death Counselling is to provide to family members of sudden death victims information, support, referral and follow-up services relating to sudden death and their grief, if needed. The bereaved people will tell their experience. The Sudden Death Counselling would help them to integrate life's losses by companioning them. Cardiologist and psychologists will be present to listen to their pain and try to bring comfort by answering to their questionings.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants malades	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	INSERM U970

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale, sub-section Depression (HADSD) >10	Percentage of relatives with moderate to severe symptoms of depression evaluated by the 'Hospital Anxiety and Depression Scale' score, subscale Depression (HADSD) >10	at 3 months from the sudden death
Primary	Hospital Anxiety and Depression Scale, sub-section Anxiety (HADSA) >10	Percentage of relatives with moderate to severe symptoms of anxiety evaluated by the 'Hospital Anxiety and Depression Scale' score, subscale Anxiety (HADSA) >10	At 3 months from the sudden death
Secondary	Impact of Event Scale-revised score (IES-R) = 33	Percentage of relatives with symptoms of post-traumatic stress disorder evaluated by the 'Impact of Event Scale' score (IES-R) = 33	at 3 months from the sudden death
Secondary	Medical Outcome Study Short Form Health Survey (SF-12)	Quality of life questionnaire : the SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.	At 3 months from the sudden death
Secondary	Visits number to the general physician		At 3 months from the sudden death
Secondary	Drug use		At 3 months from the sudden death
Secondary	Visits number to the psychologist and/or psychiatrist		At 3 months from the sudden death
Secondary	Relatives number integrating a grief recovery support group	Number of participants that have integrated a grief recovery support group	At 3 months from the sudden death
Secondary	Feeling of the sudden death consultation or not by the relatives		At 3 months from the sudden death
Secondary	Proportion of identified causes of sudden death		At 3 months from the sudden death
Secondary	Proportion of familial screening		At 3 months from the sudden death