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

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

Study Overview

• Status: Completed
• Conditions: Sudden Death
• Intervention / Treatment: Behavioral: Sudden death counselling

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.

• Study Type: Interventional
• Enrollment (Actual): 624
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nelly BRIAND, PhD; Phone Number: +33 1 44 38 18 62; Email: nelly.briand@aphp.fr
• Study Contact Backup: Name: Patricia JABRE, MD, PhD; Phone Number: +33 1 44 49 24 51; Email: patricia.jabre@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sudden death counselling; 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.	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.
No Intervention: Usual practice; The physician will act as usual. The relatives will not systematically benefit from this option.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Visits number to the general physician		At 3 months from the sudden death
Drug use		At 3 months from the sudden death
Visits number to the psychologist and/or psychiatrist		At 3 months from the sudden death
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
Feeling of the sudden death consultation or not by the relatives		At 3 months from the sudden death
Proportion of identified causes of sudden death		At 3 months from the sudden death
Proportion of familial screening		At 3 months from the sudden death

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: INSERM U970
• Investigators: Principal Investigator: Patricia JABRE, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): March 25, 2024

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: depression; Family members; sudden death; sudden death counseling
• Additional Relevant MeSH Terms: Pathologic Processes; Death; Death, Sudden
• Other Study ID Numbers: K160905; 2017-A0098-45 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No