A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

In France, a study has reported that about 0.2% of patients visiting the ED died in the ED. A large survey of 145 EDs in 3 French speaking countries has reported that a median of 2 patients dies each week in each ED and its observation unit.

After the death of a loved one, prolonged grief disorder (PGD) is a bereavement-specific syndrome that is defined as intense, prolonged yearning and preoccupation with thoughts of the deceased. PGD prevalence after the loss of a relative was 10% (95%CI 7-14) in the general population.Post-traumatic stress disorder (PTSD) is a mental health condition that is triggered by experiencing a terrifying event. Symptoms may include flashbacks, nightmares, and severe anxiety. The reported lifetime PTSD prevalence is 7% among adults in the general population. Admission and death in the hospital can be a traumatic and stressful experience for relatives, and is associated with an up to 50% risk of PGD and PTSD at 6 months.

In the setting of ICU, several studies have reported that implementation of simple human interventions (information supports including written information on end-of-life care and pro-active communication strategy with systematic interviews with relatives), was associated with a lower risk of PTSD at 3 months (45% vs. 69%) and PGD at 6 months (21% vs 57%). Furthermore, it has been reported that offering the possibility of relatives to be present during nursing and medical care may be beneficial.

In the out of hospital setting, offering the possibility for relative to be present during resuscitation was also associated with a reduction of PTSD at 3 months (15% vs 26%), which was confirmed at 1 year.

The ED setting differs from the one of ICU mainly because exposition time to the dying process is shorter and healthcare workers are less used to manage end of life.

Whether these strategies are beneficial for patients dying in the ED, where dying patients are older with more end- stage chronic diseases and shorter length of stay, remains unknown. The hypothesize of the study is that a multifaceted intervention, including pro-active communication strategy, visual supports, and offering the possibility to be present during nursing and medical care would decrease the risk of PGD in relatives of patients dying in the ED.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age >= 18 years

Agrees to be followed-up by phone interview at 3 and 6 months

Informed oral consent

Relative with health insurance (except AME).

Disqualifiers

Relative of a patient under 18 years of age

Relative who do not understand, read, or speak French

Relatives of organ donor patients (these relatives benefit from specific support and communication by the transplant coordination teams)

Inability to follow up

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multi-faceted Intervention

    Other intervention

    The participant, i.e. relative, will receive the multifaceted intervention which include: a first meeting with the healthcare team including written information about palliative care for dying patients, information on possibility to participate in care, pro-active communication, and dedicated interview and brochure after the patient's death with possibility of psychological follow up.

Treatment groups

924 Participants
are divided into 2 treatment groups
Group A: Usual careNo intervention 0 interventions
Group B: Multi-faceted InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Prolonged Grief 13-item revised scale (PG-R-13)

The PG-R-13 measures the new DSM-V criteria for prolonged grief: yearning, preoccupation, identity disruption, disbelief, avoidance, intense emotional pain, difficulty with reintegration, emotional numbness, feeling that life is meaningless and intense loneliness. The score ranges from 10-50 and a score of 30 or more defined the prolonged grief disorder.

Time frame
6 months after inclusion.

Secondary outcomes

1

Signs of PTSD assessed by the PCL-5 scale.

20-item self-report measure (about 5-10 min per participan that assesses the 20 DSM-V symptoms of PTSD. Each item from 0 ("not at all") to 4 ("extremely) indicate the degree to which they have been bothered by this symptom over the past month. Interpretation of the PCL-5 should be made by a clinician. Scores consist of a total symptom severity score (from 0 to 80) and four subscales: * Re-experiencing (items 1-5) * Avoidance (items 6-7) * Negative alterations in cognition and mood (items 8-14) * Hyper-arousal (items 15-20) A cut-off raw score is equal or over 38 for a provisional diagnostic of PTSD.

Time frame
3 months
2

signs of anxiety and depression HADS scale

This self-assessment scale (about 2-6 min per participant) is divided in two subscores: anxiety subscores (HADS-A) and depression subscores (HADS-D), both containing seven interrelated items. (34) Score for each subscale range from 0 to 21, categorized as follows: To screen for anxiety and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D) * Normal \< 8 * Mild to severe equal or over 8

Time frame
3 months

Other outcomes

1

signs of PTSD

Exploratory outcome: HADS-A and HADS-D respectively assessed by the PCL-5 and HADS scales and any new prescription of antidepressant, anxiolytic, or antipsychotic drugs between inclusion and 6 months.

Time frame
6 months
2

signs of anxiety

Exploratory outcome: HADS-A and HADS-D respectively assessed by the PCL-5 and HADS scales and any new prescription of antidepressant, anxiolytic, or antipsychotic drugs between inclusion and 6 months.

Time frame
6 months
3

signs of depression

Exploratory outcome: HADS-A and HADS-D respectively assessed by the PCL-5 and HADS scales and any new prescription of antidepressant, anxiolytic, or antipsychotic drugs between inclusion and 6 months.

Time frame
6 months
4

satisfaction with communication with the emergency physician and nurse using the medical Interview satisfaction scale (MISS-21)

To assess satisfaction with communication with the emergency physician and nurse, the rapport subscale of the medical interview satisfaction scale (MISS-21) In the intervention group, physicians and nurses complete a questionnaire during the patient's course to evaluate the communication strategy and assess adherence to the intervention.

Time frame
3 months after the death

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