Grief Disorder, ProlongedMYRIADENCT06733974
A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department
A study testing Multi-faceted Intervention in people with Grief Disorder, Prolonged, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Grief Disorder, Prolonged
- What is being tested?
- Multi-faceted Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 924 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Relative of a patient, that is dying in the ED, defined by an anticipated life expectancy of less than 72H with previous do not resuscitate order or treatment withholding.
- If several relative are present, participation to the trial will be offered in priority to the patient's trustworthy person, the relative most involved in the patient's care, the partner, a parent or child, another family member.
- 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).
Who cannot join
- 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
- Participation in another intervention trial
- Relative under legal protection (tutorship or curatorship)
- Relative deprived of their liberty by a judicial or administrative decision
- Relative physically unable to give his/her oral consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mélanie ROUSSEL, MD-PhD contact
France1 site, 1 recruiting
- Recruiting
Emergency Department Hospital Pitié-Salpêtrière
Paris, Paris, 75013
Yonathan FREUND, PU-PH, +33663549017, yonathan.freund@aphp.fr
About this study
Official title: A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department: a Cluster Randomized 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.
Read more
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.
- Conditions
- Grief Disorder, Prolonged
- Being tested
- Multi-faceted Intervention
- Keywords
- Post-traumatic stress disorder (PTSD), prolonged grief disorder (PGD)
- Medical subject headings
- Prolonged Grief Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-faceted InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Multi-faceted Intervention | Experimental | Not described Receives: Other: Multi-faceted Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after inclusion.
Secondary outcomes (2)
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.
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start4 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grief Disorder, ProlongedStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 924 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yonathan FREUND, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733974
- Sponsor's protocol ID
- APHP230838
- Other IDs
- IDRCB no. 2023-A02158-37
- Acronym
- MYRIADE
- Status last verified
- Jul 2026
- First submitted
- 5 Dec 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06733974
- Acronym / sponsor ID
- MYRIADE / APHP230838
- Conditions
- Grief Disorder, Prolonged
- Keywords
- Post-traumatic stress disorder (PTSD), prolonged grief disorder (PGD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 924 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Multi-faceted Intervention | Experimental | Other: Multi-faceted Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Relative of a patient, that is dying in the ED, defined by an anticipated life expectancy of less than 72H with previous do not resuscitate order or treatment withholding.
- If several relative are present, participation to the trial will be offered in priority to the patient's trustworthy person, the relative most involved in the patient's care, the partner, a parent or child, another family member.
- Age >= 18 years
- Agrees to be followed-up by phone interview at 3 and 6 months
- Informed oral consent
Key exclusion criteria (8 listed)
- 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
- Participation in another intervention trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-faceted InterventionThe 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. | Other | Multi-faceted Intervention |
Primary outcome
Prolonged Grief 13-item revised scale (PG-R-13)
Time frame: 6 months after inclusion.
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.
2 secondary outcomes
Signs of PTSD assessed by the PCL-5 scale.
Time frame: 3 months
signs of anxiety and depression HADS scale
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Grief Disorder, Prolonged
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Iyengar Yoga for Prolonged Grief Disorder
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Mechanisms Underlying Late-Life Prolonged Grief Disorder
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Emotion-Focused Therapy in the Treatment of Prolonged Grief Disorder
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Enrolling by invitation
F-PGT - Prolonged Grief Treatment for Families Affected by Suicide
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mélanie ROUSSEL, MD-PhD contact
Yonathan FREUND, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-faceted Intervention in people with Grief Disorder, Prolonged, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yonathan FREUND, PU-PH (+33663549017, yonathan.freund@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged Grief 13-item revised scale (PG-R-13) (time frame: 6 months after inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.