"Impacts of the Letter of Condolence to the Bereaved Families Experience After a Death in ICU " - Study Famirea 22

Not Applicable

Completed

• Conditions: Death; Mourning
• Interventions: Other: Letter of condolence

• Registration Number: NCT02325297
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

After the death of a patient in the hyper-technical context of intensive care, his relatives are particularly vulnerable and often exhibit symptoms of anxiety, depression, post traumatic stress and complicated grief. The first results of a qualitative study Famiréa current (CAESAR) support the idea that the bereaved relatives suffer from persistent misunderstandings and a feeling of abandonment of the resuscitation team. Many families suggest the need for contact with the team after the patient's death. The letter of condolence received by some families allowed them to feel recognized in their pain resuscitation teams. This has led us to ask the question of post-death monitoring and interest to send to bereaved relatives a letter of condolence, as recommended by the American consensus conference in 2004 on good palliative care. This strategy would allow the recognition of both close to the pain but also the strong bond that united the resuscitation team. The hypothesis of the study is that the post-death followed in the form of a letter of condolence sent by the intensive care physician who was in charge of the patient, could reduce the risk of having symptoms of anxiety / depression and post-traumatic stress and reduce the rate of complicated grief.

Famirea 22 is randomized clinical trial aimin to compare two bereaved groups: one group who did not receive a letter of condolence and a group that received a letter of condolence 15 days after the death.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-24
• Primary Completion: 2015-11
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• death of a relative patient in intensive care whose relatives were interviewed at least once by resuscitation team
• death of an adult relative patient
• ICU stay of the relative patient more than 2 days

Exclusion Criteria

• death of a pregnant woman
• opposition to the use of its data by the patient
• relative does not speak French
• refusal of the relative

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letter of condolence	Letter of condolence	Letter of condolence 15 days after the death of the relative.

Primary Outcome Measures

Name	Time	Method
HADS (Hospital Anxiety and Depression Scale)	1 month

Secondary Outcome Measures

Name	Time	Method
Caesar scale	1 month	a questionnaire describing ICU end-of-life practices and satisfaction with the patient's care, communication, and symptom management during the dying process.
IES-R (Impact of Event Scale, Revised)	6 months
ICG (Inventory of Complicated grief)	6 months
HADS (Hospital Anxiety and Depression Scale)	6 months

Trial Locations

Locations (1)

Saint-Louis Hospital; 🇫🇷 Paris, France