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

Death Clinical Trial

— Famirea 22  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325297
• Other study ID #: Famirea22
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: June 23, 2016
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: June 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Death
• Mourning

Intervention

Other:
• Letter of condolence

Locations

Country	Name	City	State
France	Saint-Louis Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HADS (Hospital Anxiety and Depression Scale)		1 month	No
Secondary	Caesar scale	a questionnaire describing ICU end-of-life practices and satisfaction with the patient's care, communication, and symptom management during the dying process.	1 month	No
Secondary	IES-R (Impact of Event Scale, Revised)		6 months	No
Secondary	ICG (Inventory of Complicated grief)		6 months	No
Secondary	HADS (Hospital Anxiety and Depression Scale)		6 months	No