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Completed

NCT Number: NCT02325297

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint-Louis Hospital

Paris, 75010, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Letter of condolence

Other

Primary outcomes

  1. HADS (Hospital Anxiety and Depression Scale)

    Time frame: 1 month

Secondary outcomes

  1. Caesar scale

    Time frame: 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.

  2. IES-R (Impact of Event Scale, Revised)

    Time frame: 6 months

  3. ICG (Inventory of Complicated grief)

    Time frame: 6 months

  4. HADS (Hospital Anxiety and Depression Scale)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: Famirea 22

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 24, 2014
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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