title: Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  As intensive care mortality is high, end of life is a subject of major concern for intensivists. In this context, relatives are particularly vulnerable and prone to post-ICU syndrome, in the form of high levels of anxiety, depression, post-traumatic stress, and complicated grief. Grieving families suffer from a feeling of abandonment and evoke the need to get back in touch with the team to ask questions and remove doubts, but very few actually do. Aiding families during the grieving process is an important aspect of palliative care. A condolence letter represents an opportunity to recognize the pain of the family member and the strong tie that linked the family member to the ICU team, and to offer additional information if necessary. The goal of the study is to measure the impact of the condolence letter on the experience of bereaved families after a death in the ICU. Our hypothesis is that a post-death follow-up in the form of a condolence letter sent by the ICU physician who was in charge of the patient may help to reduce the risks of presenting symptoms of anxiety/depression, post-traumatic stress, and complicated grief.
  
  
  METHODS
  This is a randomized, controlled, multicenter study. Research will compare two groups of bereaved family members: one group that does not receive a condolence letter (control) and one group that receives a condolence letter 15 days after the death (intervention). Each of the 22 participating centers will include 12 relatives. Participating relatives will be followed up by phone with a call at 1 month and one at 6 months to complete questionnaires, permitting evaluation of post-ICU burden. The main outcome is anxiety and depression measured at 1 month. Other outcomes include evaluation of quality of dying and death, post-traumatic stress, and complicated grief.
  
  
  CONCLUSIONS
  This study will allow us to assess if sending a condolence letter can reduce the risks of presenting symptoms of anxiety and depression, complicated grief, and symptoms of post-traumatic stress disorder after the death of a loved one in the ICU.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  Clinicaltrials.gov NCT02325297 (23 December 2014).
authors.affiliation: Saint-Louis hospital, Medical Intensive Care Unit - Famirea group, AP-HP, 1 avenue Claude Vellefaux, 75010, Paris, France. nancy.kentish@aphp.fr.
authors.forename: Nancy
authors.initials: N
authors.lastname: Kentish-Barnes
authors.affiliation: Saint Louis Hospital, Biostatistics department, AP-HP, 1 avenue Claude Vellefaux, 75010, Paris, France. sylvie.chevret@paris7.jussieu.fr.|Biostatistics and Clinical Epidemiology, UMR 1153, INSERM, Paris Diderot Sorbonne University, Paris, France. sylvie.chevret@paris7.jussieu.fr.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.affiliation: Saint-Louis hospital, Medical Intensive Care Unit - Famirea group, AP-HP, 1 avenue Claude Vellefaux, 75010, Paris, France. elie.azoulay@aphp.fr.|Saint Louis Hospital, Biostatistics department, AP-HP, 1 avenue Claude Vellefaux, 75010, Paris, France. elie.azoulay@aphp.fr.|Biostatistics and Clinical Epidemiology, UMR 1153, INSERM, Paris Diderot Sorbonne University, Paris, France. elie.azoulay@aphp.fr.
authors.forename: Elie
authors.initials: E
authors.lastname: Azoulay
mesh_terms: D000223:Adaptation, Psychological; D001007:Anxiety / Q000175:diagnosis / Q000517:prevention & control / Q000523:psychology; D001291:Attitude of Health Personnel; D001293:Attitude to Death; D001601:Bereavement; D002985:Clinical Protocols; D003142:Communication; D015709:Correspondence as Topic; D003863:Depression / Q000175:diagnosis / Q000517:prevention & control / Q000523:psychology; D005190:Family / Q000523:psychology*; D005602:France; D017051:Hospice Care / Q000379:methods*; D017052:Hospital Mortality; D006801:Humans; D007362:Intensive Care Units; D011368:Professional-Family Relations; D012107:Research Design; D013313:Stress Disorders, Post-Traumatic / Q000175:diagnosis / Q000517:prevention & control / Q000523:psychology; D011795:Surveys and Questionnaires; D013997:Time Factors